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Multimodal rheumatologic complex treatment (MRCT) is based on an acute inpatient treatment concept for patients with clinically relevant functional impairments and exacerbation of pain, which are caused by rheumatic and musculoskeletal diseases. Patients with axial spondylarthritis (axSpA) including ankylosing spondylarthritis (AS) often suffer from such health problems. Regular movement exercises and physical therapy measures are an important pillar of treatment management. The ASAS Health Index (ASAS-HI) can be used to document the global functional ability and health of axSpA patients. The selectivity of the ASAS HI for nonpharmacological treatment changes has so far not yet been proven.Evaluation of the MRCT and ASAS HI for nonpharmacological treatment measures of patients with axSpA carried out in the Ruhr Area Rheumatism Center. The primary endpoint was an improvement of the ASDAS≥ 1.1. It was assumed that 25% of the patients would achieve this threshold.Consecutively included patients with active axSpA and relevant functional impairments received inpatient treatment for 14 days during MRCT. On days 1 (V1) and 14 (V2) all patients completed questionnaires on pain (NRS), disease activity (BASDAI, ASDAS) and function (BASFI, ASAS HI). The clinical examination was carried out using BASMI and measurement of C‑reactive protein (CRP) at both times.The 66 prospectively included patients had an average age of 47.2 years (SD 14.2 years), a duration of symptoms of ca. 20 years, 65.3% were male, 75% were positive for HLA B27 and CRP was elevated in 41.3%. The disease activity at V1 was elevated: BASDAI 5.6 (1.8), ASDAS 3.1 (0.9), whereas functional ability and mobility were reduced: BASFI 3.5 (1.8), BASMI 5.6 (2.1), ASAS-HI 8.4 (3.4). During the course the global patient verdict improved (NRS 0-10) from 6.9 (1.7) at V1 to 4.8 (1.8) at V2 and the pain from 6.9 (1.9) to 4.7 (2.0) (all p 0.001). The disease activity also decreased at V2: BASDAI 4.1 (1.9), ASDAS 2.4 (1.0), function and mobility were also improved: BASFI 4.3 (2.4), BASMI 2.7 (1.6), ASAS HI 6.5 (3.8) (all p 0.001).In this study the effectiveness of a 2‑week MRCT according to OPS 8-983.1 with respect to important patient-centered outcomes (PCO) could be proven and the results of previous studies could be confirmed. In this context ASAS-HI was also sensitive to change.HINTERGRUND: Die multimodale rheumatologische Komplexbehandlung (MRKB) beruht auf einem akutstationären Versorgungskonzept zur Behandlung von Patienten mit klinisch relevanten Funktionseinschränkungen und Schmerzexazerbationen, die durch rheumatische und muskuloskeletale Erkrankungen bedingt sind. Patienten mit axialer Spondyloarthritis (axSpA) einschließlich der ankylosierenden Spondylitis (AS) leiden häufig unter solchen Gesundheitsproblemen. Regelmäßige Bewegungsübungen und physikalische Therapiemaßnahmen sind ein wichtiger Pfeiler im Behandlungsmanagement. Mit dem ASAS Health Index (ASAS HI) können die globale Funktionsfähigkeit und Gesundheit von axSpA-Patienten erfasst werden. Die Trennschärfe des ASAS HI für nichtpharmakologische Therapieänderungen ist bisher noch nicht nachgewiesen worden.Evaluation der im Rheumazentrum Ruhrgebiet durchgeführten MRKB und des ASAS HI für nichtpharmakologische Therapiemaßnahmen bei Patienten mit axSpA. Als primärer Endpunkt wurde eine Verbesserung des ASDAS ≥ 1,1 festgelegt. Hierbei wurde angenommen, dass 25 % der Patienten diesen Schwellenwert erreichen.Konsekutiv eingeschlossene Patienten mit aktiver axSpA und relevanten Funktionseinschränkungen wurden im Rahmen einer MRKB 14 Tage stationär behandelt. Alle Patienten beantworteten am ersten (V1) und am 14. Tag (V2) des Aufenthalts Fragebögen zu Schmerzen (NRS), Krankheitsaktivität (BASDAI, ASDAS) und Funktion (BASFI, ASAS HI). Die klinische Untersuchung erfolgte mittels BASMI und eine Messung des C‑reaktiven Proteins (CRP) zu beiden Zeitpunkten.Die prospektiv eingeschlossenen 66 Patienten hatten ein mittleres Alter von 47,2 Jahren (SD 14,2), eine Symptomdauer von ca. 20 Jahren, 65,3 % waren Männer und 75 % HLA B27+, das CRP war bei 41,3 % erhöht. Die Krankheitsaktivität zu V1 war erhöht: BASDAI 5,6 (1,8), ASDAS 3,1 (0,9), während Funktionsfähigkeit und Mobilität vermindert waren: BASFI 3,5 (1,8), BASMI 5,6 (2,1), ASAS HI 8,4 (3,4). Im Verlauf verbesserte sich das globale Patientenurteil (NRS 0–10) von 6,9 (1,7) zu V1 auf 4,8 (1,8) zu V2 und der Schmerz von 6,9 (1,9) auf 4,7 (2,0) (alle p 0,001). Auch die Krankheitsaktivität nahm zu V2 ab: BASDAI 4,1 (1,9), ASDAS 2,4 (1,0), Funktion und Mobilität waren auch verbessert: BASFI 4,3 (2,4), BASMI 2,7 (1,6), ASAS HI 6,5 (3,8) (alle p 0,001).In dieser Studie konnte die Wirksamkeit einer 2‑wöchigen MRKB gemäß OPS 8–983,1 hinsichtlich wichtiger patientenzentrierter Outcomes (PRO) nachgewiesen und frühere Studienergebnisse konnten bestätigt werden. In diesem Rahmen war auch der ASAS-HI veränderungssensitiv.

This review article presents the innovations in the update of the S3 guidelines on axial spondylarthritis. The total of eight new recommendations address the areas of the consideration of differential diagnoses, coordination of comorbidity management, including a vaccination strategy, treatment targets, safety of nonsteroidal anti-inflammatory drugs (NSAID), treatment response to biological disease-modifying antirheumatic drugs (bDMARD) and discontinuation strategies when remission has been achieved. In this article the authors deal particularly with the areas of early diagnosis and referral as well as exercise therapy and drug treatment.Die vorliegende Übersicht stellt die Neuerungen des Updates der S3-Leitlinie zur axialen Spondyloarthritis vor. Die insgesamt 8 neuen Empfehlungen adressieren die Bereiche der Beachtung von Differenzialdiagnosen, Koordination des Komorbiditätenmanagements einschließlich einer Impfstrategie, Therapieziele, der NSAR(nichtsteroidale Antirheumatika)-Sicherheit, Therapieansprechen von b(„biological“)DMARD („disease-modifying antirheumatic drugs“) und Absetzstrategien bei Erreichen einer Remission. Die Autoren gehen in dem Beitrag insbesondere auf die Bereiche Frühdiagnose und Überweisung sowie Bewegungstherapie und medikamentöse Therapie ein.

BackgroundThe efficacy of Upadacitinib (UPA), a selective Janus kinase inhibitor, has been evaluated in the SELECT clinical program 1-6. In addition, recent results from the non-interventional UPwArds study further confirmed UPAs clinical effectiveness regarding standard disease activity scores for rheumatoid arthritis (RA) in a real-world setting 7. However, patient-reported outcomes (PROs) as another cornerstone of clinical decision making yet remain to be addressed in the context of a post-marketing setting. This interim analysis, conducted after 250 patients had completed the 6-month follow-up visit, aims to fill this gap.ObjectivesTo evaluate the change of selected PROs over 6 months in patients treated with UPA in a real-world data environment.MethodsUPwArds is a prospective, open-label, multicenter, non-interventional, post-marketing study including adult patients with moderate-to-severe RA (swollen joint count [SJC28] ≥ 3 and inadequate response or intolerance to at least one previous disease-modifying antirheumatic drug). According to the German label, patients were treated with UPA 15 mg once daily, as monotherapy or in combination with methotrexate. For this analysis, the following PROs were included: 0-10 numerical rating scales (NRS) for pain and fatigue, the Health Assessment Questionnaire Disability Index (HAQ-DI), the duration and severity of morning stiffness, the Patient Health Questionnaire 9 (PHQ-9), and the Rheumatoid Arthritis Impact of Disease Questionnaire (RAID). Changes from baseline were evaluated for follow-up periods of 1 month, 3 months, and 6 months. Results are presented for the total sample using descriptive measures reflecting sample size (N), average values (standard deviation) for each assessment and average change scores (standard deviation) for follow-up visits. All data were analyzed as observed, with no imputation of missing data.Results483 patients (369 female, 114 male) were included in the study, with available baseline PRO information for 481 patients. 6-months follow-up data were yet available from 279 patients The baseline average age and disease duration were 58.0 (12.3) years and 9.0 (8.0) years, respectively, whereas the mean initial DAS28-CRP was 4.6 (1.0). At baseline, 60.8% of enrolled patients had previously been treated with biologic or targeted synthetic disease-modifying antirheumatic drugs. Overall, PRO scores improved from baseline throughout month 6 with a considerable amelioration at month 3, which was maintained at month 6. Responses were rapid, with improvement already evident at month 1 (Table 1). The NRS pain as a crucial PRO in RA confirmed the previously described pattern of results seen for most of the other PROs (Figure 1).Table 1.Baseline scores and average changes from baseline scoresNBaseline scores (SD)NChange from baseline - month 1 (SD)NChange from baseline - month 3 (SD)NChange from baseline - month 6(SD)Pain (NRS)4816.2 (2.2)393-2.2 (2.3)392-2.5 (2.5)258-2.4 (2.4)Fatigue (NRS)4815.5 (2.6)393-1.4 (2.3)393-1.6 (2.4)259-1.5 (2.3)HAQ-DI4711.3 (0.6)380-0.2 (0.3)376-0.2 (0.4)253-0.2 (0.4)Morning stiffness (duration, minutes)43968.9 (63.9)313-25.0 (55.3)296-29.6 (54.9)179-31.6 (51.7)Morning stiffness (severity)4785.2 (2.7)386-1.8 (2.3)393-2.2 (2.6)258-2.2 (2.9)PHQ-94778.7 (5.2)383-1.9 (3.9)381-2.3 (4.0)255-2.2 (3.8)RAID4815.6 (2.0)393-1.7 (1.8)392-2.0 (2.0)258-1.9 (1.9)ConclusionThis interim analysis confirmed a meaningful improvement regarding included PROs that cover various RA-related symptoms, depressiveness and the impact of symptoms of RA on daily life.References[1]Smolen JS, et al. Lancet 2019;393:2303–11[2]Burmester GR, et al. Lancet 2018;391:2503–12[3]Genovese MC, et al. Lancet 2018;391:2513–24[4]van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20[5]Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800[6]Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21[7]Witte T et al. P0833 at ACR, Nov 5–9, 2021AcknowledgementsAbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and in the writing, review, and approval of the abstract. AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study. No honoraria or payments were made for authorship. The medical writing support was provided by Matthias Englbrecht, Freelance Healthcare Data Scientist (Eckental, Germany) and was funded by AbbVie. Statistical analyses were provided by Dr. Daniela Adolf of StatConsult GmbH (Magdeburg, Germany) which was funded by AbbVie.Disclosure of InterestsTorsten Witte Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Chugai, Gilead, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Roche, and UCB, Uta Kiltz Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer, Florian Haas Consultant of: AbbVie, Celgene, Novartis, and Pfizer, Grant/research support from: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, Roche, and Sanofi Genzyme, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, and UCB, Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Ulrich Prothmann Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Glaxo Smith Kline, Novartis, Pfizer, Roche, Sanofi, SOBI, and UCB, Daniela Adolf Shareholder of: Employee of StatConsult and may own stock or options, Employee of: Employee of StatConsult, Carsten Holland Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Alexander Roessler Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Kirsten Famulla Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Konrad Götz Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Klaus Krueger Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Gilead, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, and UCB

BackgroundThe pathophysiology of GCA is not clearly understood, but most research has pointed towards a major role of T cells with proinflammatory Th1 und Th17 cells as dominant drivers of disease. The role of B cells in the pathogenesis of GCA has not been much studied to date.ObjectivesTo study the role of proinflammatory T cell mediators and anti-inflammatory regulatory B cells (Bregs) as their counterpart in patients with GCA compared to healthy controls (HC).MethodsGCA Patients and HC were recruited prospectively and included after informed consent. Peripheral blood mononuclear cells were freshly isolated from whole blood and included into 3 experimental setups, using flow cytometry and fluorescent antibodies: (i) pro-inflammatory T cell mediators (IL-2, GMCSF, IL-17a, IFN-y), (ii) granzyme B production of Bregs after stimulation with different agents (anti-human IgG + IgM, IL-21, anti-CD40L) and (iii) the IL-10 production of Bregs were measured. Disease activity was defined as unequivocal evidence of cranial symptoms of GCA and/or increased concentrations of C-reactive protein and/or halo-sign, leading to a change in therapy according to the treating rheumatologist. Statistical comparisons between groups were performed by the Mann-Whitney-U-Test and Spearman’s rank correlation.ResultsA total of 47 GCA patients (14 with active disease and 33 in remission) and 49 HC were included (Table 1). CD4+ T cells of GCA patients with active disease produced less IFN-y than HC (p=0.016, Figure 1a). There was also a trend towards lower expression of IL-2 (p=0.18), GMCSF (p=0.1) and IL-17a (p=0.18) by CD4+ T cells from GCA patients compared to HC. Bregs of GCA patients produced lower amounts of granzyme B after stimulation with anti-human IgG and IgM compared to HC, and this was similar in active patients (p=0.04, Figure 1b) and in quiescent patients (p=0.021, Figure 1b). With other stimuli, including IL-21 and anti-CD40L, there was also a trend towards a lower expression. The IL-10 production of Bregs did not show substantial differences between groups. Importantly, the dose of glucocorticoids did not influence cytokine production of T-cells or B-cells.Table 1.DemographicsVariablesGCA Patients (n=47)Healthy Controls (n=49)Age, years71 (54-83)65 (45-86)Sex, n (%)31 female (65.9)40 female (81.6)Disease activity14 active diseaseNA(9 first diagnosis, 5 relapse)33 in remissionTherapyPrednisolone: n= 29noneMethotrexat: n=23Tocilizumab: n=13Dosage of prednisoloneNone: n=181-7,5 mg/d: n=15> 7,5 mg/d: n=14Figure 1.1a: Interferon gamma expression of CD4+ T-Cells / 1b: Granzyme B expression of Breg after anti-human IgG + IgM stimulationConclusionThe in vitro cytokine production of proinflammatory CD4+ T cells and anti-inflammatory Bregs after stimulation, especially regarding granzyme B production, showed some differences between patients and HC. A lower granzyme B production was found in patients with active disease indicating a lack of Breg–mediated suppressive capacity towards pro-inflammatory T cells. This finding may play a role in the pathogenesis of GCA.References-Disclosure of InterestsMarian Stöcker: None declared, Uta Kiltz Speakers bureau: Abbvie, Fresenius, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer, Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer, UCB, Paid instructor for: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer, UCB, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer, UCB, Grant/research support from: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer, UCB, Benjamin Wilde Consultant of: Alexion, Chiesi, Hexal, Otsuka, Pfizer, TEVA, Sanofi, Wyeth

BackgroundPatients (pts.) with chronic inflammatory rheumatic diseases (CIRD) are often not adequately protected against infectious diseases. As shown in an earlier study, less than 50% of CIRD pts. were vaccinated against pneumococci and influenza before the SARS-CoV2 pandemic started 1. High vaccination rates are critical to achieve herd immunity. Knowledge on barriers and facilitators of vaccine uptake in CIRD pts. is limited.ObjectivesThe aim of this study was to characterize barriers and facilitators towards vaccines in general and specifically against pneumococci, influenza and SARS-CoV-2 in adult CIRD pts.MethodsIn early 2021, consecutive CIRD pts. completed a structured questionnaire including knowledge on vaccination, attitudes, and perceived barriers and facilitators towards vaccination. A total of 12 facilitators and 11 barriers towards vaccination was assessed in general, and specifically for vaccination against pneumococci, influenza and SARS-CoV2. The Likert scales had 4 response options, ranging from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination history and attitudes towards vaccination against SARS-CoV-2 were assessed.ResultsOf 514 prospectively recruited pts., 441 responded (85.8%) to the questionnaire (table 1). Self-reported vaccine uptake was 48.8% against pneumococci and 66.2% against seasonal influenza. The majority (82.2%) was willing to be vaccinated against SARS-CoV-2. The majority (≥70%) had decent knowledge about vaccination, and only Table 1.Patient and disease characteristicsAge, y54.1 (12.6)Women, No. (%)272 (61.7)Rheumatoid Arthritis, No. (%)156 (35.4)Axial Spondyloarthritis, No. (%)120 (27.2)Psoriatic Arthritis, No. (%)61 (13.8)Other diagnoses, No. (%)104 (23.6))Treatment, csDMARD, No. (%)121 (27.4)Treatment, bDMARD, No. (%)280 (63.5)Treatment, tsDMARD, No. (%)24 (5.4)CDAI, n=19411.1 (9.0)CRP, mg/L, n=4400.4 (0.7)HAQ score, n=3171.1 (0.7)BASDAI, n=1183.8 (2.2)BASFI, n=1183.8 (2.3)Patient global, NRS 0-104.1 (2.5)HADS-A, n=4366.6 (4.0)HADS-D, n=4365.8 (4.3)variables as mean (SD)Figure 1.Facilitators of vaccine uptake in general and for SARS-CoV-2ConclusionA relatively high number of pts. was vaccinated against pneumococci and influenza, – a probable campaign success during the last years. In addition, more than 80% of pts. were willing to be vaccinated against SARS-CoV2. Facilitators were of greater significance than barriers in this scenario. The high number of societal and organizational facilitators enables the implementation of effective strategies to increase future vaccination rates.References[1]Kiltz et al. RMD Open 2021Disclosure of InterestsIoana Andreica Speakers bureau: UCB, MSD, Novartis, Abbvie, Lilly, Janssen, Sobi, Consultant of: Novartis, Lilly, Sobi, Galapagos, Amgen, Takeda, Grant/research support from: Lilly, Iulia Roman: None declared, Xenofon Baraliakos Speakers bureau: Abbvie, Lilly, Pfizer, UCB, MSD, Novartis, Galapagos, Hexal, Paid instructor for: Abbvie, Lilly, Pfizer, UCB, MSD, Novartis, Galapagos, Hexal, Consultant of: Abbvie, Lilly, Pfizer, UCB, MSD, Novartis, Galapagos, Hexal, Grant/research support from: Abbvie, MSD; Novartis, Lilly, Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, FResenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Pfizer, UCB, Novartis, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, FResenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Pfizer, UCB, Novartis, Grant/research support from: Abbvie, Amgen, Biogen, Fresenius, Hexal, Janssen, Lilly, MSD, Pfizer, UCB, Novartis, Uta Kiltz Consultant of: AbbVie, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche and UCB, Grant/research support from: Abbvie, Amgen, Hexal, Fresenius, Novartis und Pfizer.

BackgroundSERENA is an ongoing, longitudinal, observational study of more than 2900 patients (pts) with moderate to severe psoriasis, active psoriatic arthritis (PsA), and ankylosing spondylitis (AS) conducted at 438 sites across Europe with an expected duration of up to 5 years.1,2ObjectivesWe report long-term results (at least 3 years follow up) on secukinumab (SEC) retention, effectiveness and safety in pts with active PsA or AS from the SERENA study.MethodsThis analysis includes data of 524 PsA and 473 AS pts enrolled in the study and followed up for at least 3 years. Pts (aged ≥18 years) with active PsA or AS were required to have received at least 16 weeks of SEC treatment before enrolment in the study. Retention rate was defined as the percentage of pts who have not discontinued SEC treatment. Effectiveness assessments included swollen and tender joint counts (SJC and TJC) in pts with PsA, and BASDAI score in pts with AS. Safety assessments included the number of pts with any adverse events (AEs) and serious AEs, treatment-emergent AEs, AEs of special interest and their incidence rates.ResultsThe mean (SD) treatment duration prior to enrolment in the study for PsA and AS pts was 1.0 (0.5) years and 0.9 (0.5) years, while time since diagnosis was 8.7 (7.4) and 9.8 (9.5) years, respectively. Prior to SEC initiation, 67.4% of pts with PsA and 63.0% of pts with AS received a biologic therapy, with lack of efficacy reported as major reason for discontinuation (PsA: 89.5%; AS: 87.6%). SEC retention rates after at least 3 years since enrolment in the study were 67.3% for pts with PsA and 72.1% for pts with AS. Survival probabilities for individual indications are presented in Figure 1. Over 3 years of observation, SEC showed sustained effectiveness in pts with PsA [SJC, mean (SD): baseline, 3.2 (5.6); Year 3, 1.7 (2.7) and TJC: baseline, 6.4 (9.4); Year 3, 4.9 (6.4)] and AS [BASDAI, mean (SD): baseline, 3.2 (2.3); Year 3, 2.7 (2.2)]. No new or unexpected safety signals were reported; 11.0% of pts with PsA (N=574) and 12.9% of pts with AS (N=505) reported serious AEs (Table 1).Table 1.Overall safety profile within the study period (Safety set)Variable, n (%) unless otherwise specifiedPsA (N=574)AS (N=505)Pts with AE (≥1)327 (57.0)291 (57.6)Pts with SAE (≥1)63 (11.0)65 (12.9)AE leading to death3 (0.5)3 (0.6)AE leading to discontinuation119 (20.7)81 (16.0)Treatment emergent AE leading to discontinuation (in >1% pts in any group)n (%)IRn (%)IRGeneral disorders and administration site conditions74 (12.9)4.9050 (9.9)3.75Skin and subcutaneous tissue disorders13 (2.3)0.863 (0.6)0.22Musculoskeletal and connective tissue disorders26 (4.5)1.729 (1.8)0.67Infections and infestations2 (0.3)0.137 (1.4)0.52Gastrointestinal disorders2 (0.3)0.133 (0.6)0.22Neoplasms benign, malignant and unspecified (incl cysts and polyps)4 (0.7)0.263 (0.6)0.22Injury, poisoning and procedural complications002 (0.4)0.15Treatment emergent AE of special interest (PT)n (%)IRn (%)IRCandida infections2 (0.3)0.134 (0.8)0.30Malignancy8 (1.4)0.535 (1.0)0.37MACE3 (0.5)0.204 (0.8)0.30Injection site reaction002 (0.4)0.15Inflammatory bowel disease1 (0.2)0.072 (0.4)0.15Safety set consisted of pts who received at least one dose of SEC treatment after signing the informed consentAE, adverse event; AS, ankylosing spondylitis; IR, incidence rate; MACE, major adverse cardiac events; N, total number of pts; n, number of pts; PsA, psoriatic arthritis; pts, patients; PT, preferred term; SAE, serious adverse event; SEC, secukinumabConclusionAfter more than 3 years of observation in the SERENA study, SEC showed sustained retention rates, indicating high persistence in a real-world setting. Responses across effectiveness assessments in both PsA and AS cohorts were maintained or improved during the 3 years of follow up in the study. SEC showed a favourable safety profile, consistent with previous reports.References[1]Kiltz, U et al. Adv Ther 2020;37:2865–83[2]Kiltz, U et al. Ann Rheum Dis 2021;80:337–38Disclosure of InterestsUta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Petros Sfikakis Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli-Lilly, Janssen, Novartis and Pfizer, Nicola Gullick Speakers bureau: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, Consultant of: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, Grant/research support from: AbbVie, Astra Zeneca, Celgene, Eli Lilly, Izana, Janssen, Novartis, UCB, PELAGIA KATSIMPRI Speakers bureau: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Consultant of: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Grant/research support from: AbbVie, UCB, Genesis Pharma, Janssen, Novartis and Pfizer, Anastassios Kotrotsios: None declared, Jan Brandt-Juergens Speakers bureau: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Consultant of: AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Lilly, MSD, UCB, BMS, Janssen, and Medac, Eric Lespessailles Speakers bureau: Amgen, Expanscience, Lilly and MSD, and research grants from Abbvie, Amgen, Lilly, MSD and UCB, Consultant of: Amgen, Expanscience, Lilly and MSD, and research grants from Abbvie, Amgen, Lilly, MSD and UCB, Nicola Maiden Consultant of: Eli-Lilly and UCB, Karl Gaffney Speakers bureau: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Consultant of: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Grant/research support from: AbbVie, Celgene, Lilly, Pfizer, Gilead, MSD, Novartis and UCB, Daniel Peterlik Employee of: Novartis, Barbara Schulz Employee of: Novartis, Effie Pournara Shareholder of: Novartis, Employee of: Novartis, Piotr Jagiello Employee of: Novartis

BackgroundCurrent knowledge on the health status of patients (pts.) with axial spondyloarthritis (axSpA) mainly focusses on physical function and disease activity. Using a generic measure for physical- or mental health (SF36), a hierarchical relationship between disease activity, spinal damage, spinal mobility, physical function and overall health has been demonstrated in pts. with radiographic axSpA (r-axSpA) 1. Disease-specific global functioning and health can be assessed in pts. with axSpA using the ASAS Health Index (ASAS HI), which encompasses physical function, as well as aspects of emotional and social functioning and aspects of activity and participation.ObjectivesTo build a structural model that visualizes interrelationships of different patient- and disease characteristics with global functioning and health in pts. with early axSpA.MethodsData of pts. with axSpA from the DESIR cohort was analyzed, which included information on socio-demographics (age, BMI), disease activity (ASDAS), physical function (BASFI), spinal mobility (BASMI), structural damage (mSASSS), disease-specific global functioning (ASAS HI), and comorbidity count. Information on patient- and disease characteristics was retrieved from the visit performed 72 months after inclusion, which was the first time point of ASAS HI collection. A Bayesian network (BN) was used to obtain insight of the underlying structural model. BNs are probabilistic graphical models consisting of “nodes” (representing specific variables) joined by “edges” (lines representing directions of effects). They are capable of capturing complex relationships between variables and allow the incorporation of existing (prior) knowledge from previous studies.ResultsThe DESIR cohort contained data from 582 pts. at month 72, of whom 398 had data for ASAS HI. Descriptive information of these pts. is shown in Table 1. The mean ASAS HI was 5.7 (range: 0 - 16). Applying existing cut-offs for ASAS HI, 51% had ‘good’ global functioning (ASAS HI ≥5), 40% had ‘moderate’ global functioning (5< ASAS HI Table 1.Patient and disease characteristics at month 72N = 398Gender (male), N (%)181 (45%)Age (years)40.7 (8.7)Symptom duration (years)7.5 (0.9)BMI (kg/m2)25.0 (4.6)ASDAS2.0 (1.0)BASFI (0–10)2.3 (2.1)BASMI (0–10)2.5 (1.0)mSASSS (0-72)1.0 (3.6)ASAS HI (0-17)5.7 (3.9)good global functioning: ASAS HI ≤5, N (%)201 (51%)moderate global functioning: 5< ASAS HI 160 (40%)bad global functioning: ASAS HI ≥12, N (%)37 (9%)Comorbidity count1.4 (0.7)Figure 1.Structural model on interrelationships of different patient- and disease characteristics with global functioning and health (ASAS HI) in patients with early axSpAConclusionThe BN-analysis approach, that combines prior knowledge and measured data, serves to better understand the construct of global functioning and health in pts. with early axSpA. Our model shows that global functioning (ASAS-HI) is determined both by patient-reported physical function (BASFI) and by disease activity (ASDAS), which confirms the hierarchical model once proposed by Machado et al. The observed directional relationship between ASAS HI and comorbidity count is counterintuitive and requires further investigation.References[1]Machado P, ARD 2011.Disclosure of InterestsImke Redeker: None declared, Robert B.M. Landewé Speakers bureau: AbbVie, BMS, GSK Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, BMS, GSK Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, UCB, Désirée van der Heijde Speakers bureau: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Sofia Ramiro Speakers bureau: Eli Lilly, MSD, Novartis, UCB, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, UCB, Sanofi, Grant/research support from: AbbVie, Galapagos, Novartis, Pfizer, UCB, Annelies Boonen Speakers bureau: Abbvie / Galapagos, Consultant of: Galapagos, Grant/research support from: Abbvie, Maxime Dougados: None declared, Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Grant/research support from: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Uta Kiltz Speakers bureau: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Biogen, Fresenius, Amgen, Hexal, Novartis, Pfizer

BackgroundThe prevalence of depression is increased in spondyloarthritis (SpA). Research on this topic in SpA is challenging for several reasons, one of them being the wide variety of different instruments used to assess depressive symptoms. It is unknown whether these instruments are comparable in measuring the construct ‘depression’ and can be considered interchangeable. If these instruments actually differ in what they measure, this should be taken into account when designing and interpreting studies, and in clinical practice when monitoring patients with SpA.ObjectivesTo compare the constructs of several instruments used to assess depressive symptoms in patients with SpA.MethodsData from the international ASAS Health Index Validation Study were used. Included patients had a diagnosis of SpA and fulfilled the ASAS classification criteria for axial/peripheral SpA. Data on demographics and disease characteristics were collected. The following instruments that have been used to assess depressive symptoms in SpA were available: the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D), the Short Form 36 (SF-36) and item 5 of the 5-level EuroQoL 5D (EQ-5Di5). The HADS-D ranges 0-21 (best-worst), with scores ≥8 and ≥11 indicating possible (HADS-possible) and probable depression (HADS-probable), respectively. The SF-36 was summarized using all 36 items in a Mental Component Summary (SF-36MCS, score ≤40 indicating depression), or using only 5 items in the Mental Health subscale (SF-36MH, score ≤56 indicating depression). For the EQ-5Di5, a score of at least “moderately” (level ≥3 on 1-5 scale) or “severely” depressed (level ≥4) indicated depression. Spearman correlations between instrument scores, agreement (kappa) between depressed states, and test characteristics (sensitivity [SE], specificity [SP], positive and negative predictive value [PPV, NPV]) were calculated with HADS-D as external standard, as it was specifically designed to detect depression and considered to have highest content validity.ResultsIn total, 1548 patients were included, of which 1281 (83%) had axial SpA, mean age was 41.6 (SD 13.5) years, 1005 were male (65%), mean symptom duration 14.5 (11.4) years, mean ASDAS 2.6 (1.2) and BASDAI 4.1 (2.5). The prevalence of depression varied around 1 in 3 patients for the lower thresholds of depression (32% for HADS-possible, 45% for SF-36MH, 33% for SF-36MCS and 24% for EQ-5Di5-moderately) and was lower for the more stringent thresholds of HADS-probable (15%) and EQ-5Di5-severely (6%); 192 patients (24% of those who scored positive for depression on ≥1 instrument) scored positive on all instruments (Figure 1). Correlations between instruments were moderate (rho = 0.59-0.66), except between SF-36MH and MCS (rho = 0.85). Agreement between instruments was moderate for lower thresholds for depression (pairwise kappa = 0.47-0.58 for HADS-possible, SF-36MCS, SF-36MH, EQ-5Di5-moderately) and substantial for higher thresholds (pairwise kappa = 0.75 for HADS-probable/EQ-5Di5-severely). Using HADS-D as external standard, EQ-5Di5 was very specific but less sensitive, while SF-36MCS/MH were more sensitive but less specific (Table 1).Table 1.Test characteristics of instrumentsExternal standard: HADS-D≥8 (possible)Definition of ‘depression’SESPPPVNPVEQ-5Di5 ≥3 (moderate)51896980EQ-5Di5 ≥4 (severe)17998572SF-36MCS ≤4068836685SF-36MH ≤5678715687External standard: HADS-D≥11 (probable)Definition of ‘depression’SESPPPVNPVEQ-5Di5 ≥3 (moderate)67844194EQ-5Di5 ≥4 (severe)30986889SF-36MCS ≤4083753796SF-36MH ≤5688632997All values are percentages.ConclusionInstruments used to assess depression in SpA are not interchangeable. The choice of instrument should be taken into account when interpreting studies on depression in SpA. SF-36MCS and SF-36MH are sensitive and could be considered for screening while EQ-5Di5 is useful when high specificity is required. In situations where assessment of depression is the primary objective, depression-oriented instruments such as the HADS are recommended.Disclosure of InterestsCasper Webers: None declared, Uta Kiltz: None declared, Juergen Braun: None declared, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Employee of: Director of Imaging Rheumatology bv., Annelies Boonen Speakers bureau: Abbvie, Galapagos, Consultant of: Galapagos, Grant/research support from: Abbvie

BackgroundIn both, ankylosing spondylitis (AS) and psoriatic arthritis (PsA), women typically have a longer delay in diagnosis.1,2 There is scientific evidence that prognosis for AS and PsA improves when diagnosed early. The German non-interventional study AQUILA provides real-world data on the influence of time to diagnosis and gender on treatment outcomes under secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics of AS and PsA patients (pts) and to evaluate the impact of time to diagnosis and gender on secukinumab treatment outcomes, such as disease activity and global functioning and health.MethodsAQUILA is an ongoing, multi-center, non-interventional study including up to 3000 pts with AS or PsA. Pts were observed from BL up to week (w) 52 according to clinical routine. Real-world data were assessed prospectively and analyzed as observed. Validated questionnaires were used to collect data on disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), global functioning and health (Assessment of SpondyloArthritis-Health Index, ASAS-HI) in AS, and skin and joint-related disease activity (Psoriasis Area and Severity Index, PASI; tender/swollen joint counts, TJC/SJC) and impact of disease (Psoriatic Arthritis Impact of Disease - 12 items, PsAID-12 score) in PsA pts. This interim analysis focused on the subgroups of male and female AS and PsA pts stratified by time to diagnosis after disease onset (˂1 year [y] and ≥1y for early and late diagnosis, respectively).ResultsAt BL, 609 AS and 1145 PsA pts were included with information on time to diagnosis (Table 1); only 18.7% of AS and 25.8% of PsA pts were diagnosed within one year. Of interest, both female AS and PsA pts as well as male PsA pts with increased BMI tended to be diagnosed later (Table 1). Regarding BASDAI scores, male AS pts diagnosed late had increased disease activity at BL and throughout the study (Figure 1A); female AS pts diagnosed late showed reduced total treatment effect with increasing time to diagnosis (Figure 1B). Similarly, both male and female AS pts diagnosed late had slightly increased ASAS-HI at BL and throughout the study (Table 1). For PsA pts, there was no difference in skin- (PASI, Figure 1C/D) and joint-related (Figure 1E/F) disease activity with respect to time to diagnosis. Furthermore, there was no difference in PsAID scores (data not shown) between early- and late-diagnosed PsA pts.Table 1.Overview of selected BL characteristics in AS and PsA pts stratified by time to diagnosisAS (N=609)Time to diagnosis ˂1 year (n=114)Time to diagnosis ≥1 year (n=495)Male (n=63)Female (n=51)Male (n=301)Female (n=194)Age, years43.146.345.947.7BMI27.725.927.327.8BASDAI4.75.05.35.2ASAS-HI6.78.07.48.2PsA (N=1145)Time to diagnosis ˂1 year (n=295)Time to diagnosis ≥1 year (n=850)Male (n=126)Female (n=169)Male (n=363)Female (n=487)Age, years50.151.852.353.1BMI28.729.429.328.8PASI6.56.27.07.2PsAID4.65.24.85.3TJC/SJC5.9/3.37.3/3.27.0/3.77.3/3.8All variables given as meanFigure 1.Disease activity in early- and late-diagnosed AS and PsA ptsConclusionIn a real-world setting, secukinumab improved disease activity and global functioning in both AS and PsA pts. Both, male and female AS pts had a higher treatment response when diagnosed early. Interestingly, delay in diagnosis appeared to be BMI-dependent in female AS pts and PsA pts of both genders. However, in contrast to AS, treatment response of early- and late-diagnosed PsA pts did not differ in the further course.References[1]Rusman, T., van Bentum, R.E. & van der Horst-Bruinsma, I.E. Rheumatology59, iv38-iv46 (2020). 2. Passia, E., et al. OP0057. Annals of the Rheumatic Diseases79, 38-39 (2020).Disclosure of InterestsKarolina Benesova Speakers bureau: Abbvie, BMS, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Roche, Viatris, Consultant of: Gilead/Galapagos, Novartis, Grant/research support from: Abbvie, Novartis, Oliver Hansen Grant/research support from: Novartis, Uta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, UCB, Grant/research support from: AbbVie, Chugai, Novartis, UCB, Pfizer, Daniel Peterlik Employee of: Novartis, Christina Budden Employee of: Novartis, Annika Boas Employee of: Novartis, Stefanie Welle Employee of: Novartis, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

Despite a qualitatively and structurally good care of patients with rheumatoid arthritis (RA) in Germany, there are still potentially amendable deficits in the quality of care. For this reason, the German Society for Rheumatology (DGRh) has therefore decided to ask a group of experts including various stakeholders to develop quality standards (QS) for the care of patients with RA in order to improve the quality of care. The QS are used to determine and quantitatively measure the quality of care, subject to relevance and feasibility. The recently published NICE and ASAS standards and a systematic literature search were used as the basis for development. A total of 8 QS, now published for the first time, were approved with the intention to measure and further optimize the quality of care for patients with RA in Germany.Trotz einer qualitativ und strukturell guten Versorgung von Patient*innen mit rheumatoider Arthritis (RA) in Deutschland bestehen weiterhin potenziell behebbare Defizite in der Qualität der Versorgung. Aus diesem Grund hat die Deutsche Gesellschaft für Rheumatologie (DGRh) eine Expert*innengruppe, in der verschiedene Interessengruppen vertreten waren, beauftragt, nationale Qualitätsstandards (QS) mit dem Ziel zu entwickeln, die rheumatologische Versorgung von Patient*innen mit RA in Deutschland qualitativ zu verbessern. QS dienen der Festlegung und quantitativen Messung guter Versorgungsqualität unter dem Vorbehalt von Relevanz und Realisierbarkeit. Als Grundlage für die Entwicklung dienten die kürzlich publizierten Standards von NICE und ASAS und eine systematische Literatursuche. Insgesamt wurden 8 hiermit erstmals veröffentlichte QS konsentiert, die als Grundlage dienen können, die Versorgungsqualität von Patient*innen mit RA in Deutschland zu messen und weiter zu optimieren.

The Apple and Google app stores offer a wide range of health apps. It is still a challenge to find valuable and qualified apps.Can German language apps be identified using the "semiautomated retrospective app store analysis" (SARASA) method for the field of rheumatology?The SARASA is a semiautomated method to select and characterize apps listed in the app store. After the first application in February 2018 SARASA was applied again to the Apple app store in February 2020.In February 2018 it was possible to acquire metadata for 103,046 apps and in February 2020 data for 94,735 apps that were listed in the category "health and fitness" or "medicine" in Apple's app store frontend for Germany. After applying the search terms 59 apps with a German language app description were identified for the field of rheumatology in 2018 and 53 apps in 2020. For these, more detailed manual reviews seem worthwhile. In 2018, the apps found were more likely to address patients than physicians and this was more balanced in 2020. In addition, it became apparent that for certain diseases there was no app developer activity. The percentage breakdown of matches by search term revealed substantial fluctuations in the app market when comparing 2018 to 2020.The SARASA method provides a useful tool to identify apps from app stores that meet predefined, formal criteria. Subsequent manual checks of the quality of the contents are still necessary. Further development of the SARASA method and consensus and standardization of quality criteria are worthwhile. Quality criteria should be considered for offers of mobile health apps in app stores.HINTERGRUND: Die App Stores von Apple und Google bieten eine Vielzahl von Gesundheits-Apps an. Das Auffinden qualitativ hochwertiger Apps ist immer noch eine Herausforderung.Lassen sich unter Anwendung der SARASA(„semiautomated retrospective App Store analysis“)-Methode für das Fachgebiet Rheumatologie deutschsprachige Apps identifizieren?SARASA ist eine Methode zur teilautomatisierten Auswahl und Charakterisierung von App Store-gelisteten Apps nach formalen Kriterien. Nach der ersten Anwendung in 02/2018 wurde SARASA 02/2020 erneut auf den Apple App Store angewendet.In 02/2018 konnten für Apps in den Store-Kategorien „Medizin“ oder „Gesundheit und Fitness“ Metadaten zu 103.046 Apps und bei einer erneuten Erhebung in 02/2020 Daten zu 94.735 Apps über das deutsche Frontend des Apple App Stores ausgelesen werden. Im Jahr 2018 wurden nach Anwendung der Suchbegriffe 59 Apps mit einer deutschsprachigen Beschreibung für das Fachgebiet Rheumatologie identifiziert, 2020 waren dies 53 Apps, die jeweils manuell weiter überprüft wurden; 2018 waren noch mehr der gefundenen Apps für Patienten als für Ärzte vorgesehen, dies war 2020 ausgeglichener. Zudem zeigte sich, dass bei bestimmten Krankheitsbildern von den App-Entwicklern keine Bearbeitungen erfolgten. Die prozentuale Verteilung von Treffern nach Suchbegriffen zeigte im Vergleich von 2018 zu 2020 große Schwankungen.Die SARASA-Methode stellt ein hilfreiches Werkzeug dar, um Gesundheits-Apps teilautomatisiert zu identifizieren, die vordefinierten, formalen Kriterien entsprechen. Die inhaltliche Qualität muss anschließend manuell überprüft werden. Weiterentwicklungen der SARASA-Methode und die weitere Konsentierung und Standardisierung von Qualitätskriterien sind sinnvoll. Qualitätskriterien sollten beim Angebot von Gesundheits-Apps in den App-Stores berücksichtigt werden.

Physical activity and exercise are beneficial for people with rheumatic diseases; however, recommendations for the management of rheumatoid arthritis (RA), spondyloarthritis (SpA) and hip- and knee osteoarthritis (HOA/KOA) are usually unspecific with respect to mode and dose of exercise. This is why the 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis were formulated. The recommendations consist of 4 overarching principles and 10 recommendations. These were also published as a lay version in the English language.Translation of the lay version into German and its linguistic validation in Austria, Germany and Switzerland.A professional translation was reviewed by the authors, including people with, RA, SpA, HOA/KOA from the three German-speaking countries, which provided a prefinal lay version. Subsequently, eight interviews with people with RA, SpA, HOA/KOA were conducted in each country to evaluate understandability, wording, completeness and feasibility of the prefinal lay version. Finally, the authors, i.e. those with RA, SpA, and osteoarthritis, anonymously rated their agreement to the final lay version on a 0-10 scale.The professional translation was substantially revised by the authors and based on the interviews. Formulations were adapted to increase readability and understandability and specify statements. Comments that would have changed content or structure were not considered. Average agreement with the particular recommendations was between 10 (SD 0) and 7.6 (SD 1.67).For people with RA/SpA/HOA/KOA the EULAR physical activity recommendations should be available in their mother language. The final German lay version is valid and accepted across all three German-speaking countries. Thus, the physical activity recommendations can be provided to people with rheumatic diseases in an understandable and feasible way.HINTERGRUND: Körperliche Aktivität und spezifisches Training haben großen gesundheitlichen Nutzen. Empfehlungen zum Management von rheumatoider Arthritis (RA), Spondyloarthritis (SpA) sowie Hüft- und Kniegelenkarthose (HKA) sind bisher in Bezug auf Art und Dosierung aber unspezifisch. Darum wurden die 2018 EULAR Empfehlungen zu körperlicher Aktivität für Menschen mit entzündlich-rheumatischen und degenerativen Erkrankungen formuliert. Sie bestehen aus 4 übergeordneten Prinzipien und 10 Empfehlungen. Die EULAR Bewegungsempfehlungen wurden auch als laienverständliche Version in englischer Sprache publiziert. ZIEL: Übersetzung der laienverständlichen Version ins Deutsche und sprachliche Validierung in Deutschland, Österreich und der Schweiz.Eine professionelle Übersetzung ins Deutsche wurde von den Autor*innen einschließlich Personen mit RA, SpA und HKA zu einer präfinalen Version bearbeitet. Anschließend wurden in den 3 Ländern je 8 Interviews mit Personen mit RA, SpA und HKA durchgeführt, um die Verständlichkeit, Wortwahl, Vollständigkeit und Umsetzbarkeit zu prüfen. Die Patientenvertreter*innen der Autor*innengruppe bewerteten anonym ihre Zustimmung zur finalen Version auf einer Skala von 0 bis 10.Die professionelle Übersetzung wurde von den Autor*innen und auf Grundlage der Interviews substanziell überarbeitet. Dabei wurden Formulierungen angepasst, um Lesbarkeit und Verständlichkeit zu verbessern und Aussagen zu präzisieren. Inhalt und Struktur des Originaltextes wurden dabei nicht verändert. Die Zustimmung zu den einzelnen Empfehlungen lag zwischen 10 (SD 0) und 7,6 (SD 1,67).Für Menschen mit RA/SpA/HKA sollten die EULAR Bewegungsempfehlungen in deren Muttersprache vorliegen. Die laienverständliche deutsche Version ist valide und wurde in allen 3 Ländern gut akzeptiert. Damit können die EULAR Bewegungsempfehlungen verständlich und praktikabel vermittelt werden.

To assess the effectiveness of secukinumab in patients with axSpA treated in routine clinical settings in 5 European countries.Retrospective analysis of a cross-sectional survey to assess real-world effectiveness of secukinumab in the management of axSpA and rheumatologist satisfaction with treatment in France, Germany, Italy, Spain and the UK from March to December 2018. Outcomes collected included patient demographics, clinical characteristics and rheumatologist- and patient-reported satisfaction with secukinumab treatment.Five hundred thirty-five patients receiving secukinumab for more than 4 months were assessed, 359 of whom were diagnosed with AS and 178 with nr-axSpA. Rheumatologist assessment of disease status at treatment initiation indicated that 39 (7.3%) had stable/improving disease. Secukinumab treatment for 4 months or longer resulted in 515 (95.9%) patients judged as stable/improving. Treatment was associated with benefits from initiation to assessment in terms of BASDAI (6.2 vs 2.8), 44-joint count score (9.7 vs 6.6), rheumatologist global VAS score (56.9 vs 23.0) and patient global VAS scores (64.4 vs 25.5). These benefits for key clinical outcomes were sustained for periods of 12 months or longer. Patient-reported outcomes on health status using EQ-5D, global functioning using the ASAS health index and overall work impairment via WPAI were sustained over the treatment period, while patient and rheumatologist satisfaction with secukinumab treatment remained very high at 80.2 and 91.2%, respectively.Consistent benefits across multiple clinical and patient-reported outcomes were seen with secukinumab treatment in patients with AS and nr-axSpA treated in routine clinical settings across five European countries. Key Points • In routine clinical settings across five European countries, secukinumab treatment resulted in improvements in a wide range of clinical outcomes including physician-reported disease severity, disease status, pain, BASDAI, 44-joint count score and global VAS scores. • Key clinical and patient reported outcomes were sustained for a 12-month period or longer with secukinumab treatment. • Rheumatologist- and patient-reported treatment satisfaction was high with secukinumab.

Quality standards (QS) are measurable constructs designed to quantify gaps in care and subsequently to improve quality of care. The Assessment of SpondyloArthritis International Society (ASAS) recently generated and published international QS for the management of patients with axial spondyloarthritis (axSpA) for the first time. The German Society of Rheumatology (DGRh) then decided to translate, review and possibly adopt these standards by a group of experts from different care settings. Against this background, national QS for the management of patients with axSpA for Germany were developed for the first time. The main focus was on feasibility and practical relevance. Ultimately, nine QS were defined with which the quality of care in Germany can and should be measured and improved.Qualitätsstandards (QS) sind messbare Konstrukte, die helfen sollen, Versorgungslücken quantitativ zu erfassen, um langfristig die Versorgungsqualität zu verbessern. Die Assessment of SpondyloArthritis International Society (ASAS) hat kürzlich erstmals internationale QS für das Management von Patient*innen mit axialer Spondyloarthritis (axSpA) konsentiert und veröffentlicht. Die Deutsche Gesellschaft für Rheumatologie (DGRh) hat daraufhin beschlossen, diese Standards durch eine Gruppe von Expert*innen aus unterschiedlichen Versorgungsbereichen zu übersetzen, zu prüfen und ggf. zu übernehmen. Vor diesem Hintergrund wurden erstmals nationale QS für das Management von Patient*innen mit axSpA für Deutschland entwickelt. Hierbei wurde v. a. auf Machbarkeit und Praxisrelevanz geachtet. Letztlich wurden 9 QS definiert, mit denen die Qualität der Versorgung in Deutschland gemessen und verbessert werden kann bzw. soll.

BackgroundThere is some evidence that NSAIDs, in particular celecoxib (CEL), might possess not only symptomatic efficacy but also disease-modifying properties in radiographic axial spondyloarthritis (r-axSpA) formerly known as ankylosing spondylitis, retarding progression of structural damage in the spine if taken continuously. For biological disease-modifying antirheumatic drugs (bDMARDs), retardation of structural damage progression has also been demonstrated, but at least 4 years of treatment seem to be necessary (at least for tumour necrosis factor inhibitors – TNFi) to see such an effect. Therefore, a combination of an NSAID with a TNFi might bring additional benefits in terms of retardation of structural damage progression especially in high-risk patients.ObjectivesThe aim of this RCT was to evaluate the impact of treatment with the COX-II-selective NSAID (CEL) when added to a TNFi (golimumab - GOL) compared with TNFi (GOL) alone on progression of structural damage in the spine over 2 years in patients with r-axSpA.MethodsEligible patients had r-axSpA and high disease activity (BASDAI ≥4), NSAID failure and risk factors for radiographic spinal progression: C-reactive protein >5 mg/l and/or ≥1 syndesmophyte(s). The trial consisted of two phases: a 12-week run-in phase, in which all included patients received treatment with GOL 50 mg every 4 weeks sc, followed by a 96-week controlled treatment period, in which patients who achieved a BASDAI improvement of ≥2 points were randomly assigned to GOL + CEL 200 mg bid or GOL alone arms. The primary endpoint was radiographic spinal progression as assessed by the change in the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) after 108 weeks in the intent-to-treat population, read by 3 independent readers blinded for the treatment arm and the time-point.ResultsOf the 157 screened patients, 81.5% (n=128) were enrolled into the run-in phase. 109 patients fulfilled the BASDAI response criterion at w12 and were randomized 1:1 (54 vs. 55) to GOL+CEL or GOL alone; 97 (45 vs. 52) patients completed the study at w108. Clinical characteristics of the randomized patients are shown in Tab. 1. The mSASSS change after w108 was 1.1 (95%CI 0.2; 2.0) vs. 1.7 (95%CI 0.8; 2.6) in the GOL+CEL vs. GOL alone groups, respectively, p=0.79. Figure 1 shows the cumulative probability of the mSASSS change in both treatment arms. New syndesmophytes in the opinion of three readers occurred in 11% vs. 25% of the patients in the GOL+CEL vs. GOL alone groups, respectively, p=0.12. During the study, a total of 14 serious adverse events (SAE) were reported (7 in the GOL+CEL group, 5 in the GOL alone group and 2 during the run-in phase).Figure 1.Cumulative probability plot of mSASSS progression over 108 weeks of treatment.ConclusionIn this study, a combined therapy with GOL+CEL did not show significant superiority over GOL monotherapy in retarding radiographic spinal progression over two years in r-axSpA patients.However, the observed numerical reduction in radiographic spinal progression associated with the combined treatment might be, however, clinically relevant for patients at high risk for progression.Table 1.Baseline characteristics of randomized patientsParametersGOL+CEL N=54GOL alone N=55All patients N=109validnvaluevalidnvaluevalidnvalueSex, malen (%)5440 (74.1)5541 (74.5)10981 (74.3)Age, yearsMean (SD)5439.9 (9.9)5537.5 (10.8)10938.7 (10.4)Smokern (%)5319 (35.8)5522 (40)10841 (38)HLA-B27 positivityn (%)5445 (83.3)5147 (92.2)10592 (87.6)BASDAIMean (SD)546.2 (1)556.1 (1.1)1096.1 (1.1)BASMIMean (SD)542.6 (1.9)542.9 (1.4)1082.8 (1.6)CRP > 5 mg/Ln (%)5438 (70.4)5538 (69.1)10976 (69.7)ASDAS-CRPMean (SD)543.6 (0.6)553.7 (0.9)1093.7 (0.8)Prior bDMARDsn (%)5417 (31.5)559 (16.4)10926 (23.9)Presence of ≥ 1 syndesmophyte(s)n (%)5427 (50)5528 (50.9)10955 (50.5)mSASSSMean (SD)5413.5 (16.9)5510.3 (13.2)10911.9 (15.2)AcknowledgementsThe CONSUL study has been supported by a grant from the German Ministry of Education and Research (BMBF), grant number FKZ 01KG1603 and study medication (golimumab) was provided free of charge by MSD Sharp & Dohme GmbH, Munich, Germany.Furthermore we would like to thank Anne Weber, Bianca Mandt, Claudia Lorenz, Hildrun Haibel, Judith Rademacher, Laura Spiller, Petra Tietz as well as all participating rheumatologist and included patients.Disclosure of InterestsFabian Proft Speakers bureau: AMGEN, AbbVie, BMS, Celgene, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: Novartis, Grant/research support from: Novartis, UCB, Lilly, Burkhard Muche Speakers bureau: UCB Pharma, AMGEN, Consultant of: UCB Pharma, AMGEN, Valeria Rios Rodriguez Speakers bureau: AbbVie, Falk e.V., Murat Torgutalp: None declared, Mikhail Protopopov Consultant of: Novartis, Joachim Listing: None declared, Maryna Verba: None declared, Uta Kiltz: None declared, Jan Brandt-Juergens: None declared, Maren Sieburg: None declared, Swen Holger Jacki: None declared, Joachim Sieper Speakers bureau: AbbVie, Janssen, Merck, Novartis, Consultant of: Abbvie, Janssen, Lilly, Merck, Novartis, UCB, Denis Poddubnyy Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Biocad, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, MSD, Novartis, Pfizer, Samsung Bioepis, and UCB, Grant/research support from: AbbVie, Eli Lilly, MSD, Novartis, and Pfizer.

BackgroundThe availability of biosimilars has created a financial incentive to encourage non-medical switching if cheaper products are on the market. In patients with chronic inflammatory rheumatic diseases (CIRD), we have previously reported a relatively high retention rate after switching from originator etanercept to its biosimilar. However, this has been different in other studies and the reasons for non-adherence are poorly understood. Comorbidity has recently gained much attention in patients with CIRD and might be a reason for non-adherence.ObjectivesThe aim of this study was to analyse the effectiveness and safety of systematic non-medical switching from originator adalimumab (ADA) to ADA ABP501 biosimilar (ABP) over 6 months in patients with CIRD and to investigate the influence of comorbidities on retention rates.MethodsPatients with CIRD on originator ADA who switched to ABP subsequently from October 2018 onwards were identified from a large routine database and then followed for 6 months. The presence of comorbidities and disease characteristics as well as measures of disease activity, physical function and changes in treatment were documented at baseline (the time of switching from originator ADA to ABP), and at months 3 and 6. Longitudinal data including information on the clinical efficacy and safety of ABP, and the reasons for discontinuation were documented.ResultsA total of 111 CIRD patients on treatment with originator ADA were switched to the biosimilar ABP (Table 1). More than half of the patients (62%) had a Charlson comorbidity score of 0, though there were differences between disease subtypes. RA patients were comparatively older (mean age 65 years) and had the highest mean Charlson score (1.8). Treatment retention varied only slightly between patients with a Charlson score of 0 and those with ≥0 (Figure 1). In both groups, the majority of patients (90% vs 95%) continued therapy with ABP, while only a small proportion either switched back to originator ADA (6% vs 5%), switched to a different biologic (3% vs 0%), or dropped out (1% vs 0%). The main reason for back switch was the occurrence of adverse events, mostly subjective complaints, most frequently pain. Patients with a Charlson comorbidity score > 0 tended to have poorer scores in trajectories of scores for disease activity and physical function stratified by disease subtype.Figure 1.Treatment retention after 6 months stratified by the Charlson comorbidity scoreTable 1.Patients and disease characteristicsRAaxSpAPsAOtherN=23N=68N=15N=5Age (years), mean (SD)65.1 (12.0)47.3 (13.1)51.1 (11.2)41.8 (14.2)Women60.9% (14)32.4% (22)53.3% (8)40.0% (2)Disease duration (years), median (IQR)4.0 (3.0-8.0)5.0 (2.0-8.0)4.0 (2.0-13.0)7.0 (4.0-7.0)Duration originator ADA therapy (month), mean (SD)43.8 (28.6)39.4 (26.9)34.7 (29.0)60.9 (27.7)Charlson score, mean (SD)1.8 (2.1)0.6 (1.1)0.7 (1.2)0.2 (0.4)Gastroenterological comorbidities26.1% (6)22.1% (15)6.7% (1)0Hepatic comorbidities17.4% (4)2.9% (2)13.3% (2)0Hematological conditions8.7% (2)2.9% (2)13.3% (2)0Cardiovascular comorbidities60.9% (14)32.4% (22)33.3% (5)60.0% (3)Neurological and psychological comorbidities8.7% (2)17.6% (12)33.3% (5)0Metabolic comorbidities21.7% (5)7.4% (5)26.7% (4)40.0% (2)Osteoporosis43.5% (10)11.9% (8)6.7% (1)20.0% (1)Lung diseases21.7% (5)8.8% (6)040.0% (2)Skin diseases26.1% (6)26.5% (18)80.0% (12)20.0% (1)Eye diseases8.7% (2)23.5% (16)6.7% (1)60.0% (3)Kidney diseases13.0% (3)10.3% (7)040.0% (2)ConclusionComorbidity had no influence on the biosimilar retention rate after 6 months in this study but the majority of patients did not have Charlson scores > 0. However, disease activity and physical function tended to be worse among CIRD patients with comorbidity. Cardiovascular disease and osteoporosis were more often present in RA patients than in axSpA or PsA patients, while neurological and psychological comorbidities were more often observed in the latter.Disclosure of InterestsImke Redeker: None declared, Stefan Moustakis: None declared, Styliani Tsiami: None declared, Xenofon Baraliakos Speakers bureau: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Paid instructor for: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Consultant of: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Grant/research support from: Abbvie, Pfizer, MSD, UCB, Novartis, Lilly, Galapagos, Hexal, Ioana Andreica Speakers bureau: UCB, MSD, Novartis, Abbvie, Lilly, Janssen, SOBI, Consultant of: Lilly, Novartis, Galapagos, Amgen, Takkeda, SOBI, Grant/research support from: Lilly, Bjoern Buehring Speakers bureau: UCB, Amgen, Gilad/Galapagos, Biogen, Sanofi/Genzyme, Consultant of: UCB, Theramex, Gilead/Galapagos, Amgen, Abbvie, Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Grant/research support from: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Uta Kiltz Speakers bureau: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer.

BackgroundThere is a higher prevalence of obesity in patients (pts) with psoriatic disease1. The German non-interventional study AQUILA provides real-world data on the influence of body mass index (BMI) of pts with psoriatic arthritis (PsA) on therapeutic effectiveness and safety under treatment with secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics and to evaluate secukinumab treatment outcomes on disease activity and impact of disease on health and to report safety profile depending on the BMI of PsA pts.MethodsAQUILA is an ongoing, multi-center study including up to 3000 pts with active PsA or ankylosing spondylitis. Pts were observed from BL up to week (w) 52. Real-world data were assessed prospectively and analyzed as observed. Data were collected on Psoriatic Arthritis Impact of Disease-12 items (PsAID-12 score) and Patient’s Global Assessment (PGA). For calculation of proportion of pts that experienced (serious) adverse events ((S)AEs), all PsA pts were included that received at least one dose of secukinumab. This interim analysis focuses on BMI subgroups ≤25 kg/m2 (normal weight), >25 to ≤30 kg/m2 (overweight) and >30 kg/m2 (obese) in PsA pts.ResultsAt BL, BMI data were available for 1228 PsA pts: 26.5% (n=325) normal weight, 35.0% (n=430) overweight and 38.5% (n=473) obese PsA pts. Proportion of men was lower in normal weight and obese PsA pts. As BMI increased, so did age and comorbidities/extraarticular manifestations (EAMs; Table 1); e.g. percentage of PsA pts with heart-related disease increased from 5.2% in normal weight to 9.3% in obese PsA pts.Table 1.Overview of baseline characteristics in PsA pts depending on BMIDemographicsBMI ≤25 kg/m2(N=325)BMI >25 to ≤30 kg/m2(N=430)BMI >30 kg/m2(N=473)Male*105 (32.3)219 (50.9)188 (39.7)Age, years**49.5 (±12.7)53.2 (±11.0)54.1 (±10.6)PsAID**4.7 (2.4)4.9 (2.2)5.4 (2.0)PGA**4.8 (2.6)5.4 (2.4)5.5 (2.4)Comorbidities/EAMs* Heart-related disease17 (5.2)29 (6.7)44 (9.3) Coronary heart disease10 (3.1)25 (5.8)35 (7.4) Stroke1 (0.3)9 (2.1)11 (2.3) Heart insufficiency9 (2.8)15 (3.5)15 (3.2) Uveitis5 (1.5)6 (1.4)10 (2.1) Depression137 (53.5)190 (55.2)231 (58.5)*variables are given as n (%); **variables given as mean (SD)Mean PsAID at BL was similar for all BMI subgroups (≤25: 4.7; >25-≤30: 4.9; >30: 5.4; Figure 1A). Mean improvement from BL to w52 was 1.9 (40.4%) for normal weight, 1.8 (36.7%) for overweight, and 1.7 (31.5%) for obese PsA pts.Figure 1.Impact of disease and PGA in PsA pts stratified by BMI.Note: p-values are of exploratory nature. Wilcoxon tests were used to show significant subroup differences.Mean PGA developed in a similar way over time with lowest scores for normal weight and highest scores for obese PsA pts (Figure 1B). Mean improvement from BL to w52 was 2.0 (41.6%) for normal weight, 2.2 (40.7%) for overweight, and 1.8 (32.7%) for obese PsA pts.The occurrence of AEs/SAEs with or without suspected relationship to secukinumab was most frequent in overweight and obese PsA pts. For example, the percentage of SAEs in normal weight PsA pts was 21.6%, in overweight 26.3% and in obese 25.9%. There were no unexpected safety signals in either subgroup. One male obese PsA patient died. Cause of death was not reported, however, treating physician did not suspect a causal relationship to secukinumab.ConclusionIn a real-world setting, secukinumab improved impact of disease and patient´s global assessment of disease activity in all BMI subgroups of PsA pts. However, normal weight PsA pts had numerically better PsAID and PGA scores than obese PsA pts. Altogether, real-world data of this interim analysis show that secukinumab is an effective treatment with a favorable safety profile up to 52 weeks in PsA pts in all BMI subgroups.References[1]Queiro, R., Lorenzo, A., Tejón, P., Coto, P. & Pardo, E. Medicine (Baltimore) 98, e16400 (2019).Disclosure of InterestsUta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, UCB, Grant/research support from: AbbVie, Chugai, Novartis, UCB, Pfizer, Daniel Peterlik Employee of: Novartis, Christina Budden Employee of: Novartis, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

BackgroundObesity is a risk factor for psoriatic arthritis (PsA) and is associated with higher disease activity [1].ObjectivesWe aimed to evaluate whether obese patients with PsA were less likely to achieve remission/low disease in a real-life multi-centre cohort.MethodsWe used data from the ReFlap study (NCT03119805)[2], which recruited consecutive adult patient with definite PsA for more than 2 years of disease duration from 14 countries. We collected demographic characteristics, self-reported weight and height, clinical data and patient reported outcomes. Remission/low disease was defined as Disease Activity in PSoriatic Arthritis (DAPSA) ≤ 4, or Minimal disease activity (MDA). Obesity was defined as body mass index (BMI) ≥ 30kg/m2. We compared patient characteristics, disease activity parameters and impact scores between patients with obesity versus non-obese. A multivariable regression model was performed for demographic variables associated with reaching each definition of remission/low disease, adjusted on age, sex, level of education, disease duration, current use of conventional (c-) and biological (b-) disease modifying anti-rheumatic drugs (DMARDs).ResultsAmong 414 patients (49.3% women, mean disease duration 11.0 ±8.2 years), 119 (28.7%) had BMI ≥ 30kg/m2 (obese). Obese patients were more likely to be female, had higher swollen joint and enthesitis counts, higher self-reported pain, poorer physical function, more fatigue and poorer mental health (Table 1). Obese patients were half as likely to achieve MDA or DAPSA remission in multivariable analysis with odd ratios of 0.6 (95% confidence interval, CI: 0.3, 0.8, p=0.049) and 0.4 (95% CI: 0.2, 0.8, p=0.012), respectively for obese compared to non-obese patients (Figure 1).Table 1.Patient characteristics and remission achievement between obese and non-obese patients with psoriatic arthritisNon-obese (n=295)BMI ≥30 (n=119)pFemale, %44.361.50.002Number of comorbidities1.61 (0.93)2.83 (2.01)Tender joints, 0-683.56 (7.81)5.75 (10.0)0.018Swollen joints, 0-662.19 (7.29)1.46 (2.39)0.285Leeds enthesitis index, 0-60.48 (1.23)0.86 (1.70)0.012PGA disease activity, 0-103.90 (2.73)4.76 (2.67)0.004DAPSA14.9 (15.5)18.3 (16.1)0.045HAQ-DI, 0-30.56 (0.65)0.89 (0.70)PsAID-12, 0-103.11 (2.36)3.96 (2.50)0.001pain, 0-103.80 (2.81)4.54 (2.83)0.017fatigue, 0-103.93 (3.01)4.68 (3.17)0.025work or leisure activities, 0-103.39 (3.01)4.75 (3.11)functional capacity, 0-103.36 (2.97)4.40 (3.16)0.002depression, 0-101.88 (2.70)2.75 (3.26)0.006Mean (SD) shown unless specified otherwise. HAQ-DI: Health Assessment Questionnaire – Disability Index; PsA: psoriatic arthritis; PGA: patient global assessment of disease activity; DAPSA: Disease Activity in PSoriatic Arthritis; PsAID: Psoriatic Arthritis Impact of Disease.ConclusionIn this real-life data from 14 countries, obesity was frequent and PsA patients with BMI ≥ 30kg/m2 were more likely to be female, and had higher subjectively reported disease activity and illness impact compared to those with lower BMI. Obese patients had a two-fold lower likelihood of achieving remission/low disease defined by both MDA and DAPSA compared to non-obese patients. PsA patients with comorbid obesity may have different disease profiles from non-obese patients, and require specific management.References[1]Eder, L., et al., Obesity is associated with a lower probability of achieving sustained minimal disease activity state among patients with psoriatic arthritis. Ann Rheum Dis, 2015. 74(5): p. 813-7.[2]Gorlier, C., et al., Comparing patient-perceived and physician-perceived remission and low disease activity in psoriatic arthritis: an analysis of 410 patients from 14 countries. Ann Rheum Dis, 2019. 78(2): p. 201-208.AcknowledgementsThis study was funded by Pfizer.Disclosure of InterestsNone declared

BackgroundThe use of bDMARDs treatments in patients with psoriatic arthritis (PsA) usually requires treatment failure or intolerance of csDMARD/MTX before initiation. The value of MTX in combination with bDMARDs is still unclear. We designed an investigator-initiated, randomized, placebo-controlled trial (IIT) in active PsA to examine if outcomes of treatment with ustekinumab (UST) in combination with MTX (either newly initiated or ongoing) were different from UST only (+Placebo; PBO). With known efficacy of MTX on skin psoriasis outcomes may differ in patients with or without significant skin involvement of their psoriatic disease.ObjectivesTo compare efficacy outcomes in UST+PBO vs UST+MTX in dependency of skin involvement (Body Surface Area [BSA]) at baseline.MethodsA total of 186 patients with active PsA (defined as TJC≥4, SJC≥4 [68/66 joint count] and DAS28≥3.2) were screened for eligibility. 173 patients were randomized to UST+MTX (new or ongoing) or UST+PBO.With this post hoc subgroup analysis outcome parameters were compared between patients with or without skin psoriasis > 3 % BSA. Demographic data and disease activity status of arthritis (joint count [TJC/SJC], DAPSA, DAS28), skin (PASI, BSA), HR-QoL (EQ5D, DLQI) and physical function (HAQ) were compared between groups.ResultsBL data were well-balanced between main treatment groups (UST+MTX, n=86; UST+PBO, n=74) including gender (42.5% vs 40.5% female) and mean values for age (49.2 vs 47.2 years), BMI (29.4 vs 28.9 kg/m2), SJC (8 vs 8), TJC (12 vs 12), DAS28-CRP (4.6 vs 4.4), DAPSA (36.7 vs 34.9) and PASI (2.8 vs 2.4. Disease activity remained well-balanced even after dividing groups according to skin involvement ((a) BSA ≤3% and (b) BSA >3%) with a trend of more severe joint involvement (SJC, TJC) in BSA >3% for UST+MTX compared to UST+PBO. At week 24, relative changes in TJC (-62% vs -62%), change in DAS28 and DAPSA were equal in all treatment groups independent from skin involvement (Table 1). Differences between the groups according to skin involvement were seen for relative changes in SJC (BSA >3%: -74.8% UST+MTX vs -84.3% UST+PBO), subject global assessment (SGA), physician global assessment (PGA), DLQI and EQ5D. Highest levels for changes were detected in the UST+PBO group with high skin involvement (BSA >3%).Table 1.Outcomes at Week 24 (LOCF)UST+MTXUST+PBOBSA ≤3%BSA >3%BSA ≤3%BSA >3%n=46n=40n=51n=23TJC68 change from BL-7.83 (SD 10.3)-9.5 (SD 10.3)-8.9 (SD 9.5)-7.3 (SD 7.4)SJC66 change from BL-6.0 (SD 5.4)-7.1 (SD 3.5)-6.5 (SD 6.2)-6.4 (SD 3.8)PASI change from BL+-1.3 (SD 1.9)-8.5 (SD 9.6)-1.5 (SD 2.4)-9.0 (SD 10.7)DAS-28 ESR [mm/hr] change from BL-1.6 (SD 1.1)-1.8 (SD 1.2)-1.7 (SD 1.4)-1.8 (SD 1.1)DAS-28 CRP [mg/l] change to BL-1.5 (SD 1.2)-1.5 (SD 1.3)-1.6 (SD 1.2)- 1.7 (SD 1.1)DAPSA change from BL-17.4 (SD 16.8)-20.8 (SD 13.2)-20.5 (SD 16.6)-20.4 (SD 15.3)HAQ change from BL-0.1 (SD 0.4)-0.2 (SD 0.5)-0.3 (SD 0.3)-0.3 (SD 0.5)DLQI change from BL-3.1 (SD 5.5)-5.5 (SD 8.2)-2.3 (SD 3.3)-6.4 (SD 7.9)EQ5D VAS Health State change from BL6.7 (SD 24.7)11.7 (SD 23.6)8.0 (SD 24.2)21.3 (SD 25.3)ConclusionIL12/23 inhibition with UST is an effective treatment for active PsA independent of MTX use. Data from this IIT indicate that additional MTX has no positive impact on UST efficacy for arthritis, skin, HR-QoL and physical function. This independency of UST effect from MTX can also be demonstrated in patients with active skin involvement despite known efficacy of MTX for skin psoriasis.AcknowledgementsWe thank Janssen for support of the study with a research grant.Disclosure of InterestsMichaela Köhm Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen, Tanja Rossmanith Grant/research support from: Janssen, Ann Christina Foldenauer Grant/research support from: Janssen, Herbert Kellner Speakers bureau: Janssen, Consultant of: Janssen, Uta Kiltz Speakers bureau: Abbvie, Fresenius, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer, Jürgen Rech Speakers bureau: Abbvie, Biogen, BMS, Chugai, GSK, Lilly, MSD; Novartis, Roche, Sanofi, Sobi, UCB, Consultant of: Biogen, BMS, Chugai, GSK, Lilly, MSD, Novartis, Roche, Sanofi, Sobi, UCB, Grant/research support from: Novartis, Sobi, Gerd Rüdiger Burmester Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen, David M Kofler Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen, Jan Brandt-Juergens Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen, Christin Jonetzko Grant/research support from: Janssen, Harald Burkhardt Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen, Frank Behrens Speakers bureau: Janssen, Consultant of: Janssen, Grant/research support from: Janssen

BackgroundRecent surveys in chronic inflammatory rheumatic diseases (CIRD) showed a high degree of vaccine hesitancy. Current knowledge about patients’ attitudes towards vaccination against SARS-CoV-2 is limited.ObjectivesTo assess the willingness of CIRD patients to be vaccinated against SARS-CoV-2 and to identify influencing factors compared to non-CIRD patients.MethodsIn this cross-sectional study, two cohorts of consecutively in parallel recruited patients with and without CIRD presenting to our tertiary hospital answered questions of a structured interview to assess vaccination willingness to SARS-CoV-2, experience with SARS-CoV2 in their environment and their personal history of infections and vaccinations. Vaccination willingness was assessed by a numerical rating scale (0: fully disagree; 10: fully agree). Arbitrarily defined cut-offs were used to define definite (score ≥7) and probable willingness (scores of 5 or 6) to be vaccinated. Statistical analyses were performed with appropriate tests such as Kendall-tau b.ResultsA total of 514 CIRD and 100 non-CIRD patients, mean age 54.7±12.8 and 55.6±9.8 years, were included. Definite and probable willingness to be vaccinated against SARS-CoV-2 was declared by 79.6% and 90.7% vs. 76.0% and 85.0% of CIRD and non-CIRD patients, respectively. Only 60% of CIRD patients believed that the vaccines against SARS-CoV-2 were safe, and 42% indicated to be afraid of side effects. Vaccination willingness correlated significantly with the degree of education, age, identification with a risk group for COVID-19 disease, hypertension, and the degree of information about preventable diseases. There was no correlation with the history of infections or with immunosuppressive therapy.ConclusionAlthough our results show a high willingness for vaccination against SARS-CoV-2 in both groups, there was quite some uncertainty regarding the safety and efficacy of the vaccines. Since major influencing factors were education and information about SARS-CoV-2 and COVID-19, patient education should be immediately improved.Table 1.Patient demographics, disease characteristics and infection historyCIRD patientsNon-CIRD patientsMissing values of CIRD and non-CIRD patients No. (%)Group differences p-valueAge (years), mean (SD)54.7 ± 12.855.6 ± 9.800Women, No. (%)315 (61.3)83 (83)00Body mass index (BMI, kg/m2), mean (SD)27.9 ± 5.930.4 ± 7.800CIRD, No. (%)192 (37.3)0Rheumatoid arthritis134 (26)Axial spondyloarthritis72 (14)Psoriatic arthritis116 (22.6) Connective tissue disease/vasculitisDisease duration (years), mean (SD)9.8 ± 8.94.0 ± 6.500Therapy, No. (%)316 (61.5)0 bDMARDs147 (28.6) csDMARDs33 (6.4) tsDMARDs18 (3.5) no DMARDsHistory of a positive SARS-CoV-2 PCR test No. (%)22 (4.3)5 (5.0)3 (0,6)5 (5)0.79History of recurrent infection No. (%)54 (10.5)16 (16.0)1 (0.2)00.12History of severe infection No. (%)23 (4.5)13 (13.0)3 (0.6)00.004Educational level, No. (%)9 (9.3)35 (6.8)3 (3)0.13 low (< 8 years)50 (10.4)67 (69.1) moderate (8 to 12 years)275 (57.4)21 (21.6) high (> 12 years)154 (32.2)BMI body mass index, SD standard deviation, no number, DMRD Disease Modifying Anti-Rheumatic Drugs, b biological, ts targeted synthetic, cs conventional syntheticFigure 1.Vaccination willingness of CIRD patientsAcknowledgementsWe wish to thank all persons who participated in the current study.Furthermore, we thank Dr. Styliani Tsiami, Tanja Kobylinski and the clinical departments for assisting with recruitment of participants.Disclosure of InterestsNone declared

BackgroundEULAR recommends participation in patient (pt) organizations to improve pt self-management of axial spondyloarthritis (axSpA)1. Non-pharmacological treatment modalities (NPTM)2 are recommended in axSpA treatment guidelines.3ObjectivesTo characterize the impact of pt advocacy group membership and its association with NPTM frequency and clinical parameters in axSpA.MethodsPts with a confirmed axSpA diagnosis were enrolled in the multicenter, observational ATTENTUS-axSpA survey conducted across Germany (11/2019–07/2020). Demographics, clinical and pt-related data were collected electronically.ResultsOf the 787 enrolled axSpA pts, this analysis was conducted on the working population (n=695)4. Overall, 12.2% (n=85) pts were members of a pt advocacy group and 87.8% (n=610) were not. Pt advocacy group members had higher Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, increased functional impairment (BASFI, Bath Ankylosing Spondylitis Functional Index) and higher impact of axSpA on health (ASAS-HI, Assessment of SpondyloArthritis International Society-Health Index; Table 1). Despite worse prognostic factors, there was no significant difference in Work Productivity and Activity Impairment (WPAI) score [40.6 (27.0) for pt advocacy group members vs 36.8 (29.9) for non-members; p=0.380]. Membership in a pt advocacy group was associated with increased prescribed, supervised NPTM (57.6% [n=49] vs 34.4% [n=210]). Pts reported to have ever received 2.6 rehabilitation measures, and ≥3.0 different rehabilitation NPTM measures. Cumulatively, 25.0% (N=654) of rehabilitation measures were physiotherapy (Figure 1).Table 1.Descriptive characteristics and impact of membership in pt advocacy groupCharacteristicPatient advocacy group member (n=85)Not patient advocacy group member (n=610)Total (n=695)p-valueAge (yrs), mean (SD)50.2 (7.7)44.6 (11.1)45.3 (10.9)BMI (kg/m2) mean (SD)27.5 (5.0)28.0 (12.7)28.0 (12.0)0.713Male, n (%)45 (52.9)378 (62.0)423 (60.9)0.128Disease duration (yrs) mean (SD)13.7 (10.3)12.5 (11.1)12.6 (11.0)0.303ASAS-HI, 0-177.3 (3.4)6.4 (3.9)6.5 (3.8)0.045BASDAI, 0-104.3 (1.9)3.8 (2.2)3.9 (2.2)0.044BASDAI ≥4, n (%)49 (57.6)275 (45.1)324 (46.6)0.025BASFI, 0-103.9 (2.3)3.2 (2.5)3.3 (2.4)0.015Biologic treatment, n (%)52 (61.2)312 (51.1)364 (52.4)0.072Full time employment, n (%)48 (56.5)410 (67.2)458 (65.9)0.06Absenteeism*, mean (SD)8.4 (21.2)10.9 (26.8)10.6 (26.2)-Presenteeism*, mean (SD)38.4 (24.6)31.8 (25.7)32.6 (25.6)-Overall work impairment score*, mean (SD)40.6 (27.0)36.8 (29.9)37.2 (29.6)0.380Activity impairment, mean (SD)46.7 (21.7)40.5 (26.8)41.3 (26.4)0.058Pts having ever received medicinal rehabilitation measures, mean (SD)67 (78.8)328 (53.8)395 (56.8)Prescribed supervised group NPTM#, mean (SD)49 (57.6)210 (34.4)259 (37.3)Regular physical training†, mean (SD)76 (89.4)515 (84.4)591 (85.0)0.231*Work-related questions of WPAI-score have been calculated for pts in employment (N=340); †regular physical training in the context of axSpA; #rehabilitation sport and/or functional training. ASAS-HI, Assessment of SpondyloArthritis International Society-Health Index; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BMI, Body Mass Index; n, number of pts; pts, patients; SD, Standard Deviation; WPAI, Work Productivity and Activity Impairment; yrs, years.ConclusionPt advocacy group membership was associated with increased prescribed NPTM in axSpA. Pt organizations may support the implementation of guidelines and improvement of self-management strategies in pts with axSpA, which may influence work participation.References[1]Nikiphorou E, et al. Ann Rheum Dis 2021;0:1–8[2]Rausch Osthoff A-K, et al. Ann Rheum Dis 2018;77:1251–1260[3]van der Heijde D, et al. Ann Rheum Dis 2017;76:978–991[4]Kiltz et al. 2021. EULAR eposter; POS0983Disclosure of InterestsDirk Meyer-Olson Speakers bureau: Speakers bureau: Abbvie, Amgen,Berlin Chemie, Bristol Myers Squibb, Cellgene, Chugai, Fresenius Kabi, GSK, Jansen Cilag, Lilly, Medac, Merck Sharp & Dome, Mylan, Novartis, Pfizer, Sandoz Hexal, Sanofi and UCB, Consultant of:Abbvie, Amgen, Berlin Chemie, Bristol Myers Squibb, Cellgene, Chugai, Fresenius Kabi, GSK, Jansen Cilag, Lilly, Medac, Merck Sharp & Dome, Mylan, Novartis, Pfizer, Sandoz Hexal, Sanofi and UCB, Kirsten Hoeper Speakers bureau: Speakers bureau: Abbvie, Chugai, Gilead, Lilly, Novartis, Sandoz Hexal and Sanofi., Consultant of: Abbvie, Chugai, Gilead, Lilly, Novartis, Sandoz Hexal and Sanofi., Ludwig Hammel: None declared, Sebastian Lieb Employee of: Employee of Novartis, Andreas Haehle Employee of: Employee of Novartis, Uta Kiltz Speakers bureau: Speakers bureau: AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB, Grant/research support from: Abbvie, Amgen, Biogen, Fresenius, GSK, Novartis and Pfizer

BackgroundThe main goal of treatment for patients (pts) with rheumatoid arthritis (RA) is remission to preserve physical function and prevent radiographic damage. However, less than 50% of pts with early RA have achieved remission in clinical studies and inception cohorts 1. Little is known about the course of disease and the clinical patterns when remission is tried to be achieved in pts with RA.ObjectivesTo identify subgroups with distinct trajectories of DAS28-CRP in pts with RA.MethodsLongitudinal data from adult RA pts presenting to a tertiary centre were used. Socio-demographic data, disease characteristics and standard assessments including established outcome parameters for disease activity (DAS28-CRP) and physical function (FFbH) were retrospectively analysed. Group-based trajectory modelling (GBTM) was used to identify homogeneous classes of DAS28-CRP trajectories, where the number of classes was selected using Nagin’s Bayesian information criterion (BIC). Differences between the identified classes and clinical variables were studied.ResultsData of 134 pts with 849 DAS28-CRP values were analysed. Retrospective chart data were available for a follow-up of 33.7 (SD 18.0) months. One third of pts already had erosions and severe limitations in physical functioning. About half of the pts were on bDMARDS and Table 1.Patients demographics and disease characteristics at baseline in trajectory groupsClass 1(N=10)Class 2(N=36)Class 3(N=56)Class 4(N=23)Class 5(N=9)Age, years65.8 (12.7)60.6 (10.6)56.7 (16.0)50.5 (15.4)56.8 (12.0)Gender, female80.0% (N=8)77.8% (N=28)82.1% (N=46)52.2% (N=12)66.7% (N=6)Education level university0.0% (N=0)11.1% (N=4)16.1% (N=9)21.7% (N=5)0.0% (N=0)Employment10.0% (N=1)33.3% (N=12)53.6% (N=30)69.6% (N=16)33.3% (N=3)Body mass index30.6 (5.4)27.8 (4.3)27.1 (4.7)25.2 (4.2)29.0 (6.4)Symptom duration, years12.8 (7.3)10.4 (8.3)9.5 (9.6)6.7 (3.6)12.4 (13.2)Anti-CCP49.2 (63.9)101.3 (89.7)98.6 (95.6)94.9 (78.2)114.5 (84.6)CRP1.0 (1.1)0.7 (0.9)0.4 (0.4)0.4 (0.5)1.2 (1.1)Erosions20.0% (N=2)36.1% (N=13)28.6% (N=14)45.5% (N=10)44.4% (N=4)At least one Comorbidity100.0% (N=10)94.4% (N=34)78.6% (N=44)65.2% (N=15)88.9% (N=8)Charlson Comorbidity Index (0-29)1.1 (1.4)1.1 (1.3)0.6 (0.9)0.4 (0.7)1.2 (1.3)No. of patients on steroids0.0% (N=0)0.0% (N=0)2.9% (N=1)15.4% (N=2)0.0% (N=0)No. of patients on bDMARD77.8% (N=7)45.8% (N=11)41.2% (N=14)30.8% (N=4)71.4% (N=5)No. of patients on tsDMARD0.0% (N=0)0.0% (N=0)5.9% (N=2)7.7% (N=1)0.0% (N=0)Pain (NRS 0-10)6.1 (1.8)5.8 (1.8)4.2 (2.0)2.3 (2.6)4.2 (2.0)Patient Global (NRS 0-10)5.8 (2.8)5.3 (1.7)3.7 (2.1)2.8 (3.0)6.3 (2.2)DAS28-CRP5.3 (1.2)3.9 (0.7)2.5 (0.7)2.1 (1.0)4.6 (0.9)FFbH38.5 (29.0)48.8 (21.8)74.2 (18.9)90.4 (8.8)61.1 (19.4)RAID (0-10)6.5 (2.0)5.3 (2.1)3.8 (1.9)1.8 (1.8)4.6 (1.8)Figure 1.Longitudinal DAS-28-CRP in trajectory groupsConclusionUsing GBTM five distinct trajectories in pts with RA were identified. Only a small proportion of pts showed a reduction in disease activity over time, whereas the largest proportion of pts showed rather constant high or constant low disease activity. The cohort size may have impacted the modelling and further analyses in larger cohorts are needed. Importantly, even though well established in our hospital it is unclear how consequent the T2T strategy was followed and which intervention was successful to reach remission. The impact of pts global assessment on DAS28 values also needs further study.References[1]Nikiphorou Rheumatol 2020Disclosure of InterestsNone declared

BackgroundPatients with polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) are commonly treated with glucocorticoids (GC) in different dosages. Therefore, the most common comorbidities that may develop are osteoporosis (OPO) and diabetes mellitus (DM).ObjectivesTo study the development of these comorbidities in the management of PMR and GCA in a real-life setting.MethodsIn a retrospective study design, longitudinal data of patients with a clinical diagnosis of PMR and GCA treated in a tertiary center were studied. Patients and disease characteristics were documented according to clinical routine in patients in whom ≥ 2 documented visits ≥ 3 months apart had been documented.ResultsA total of 550 patients (382 PMR, 168 GCA) was analysed (Table 1). The time period of follow up (FU) ranged between 3 months and 13.6 years (mean 1.4 (0.3) years). The majority of patients received a diagnosis of PMR or GCA in our center while 29.5% of patients came for a second opinion. Their mean age was around 70 years, and most patients were female (Table 1). Eight GCA patients were already blind (4.8%) at first presentation, and 77 and 80 patients had a diagnosis of DM (15.5%) and OPO (16.0), respectively, already at baseline. During FU 56 PMR (16.0%) and 7 GCA patients (4.2%) were diagnosed with another autoimmune disease, mainly with rheumatoid arthritis (n=50 (69.4%)). The mean dose of GC differed substantially between groups (Table 1). On FU, 9 (2.4%) and 5 (3.0%) of PMR and GCA patients developed DM and 17 (4.5%) and 14 (8.4%) OPO, respectively. Thus, about 20% and 25% of patients with PMR or GCA finally had DM and OPO, respectively. Almost all patients received vitamin D and antiresorptive agents.Table 1.Patients and disease characteristicsPMR patients (n=382)GCA patients (n=168)SignificanceAge (years)68,2 (9.3)71.1 (8,6)0.9BMI (kg/m2)27.0 (4.9)26.0 (5,3)0.44Female sex, n (%)216 (56.6)121 (72,0)Time to rheumatologist (months)2.1 (9,7)1.4 (5,4)0,33CRP at baseline (mg/dl)3,8 (4,6)4,5 (5,5)0,07Prednisolone at baseline (mg/d)25.1 (20,2)52.0 (69,7)Comorbidities at baseline-Number of comorbidities (mean)1.45 (1.12)1.51 (1.12)0.26-Diabetes, n (%)61 (16.0)24 (14.3)0.36-Osteoporosis, n (%)64 (16.8)30 (17.9)0.7-Ischemic heart disease, n (%)38 (9.9)19 (11.4)0.46Organ manifestation and comorbidities at FU-Blindness n (%)6 (1.6)8 (4.8)0.048-Aneurysm n (%)1 (0.3)9 (5.4)-Diabetes, n (%)70 (18.4)29 (17.3)0.89-Osteoporosis, n (%)81 (21.4)44 (26.3)0.003-Vascular stenosis4,610,10,048values given as mean (SD)ConclusionIn this large real-life cohort, patients with PMR and GCA aged around 70 years were seen by rheumatologists about 1-2 months after their first symptom but 8 GCA patients were already blind at first visit. DM and OPO were frequent comorbidities in both, PMR and GCA patients, already at baseline and during follow-up more patients developed these comorbidities despite prophylactic and therapeutic medication. OPO and DM should be a routine concern in the care of PMR and GCA patients - already when glucocorticoids are started.Disclosure of InterestsNone declared

BackgroundPatients with chronic inflammatory rheumatic diseases (CIRD) may be at increased risk of Corona Virus Disease 2019 (COVID-19).1 The quality of information obtained plays a crucial role for patients’ decision to be vaccinated. Knowing patients’ needs for information and which sources are used is important for the management of CIRD patients by rheumatologists and other physicians.ObjectivesTo identify main sources of information on SARS-CoV-2 used by patients with CIRD and to analyze their influence on opinions and willingness to be vaccinated.MethodsCIRD patients presenting to our tertiary rheumatology hospital were, after informed consent, consecutively included in the study once the vaccination campaign in Germany had started, to fill out a questionnaire. Next to sociodemographic and disease-specific data, vaccination willingness and knowledge regarding SARS-CoV-2 were assessed. Furthermore, patients’ sources of information and their concerns about accuracy of information were evaluated. A numerical rating scale (NRS) ranging from 0 (completely disagree) to 10 (completely agree) was used. Values between ≥7 were taken as positive answer. Nonparametric tests and multivariate linear regression analyses were performed.ResultsIn early 2021, a total of 514 patients were interviewed (Table 1). The majority (63.9 %) reported to be well-informed (NRS ≥7), whereas 18% had doubts regarding information on SARS-CoV-2. The most often used source of information was television, and only 8.6% reported to have been informed by a rheumatologist (Figure 1). About 20% of patients were no longer interested in receiving any information on SARS-CoV-2 through media. Information from rheumatologists, general practitioners, public health authorities or health related web sites did not reach 30.5% of patients. Of interest, 16% of subjectively well-informed patients were hesitant towards vaccination. As many as 43.6% of patients with doubts regarding information about SARS-CoV-2 indicated that they were not willing to be vaccinated. No source of information showed a strong correlation with SARS-CoV-2 vaccination willingness or with knowledge on SARS-CoV-2. Weak positive correlations were found between age and education level on the one hand and information sources about SARS-CoV-2 on the other hand. A weak negative correlation was found between doubts about information and health authorities, whereas positive correlations were found with social networks, friends and family.Table 1.Sociodemographic and disease characteristicsAge (years)54.7 ± 12.8Women, No.* (%)315 (61.3%)Educational level, No.* (%) < 8 years50 (10.4 %) 8-12 years275 (57.4 %) >12 years154 (32.2 %)Occupation, No.* (%) Full time198 (38.5 %) Pensioner157 (30.5 %) Part-time80 (15.6 %) Housewife/husband37 (7.2 %) Occupational incapacity29 (5.6 %) In training7 (1.4 %) Healthcare5 (1 %)CIRD, No.* (%)Rheumatoid arthritis192 (37.3 %)Axial spondyloarthritis134 (26.1 %)Connective tissue disease and vasculitis106 (22.6 %)Psoriatic arthritis72 (14.0 %)Disease duration, mean (years)Therapy, No.* (%)9.8 ± 8.9 bDMARD316(61.5 %) csDMARD147(28.6 %) tsDMARD33 (6.4 %) no DMARDs18 (3.5 %)*Number of patientsFigure 1.Sources of information of CIRD patients about SARS-CoV-2ConclusionMost CIRD patients think that they are well-informed about SARS-CoV-2. However, their information rarely comes from expert-based sources and rarely from rheumatologists. Thus, there is an unmet need for CIRD patients to receive appropriate and comprehensive information about SARS-CoV-2, its influence on rheumatic diseases, and about vaccination of patients with CIRD.References[1]Strangfeld A et al. Ann Rheum Dis 2021Disclosure of InterestsNone declared

BackgroundRecently, the core domains of the 20-years old core outcome set for ankylosing spondylitis were updated.1 The next step is to define the measurement core set, which includes at least one instrument for each domain.ObjectivesTo define the instruments for the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).MethodsThe scientific committee invited an international working group representing all key stakeholders (patients, rheumatologists, health professionals and pharmaceutical industry). The instrument selection process is presented in Figure 1.Figure 1.Development process to determine the core measurement setResultsThe updated core measurement set for axSpA is shown in Table 1. This includes seven instruments for six domains that are mandatory for all trials: ASDAS and NRS patient global assessment for disease activity, NRS total back pain for pain, composite index for morning stiffness, NRS fatigue for fatigue, BASFI for physical function, and ASAS Health Index for overall functioning and health. There are 9 additional instruments for disease modifying drugs (DMARDs): two MRI activity scores (SPARCC SIJ and SPARCC spine) for disease activity, the three extra-musculoskeletal manifestations uveitis, IBD and psoriasis assessed as recommended by ASAS2, the three peripheral manifestations (44 swollen joint count, MASES and Dactylitis count2) and mSASSS for structural damage. The imaging outcomes are mandatory to be included at least in one trial for a drug that is considered to be a DMARD. The other instruments specific for DMARDs should be included in every trial. This core set is applicable to patients with radiographic and non-radiographic axSpA. Furthermore, 11 other instruments were also endorsed by ASAS and can additionally be used in axSpA trials: BASDAI, CRP, Berlin MRI-SIJ and MRI-spine activity scores for disease activity, NRS back pain at night for pain, severity (BASDAI Q5) and duration (BASDAI Q6) for morning stiffness, SF-36 for overall functioning and health, 66 swollen joint count and SPARCC enthesitis for peripheral manifestations and MRI-SIJ erosions scores (SPARCC SSS) for structural damage.Table 1.Updated core measurement set for axial spondyloarthritis.Instruments mandatory for all trialsDomainInstrument Disease activityASDASPatient global assessment of disease activity (NRS) PainNRS total back pain (BASDAI Q2) Morning stiffnessSeverity and duration (BASDAI (Q5+Q6)/2)) FatigueNRS fatigue (BASDAI Q1) Physical functionBASFI Overall functioning & healthASAS Health IndexAdditional instruments mandatory for disease modifying drugs trials Disease activitySPARCC MRI-SIJ*SPARCC MRI-spine* Extra-musculoskeletal manifestationsuveitis (ASAS CRF)2psoriasis (ASAS CRF)2inflammatory bowel disease (ASAS CRF)2 Peripheral manifestations44 Swollen joint countMASESDactylitis count (ASAS CRF)2 Structural damagemSASSS**Needs to be assessed at least once in a disease modifying drug programme; 2Dougados M, et al. Ann Rheum Dis 2012;71(6):1103-04. ASDAS: Ankylosing Spondylitis Disease Activity Score; NRS: Numerical Rate Scale; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; Q: question; BASFI: Bath Ankylosing Spondylitis Functional Index; SPARCC: SpondyloArthritis Research Consortium of Canada Scoring System; MRI: Magnetic Resonance Imaging; SIJ: Sacroiliac Joint; CRF: Case Report Form; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; mSASSS: modified Stoke Ankylosing Spondylitis Spinal Score.ConclusionThe previous core measurement set has been updated and endorsed by ASAS for the use in all axSpA trials.References[1]Navarro-Compán V, et al. Semin Arthritis Rheum 2021;51(6):1342-49.[2]Dougados M, et al. Annals of the Rheumatic Diseases 2012;71(6):1103-04.AcknowledgementsThe ASAS axSpA core measurement set working group:Désirée van der HeijdeVictoria Navarro CompánAnnelies BoonenPhilip MeaseAnne BoelUta KiltzRobert LandewéMaxime DougadosXenofon BaraliakosWilson BautistaPravina ChiowchanwisawakitYu Heng KwanLianne GenslerBassel El-ZorkanyKarl GaffneyNigel HaroonPedro MachadoWalter MaksymowychAnna MoltoDenis PoddubnyyMikhail ProtopopovSofia RamiroSalima van WeelyMarco Garrido CumbreraNatasha de PeyrecaveLara FallonIn-Ho SongHanne DagfinrudThe Assessment of Spondyloarthritis international Society (ASAS) supported Anne Boel and Victoria Navarro-Compán financially to update the core outcome set.Disclosure of InterestsVictoria Navarro-Compán Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB Pharma; Research grants from AbbVie and Novartis, Grant/research support from: AbbVie and Novartis, Anne Boel: None declared, Annelies Boonen Speakers bureau: Abbvie / Galapagos, Consultant of: Galapagos, Grant/research support from: AbbVie, Philip J Mease Speakers bureau: Abbvie, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: Abbvie, Bristol Myers, Gilead, Inmagene, Janssen, Lilly, Novartis, Pfizer, UCB, Maxime Dougados: None declared, Uta Kiltz Consultant of: AbbVie, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche and UCB, Grant/research support from: Abbvie, Amgen, Biogen, Hexal, Novartis und Pfizer, Robert B.M. Landewé Consultant of: AbbVie, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, UCB, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Employee of: Director of Imaging Rheumatology bv.

BackgroundImprovement in functioning and health as assessed by the ASAS Health Index (HI) is an important outcome of interventions in patients with axial spondyloarthritis (axSpA). ASAS HI thresholds for measuring improvement have been proposed but not yet tested in an independent intervention trial to study its discriminant capacity.ObjectivesTo test the discriminant capacity of the ASAS HI using data from a randomized, active-controlled trial.MethodsIn this post-hoc analysis from the tight-controlled, treat-to-target (T2T) trial TICOSPA [1], data of active axSpA patients randomized to either the T2T arm (visits every 4 weeks, prespecified strategy of treatment intensification until achieving low disease activity) or standard of care (SOC; visits every 12 weeks, treatment at the rheumatologist’s discretion) were compared to test whether different thresholds for improvement or achieved state of ASAS HI could discriminate between treatment arms. Week 48 effect sizes (ES) of improvement from baseline were calculated for each treatment arm as Phi Coefficient (higher means better discrimination) and OR (95% CI).ResultsThe table shows the ES between treatment arms for all tested improvements and health states achieved in ASAS HI. Overall, absolute improvement outcomes performed better than percentage changes outcome followed by status outcomes. The absolute improvement of ≥2.0, ≥2.5, and ≥3.0 performed best followed by the 20% improvement. As the ASAS HI ≥3.0 is the smallest detectable change for this outcome, this seem to be the most appropriate proposed outcome.Table 1.Thresholds by treatment groups.Non-responder imputation at 48 weeksEffect size measuresTC/T2TUCPhi Coefficient*OR [95% CI]ASAS HI 20% improvement56.9%45.8%0.11 [0-1.0]0.64 [0.33-1.23]ASAS HI 25% improvement51.4%41.7%0.10 [0-1.0]0.68 [0.35-1.30]ASAS HI 30% improvement43.1%34.7%0.09 [0-1.0]0.70 [0.36-1.38]ASAS HI 35% improvement40.3%31.9%0.09 [0-1.0]0.70 [0.35-1.38]ASAS HI 40% improvement37.5%31.9%0.06 [0-1.0]0.78 [0.39-1.56]ASAS HI 50% improvement29.2%22.2%0.08 [0-1.0]0.69 [0.33-1.47]ASAS HI 60% improvement26.4%18.1%0.10 [0-1.0]0.61 [0.28-1.36]ASAS HI 70% improvement16.7%12.5%0.06 [0-1.0]0.71 [0.28-1.82]ASAS HI 80% improvement13.9%11.1%0.01 [0-1.0]0.78 [0.29-2.09]ASAS HI 90% improvement9.7%9.7%0.0[0-1.0]1.0 [0.33-3.01]ASAS HI improvement ≥1.066.7%61.1%0.06[0-1.0]0.79 [0.40-1.55]ASAS HI improvement ≥2.055.6%41.7%0.14 [0.0-1.0]0.57 [0.30-1.11]ASAS HI improvement of ≥2.544.4%31.9%0.13 [0-1.0]0.59 [0.30-1.16]ASAS HI improvement of ≥3.041.7%29.2%0.13 [0-1.0]0.58 [0.29-1.15]ASAS HI improvement of ≥ 3.529.2%22.2%0.08 [0-1.0]0.69 [0.33-1.47]ASAS HI improvement ≥4.029.2%22.2%0.08 [0-1.0]0.69 [0.33-1.47]ASAS HI improvement ≥5.016.7%12.5%0.06 [0-1.0]0.71 [0.28-1.82]ASASHI, end of study, ≤12.087.5%80.6%0.09 [0.0- 1.0]0.59 [0.24, 1.47]ASASHI, end of study, ≤5.037.5%33.3%0.04 [0.0, 1.0]0.83 [0.42, 1.65]A value of PHI = 0.1 is considered to be a small effect, 0.3 a medium effect, and 0.5 a large effect.ConclusionIn this active-controlled trial an absolute improvement in the ASAS HI discriminated best between treatment arms. A similar evaluation is needed in a placebo-controlled trial to be able to propose the best outcome for the ASAS HI in a trial.References[1]Molto A et al. Ann Rheum Dis 2021Disclosure of InterestsUta Kiltz Speakers bureau: AbbVie, Biocad, Biogen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Biocad, Amgen, Chugai, Eli Lilly, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer., Anna Moltó: None declared, Clementina López-Medina: None declared, Maxime Dougados: None declared, Désirée van der Heijde Speakers bureau: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Grant/research support from: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Annelies Boonen Speakers bureau: Abbvie / Galapagos, Consultant of: Galapagos, Grant/research support from: Abbvie, Filip van den Bosch Speakers bureau: Abbvie, Amgen, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB., Consultant of: Abbvie, Amgen, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB., Grant/research support from: Abbvie, Amgen, Eli Lilly, Galapagos, Janssen, Novartis, Pfizer and UCB., Juergen Braun Speakers bureau: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Consultant of: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB, Grant/research support from: Abbvie, Amgen, Biogen, BMS, Boehringer, Celltrion, Chugai, Fresenius, Hexal, Janssen, Lilly, Medac, MSD, Mylan, Mundipharma, Novartis, Pfizer und UCB

BackgroundPatients with spondyloarthritis (SpA) are at increased risk of depression compared to the general population. Currently, it is unknown whether this increased risk is only secondary (due to SpA-related symptoms), or also due to a shared inflammatory pathway. From both clinical and pathophysiological perspectives, it is relevant to know whether comorbid depressive symptoms improve with treatment of SpA, and if so, whether such an improvement depends on drug type/mechanism of action.ObjectivesTo investigate the effect of pharmacological treatment of SpA on depressive symptoms, and to explore whether this effect differs between drug types.MethodsData from the international ASAS Health Index Validation Study were used. Included patients had a diagnosis of SpA and fulfilled the ASAS classification criteria for axial/peripheral SpA. Patients were assessed at baseline, and for those who required a therapeutic change (initiation of NSAID, conventional synthetic (cs)DMARD or TNFi) due to high disease activity, a follow-up assessment was conducted. The current analysis included only those with a therapeutic change. Data on demographics, disease characteristics and disease activity (ASDAS, BASDAI, CRP) were available. Depressive symptoms were assessed with the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D, range 0-21 [best-worst]). HADS-D scores ≥8 and ≥11 indicated possible and probable depression, respectively. Change in depressive symptoms from baseline was compared between treatments (NSAID, csDMARD, TNFi) with ANOVA and linear regression analysis, adjusting for potential confounders.ResultsIn total, 1548 patients were assessed at baseline. A therapeutic change was initiated in 304 patients (n=102/45/157 initiated an NSAID/csDMARD/TNFi). Of these, 260 (85%) had axSpA, 190 (63%) were male, mean age was 37.3 (SD 12.6) years and mean ASDAS at baseline 3.3 (1.1). The mean HADS-D was 6.9 (4.2); 126 (42%) were possibly depressed and 66 (22%) probably depressed. At baseline, there were no significant differences in demographics, disease parameters or depressive symptoms between treatment groups. At follow-up, mean HADS-D had improved to 5.1 (change -1.9 (3.8), pTable 1.Multivariable regression analysis of change in HADS-D from baselineBase modelASDAS modelBASDAI modelVariableB95%CIB95%CIB95%CIAge, years0.040.00 to 0.070.03-0.01 to 0.070.030.00 to 0.06Male gender0.23-0.67 to 1.140.55-0.39 to 1.490.28-0.54 to 1.10HLA-B27 (vs negative) Positive1.560.46 to 2.671.380.27 to 2.491.170.17 to 2.18 Unknown1.700.19 to 3.222.210.66 to 3.751.410.04 to 2.77Therapy initiated (vs NSAID) csDMARD0.19-1.16 to 1.540.02-1.34 to 1.390.14-1.07 to 1.36 TNFi-1.27-2.23 to -0.32-0.51-1.58 to 0.55-0.23-1.13 to 0.67ASDAS, change1.270.84 to 1.71†BASDAI, change†0.780.60 to 0.96Associations in bold are statistically significant (pConclusionTreatment of active SpA also improves depressive symptoms. TNFi have a larger effect than NSAIDs, which can mainly be explained by a stronger effect on disease activity. This analysis did not find evidence for a direct link between CRP-mediated inflammation and depressive symptoms in SpA.Disclosure of InterestsCasper Webers: None declared, Uta Kiltz: None declared, Juergen Braun: None declared, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Employee of: Director of Imaging Rheumatology bv, Annelies Boonen Speakers bureau: Abbvie, Galapagos, Consultant of: Galapagos, Grant/research support from: Abbvie

BackgroundObesity is a risk factor for worse overall health in people with ankylosing spondylitis (AS)1. The German non-interventional study AQUILA provides real-world data in AS on the influence of body mass index (BMI) on therapeutic effectiveness and safety under treatment with secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics and to evaluate secukinumab treatment outcomes on disease activity and global functioning and health and to report safety profile depending on the BMI of AS patients (pts).MethodsAQUILA is an ongoing, multi-center, non-interventional study including up to 3000 pts with active AS or psoriatic arthritis. Pts were observed from BL up to week (w) 52 according to clinical routine. Real-world data were assessed prospectively and analyzed as observed. Validated questionnaires were used to collect data on disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI) and global functioning and health (Assessment of SpondyloArthritis-Health Index, ASAS-HI). For calculation of proportion of pts that experienced (serious) adverse events ((S)AEs), all AS pts were included that received at least one dose of secukinumab. This interim analysis focuses on BMI subgroups ≤25 kg/m2 (normal weight), >25 to ≤30 kg/m2 (overweight) and >30 kg/m2 (obese) in AS pts.ResultsAt BL, BMI data were available for 667 AS pts: 33.6% (n=224) normal weight, 39.9% (n=266) overweight and 26.5% (n=177) obese AS pts (Table 1). In all BMI subgroups the proportion of men was higher, even doubled among overweight AS pts. As BMI increased, so did age and comorbidities/extraarticular manifestations (EAMs, Table 1).Table 1.Overview of baseline characteristics in AS pts depending on BMIDemographicsBMI ≤25 kg/m2 (N=224)BMI >25 to ≤30 kg/m2 (N=266)BMI >30 kg/m2 (N=177)Male*123 (54.9)178 (66.9)94 (53.1)Age, years**43.3 (12.1)47.5 (12.3)49.2 (11.0)BASDAI**4.8 (2.0)5.5 (1.8)5.5 (2.0)ASAS-HI**7.4 (3.7)7.7 (3.3)8.1 (3.6)Comorbidities/EAMs*Heart-related disease4 (1.8)12 (4.5)12 (6.8)Coronary heart disease4 (1.8)10 (3.8)8 (4.5)Stroke1 (0.4)0 (0.0)2 (1.1)Heart insufficiency1 (0.4)4 (1.5)8 (4.5)Uveitis11 (4.9)17 (6.4)13 (7.3)Depression88 (55.3)121 (58.2)73 (54.9)*variables are given as n (%); **variables given as mean (SD)Mean BASDAI developed similarly over time with lowest scores for normal weight and highest scores for obese AS pts (Figure 1A). Mean improvement from BL to w52 was 1.3 (27.1%) for normal weight, 1.5 (27.2%) for overweight, and 1.2 (21.8%) for obese AS pts.Figure 1.Disease activity and global functioning under secukinumab treatment in AS pts stratified by BMIMean ASAS-HI at BL was similar for all BMI subgroups (≤25: 7.4; >25-≤30: 7.7; >30: 8.1); the best improvement was observed in normal weight, the least in obese AS pts (Figure 1B). Mean improvement from BL to w52 was 2.1 (28.4%) for normal weight, 1.3 (16.9%) for overweight, and 0.6 (7.4%) for obese AS pts.The occurrence of AEs/SAEs with or without suspected relationship to secukinumab increased with increasing BMI. For example, the percentage of SAEs in normal weight was 21%, in overweight 26.7% and in obese AS pts 30.9% (data not shown). There were no events with fatal outcome or unexpected safety signals in either subgroup.ConclusionIn a real-world setting, secukinumab improved disease activity and global functioning and health in all BMI subgroups of AS pts; normal weight AS pts had numerically better ASAS-HI and BASDAI scores than obese AS pts. Altogether, real-world data of this interim analysis show that secukinumab is an effective treatment with a favorable safety profile up to 52 weeks in AS pts in all BMI subgroups.References[1]Chen, C.-H., et al. International Journal of Rheumatic Diseases23, 1165-1174 (2020).Disclosure of InterestsUta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, UCB, Grant/research support from: AbbVie, Chugai, Novartis, UCB, Pfizer, Daniel Peterlik Employee of: Novartis, Christina Budden Employee of: Novartis, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

BackgroundIn psoriatic arthritis (PsA), disease activity states have been defined using the DAPSA (Disease Activity index for Psoriatic Arthritis) score (1). The disease activity states have been validated using structural progression as the gold standard (2). However, the worsening in DAPSA states has not been compared to the patient’s perspective.ObjectivesTo assess the association between a worsening in disease activity (i.e., change in DAPSA disease activity category) versus the patient’s judgement of disease worsening.MethodsReFlap (NCT03119805) was a longitudinal study in 14 countries of consecutive adult patients with definite PsA and more than 2 years of disease duration. Patients were seen twice in the context of usual care, around 4 months apart (3). Worsening in disease activity between the 2 visits was defined as a transition to a more active disease category, based on the DAPSA categories [(remission, low disease activity (LDA), moderate disease activity (MDA) and high disease activity (HDA)] (1).This change was compared to (a) patient perceived-flares collected according to a patient-reported question: “At this time, are you having a flare of your psoriatic arthritis, if this means the symptoms are worse than usual?”; and (b) a worsening according to the MCID (Minimal Clinical Important Difference) question. The agreement between the definitions of worsening were calculated by frequency, Cohen’s kappa and prevalence adjusted bias adjusted kappa (PABAK). There was no imputation of missing data.ResultsOverall, 222 patients were analyzed: 127 (58.8%) were male, aged 53.5±12.3 years and with 10.8±8.3 years of disease duration. Disease activity was moderate: 35.9% had no current psoriasis skin lesions, mean tender joint count (TJC, 0-68) was 3.0±7.5, mean swollen joint count (SJC, 0-66) was 1.6±6.6, and mean DAPSA was 11.5±14.0.At 4.5±2.2 months follow-up, the proportion of DAPSA worsening was 40.1% [95% confidence interval, 33.9-46.7] (n=89). Most of the changes corresponded to patients going from remission to LDA (N=24, 27.0% of worsened patients) or from LDA to MDA (N=24, 27.0%).Patient-reported flares were reported in 27.0% [21.6-33.2] (n=60), and MCID worsening was reported in 14.0% [33.9-46.5] (n=31).Figure 1 shows the distribution of patients with worsening in DAPSA category, versus patient-defined worsening. Of the 89 patients who worsened according to DAPSA categories, 41 (46.1%) had self-perceived flares and 20 (22.5%) had worsening according to MCID. Among patients who worsened in DAPSA category, the mean change in DAPSA was higher in patients with self-perceived flares (increase of 22.2±15.0) than in patients without self-perceived flares (increase of 14.3±12.3). Of 133 patients with no worsening according to DAPSA, 114 (85.7%) had no self-perceived flares and 122 (91.7%) had no MCID worsening. The kappa [95% confidence interval] (PABAK) coefficients between DAPSA and either patient flare or MCID worsening were 0.34 [0.21-0.46] (0.40) and 0.16 [0.05-0.27] (0.28), respectively.Figure 1.Venn diagram for disease worsening between 2 visitsConclusionAfter 4 months of follow-up, 40.1% patients with long-standing PsA had a change in DAPSA category corresponding to more active disease. Most of these changes reflected transitions from remission to LDA, or from LDA to MDA. Among patients changing DAPSA category, only 46.1% reported themselves in flare at the second visit and only 22.5% reported themselves as worsened by MCID, leading to only fair (for flares) to low (for MCID worsening) agreement between the assessments of worsening. It is important to assess both disease activity, and the patient’s perspective of flare.References[1]Schoels M, et al. Ann Rheum Dis. 2016;75(5):811-8.[2]Aletaha D, et al. Ann Rheum Dis. 2017;76(2):418-421.[3]Gorlier C, et al. Ann Rheum Dis 2019;78:201-208.Disclosure of InterestsNone declared

BackgroundPatients with chronic inflammatory rheumatic diseases (CIRD) remain underrepresented in receiving vaccinations despite being disproportionately affected by infectious complications.ObjectivesTo systematically review the literature regarding vaccination willingness and vaccination hesitancy in CIRD patients with focus on the perspective of patients and physicians.MethodsA scoping review was conducted in PUBMED, EMBASE and the Cochrane Library through 2021. Study selection was performed by two independent reviewers, data were extracted using a standardized form and risk of bias was assessed using instruments from the McMaster University. Identified barriers and hurdles were synthesized by categorizing them into the WHO’s Measuring Behavioural and Social Drivers of Vaccination (BeSD) conceptual model.ResultsThe search yielded 1,644 hits, of which 30 were included (cross-sectional studies (n=27) based on interviews and 3 intervention studies). The majority of studies reported barriers to influenza and pneumococcal vaccination (n=11), or influenza vaccination only (n=9) from the patients perspective. Two studies assessed the attitudes towards COVID-19 vaccinations. Only one study assessed the view of rheumatologists. Patients mainly mentioned behavioral and social factors that negatively influence their willingness to be vaccinated while physicians see deficits in the organization and lack of time as a major barrier. Coverage of domains matched to the BeSD model suggests a lack of awareness of infection risk by both patients and physicians (Figure 1).Figure 1.Coverage of domains matched to the WHO BeSD ModelConclusionThe view of vaccination in CIRD patients diverges between patients and rheumatologists. Our results show that in-depth counseling on vaccines is important for patients, whereas physicians need support in implementing specific immunization recommendations. The themes identified provide a starting point for future interventions to improve vaccine rates in CIRD patients.Disclosure of InterestsNone declared

BackgroundThe interplay between humoral and cellular response after vaccination against SARS-CoV-2 in patients (pts.) with autoimmune inflammatory rheumatic diseases (AIRD) remains unknown.ObjectivesTo investigate the impact of different immunosuppressive therapies on the development of humoral and cellular immune responses to full 2-dose SARS-CoV-2 vaccination in AIRD pts. with stable low disease activity.MethodsThe immune reactivity to COVID-19 vaccination was investigated in a prospectively recruited AIRD cohort with rheumatoid arthritis, axial spondyloarthritis or psoriatic arthritis which received a therapy with IL-17i, TNFi, JAKi or MTX (alone or in combination). Almost all patients received mRNA-based vaccine, only 4 patients had a heterologous scheme. Anti-spike(S) antibodies(ab.) and sera neutralizing capacity (neutralization dilution 50; ND50) were measured 4 weeks after the first (prime+4w) and 4 weeks after the second vaccination (boost+4w). Vaccine-specific cellular immunity was evaluated by quantifying expression of activation markers on T cells as well as their production of key cytokines, at prime+4w and boost+4w.ResultsOverall, a total of 92 pts. were included in the final cohort. 31 (33.7%) pts. were on TNFi, 24 (26.1%) on IL-17i, 24 (26.1%) on JAKi, each group encompassing pts. receiving drug inhibitors alone or in combination with MTX.13 (14.1%) were treated with MTX alone. The median time between the vaccination and blood sampling was 31 [IQR: 28-34] days after prime+4w and 28 [IRQ: 28-28] days after boost+4w. Although at prime+4w only 34/90 (37.8%) of pts. presented neutralizing ab., the majority (86/91, 94.5%), developed them at boost+4w. The highest neutralization titer developed the pts. on IL-17i both at prime+4w (74 [IQR: 13-91]) and boost+4w (798 [IQR: 511-1344]), while no statistically significant differences were found in the neutralization titer at boost+4w for the TNFi, JAKi, and MTX groups: 207 ND50 [IQR: 120-576], 319 [IQR: 133-461] and 749 [IQR: 264-1920], respectively. 81/90 (90.0%) pts. developed IgG ab. against SARS-CoV-2 S-protein at prime+4w and 91/92 (98.9%) at boost+4w. Pts. receiving IL-17i developed higher ab. titers (8295 U/mL [IQR: 4586-11,237]) compared to the other three groups: JAKi (4405 U/mL [IQR: 1436-7265], TNFi (2313 [IQR: 1156-3630] U/mL) and MTX (2010 U/mL [IQR: 693-9254]). Neutralization capacity correlated well with the titer of anti-S ab. at both timepoints. Co-administration of biologic/tsDMARDs and MTX led to lower titers compared to biologic/tsDMARDs monotherapy. All therapies left frequencies of CD154+CD137+ CD4+ T cells and CD137+ CD8+ T cells at prime+4w and boost+4w unchanged. Polyfunctionality and T cell cytokine profiles across therapies did not significantly vary at boost+4w.ConclusionEven after insufficient seroconversion for neutralizing capacity and ab. response against SARS-CoV-2 S-proteins between pts. of different mod of action agents, particularly for MTX and JAKi after first vaccination, a second vaccination covered almost all pts. regardless of DMARDs therapy, with better outcomes in those on IL-17i. T cell immunity revealed similar frequencies of activated T cells in all modes of action after the second vaccination.Table 1.Demographics and therapyAllIL-17iIL-17i+MTXTNFiTNFi+MTXJAKiJAKi+MTXMTXPatients (n)9219527418613Age (years)50 [39-56]42 [36-53]37 [32-38]51 [42-56]58 [54-61]50 [43-56]55 [49-59]54 [37-64]Female sex46 (50.0%)6 (31.6%)3 (60.0%)10 (37.0%)3 (75.0%)13 (72.2%)3 (50.0%)8 (61.5%)Patients with concomitant glucocorticoids (n)13 (14.1%)1 (5.3%)1 (20.0%)0 (0.0%)0 (0.0%)5 (27.8%)3 (50.0%)3 (23.1%)Prednisolone dosage (mg)5.0 [2.5-5.0]5.0[5.0-5.0]3.0 [3.0-3.0]5.0 [2.5-5.0]2.0 [2.0-4.0]5.0 [4.0-5.0]IL interleukin, i inhibitor, MTX methotrexate: TNF tumor necrosis factor, JAK janus kinase. For quantitative variables, data are provided as median [IQR], for categorical variables the count (% frequency)AcknowledgementsWe thank all the patients who participated in this study. We thank the study nurses Gordana Brnos and Silke Kunkel for their support in the implementation of the study. We thank Toralf Roch, Sarah Skrzypczyk, Jan Zapka, Julia Kurek and Eva Kohut for their technical assistanceDisclosure of InterestsNone declared

The standardized assessment of health-related quality of life is becoming increasingly more important. The English questionnaire on psoriatic arthritis quality of life (PsAQoL) is a disease-specific instrument for measuring the quality of life of patients with psoriatic arthritis (PsA). The aim of the present study was to translate the PsAQoL into German and to validate the German version in a cohort of PsA patients recruited from routine care.The translation and validation of the PsAQoL questionnaire was carried out in a stepwise procedure involving affected patients with PsA. After translation of the original English questionnaire the German version was evaluated in a field test. The psychometric features of the questionnaire were then examined in a PsA cohort from routine care. In addition to the construct and group validity, the reliability of the questionnaire was tested using test-retest reliability and internal consistency. The physical functioning was measured with the health assessment questionnaire (HAQ) and domains of the quality of life with the Nottingham health profile (NHP).In a field test with 10 patients the German version of the PsAQoL questionnaire proved to be relevant, easily understandable and feasible (processing time 4.7 ± 2.1 min). A total of 126 patients (37.3% male, age 55.6 ± 11.3 years) were included in the validation cohort. The PsAQoL showed moderate correlation with the HAQ (r = 0.65) and moderate to good correlation with the NHP (subdomains r = 0.58-0.75). The internal consistency was high (Cronbach's α 0.92) and reliability in patients with stable disease course was very good (Spearman correlation coefficient 0.94). The PsAQoL can differentiate between different patient groups.The German translation of the PsAQoL provides a valid disease-specific instrument for the standardized assessment of health-related quality of life in patients with PsA. The psychometric characteristics of this questionnaire are comparable with the original English version. The German PsAQoL can therefore be recommended for clinical and scientific application.EINLEITUNG: Die standardisierte Beurteilung der gesundheitsbezogenen Lebensqualität gewinnt in der Rheumatologie zunehmend an Bedeutung. Der englische Fragebogen „Psoriasis Arthritis Quality of Life Questionnaire (PsAQoL)“ ist ein krankheitsspezifisches Instrument zur Messung der Lebensqualität von Patienten mit Psoriasisarthritis (PsA). Ziel der vorliegenden Arbeit ist die Übersetzung des PsAQoL ins Deutsche und die Validierung der deutschen Version in einer aus der Routineversorgung rekrutierten Kohorte von PsA-Patienten.Die Übersetzung und Validierung des Fragebogens PsAQoL wurde in einem mehrstufigen Verfahren unter Beteiligung von betroffenen Patienten mit PsA durchgeführt. Nach Übersetzung des englischsprachigen Fragebogens wurde die deutsche Version in einem Feldtest überprüft. Die psychometrischen Merkmale des Fragebogens wurden anschließend in einer PsA-Kohorte aus der Routineversorgung untersucht. Neben der Konstrukt- und Gruppenvalidität wurden die Zuverlässigkeit des Fragebogens mittels Test/Retest-Reliabilität sowie die interne Konsistenz getestet. Die körperliche Funktionsfähigkeit wurde mit dem Health Assessment Questionnaire (HAQ) und Domänen der Lebensqualität mit dem Nottingham Health Profile (NHP) gemessen.In einem Feldtest mit 10 Patienten erwies sich die deutsche Version des PsAQoL-Fragebogens als relevant, gut verständlich und durchführbar (Bearbeitungszeit: 4,7 ± 2,1 min). Insgesamt 126 Patienten (37,3 % männlich, Alter 55,6 ± 11,3 Jahre) wurden in die Validierungskohorte eingeschlossen. Der PsAQoL korrelierte moderat mit dem HAQ (r = 0,65) sowie moderat bis gut mit dem NHP (Subdomänen r = 0,58–0,75). Die interne Konsistenz war hoch (Cronbach’s α 0,92), und die Zuverlässigkeit bei Patienten mit stabilem Krankheitsverlauf war sehr gut (Spearman-Korrelationskoeffizient 0,94). Der PsAQoL kann zwischen unterschiedlichen Patientengruppen differenzieren.Mit der deutschen Übersetzung des PsAQoLs steht ein valides und krankheitsspezifisches Messinstrument zur standardisierten Erfassung der gesundheitsbezogenen Lebensqualität bei Patienten mit PsA zur Verfügung. Die psychometrischen Eigenschaften der englischsprachigen Originalversion sind vergleichbar. Der deutsche PsAQoL kann damit für die klinische und wissenschaftliche Verwendung empfohlen werden.

The often slow onset of ankylosing spondylitis (AS), the initially partially unspecific symptoms (back pain) and the scarcity of resources in rheumatological care are important factors leading to delayed diagnosis and treatment of these mostly young patients in Germany. Qualified nurses specialized in rheumatology might improve quality of care by providing medical services delegated by the rheumatologists.The aim was to investigate whether qualified nurses specialized in rheumatology can interpret anamnestic and clinical findings such as rheumatologists in patients with chronic low back pain and still unclear diagnosis using a structured questionnaire.In the multicenter PredAS study a structured anamnestic questionnaire was applied independently by qualified nurses specialized in rheumatology and rheumatologists to patients referred to rheumatology practices with the leading symptom of low back pain. The questionnaire covered basic demographic data, medical history and patient reported outcomes. Additionally, measurements of physical function using the Bath ankylosing spondylitis functional index (BASFI) and spinal mobility using the Bath ankylosing spondylitis metrology index (BASMI) were standardized. In order to test the possible facilitation by using digital media, the results of two patient groups were separately documented on paper-based report forms and on an i‑pad. Concordance between documentation by qualified nurses specialized in rheumatology and rheumatologists was studied by calculating Cohen's kappa, intraclass correlation coefficients (ICC) and percentage agreement on an individual patient level.Nearly 75% of the 141 patients with chronic low back pain were identified as having the characteristics of inflammatory back pain. The concordance of the documentation for the anamnesis of back pain by qualified nurses specialized in rheumatology and physicians was higher than for the localization of the back pain. The results for the BASMI showed no differences between qualified nurses specialized in rheumatology and physicians (ICC 0.925, 95 % confidence interval, CI 0.879-0.953). The time taken for the structured documentation was 20 ± 6.7 min for physicians and 28.5 ± 13 min for qualified nurses specialized in rheumatology.The results indicate that well-trained qualified nurses specialized in rheumatology have a high potential to take over some of the workload from rheumatologists during documentation of the anamnesis and the initial physical examination in the diagnosis of ankylosing spondylitis.HINTERGRUND: Der oft langsame Beginn einer axialen Spondyloarthritis (axSpA), die initial zum Teil wenig spezifischen Symptome (Rückenschmerzen), aber auch begrenzte Ressourcen und die damit verbundenen Verzögerungen in der rheumatologischen Versorgung sind Faktoren, die zu verspäteter Diagnose und Therapie dieser meist jungen Patienten mit beitragen. Rheumatologische Fachassistenten (RFA) können zur Verbesserung der Versorgung beitragen, indem sie vom Rheumatologen delegierte ärztliche Leistungen übernehmen.Ziel ist, zu untersuchen, ob geschulte RFA bei Patienten mit chronischem Rückenschmerz und noch unklarer Diagnose mithilfe eines strukturierten Fragebogens anamnestische und klinische Befunde wie Rheumatologen erheben können.In der multizentrisch durchgeführten PredAS-Studie wurden bei Patienten mit dem Leitsymptom chronischer Rückenschmerz demografische Basisdaten, Anamnese und patientenberichtete Endpunkte mittels strukturierter Fragebögen von RFA und Rheumatologen unabhängig voneinander erfasst. Zudem wurden Funktion (BASFI) und Wirbelsäulenbeweglichkeit (BASMI) standardisiert gemessen. Um die mögliche Erleichterung durch Nutzung digitaler Medien zu testen, wurden 2 Patientengruppen getrennt untersucht: Die Ergebnisse der einen Kohorte wurden mittels papierbasierter Case Report Forms (CRF) und die Ergebnisse der anderen elektronisch mittels iPad dokumentiert. Die Konkordanz der Dokumentationen zwischen RFA und Rheumatologen wurde als Kappa-Koeffizient, als prozentuale Übereinstimmung und auf individueller Patientenebene berechnet.Bei fast drei Viertel der 141 Patienten mit chronischen Rückenschmerzen wurden Charakteristika des entzündlichen Rückenschmerzes identifiziert. Die Konkordanz bei Dokumentation durch RFA und Arzt war bei den anamnestischen Angaben zum Rückenschmerz höher als bei der Angabe zur Lokalisation des Rückenschmerzes. Bei der Erhebung des BASMI zeigte sich kein Unterschied zwischen RFA und Arzt (ICC 0,925) (95 %-CI 0,879–0,953). Der Zeitaufwand für die strukturierte Dokumentation betrug beim Arzt 20 ± 6,7 min und bei der RFA 28,5 ± 13 min.Die Ergebnisse sprechen dafür, dass geschulte RFA die Rheumatologen bei der anamnestischen Aufarbeitung und ersten körperlichen Untersuchung im Rahmen der Diagnosestellung erheblich und qualifiziert unterstützen können.

Digitalization in the healthcare system is a great challenge for rheumatology as for other medical disciplines. The German Society for Rheumatology (DGRh) wants to actively participate in this process and benefit from it. By founding the commission on digital rheumatology, the DGRh has created a committee that deals with the associated tasks, advises the DGRh on questions and positions associated with digital health. For the DGRh, this affects the most diverse areas of digitalization in medicine and rheumatology. This position paper presents the topics and developments currently handled by the commission and the tasks identified.

ZusammenfassungDie durch Ablagerung von Natriumuratkristallen verursachte Gicht ist die häufigste rezidivierend auftretende Gelenkentzündung in Deutschland. Aufgrund der besonders im höheren Lebensalter ansteigenden Prävalenz der Gicht wird die Erkrankung in Deutschland sehr wahrscheinlich zunehmend an Bedeutung gewinnen. Wichtige Ziele von therapeutischen Interventionen sind zum einen die symptomatische Behandlung der akuten Arthritis und zum anderen die kausale Behand-lung der zugrundeliegenden metabolischen Ursache, der Hyperurikämie. Neben der zweifelsohne wichtigen medikamentösen Therapie (Harnsäuresenkung und Entzündungshemmung) hat die Veränderung von Lebensgewohnheiten bei Patienten mit Gicht einen möglichen positiven Einfluss auf den Erkrankungsverlauf. Eine bewusstere Ernährung, vor allem die Einschränkung des Alkohol-genusses, und eine dosierte Gewichtsabnahme, verbunden mit ausreichender Bewegung im Alltag, sind Faktoren, die nicht nur zu einem insgesamt besseren metabolischen Profil führen, sondern auch den Harnsäurespiegel positiv beeinflussen und die Lebensqualität der Patienten verbessern können. Letztlich ist es aber nur die konsequente dauerhafte Senkung des Serumharnsäurespiegels, die zur Verhinderung weiterer Gichtanfälle und möglicherweise auch zum Erhalt der Lebensqualität und Erwerbsfähigkeit führt. Die vorbeugende Therapie mit Colchizin unterstützt diesen Vorteil durch Verhinderung von Rezidivattacken.

Biosimilars have been approved for use in Germany for many years and in the meantime also in rheumatology but only a few years ago. Biosimilars, which are biotechnologically manufactured products the same as reference biologicals, have actually now achieved a substantial proportion of the market in some regions but there are still doubters among patients and physicians who fear a loss of quality even if there is no evidence for this. A part of this problem can be explained by the nocebo effect but which furthermore also has a substantial medical importance. This effect is described and explained in this article. Psychosocial and context-related factors, such as the relationship between patient and physician, previous experience with treatment and treatment expectations can either improve or impair the efficacy of treatment interventions. These phenomena are commonly known as placebo and nocebo effects. As placebo and nocebo effects can influence the development of symptoms, the frequency of undesired events and the efficacy of treatment, it is decisive to know these effects and to develop strategies for prevention in order to optimize the treatment results. Although in recent years experimental studies have achieved substantial progress in the clarification of the psychosocial and neurobiological mechanisms of placebo effects, detailed mechanisms of nocebo effects are still widely unexplored. An improved understanding of these mechanisms promises the development of user-friendly strategies for the clinical care to improve treatment results and patient satisfaction.

Drug treatment in patients with axial spondylarthritis (axSpA) aims to modify symptoms and complaints and currently includes the substance groups of nonsteroidal anti-inflammatory drugs (NSAID) and biologicals (disease-modifying antirheumatic drugs, bDMARDS). Treatment with NSAIDs is the first line treatment according to international and national recommendations. Patients with persisting high disease activity despite continuous standard treatment with NSAIDs, should be treated with biologicals. In Germany treatment with tumor necosis factor (TNF) inhibitors or interleukin 17 inhibitor (secukinumab) are currently approved for treating patients with ankylosing spondylitis (AS). Treatment of patients with non-radiographic axSpA (nr-axSpA) is restricted to TNF inhibitors (except infliximab) in Germany. The efficacy and safety are documented for both substance groups; however, due to the longer time since approval longitudinal data for TNF inhibitors are more robust and the data contain information about switching within a substance group. Although overall retention rates of TNF inhibitors are similar despite the difference in formation of antidrug antibodies, data from cohorts provide information about long-term loss of efficacy, switching and also discontinuation strategies. In the meantime, various biosimilars have been approved for infliximab, etanercept and adalimumab. Conventional basic treatment (csDMARDs) and in particular intra-articular administration of glucocorticoids can only be prescribed for axSpA patients with peripheral arthritis.

Axial spondylarthritis (axSpA) is a chronic inflammatory disease of the spine that can be associated with loss of physical function, mobility and upright postural impairment. Established tools for the assessment of function that are largely based on subjective perception are semiquantitatively recorded by standardized questionnaires (Bath ankylosing spondylitis functional index, BASFI), while measurement of spinal mobility of patients with axSpA is based on physical examination of various movement regions particularly the axial skeleton (Bath ankylosing spondylitis metrology index, BASMI). Recently, a performance test has been added to assess the range of motion and speed of certain tasks (AS performance-based improved test, ASPI); however, since these tests have limited reliability and reproducibility, more objective tests would be desirable. In this study the spinal mobility of patients with axSpA was quantified using the Epionics SPINE device (ES) and data were evaluated using the outcome measures in rheumatology (OMERACT) criteria. The ES automatically measures various patterns of spinal movements using electronic sensors, which also assess the range and speed of carrying out movements. Patients with back pain from other causes and persons without back pain served as controls. The measurement results obtained with ES differed between the groups and correlated with BASMI values (r = 0.53-0.82, all p = 0.03). Patients with radiographically detectable axSpA had more limited and slower mobility than those with non-radiographically detectable axSpA. Overall, the results presented here suggest that ES measurements represent a valid and objective measurement procedure of spinal mobility for axSpA patients.Die axiale Spondyloarthritis (axSpA) ist eine chronisch entzündliche Erkrankung der Wirbelsäule, die langfristig mit einem Verlust körperlicher Funktionen, der Beweglichkeit und der aufrechten Haltung einhergehen kann. Bisher gängige Methoden zur Messung der Beweglichkeit basieren zum einen auf subjektiver Patientenwahrnehmung, wobei verschiedene Funktionen durch standardisierte Fragebögen (BASFI) semiquantitativ erfasst werden, und zum anderen werden im Rahmen einer körperlichen Untersuchung verschiedene Bewegungsbereiche v. a. des Achsenskeletts vermessen (BASMI). Vor Kurzem kam der erste Test hinzu, mit dem die Durchführung und Geschwindigkeit bestimmter Aufgaben erfasst werden kann (ASPI). Da diese Tests nur begrenzt verlässlich und reproduzierbar sind, wäre ein objektiverer Test wünschenswert. In der hier berichteten Studie wurde die Mobilität der Wirbelsäule (WS) von Patienten mit axSpA mit dem Epionics SPINE-Gerät (ES) quantitativ untersucht und anhand der OMERACT(outcome measures in rheumatology)-Kriterien evaluiert. Das Gerät misst verschiedene Bewegungsmuster der Wirbelsäule anhand elektronischer Sensoren automatisiert, das schließt die Geschwindigkeit der Bewegungsdurchführung ein. Als Kontrollen dienten Patienten mit Rückenschmerzen anderer Genese und Menschen ohne Rückenschmerzen. Die mit ES erhobenen Messungen unterschieden sich zwischen den Gruppen und korrelierten mit den BASMI-Werten (r =0,53–0,82, alle p = 0,03). Röntgenologische axSpA-Patienten hatten zudem eine eingeschränktere und langsamere Beweglichkeit als die mit nr-axSpA. Insgesamt sprechen die Ergebnisse dieser Arbeit dafür, dass Messungen mit dem ES ein valides und objektives Messverfahren der Wirbelsäulenbeweglichkeit für axSpA-Patienten darstellen.

Early detection of patients with axial spondylarthritis (axSpA) in primary care is difficult. The combination of various parameters indicative of inflammatory back pain (AWARE criteria) was found to be beneficial in an initial study.Review of the criteria for the identification of young patients with axSpA and chronic back pain (≥3 months of back pain).In adult patients with chronic back pain and age at onset of symptoms45 years, orthopedic surgeons documented various possible axSpA characteristics before referral to the rheumatologist.Overall, the data from 1306 patients were recorded. Of these, ultimately 500 patients were also seen by rheumatologists, 199 patients (39.8%) were diagnosed with axSpA while 301 (60.2%) had non-specific back pain. A total of 87 patients had ankylosing spondylitis (44%) and 112 non-radiographic axSpA (56%). The ASAS classification criteria were fulfilled by 226 patients (45.2%). The mean age of axSpA patients was 38 years, 56% were male with a mean duration of back pain of 98 months. The AWARE criteria had a sensitivity and specificity of 69.3% and 40.3% (n = 343), respectively, when ≥4/5 criteria were chosen. Positive imaging for sacroiliitis using magnetic resonance imaging (MRI) or X‑ray was present in 77% of patients and positive HLA-B27 was identified in 59% of axSpA patients. The combination of positive imaging and HLA-B27 had the highest likelihood ratio for diagnosis of axSpA.Although the study design used here led to a preselection and thus to a bias in the statistical evaluation, the study confirmed the benefit of the AWARE criteria for the early detection of patients with axSpA. In further studies, the 2‑stage approach with initially 3 clinical questions and then an optional HLA-B27 test is currently being investigated further.

The Ruhrgebiet Rheumatism Center, which is highly specialized for rheumatic diseases, is the largest of its kind in Germany. For many years it has fulfilled all the requirements for structural quality required by the Association of Rheumatological Acute Clinics (VRA) including regular participation in the KOBRA benchmarking project. Therefore, the center regularly receives the VRA seal for quality of care. In 2018 more than 7500 patients were treated as inpatients. Within the framework of care according to §116b (ASV since May 2019) there were nearly 25,000 outpatient patient contacts. Furthermore, an early screening program (triage) was established 5 years ago in order to be able to identify patients with musculoskeletal complaints on a potentially inflammatory rheumatic basis. This functions in the sense of an early diagnosis and treatment in accordance with the treat-to-target concept within less than 4 weeks (initially) on an outpatient basis with respect to the required urgency, in order to subsequently provide sound diagnostic support. In the last 2 years 2017 and 2018, this deadline was met in more than 90% of cases. Within the scope of inpatient care approximately one third of patients were treated in recent years with a defined rheumatological complex therapy and 10% with pain complex therapy. Approximately 3% were treated with geriatric complex therapy and 65% were short-stay patients (4 days), i.e. patients who received the necessary diagnostics and treatment on an inpatient basis at short notice. The overall structure of the rheumatism center, the cooperation with rheumatologists in private practice, many cooperation partners, referring physicians and patients represents a model for rheumatological care in large conurbations. The care of large numbers of patients also enables the further training of many assistants and this is essential for the future of good rheumatological medicine.