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Summary Background Owing to increasing remission rates, the management of patients with rheumatoid arthritis in sustained remission is of growing interest. The Rheumatoid Arthritis in Ongoing Remission (RETRO) study investigated tapering and withdrawal of disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis in stable remission to test whether remission could be retained without the need to take DMARD therapy despite an absence of symptoms. Methods RETRO was an investigator-initiated, multicentre, prospective, randomised, controlled, open-label, parallel-group phase 3 trial in patients aged at least 18 years with rheumatoid arthritis for at least 12 months before randomisation who were in sustained Disease Activity Score using 28 joints with erythrocyte sedimentation rate (ESR) remission (score ClinicalTrials.gov ( NCT02779114 ). Findings Between May 26, 2010, and May 29, 2018, 303 patients were enrolled and allocated to continue (n=100), taper (n=102), or stop DMARDs (n=101). 282 (93%) of 303 patients were analysed (93 [93%] of 100 for continue, 93 [91%] of 102 for taper, and 96 [95%] of 101 for stop). Remission was maintained at 12 months by 81·2% (95% CI 73·3–90·0) in the continue group, 58·6% (49·2–70·0) in the taper group, and 43·3% (34·6–55·5) in the stop group (p=0·0005 with log-rank test for trend). Hazard ratios for relapse were 3·02 (1·69–5·40; p=0.0003) for the taper group and 4·34 (2·48–7·60; p Interpretation Reducing antirheumatic drugs in patients with rheumatoid arthritis in stable remission is feasible, with maintenance of remission occurring in about half of the patients. Because relapse rates were significantly higher in patients who tapered or stopped antirheumatic drugs than in patients who continued with a 100% dose, such approaches will require tight monitoring of disease activity. However, remission was regained after reintroduction of antirheumatic treatments in most of those who relapsed in this study. These results might help to prevent overtreatment in a substantial number of patients with rheumatoid arthritis. Funding None.

Despite aqualitatively 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 agroup 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 asystematic literature search were used as the basis for development. Atotal of 8QS, 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. © 2021. The Author(s)., Zusammenfassung 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.

Even in the era of modern guidelines, the treatment of rheumatic diseases is only as good as the framework of rheumatological care within which the treatment is carried out. The access to high-quality medical treatment for all patients is therefore essentially decisive for the prognosis of the patients. This article describes the current state of outpatient treatment in rheumatology and demonstrates which quality projects, such as treatment contracts, outpatient specialized medical treatment (ASV), digitalization and training as specialized rheumatological assistant (RFA), have been created in order to ensure the treatment of our patients. Furthermore, standards are defined that can guarantee a contemporary and guideline-conform treatment in outpatient rheumatological units. As an example it is an affirmation of the Professional Association of German Rheumatologists (BDRh) for ensuring optimal care for all rheumatology patients through early or emergency rheumatology clinics, treat to target, appropriate delegation of medical duties and diversification of treatment, thus an assurance of the quality and comprehensive treatment in rheumatology. The important topic of safeguarding the next generation of rheumatologists, which is indispensable for this, is also discussed.

Modern rheumatology enables better and earlier diagnosis and therapy of inflammatory rheumatic system diseases. At the same time, the requirements for the care of rheumatologic patients have risen considerably for non-medical assistant professions and specialists for nursing professions. Since 2006 there has been established an education curriculum "Rheumatological Specialist Assistant DGRh-BDRh" (RFA) with the training to become a "Rheumatological Specialist Assistant (DGRh-BDRh)". In Europe and in parallel in Germany, assistant professions are increasingly involved in the early detection and care of patients with rheumatic diseases and entrusted with tasks.In this work, the overarching principles for delegation of medical tasks to RFA and recommendations for the delegation are published by the Commission for Delegation of the German Society for Rheumatology (DGRh). These recommendations are based on the requirements of the German Medical Association and have been legally evaluated. With the extension of the training of the RFA board certification is aimed for "MFA for Rheumatology". These recommendations enable more transparency and security for delegating doctors and the delegated RFA's.

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.

In den letzten 4 Jahren wurden Selektivvertrage nach § 140a SGB V vom Berufsverband Deutscher Rheumatologen (BDRh) bzw. ab dem Jahr 2018 der BDRh-Service-GmbH als Vertragspartner mit 2 Krankenkassen und einer Krankenkassenorganisation abgeschlossen und in 5 Regionen (Bayern, Hessen, Mecklenburg-Vorpommern, Nordrhein und Sachsen) flachendeckend ausgerollt. Bis Ende 2018 wurden ca. 12.000 Patienten mit chronisch entzundlichen Rheumaformen in die Vertrage Besondere Versorgung Rheuma (BeVo Rheuma) eingeschrieben. Die Schnittstellen und Behandlungspfade wurde initial von den Verbanden der Hausarzte und Rheumatologen konsentiert. In das Versorgungskonzept ab 2018 sind facharztliche internistisch-rheumatologische Praxen, padiatrisch-rheumatologische Einrichtungen und Rheumaambulanzen eingebunden. Die Vertrage BV-Rheuma sind qualitatsorientiert und sollen zur Verbesserung der Versorgung beitragen. Qualitatsindikatoren wie eine Fruharthritissprechstunde, das Treat-to-Target-Prinzip, „tight control“, die Einbindung der rheumatologischen Fachassistenz und die Patientenschulung „Rheumatoide Arthritis“ (StruPi [strukturierte Patienteninformation]) werden gefordert. Die Forderung der Fruharthritissprechstunde fuhrte zu einem hohen Anteil an Erstvorstellungen (ca. 20 % der Patienten). Die Ausweitung der Vertrage auf mehrere Kassen und v. a. das bundesweite Roll-out sind die Ziele, fur die sich der BDRh einsetzt.

Real-world data are crucial to continuously improve the management of patients with rheumatic and musculoskeletal diseases (RMDs). The German RheumaDatenRhePort (RHADAR) registry encompasses a network of rheumatologists and researchers in Germany providing pseudonymized real-world patient data and allowing timely and continuous improvement in the care of RMD patients. The RHADAR modules allow automated anamnesis and adaptive coordination of appointments regarding individual urgency levels. Further modules focus on the collection and integration of electronic patient-reported outcomes in between consultations. The digital RHADAR modules ultimately allow a patient-centered adaptive approach to integrated medical care starting as early as possible in the disease course. Such a closed-loop system consisting of various modules along the whole patient pathway enables comprehensive and timely patient management in an unprecedented manner.

Considering the lack of studies determining the real TPTD efficacy in individuals who develop MRONJ, our objective was to combine the available data on MRONJ cases treated with TPTD. The findings demonstrated that TPTD in combination with another therapy, especially antibiotic therapy, can be considered an effective protocol for MRONJ.To integrate the data published on the effect of teriparatide (TPTD) therapy on cases of medication-related osteonecrosis of the jaws (MRONJ) into a comprehensive analysis of clinical features.An electronic search was undertaken in six databases. Descriptive analyses of clinicodemographic data of MRONJ were carried out. Poisson regression was also run to evaluate predictors of total resolution of MRONJ treated with TPTD.Twenty-six publications comprising 111 cases were included. Most reported cases affected female individuals (82.0%) with a mean age of 76.54 years. Osteoporosis (76.5%) represented the main reason for using antiresorptive drugs, with bisphosphonates (98.1%) as the most frequently reported. Comorbidities were commonly present. The most related trigger factor of MRONJ was dental extraction (61.7%). Mandible (75.8%) was the most commonly affected site, with a mean evolution time of 5 months. MRONJ stage 2 (61.3%) was the most prevalent. Regarding TPTD treatment, in 45.1% cases, TPTD was used alone, with the total resolution being observed in 59.5% of the individuals. Associated therapy (54.9%) included surgery, antibiotic therapy, and laser therapy. Mean follow-up was 8.7 months. Poisson regression demonstrated that individuals with MRONJ stage 1 were 1.21 times more likely to present total resolution of osteonecrosis than individuals with MRONJ stage 3 (CI = 1.02-1.43; p 0.023). Individuals who had undergone treatment with TPTD in association with another therapeutic modality were 1.21 times more likely to present total resolution of osteonecrosis than those who had undergone treatment with TPTD alone (CI = 1.40-1.39; p 0.010).TPTD in combination with another therapy, especially antibiotic therapy, should be considered an effective therapeutic modality for MRONJ.

BackgroundThe first vaccine against SARS-CoV-2 was approved in December 2020. Immunogenicity of SARS-CoV2 vaccines in patients with immune-mediated inflammatory disease (IMID) have so far been evaluated in the 2-6 weeks following complete vaccination and risk groups for poor early vaccine response have been identified leading to specific vaccination recommendations. However, data on the long-term course and persistence of vaccine response in IMID patients, as well as the outcomes of the specific recommendations are lacking.ObjectivesTo evaluate the long-term course of humoral response to SARS-CoV-2 vaccination in a large prospective cohort of IMID patients and non-IMID controls with a follow-up duration of up-to to 10 months after the first vaccine dose.MethodsWe have initiated a prospective dynamic cohort of IMID patients and healthy controls in February 2020 to monitor immune response to SARS-CoV-2 and respiratory infections including COVID-19 (1). Participants who contributed data starting from the 4 weeks before their first vaccination onwards were included in this analysis. Antibodies against SARS-CoV-2 spike protein were quantified with an ELISA from Euroimmun (Lübeck, Germany) with an optical density cutoff of 0.8. We fitted linear mixed-effect models for log-transformed antibody levels using time splines with adjustment for age and sex. Marginal mean antibody levels with 95% confidence intervals (CI) were estimated at selected time points for IMID patients and controls with double vaccination. We descriptively analyzed the observed antibody levels over time in cohort participants receiving two vaccinations vs. three vaccinations.ResultsAmong 5076 cohort participants, 3147 IMID patients and healthy controls (mean (SD) age 49 (16)) provided 4756 samples for this analysis between December 2020 and 2021, with a median (IQR) 28 (14-31) weeks of follow-up after the first vaccination (Table 1). 2965 (94%) participants had received at least 2 and 223 (7%) participants had received three vaccine doses by the date of their latest sampling. In IMID patients, age and sex-adjusted estimated marginal mean antibody levels waned after week 16 and were substantially reduced at all time points compared to the controls, finally dropping to the borderline range (1.01, 95%CI 0.86 to 1.19) at week 40 (Figure 1A, Table 1). A third dose was given to 128 (7%) of IMID patients with a poor response to 2 vaccine doses after a median 20 weeks of the second dose (IQR 10 to 26 weeks). After the third dose, antibody levels in IMID patients were comparable to those of healthy controls at 40 weeks who had three vaccine doses. These were also higher than that of IMID patients and controls who did not receive a third dose (Figure 1B).Table 1.Participant characteristics and antibody levelsHealthy controlsIMID N11991948 Age, mean (SD)40.8 (13.5)54.3 (14.8) Follow-up, weeks, median (IQR)31.1 (23.8-36.6)19.6 (12.3-26.6) Follow-up range, weeks,1.6-46.11.7-46.3Sex, n(%) Female554 (46.2)1136 (58.3)Vaccine intervals, ´median (IQR) 1st to 2nd dose4.6 (3.0-6.0)6.0 (5.0-6.1) 2nd to 3rd dose29.6 (26.9-36.4)19.9 (10.0-26.1)Diagnosis, n (%) Spondyloarthritis-713 (36.6) Rheumatoid arthritis-489 (25.1) Autoimmune disease, systemic+-420 (21.5) Inflammatory bowel disease-219 (11.2) Psoriasis-107 (5.5)Mean* antibody levels after 1st dose Week-84.16 (3.89 to 4.45)2.97 (2.83 to 3.12) Week-168.39 (7.81 to 9.02)5.04 (4.81 to 5.28) Week-325.02 (4.73 to 5.33)2.52 (2.32 to 2.74) Week-402.14 (1.95 to 2.35)1.01 (0.86 to 1.19)+ Systemic lupus, systemic sclerosis, Sjögren’s syndrome, vasculitis* Estimated marginal means adjusted for age and sex.Figure 1.ConclusionHumoral response to vaccination against SARS-CoV-2 was weaker in IMID patients compared to controls at all time points after the first vaccine dose and practically disappeared after 1 year. IMID patients can still achieve a good antibody response with a third dose even after a weak response with two doses.References[1]Simon D et al Nat Commun 2020Disclosure of InterestsNone declared

Even in the era of modern guidelines, the treatment of rheumatic diseases is only as good as the framework of rheumatological care within which the treatment is carried out. The access to high-quality medical treatment for all patients is therefore essentially decisive for the prognosis of the patients. This article describes the current state of outpatient treatment in rheumatology and demonstrates which quality projects, such as treatment contracts, outpatient specialized medical treatment (ASV), digitalization and training as specialized rheumatological assistant (RFA), have been created in order to ensure the treatment of our patients. Furthermore, standards are defined that can guarantee a contemporary and guideline-conform treatment in outpatient rheumatological units. As an example it is an affirmation of the Professional Association of German Rheumatologists (BDRh) for ensuring optimal care for all rheumatology patients through early or emergency rheumatology clinics, treat to target, appropriate delegation of medical duties and diversification of treatment, thus an assurance of the quality and comprehensive treatment in rheumatology. The important topic of safeguarding the next generation of rheumatologists, which is indispensable for this, is also discussed.Auch im Zeitalter moderner Leitlinien ist die Behandlung rheumatischer Erkrankungen nur so gut wie die rheumatologische Versorgung, in deren Rahmen die Behandlung erfolgt. Der Zugang zu einer qualitativ hochwertigen Medizin für alle Patienten entscheidet daher wesentlich über die Prognose der Patienten. Die vorliegende Arbeit beschreibt den aktuellen Stand der ambulanten Versorgung in der Rheumatologie und zeigt auf, welche Qualitätsprojekte, wie z. B. Versorgungsverträge, ambulante spezialärztliche Versorgung (ASV), Digitalisierung, Ausbildung zur rheumatologischen Fachassistentin (RFA) u. a., geschaffen wurden, um die Versorgung unserer Patienten zu sichern. Darüber hinaus definiert sie Standards, welche in ambulanten rheumatologischen Einheiten eine zeitgemäße und leitliniengerechte Behandlung sicherstellen können. Als Leitbild ist sie ein Bekenntnis des BDRh zur Versorgungssicherheit aller rheumatologischer Patienten durch Früh- bzw. Notfallsprechstunden, Treat-to-Target, angemessener Delegation ärztlicher Leistungen und Verbreiterung der Versorgung, also einer Sicherung der Qualität und umfassenden Versorgung in der Rheumatologie. Auch auf das wichtige Thema der Sicherung des rheumatologischen Nachwuchses, welches dafür unabdingbar ist, wird eingegangen.

Immune-mediated inflammatory diseases (IMIDs) of the joints, gut and skin are treated with inhibitors of inflammatory cytokines. These cytokines are involved in the pathogenesis of coronavirus disease 2019 (COVID-19). Investigating anti-SARS-CoV-2 antibody responses in IMIDs we observe a reduced incidence of SARS-CoV-2 seroconversion in IMID patients treated with cytokine inhibitors compared to patients receiving no such inhibitors and two healthy control populations, despite similar social exposure. Hence, cytokine inhibitors seem to at least partially protect from SARS-CoV-2 infection., Cytokine storm seems to be a common feature of severe COVID-19 pathology. Here, the authors show a reduced rate of SARS-CoV2 positivity in a large population of patients with immune-mediated inflammatory diseases if they are already being treated with cytokine or JAK inhibitors, indicating these treatments are safe to continue and are possibly protective against COVID19.

The aim of this case-control study was to evaluate the association between denture-related oral mucosal lesions and Alzheimer disease (AD) in older adults (60 years and older). Seventy elderly adults (35 with AD and 35 classified as mentally healthy) were included in this study, which was carried out in a Brazilian medical center. Clinical data on oral lesions and mucosal findings were recorded, including alterations in the color or appearance of any lesions, if present. The influence of possible confounding factors, including sex, age, race, education level, health conditions, harmful habits, gait speed, and oral status (use of removable prostheses and denture hygiene), was analyzed. There was no statistically significant difference between groups in the frequency of denture-related oral mucosal lesions. Logistic regression analysis showed a higher prevalence of AD among individuals aged 80 years and older, those who were illiterate, users of tobacco, and patients with a slower gait. These results suggest that AD is not a risk factor for denture-related oral mucosal lesions.

Objective.To analyze the effect of a risk-stratified disease-modifying antirheumatic drug (DMARD)–tapering algorithm based on multibiomarker disease activity (MBDA) score and anticitrullinated protein antibodies (ACPA) on direct treatment costs for patients with rheumatoid arthritis (RA) in sustained remission.Methods.The study was a posthoc retrospective analysis of direct treatment costs for 146 patients with RA in sustained remission tapering and stopping DMARD treatment, in the prospective randomized RETRO study. MBDA scores and ACPA status were determined in baseline samples of patients continuing DMARD (arm 1), tapering their dose by 50% (arm 2), or stopping after tapering (arm 3). Patients were followed over 1 year, and direct treatment costs were evaluated every 3 months. MBDA and ACPA status were used as predictors creating a risk-stratified tapering algorithm based on relapse rates.Results.RA patients with a low MBDA score (< 30 units) and negative ACPA showed the lowest relapse risk (19%), while double-positive patients showed high relapse risk (61%). In ACPA-negative and MBDA-negative (< 30 units), and ACPA or MBDA single-positive (> 30 units) groups, DMARD tapering appears feasible. Considering only patients without flare, direct costs for synthetic and biologic DMARD in the ACPA/MBDA-negative and single positive groups (n = 41) would have been €372,245.16 for full-dose treatment over 1 year. Tapering and stopping DMARD in this low-risk relapse group allowed a reduction of €219,712.03 of DMARD costs. Average reduction of DMARD costs per patient was €5358.83.Conclusion.Combining MBDA score and ACPA status at baseline may allow risk stratification for successful DMARD tapering and cost-effective use of biologic DMARD in patients in deep remission as defined by the 28-joint count Disease Activity Score using erythrocyte sedimentation rate.

Background The detection of joint swelling caused by synovitis is important for the diagnosis of inflammatory arthritis. Ultrasound (US) and MRI have proven to be more sensitive and reliable than physical examination, but they are time-consuming and expensive. The automated breast volume scanner was developed to acquire serial B-mode pictures of the female breast and these can be analyzed in all three dimensions. Objectives To analyze the value of automated B-mode ultrasound employing the ABVS system in detecting synovitis of the finger joints compared to manual ultrasound (mUS) and physical examination, using MRI as the gold standard. Methods 19 consecutive patients suffering from active rheumatoid (n=15) or psoriatic (n=4) arthritis were included. Automated and mUS were conducted with a linear array (ACUSON S2000™, 11 MHz). Multiplanar reconstruction enabled examination of the images for the presence of synovitis. Results 90% of the hand joints were assessable by automated ultrasound. Automated US detected 12.0, mUS 14.2, MRI 13.4, and clinical examination 4.1 positive joints – i. e. joints with synovitis - on average per patient. The inter-observer reliability of both assessors for automated and mUS, MRI, and physical examination, was 66.9%, 72.7%, 95.1%, and 88.9%, respectively. 84.3% of the joints classified as positive on MRI were confirmed by automated ultrasound, 85.5% on mUS, and 36.0 on physical examination. This translated into a sensitivity of 83.5%, 85.5%, and 36.0% for the three methods, respectively. Conclusion: Automated ultrasound is a promising ultrasound method for assessing small joints in patients with inflammatory arthritis.

Background:Due to better treatment strategies and higher remission rates the management of rheumatoid arthritis (RA) patients in sustained remission is of increasing interest (1). The Rheumatoid Arthritis in Ongoing Remission (RETRO) study investigated the possibility to taper and stop disease modifying anti-rheumatic drugs (DMARDs).Objectives:To compare one-year remission and relapse rates in rheumatoid arthritis patients randomized to continued treatment, reduced treatment or gradual treatment withdrawal after stable remission under routine care.Methods:Primary data of the phase III, randomized, controlled RETRO trial in RA patients with stable conventional synthetic and/or biologic DMARD treatment in sustained (>6 months) DAS28-ESR remission (Results:316 RA patients in sustained remission were included, 303 were randomized (CONT: N=100; TAP: N=102; STOP: N=101) and 282 (93%) had complete data sets after 1 year (CONT:N=93; TAP: N=93; STOP: N=96; Table 1). After 1 year, 81.2%, 58.6%, 43.3% of patients, maintained their remission state over 1 year in the CONT, TAP and STOP arms, respectively (p=0.0004 with log rank test for trend; Figure 1). Hazard ratios for flare were 3.02 (95%CI 1.69 to 5.40) and 4.34 (95%CI 2.48 to 7.60) for the TAP and STOP arms. RA patients who flared were more likely to be female, have longer disease duration, RF/ACPA positivity and higher baseline DAS-28 scores with standardized mean differences >0.2. Serious adverse events were reported in 10.8%, 7.5%, and 13.5% in the CONT, TAP and STOP arms, respectively.Table 1.Baseline CharacteristicsGroupControlReduceReduce/StopOverallN939396282Age, mean(SD)55.9 (12.7)56.9 (13.0)56.5 (13.3)56.5 (13.0)Female, n (%)53 (57.0)57 (62.0)57 (59.4)167 (59.4)RF, n (%)52 (55.9)58 (62.4)52 (54.2)162 (57.4)ACPA, n (%)53 (57.0)50 (54.9)55 (57.3)158 (56.4)Disease duration, years, mean(SD)7.6 (6.9)7.8 (6.9)6.8 (8.1)7.4 (7.3)Remission duration, months, mean(SD)20.6 (18.0)16.5 (15.9)22.7 (30.4)20.0 (22.6)Biologics, n (%)39 (41.9)44 (47.3)39 (40.6)122 (43.3)Methotrexate, n (%)71 (76.3)67 (72.0)75 (78.1)213 (75.5)Other DMARDs, n (%)24 (25.8)20 (21.5)16 (16.7)60 (21.3)Glucocorticoids, n (%)27 (29.0)23 (24.7)17 (17.7)67 (23.8)CRP, mg/L, mean(SD)0.3 (0.3)0.5 (0.5)0.5 (0.6)0.4 (0.5)ESR, mm/h, mean(SD)11.3 (8.4)12.2 (8.8)13.0 (10.0)12.2 (9.1)Tender joint count, mean(SD)0.2 (0.6)0.0 (0.2)0.1 (0.3)0.1 (0.4)Swollen joint count, mean(SD)0.1 (0.3)0.1 (0.3)0.1 (0.4)0.1 (0.3)Physician VAS,mm, mean(SD)1.8 (4.2)2.6 (4.4)2.0 (3.9)2.1 (4.2)Patient VAS,mm, mean(SD)6.4 (9.0)5.5 (8.3)4.5 (8.4)5.5 (8.6)HAQ, standard, mean(SD)0.2 (0.4)0.2 (0.3)0.2 (0.4)0.2 (0.4)HAQ, alternative, mean(SD)0.2 (0.4)0.1 (0.3)0.2 (0.3)0.2 (0.3)DAS-28, mean(SD)1.7 (0.7)1.7 (0.6)1.7 (0.6)1.7 (0.6)SDAI, mean(SD)1.4 (1.5)1.4 (1.5)1.3 (1.3)1.3 (1.4)DAS-28 remission, n (%)91 (97.8)93 (100.0)95 (99.0)279 (98.9)SDAI remission, n (%)79 (87.8)79 (84.9)88 (92.6)246 (88.5)Boolean remission, n (%)69 (75.8)71 (76.3)76 (79.2)216 (77.1)Conclusion:This randomized controlled study shows that half of RA patients in sustained remission relapse when tapering/stopping their DMARDs. Presence of autoantibodies, higher baseline DAS28-ESR and female sex are predictors for flares.References:[1]Schett G et al. Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions. Ann Rheum Dis. 2016 Aug;75(8):1428-37.Disclosure of Interests:Melanie Hagen Speakers bureau: advisory boards, Koray Tascilar Speakers bureau: advisory board, Michaela Reiser: None declared, Larissa Valor: None declared, Judith Haschka Speakers bureau: advisory board, Arnd Kleyer Speakers bureau: advisory board, Axel Hueber Speakers bureau: advisory boards, Bernhard Manger Speakers bureau: advisory boards, Jayme Cobra Speakers bureau: advisory boards, Camille Figuereido Speakers bureau: advisory boards, Stephanie Finzel Speakers bureau: advisory boards, Hans-Peter Tony Speakers bureau: advisory boards, Joerg Wendler Speakers bureau: advisory boards, Stefan Kleinert Speakers bureau: advisory boards, Florian Schuch Speakers bureau: advisory boards, Monika Ronneberger: None declared, Martin Feuchtenberger Speakers bureau: advisory boards, Martin Fleck Speakers bureau: advisory boards, Karin Manger: None declared, Wolfgang Ochs: None declared, Matthias Schmitt-Haendle: None declared, Hanns-Martin Lorenz Speakers bureau: advisory boards, Rieke Alten Speakers bureau: advisory boards, Jörg Henes Speakers bureau: advisory boards, Klaus Krueger Speakers bureau: advisory boards, Jürgen Rech Speakers bureau: advisory boards, Georg Schett Speakers bureau: advisory boards.

Background:There is some evidence that neuropsychiatric changes occur in systemic lupus(1) and rheumatoid arthritis(2). However, little is known regarding a possible disease-related impairment of cognitive abilities in axial spondyloarthritis (axSpA).Objectives:To evaluate patients with axSpA regarding cognitive impairments.Methods:Patients with axSpA attending two rheumatology practices were routinely evaluated by rheumatologists and underwent a computer-based memory and attention test (MAT) (3, 4) with subscale scores ranging from 0 (worst) to 15 (best). The results of short-term memory and working memory were compared to an age-, sex- and education-matched control group of healthy subjects. Descriptive results are presented as median (IQR) for interval data and n (%) for nominal data if not stated otherwise. Two-tailed Wilcoxon signed-rank tests including Bonferroni-Holm adjustment for multiple tests were conducted to investigate the magnitude of potential differences in cognitive abilities.Results:101 consecutive patients were tested (Table 1). After multiple testing adjustment for two subscales, Wilcoxon signed-rank tests returned significant findings for working memory (V = 539.5, p = 0.006, |r| = 0.204) but not for short-term memory (V = 1075, p = 0.351, |r| = 0.078). Regarding the scales’ anchors, descriptive results on pairwise differences suggested axSpA patients to have working memory scores that are on average 10.7% lower compared to control participants (mean Δ= -1.64, SD Δ= 5.95).Table 1.Patients and disease characteristicsn%MeanSDMedian25% Quantile75% QuantileAge10110051.111.6524260Age (female)4847.552.611.75444.561Age (male)5352.549.811.5514157< 13 years formal education4746.5≥ 13 years formal education5453.5HLA B27 positive n/N64/9263.4Disease duration (years)10110013.711.712421Disease duration (female, years)4847.511.69.99417.2Disease duration (male, years)5352.515.512.915523BASDAI9291.13.71.73.82.45BASFI9190.132.42.31.24.5BASMI7574.31.92.3103ASDAS98972.30.82.31.82.8Conclusion:The MAT computerized testing is a feasible test and was well accepted by patients. Results regarding working memory suggest that cognitive abilities needed to accomplish everyday tasks may be impaired in axSpA patients. Further work is needed to characterise possible causes of or associations with this cognitive impairment.References:[1]Zabala A, Salgueiro M, Saez-Atxukarro O, Ballesteros J, Ruiz-Irastorza G, Segarra R. Cognitive Impairment in Patients With Neuropsychiatric and Non-neuropsychiatric Systemic Lupus Erythematosus: A Systematic Review and Meta-analysis. J Int Neuropsychol Soc. 2018:1-11.[2]Vitturi BK, Nascimento BAC, Alves BR, de Campos FSC, Torigoe DY. Cognitive impairment in patients with rheumatoid arthritis. J Clin Neurosci. 2019;69:81-7.[3]Adler G, Bektas M, Feger M, Lembach Y. [Computer-based assessment of memory and attention: evaluation of the memory and attention test (MAT)]. Psychiatr Prax. 2012;39(2):79-83.[4]Adler G, Lembach Y. Memory and selective attention in multiple sclerosis: cross-sectional computer-based assessment in a large outpatient sample. Eur Arch Psychiatry Clin Neurosci. 2015;265(5):439-43.Acknowledgements:This study was funded by the RHADAR GbR (A Network of Rheumatologists), Bahnhofstr. 32, 82152 Planegg, Germany. RHADAR GbR has received a grant for this study from Novartis Pharma GmbH.Disclosure of Interests:Stefan Kleinert Consultant of: Novartis, Abbvie, Grant/research support from: Novartis, Praxedis Rapp: None declared., Florian Schuch Speakers bureau: Novartis, Abbvie, Gilead, Consultant of: Novartis, Abbvie, Gilead, Monika Ronneberger: None declared., Joerg Wendler Speakers bureau: Roche, Pharma, JanssenCilag, Novartis, Abbvie, Consultant of: JanssenCilag, Patrizia Sternad: None declared., Florian Popp: None declared., Peter Bartz-Bazzanella: None declared., Cay-Benedict von der Decken: None declared., Kirsten Karberg Speakers bureau: Roche, Sanofi, Abbvie, Lilly, Georg Gauler Speakers bureau: Abbvie, Gilead, Novartis, Lilly, Consultant of: Lilly, Gilead, Abbvie, Patrick Wurth Speakers bureau: Abbvie, Lilly, UCB, Medac, Susanna Spaethling-Mestekemper Speakers bureau: Abbvie, BMS, Celgene, Gilead, GSK, Hexal, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB, Christoph Kuhn: None declared., Matthias Englbrecht Speakers bureau: AbbVie, Chugai, Eli Lilly, Novartis, Roche, Sanofi, Mundipharma, Paid instructor for: AbbVie, Chugai, Roche, Consultant of: AbbVie, Novartis, Roche, Sanofi, Grant/research support from: Roche, Chugai, Wolfgang Vorbrüggen: None declared., Georg Adler: None declared., Martin Welcker Speakers bureau: Abbvie, Actelion, Amgen, Biogen,BMS, Berlin Chemie, Celgene, Galapagos, Gilead, GSK, Hexal, Janssen, Medac, MSD, Mundipharma, Mylan, Novartis, Pfizer, Roche, Sanofi, SOBI, UCB, Grant/research support from: Novartis, Abbvie.

In the last 4 years selective contracts according to §140a of the German Social Code Book V (SGB V) with three different health insurers were signed by the Professional Association of German Rheumatologists (BDRh) and from the beginning of the year 2018 by the management company of the association. The contracts were rolled out in five regions of Germany (Bavaria, Hesse, Mecklenburg-Western Pomerania, North Rhine and Saxony). Up to the end of 2018, 12,000 patients with chronic inflammatory rheumatic diseases were treated within the managed care of these contracts. The interface and the treatment pathways were initially consented with the associations of rheumatologists and general practitioners. The aim of the managed care was to provide the optimal quality in diagnostics and treatment and to improve management of rheumatic diseases. Quality indicators, such as treat-to-target principles, tight control, delegation to specially trained assistance personnel, patient education in rheumatoid arthritis (StruPi) and early arthritis consultation, are part of the managed care and are successfully promoted with incentive payments. Thus approximately 20% of the patients were enrolled for the first time in rheumatological care. The BDRh wants to promote the nationwide roll-out of this managed care in Germany with more participating health insurance funds.

Background Patients with rheumatic diseases have a high prevalence of depressive symptoms that affect the patients’ self-assessment, adherence to medication [1], and mortality [2]. Objectives To evaluate patients with rheumatic diseases regarding depressive symptoms by using the PHQ-2 (Patient Health Questionnaire with 2 items) and assess its feasibility during routine clinical practice. Methods 485 consecutive patients with rheumatic diseases attending a rheumatology practice that is part of the public health care system in Erlangen, Germany underwent a routine clinical assessment by different rheumatologists. In addition to disease-specific assessments and questionnaires, every patient answered two questions regarding depressive symptoms which form the PHQ-2 (range of 0[best] to 6[worst]). All questionnaires were answered digitally by touchscreen and Software RheumaDok and RheumaDokM (Nils Korber und Joachim Elgas G.b.R). A PHQ-2 score ≥ 3 points has a sensitivity of 87% and a specificity of 78% for detecting a major depressive disorder compared to a structured clinical interview. [3] A positive screening result was either addressed during subsequent medical consultation or by notifying the patient’s general practitioner. The PHQ-2 is a short form of the PHQ-9 which previously had been validated in rheumatoid arthritis. [4]. Results Overall, 26% of patients stated depressive symptoms (PHQ score ≥ 3). Table 1 shows the prevalence of depressive symptoms by disease entity which was not significantly different among the subgroups (χ2(5)=6, p=0.3). However, given our results indicating depressiveness to be common across subgroups, all of these patients merit further evaluation. The PHQ-2 was widely accepted by patients, and seemed very feasible due to its concise form. Conclusion The PHQ-2 questionnaire is a highly feasible and well accepted tool in routine clinical practice, helping to screen for depressive symptoms as a highly prevalent condition across rheumatic diseases. Real world evidence of depressive symptoms may improve healthcare by shedding light on the patients’ mental well-being and comorbidity. References [1] Brandstetter S, Riedelbeck G, Steinmann M, Loss J, Ehrenstein B, Apfelbacher C. Depression moderates the associations between beliefs about medicines and medication adherence in patients with rheumatoid arthritis: Cross-sectional study. J Health Psychol. 2016 May 04. [2] Kleinert S, Marx A, Faller H, M F, C K, Lehmann S, et al. Prevalence and Relevance of Depressive Symptoms in Patients with Rheumatic Diseases [abstract]. Arthritis Rheumatol 2015; 67 (suppl 10). 2015. [3] Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb; 58(2):163-171. [4] Englbrecht M, Alten R, Aringer M, Baerwald CG, Burkhardt H, Eby N, et al. Validation of Standardized Questionnaires Evaluating Symptoms of Depression inRheumatoid Arthritis Patients: Approaches to Screening for a Frequent Yet Underrated Challenge. Arthritis Care Res (Hoboken). 2017 Jan; 69(1):58-66. Disclosure of Interests Stefan Kleinert Grant/research support from: Novartis, Consultant for: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Speakers bureau: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Florian Schuch Consultant for: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie, Novartis, Speakers bureau: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie, Praxedis Rapp: None declared, Monika Ronneberger Consultant for: Celgene, Novartis, Paid instructor for: Abbvie, Bristol Myers Squibb, Novartis, Speakers bureau: Celgene, Novartis, Bristol Myers Squibb, Pfizer, Joerg Wendler Consultant for: Roche Pharma AG, AbbVie, Jannssen Cilag, Novartis, Speakers bureau: Roche Pharma AG, AbbVie, Jannssen Cilag, Novartis, Matthias Englbrecht Grant/research support from: Roche Pharma AG, Chugai Pharma Europe Ltd., Consultant for: Roche Pharma AG, Chugai Pharma Europe Ltd., AbbVie Deutschland GmbH & Co. KG, Celgene GmbH, Lilly Deutschland GmbH, Speakers bureau: Roche Pharma AG, Chugai Pharma Europe Ltd., AbbVie Deutschland GmbH & Co. KG, Celgene GmbH, Lilly Deutschland GmbH

Background Several studies including our own RETRO study have shown that tapering or stopping disease modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis (RA) patients in sustained remission is feasible (1-3). However, tapering/stopping bears the risk of decline in physical function as some patients may relapse and face increased disease activity. Objectives Here we analysed the impact of tapering or stopping DMARD treatment on the physical function of RA patients, who were randomized into continuation, tapering or stopping DMARD treatment in the RETRO study. Methods RETRO is a multicentre, parallel-group phase 3 trial in which RA patients in stable DAS-28-ESR remission were randomized to (i) DMARD tapering, (ii) stopping DMARDs after a 24-week-taper or (iii) control strategy that continued DMARDS.1,2,3 HAQ and DAS-28 scores were measured at 0, 3, 6, 9 and 12 months.1,2 Functional worsening was defined as a HAQ increase of≥0.25. We calculated incidences of functional worsening (per 100 person-months) in each treatment group with 95% Poisson confidence intervals and plotted event-free survival by treatment arm. The effect of treatment reduction strategy on functional worsening was assessed in a recurrent-event Cox regression model with control, taper or taper/stop group as the predictor. Results 201 patients were analysed. In 44 patients functional worsening was observed. Incidence (95%CI) of functional worsening was in the control 1.48 (0.77-2.59), taper 1.74 (0.95-2.92) and taper/stop arm 1.96 (1.16-3.10). The incidences suggest higher probability of functional worsening in tapering and/or stopping DMARDs, however at the end of study, functional worsening was similar among the groups (Figure). Thus, in comparison to the control group, hazard ratio (HR) (95%CI) for functional worsening was 1.21 (0.56 -2.62) in the taper arm and 1.32 (0.76-2.60) in the taper/stop arm. Conclusion Point estimates and survival curves show that functional decline after tapering or stopping DMARDs in RA patients with stable remission is small. Although the incidence figures suggest a trend these results do not reject with good certainty the null hypothesis of no worsening in functional status. Reference [1] Haschka, J. et al. 2016; 2 Rech, J. et al. 2016; 3 Hagen, M. et al. 2018 Disclosure of Interests Marlene Stephan: None declared, Koray Tascilar: None declared, Melanie Hagen: None declared, Judith Haschka: None declared, Michaela Reiser: None declared, Fabian Hartmann: None declared, Arnd Kleyer Grant/research support from: Lilly, Consultant for: Lilly, Speakers bureau: Abbvie, Axel Hueber Grant/research support from: Novartis, Pfizer, Consultant for: Lilly, Speakers bureau: Lilly, Novartis, Janssen, Abbvie, Bernhard Manger: None declared, Camille Figuereido: None declared, Jayme Cobra: None declared, Hans-Peter Tony Consultant for: Eli Lilly and Company, Speakers bureau: Eli Lilly and Company, Stephanie Finzel: None declared, Stefan Kleinert Grant/research support from: Novartis, Consultant for: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Speakers bureau: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Joerg Wendler: None declared, Florian Schuch Consultant for: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie, Novartis, Speakers bureau: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie, Monika Ronneberger: None declared, Martin Feuchtenberger: None declared, Martin Fleck: None declared, Karin Manger: None declared, Wolfgang Ochs: None declared, Matthias Schmitt-Haendle: None declared, Hanns-Martin Lorenz: None declared, Hubert Nuesslein: None declared, Rieke Alten Grant/research support from: Bristol-Myers Squibb, Speakers bureau: Bristol-Myers Squibb, Jorg Henes: None declared, Klaus Krueger: None declared, Georg Schett: None declared, Jurgen Rech Grant/research support from: Bristol-Myers Squibb and Celgene (greater than $10,000), Consultant for: Bristol-Myers Squibb, Celgene, Chugai, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Roche, Sanofi Aventis, and UCB (in total more than $10,000), Speakers bureau: Bristol-Myers Squibb, Celgene, Chugai, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Roche, Sanofi Aventis, and UCB (in total more than $10,000)

Background In 2006 the curriculum for rheumatology health professionals of the Academy of the German Association of Rheumatologists (DGRh) was developed. [1]. Since then more than 1400 health professionals (medical assistants [medizinische Fachangestellte] and nurses) were trained and are currently playing an increasing role in rheumatology practices in Germany. Objectives To evaluate the patients’ opinion on the assessment by medical assistants in general and regarding assessment and education on cardiovascular risk and vaccination. Methods Patients with rheumatoid arthritis were interviewed by a medical assistant in a rheumatology practice that is part of the public health care system with five rheumatologists in Erlangen, Germany A semi-standardized interview assessed disease activity, pain, medication, general health, and side effects of medication. A part of the patients was also assessed and educated regarding cardiovascular risk or vaccinations. Thereafter they were examined by the rheumatologist and finally asked to complete a questionnaire regarding their visit. The questions were numerical scales ranging from 0 [very good, very satisfied] to 10 [very poor/inadequate]. Results 293 Patients (mean age 61.3 ± 13.5 years, mean DAS28 2.8 ± 0.9, mean FFbH 76,4 ± 20.8) were documented between August and December 2018. 212 completed the general questionnaire, 34 regarding a structured cardiovascular assessment and education, and 18 regarding a structured assessment of vaccinations. Table 1 shows patients answers between 0 [very good, very satisfied] to 10 [very poor/inadequate]. Overall rating was excellent with a mean score of 1.0 (SD 1.5). The rating was only slightly different, if patients were assessed by medical assistants for the first time (n=111; mean score 1.2, SD 1.5), between the 2nd to 4th time (n=82; mean score 1.0, SD 1.3) or the 5th time or more (n=19; mean score 0.6, SD 0.6) Conclusion The semi-standardized assessment of patients with rheumatoid arthritis by medical assistants, the cardiovascular risk assessment and education, and the assessment and information on vaccination was very well accepted and appreciated by patients. Currently, there is no reimbursement by the German health care system. Reference [1] Schuch F, Kern P, Kreher G, Kruger K, Wendler J, Fiehn C. [Curriculum for “Rheumatology health professionals DGRh-BDRh” as a way of qualification for clinical nursing specialists : Concept and results of an evaluation]. Z Rheumatol. 2011 Oct; 70(8):670-677. Acknowledgement Statistical analysis was carried out by Dr. M. Englbrecht, Healthcare Data Scientist, Eckental, Germany. Disclosure of Interests Stefan Kleinert Grant/research support from: Novartis, Consultant for: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Speakers bureau: Novartis, UCB, Chugai, Celgene, Medac, Roche, Abbvie, Praxedis Rapp: None declared, Monika Ronneberger Consultant for: Celgene, Novartis, Paid instructor for: Abbvie, Bristol Myers Squibb, Novartis, Speakers bureau: Celgene, Novartis, Bristol Myers Squibb, Pfizer, Joerg Wendler Consultant for: Roche Pharma AG, AbbVie, Jannssen Cilag, Novartis, Speakers bureau: Roche Pharma AG, AbbVie, Jannssen Cilag, Novartis, Florian Schuch Consultant for: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie, Novartis, Speakers bureau: Celgene, Lilly, UCB, Roche, Sanofi-Aventis, Abbvie

An increase in general health literacy and a targeted patient information are important prerequisites for coping with the chronic disease in people with inflammatory rheumatic diseases. The education programs of the Working Group of Regional Cooperative Rheumatism Centers in the German Society for Rheumatology (AGRZ), such as StruPI, the offers of the German Rheumatism League (Deutsche Rheuma-Liga) and other elements provide a framework for those affected and their relatives, in which a participative decision-making (PEF) on equal terms can be possible. The physician-patient communication changes in the sense of a PEF and hopefully leads to a sustainably better patient compliance. Non-medicinal treatment, comorbidities and changes in life style are important issues in such cases. The StruPI is an established format for information and education of patients, particularly in outpatient rheumatism patients. In the midterm patient education (outpatient and inpatient) and self-management courses will be offered and honored nationwide, analogue to other chronic diseases, e.g. asthma and diabetes. Patients can influence the course of the disease by life style changes. The treatment of chronic diseases can only function in the long term in a consensual partnership.

ObjectiveTo determine the non-inferiority of nurse-led care (NLC) in patients with anticitrullinated protein antibody (ACPA)-positive and/or rheumatoid factor (RF)-positive rheumatoid arthritis (RA) with active disease who are starting disease-modifying antirheumatic drug therapy, following treat-to-target (T2T) recommendations.MethodsA multicentre, pragmatic randomised controlled trial was conducted to assess clinical effectiveness, anxiety, depression and patient satisfaction following a non-inferiority design. The participants were 224 adults with ACPA/RF-positive RA who were randomly assigned to either NLC or rheumatologist-led care (RLC). The primary outcome was the Disease Activity Score in 28 Joints measured with C reactive protein (DAS28-CRP) assessed at baseline and after 3, 6, 9 and 12 months. A DAS28-CRP difference of 0.6 was set as the non-inferiority margin. Mean differences between the groups were assessed following per-protocol and intention-to-treat strategies.ResultsDemographic data and baseline characteristics of patients in the NLC group (n=111) were comparable to those of patients in the RLC group (n=113). The improvement in disease activity (change in DAS28-CRP, primary outcome) over the course of 12 months was significant in both groups (pConclusionThis study supported the non-inferiority of NLC in managing T2T and follow-up care of patients with RA with moderate to high disease activity and poor prognostic factors in addition to RLC.Trial registration numberDRKS00013055.

The management of patients with spondyloarthritis (SpA) has experienced a paradigm shift in recent years. This is true for the treatment of axial as well as peripheral manifestations. International treat to target (T2T) recommendations for SpA based on the T2T strategy have now also been published, which contain 5 higher level principles (A-E) in addition to the 15 recommendations. In order to make the recommendations known and to promote national distribution, German experts have now issued a translation of the T2T recommendations for SpA into German.

In a joint initiative by the boards of the German Society for Rheumatology (DGRh) and the Association of Rheumatology Clinics (VRA) the European aEurostandards of care" for rheumatoid arthritis, recently suggested by the European Musculoskeletal Conditions Surveillance and Information Network (eumusc.net) and supported by the European League Against Rheumatism (EULAR), were translated and annotated. The recommendations include aspects of the management of the disease, actual medical care, and access to information - this includes all types of support people with RA need, and, last but not least communication of the necessary knowledge. Furthermore, health care structures such as the availability of medical staff with relevant expertise are also important.

Background DAS28-ESR is the most widely used instrument to assess remission in rheumatoid arthritis (RA) patients. Nonetheless, substantial residual disease activity can be present in RA patients fullfilling DAS28-ESR remission. Therefore, more stringent criteria for remission have been developed. While it is known that patients can fulfil DAS28-ESR but fail ACR/EULAR Boolean remission criteria, the existence of the reverse is less known. Objectives To test the possibility to loose DAS28-ESR remission while staying in ACR/EULAR remission in patients with RA Methods Data were obtained from the prospective randomised RETRO study (EudraCT: 2009–015740–42), which recruits RA patients in stable remission. Remission was assessed by the following instruments every three months: DAS28-ESR, DAS28-CRP, CDAI, SDAI, PAS, and ACR/EULAR criteria. In the group of patients, escaping DAS28-ESR remission, but fulfilling ACR/EULAR Boolean remission, the individual components of DAS28-ESR were analysed that determined their escape from remission. Results 142 patients analysed, which were all in DAS28-ESR remission at baseline. Of them, 140 (98.59%) were in DAS-CRP-remission, 131 (92.25%) in CDAI-remission, 130 (91.55%) in SDAI-remission, 109 (76.76%) in ACR/EULAR remission and 66 (46.48%) in PAS-remission. We analysed upon the 1 year follow up those patients loosing DAS28-ESR remission over time: 58 patients lost DAS-ESR remission at least once during the 4 follow-up visits. Surprisingly, 24% (3 months), 36% (6 months), 24% (9 months) and 28% (12 months) of the patients still fulfilled the Boolean remission criteria. The only plausible reason for failing DAS28-ESR remission but staying in ACR/EULAR remission is an isolated elevation of the ESR, not accompanied by increased signs and symptoms of disease. Indeed all patients loosing DAS28-ESR remission but staying in ACR/EULAR Boolean remission had an elevated ESR equal or higher than 15 mm. However, if DAS28 scores were calculated by C-reactive protein in the same patients, they all fulfilled remission criteria. Conclusions DAS28-ESR remission can be missed even if a patient fulfils the more stringent ACR/EULAR Boolean remission criteria. The reason for this remarkable constellation is an elevated erythrocyte sedimentation rate without any clinical symptoms. Hence, isolated elevations of erythrocyte sedimentation rate should be seen critical. These data show the limitations of individual instruments to assess remission in RA and show that interpretations of the erythrocyte sedimentation rate need to be done in the clinical context Disclosure of Interest None declared

Background Medical Applications have the potential to support physicians and patients to document the course of the disease and optimize therapies. We describe the linkage and integration of patient reported outcomes (PROs) into existing medical office software and rheumatologic documentation systems by means of the digital applications RheumaLive and AxSpALive. RheumaLive is certified as medical product class I, and certification for AxSpALive is in preparation. Methods RheumaLive and AxSpALive are applications that can be downloaded free of charge from the common app-stores (Android, Apple) and installed on mobile devices (smartphones, tablets). A freeware version for PCs is also available (Windows- und Mac OS X-Version). A diary functionality allows to document the medication uptake (partially filed, memory-functionality for medication uptake available), validated scores like VAS, SJC, morning stiffness, FFBh (comparable to HAQ), BASDAI, RADAI, etc. and days of sick leave (+/- related to the rheumatic disease). All App-versions are password-protected, which is provided by the treating rheumatologist (relationship patient-physician). The patient reported outcomes are stored locally on the respective device. For the subsequent visit, they can be printed or sent encrypted to the treating physician via internet in a prespecified interval. A specific software allows to integrate the data into the existing medical office software. In daily practise, data entered by patients into RheumaLive can be screened and compared with collected clinical data and laboratory measures, because of it9s certification as medical product. In case of an increasing disease activity the patient can be rapidly contacted and medication can be modified, if necessary. Regular F2F-appointments remain integral part of the medical care, even in case of good controlled disease activity. But in case of F2F-appointments, PROs can be delivered by patients, saving time and resources. The PROs can be made available to rheumatologic documentation systems like RheumaDok via predefined interfaces. Results In a first pilot phase 54 patients in 4 rheumatologic specialised practices were documented. In the next phase the number of patients and participating practices/centres shall be increased. Further studies are necessary to show if the integration of PROs which are collected via electronical application can lead to an improvement of rheumatologic diseases. Conclusions The integration of PROs collected with RheumaLive and AxSpALive into existing rheumalogic documentation systems allows a close monitoring of disease courses and therapies according to the “tight control” principle. Acknowledgements RheumaLive and AxSpALive werde developed by Starhealth GmbH on behalf of UCB Pharma GmbH. Disclosure of Interest M. Feuchtenberger Speakers bureau: UCB, S. Kleinert Speakers bureau: UCB, F. Schuch Speakers bureau: UCB, S. Spahtling-Mestekemper Speakers bureau: UCB, C. Kuhn: None declared, M. Welcker Speakers bureau: UCB

Background The datanetwork Rheuma 4.0 (DNR_4.0) is a consortium of 5 internistic-rheumatologic specialized practices. Patient data that were collected routinely will be pooled pseudonymized (e.g. via RheumaDok) and will be made available to answer numerous healthcare- and scientific research questions. Methods The participating centres document the following data in specific rheumatologic data documentation systems (RheumaDok, Emil, DocuMed.rh). These data will be routed automatically to the data base of the DNR_4.0 via a prespecified interface and can be used for certain research areas: Diagnosis (by rheumatologist (R), anamnesis (R), medication (R), morning stiffness (R, patient (P)), scores like RADAI (R, P), DAS28 (R), BASDAI (P), BASFI (P), quality of life (R, P). Also prespecified laboratory measures (R) like ESR, CRP etc. can be collected automatically. Patient reported Outcomes (PROs) that were entered via mobile applications like RheumaLive and AxSpALive can be collected in certain intervalls and be sent encrypted into the medical office data base. The data entered by patients will be screened by the rheumatologist or nurse and will be stored in the underlying data base. Clinical data that are collected during regular F2F-appointments will be stored together with the PROs according to a specific period of time. Results The datanetwork Rheuma 4.0 (DNR_4.0) is an association of 5 internistic-rheumatologic specialized practices. By the automated documentation of PROs (patient) and medical measures (rheumatologist) in an underlying data base, scientific and health care real worl data can be collected without extra workload or time requirements. These data are specific and different from data collected by other centres. In principal, the extension of the group to increase the number of participating centres is easily possible because the interface is an “open system”. This allows to build an automised collecting, big and representative data base. Now pooled data sets of 18.000 patients are available in the data base. In a first step, quality and the completeness of the existing data sets will be evaluated and the daily documentation routines will be described. Anonymised statistical analysis of the pooled data sets of the rheumatologic centres will allow to gain knowledge in respect to health care research of the own working group and external interested parties like research groups, sick funds, insurance companies and companies. Conclusions The german biologic registry Rabbit and the “Core documentation” data base deliver valid data about the safety and efficacy of rheumatologic medication. The datanetwork Rheuma 4.0 will make a valuable contribution – especially in conjunction with apps of patient9s self management like RheumaLive and AxSpALive – to health care research, therapeutic strategies and clinical questions from daily practice. Acknowledgements RheumaLive and AxSpALive werde developed by Starhealth GmbH on behalf of UCB Pharma GmbH. Disclosure of Interest S. Kleinert Speakers bureau: UCB, F. Schuch Speakers bureau: UCB, S. Spathling-Mestekemper Speakers bureau: UCB, M. Feuchtenberger Speakers bureau: UCB, C. Kuhn: None declared, M. Welcker Speakers bureau: UCB

Background Tumor necrosis factor inhibitors (TNFi) are the most frequently used bDMARDs in RA patients. TNFi induces remission in a substantial numbers of patients. Once remission, particularly sustained remission is achieved the question arises whether TNFi can be successfully tapered. To date biomarkers, which can help to predict if TNFi can be tapered or stopped, remain to be developed. Objectives To test whether residual subclinical inflammation assessed by multi-biomarker disease activity (MBDA) predicts the risk of disease relapse after tapering or stopping TNFi treatment in RA patients in sustained remission. Methods Sub-analysis of TNFi treated patients of the RETRO study, a randomized-controlled study in RA patients in sustained (>6 month) DAS28 remission comparing 3 different DMARD treatment strategies (continuation of full dose, 50% dose tapering, stopping after 50% dose tapering). Patients were followed over one year for the occurrence of relapses as defined by leaving DAS28-ESR remission (>2.6 units) (1). Vectra-DA tests were done in the baseline samples of all patients included into the RETRO study. MBDA score was calculated according to previously defined algorithms with low MDBA score defined as Results Of the 151 patients included in the RETRO study, 42 received TNFi treatment (mean age: 56 ys, 25 (60%) females, 78% concomitant csDMARDs; 69% ACPA/RF positive. Baseline demographic and disease specific characteristics of these patients were comparable to the non-TNFi treated patients of the RETRO study. 26/42 patients (62%) had low MBDA scores at baseline, while 16/42 (38%) had moderate/high scores. Relapse rates were significantly (chi square p=0.016) lower in RA patients with low MBDA scores (N=8 of 26; 31%) than in those with moderate/high scores (N=11 of 16; 69%) (Figure; left graph). When separately analyzing only patients tapering TNFi (N=29), relapse rates were moderate in RA patients with low MBDA scores (N=6 of 16; 37%) but high in those with moderate/high scores (N=10 of 13; 77%) (chi square p=0.015) (Figure; right graph). Conclusions These data show that the majority of RA patients in sustained clinical remission with low MBDA scores can successfully taper TNFi. In contrast tapering cannot be recommended in patients with moderate to high MBDA scores, as relapse rates are high in these patients. References Haschka J et al. Ann Rheum Dis 2016,75;45–51. Curtis JR et al. Arthritis Care Res 2012;64:1794–803. Disclosure of Interest None declared

Background Achieving remission is the ultimate treatment goal in patients with rheumatoid arthritis (RA). With the development and wider use of highly effective disease modifying anti-rheumatic drugs (DMARD) about half of RA patients reach the disease remission state (1), raising the question about tapering or stopping anti-rheumatic treatment and appropriate predictors (2). Objectives To analyse the effect of a risk-stratified DMARD tapering algorithm based on multiple-biomarker disease activity (MBDA) score and anti-citrullinated protein (ACPA) status for successful DMARD tapering and treatment cost reduction in RA patients in sustained remission enrolled in the prospective randomized controlled RETRO study (3,4). Methods MBDA scores and ACPA status were determined in the baseline samples of 146 patients in sustained remission. Patients either continued DMARDs (arm1), tapered dose by 50% (arm 2) or stopped DMARDs after tapering (arm 3) for one year according to the RETRO study protocol. Direct treatment costs (including testing costs at baseline) were evaluated every three months. MBDA and ACPA status were used as predictors creating a risk-stratified tapering algorithm based on relapse rates. Results RA patients with a low MBDA score ( Conclusions Combining MBDA score and ACPA status allows risk stratification for successful DMARD tapering and cost-effective use of biologic DMARD. Given that previous data of the RETRO have shown that patients relapsing after tapering their DMARDs respond well to their reintroduction, a stratified tapering and stopping of DMARDs is not only a cost economic but also clinically feasible strategy. References Aga AB et al. Ann Rheum Dis. 2013;74:381–8. Schett G et al. Ann Rheum Dis. 2016 Aug;75(8):1428–373. Haschka J et al, Ann Rheum Dis. 2016;75:45–51. Rech J et al, Ann Rheum Dis. 2015; Oct. 19. Disclosure of Interest None declared

The management of patients with spondyloarthritis (SpA) has experienced a paradigm shift in recent years. This is true for the treatment of axial as well as peripheral manifestations. International treat to target (T2T) recommendations for SpA based on the T2T strategy have now also been published, which contain 5 higher level principles (A-E) in addition to the 15 recommendations. In order to make the recommendations known and to promote national distribution, German experts have now issued a translation of the T2T recommendations for SpA into German.

In a joint initiative by the boards of the German Society for Rheumatology (DGRh) and the Association of Rheumatology Clinics (VRA) the European "standards of care" for rheumatoid arthritis, recently suggested by the European Musculoskeletal Conditions Surveillance and Information Network (eumusc.net) and supported by the European League Against Rheumatism (EULAR), were translated and annotated. The recommendations include aspects of the management of the disease, actual medical care, and access to information - this includes all types of support people with RA need, and, last but not least communication of the necessary knowledge. Furthermore, health care structures such as the availability of medical staff with relevant expertise are also important.

ObjectiveTo perform a detailed analysis of the autoantibody response against post-translationally modified proteins in patients with rheumatoid arthritis (RA) in sustained remission and to explore whether its composition influences the risk for disease relapse when tapering disease modifying antirheumatic drug (DMARD) therapy.MethodsImmune responses against 10 citrullinated, homocitrullinated/carbamylated and acetylated peptides, as well as unmodified vimentin (control) and cyclic citrullinated peptide 2 (CCP2) were tested in baseline serum samples from 94 patients of the RETRO study. Patients were classified according to the number of autoantibody reactivities (0–1/10, 2–5/10 and >5/10) or specificity groups (citrullination, carbamylation and acetylation; 0–3) and tested for their risk to develop relapses after DMARD tapering. Demographic and disease-specific parameters were included in multivariate logistic regression analysis for defining the role of autoantibodies in predicting relapse.ResultsPatients varied in their antimodified protein antibody response with the extremes from recognition of no (0/10) to all antigens (10/10). Antibodies against citrullinated vimentin (51%), acetylated ornithine (46%) and acetylated lysine (37%) were the most frequently observed subspecificities. Relapse risk significantly (p=0.011) increased from 18% (0–1/10 reactivities) to 34% (2–5/10) and 55% (>5/10). With respect to specificity groups (0–3), relapse risk significantly (p=0.021) increased from 18% (no reactivity) to 28%, 36% and finally to 52% with one, two or three antibody specificity groups, respectively.ConclusionsThe data suggest that the pattern of antimodified protein antibody response determines the risk of disease relapse in patients with RA tapering DMARD therapy.Trial registration number2009-015740-42; Results.

ObjectiveTo analyse the role of multibiomarker disease activity (MBDA) score in predicting disease relapses in patients with rheumatoid arthritis (RA) in sustained remission who tapered disease modifying antirheumatic drug (DMARD) therapy in RETRO, a prospective randomised controlled trial.MethodsMBDA scores (scale 1–100) were determined based on 12 inflammation markers in baseline serum samples from 94 patients of the RETRO study. MBDA scores were compared between patients relapsing or remaining in remission when tapering DMARDs. Demographic and disease-specific parameters were included in multivariate logistic regression analysis for defining predictors of relapse.ResultsModerate-to-high MBDA scores were found in 33% of patients with RA overall. Twice as many patients who relapsed (58%) had moderate/high MBDA compared with patients who remained in remission (21%). Baseline MBDA scores were significantly higher in patients with RA who were relapsing than those remaining in stable remission (N=94; p=0.0001) and those tapering/stopping (N=59; p=0.0001). Multivariate regression analysis identified MBDA scores as independent predictor for relapses in addition to anticitrullinated protein antibody (ACPA) status. Relapse rates were low (13%) in patients who were MBDA−/ACPA−, moderate in patients who were MBDA+/ACPA− (33.3%) and MBDA−ACPA+ (31.8%) and high in patients who were MBDA+/ACPA+ (76.4%).ConclusionsMBDA improved the prediction of relapses in patients with RA in stable remission undergoing DMARD tapering. If combined with ACPA testing, MBDA allowed prediction of relapse in more than 80% of the patients.Trial registration numberEudraCT 2009-015740-42.

Die rheumatologische Versorgung in Deutschland ist beeinflusst von limitierten Ressourcen. Die Professionalisierung von medizinischen Assistenzberufen ist ein Weg, Ressourcen besser zu nutzen. Das Curriculum „Rheumatologische Fachassistenz DGRh-BDRh“ der Deutschen Gesellschaft fur Rheumatologie (DGRh) und des Berufsverbands der deutschen Rheumatologen (BDRh) wurde entwickelt, um systematisch Fachassistenten aus Ambulanz und Klinik zu qualifizieren. Seit 2006 wurden insgesamt 499 Teilnehmer an jeweils 4 Wochenenden geschult und der Erwerb der Qualifikation durch Examen uberpruft. Das Themengebiet umspannt Grundlagen der Anatomie und der Krankheitslehre bis hin zu modernen Methoden der Diagnostik und Therapie, inklusive praktischer Fahigkeiten. Aufbauend auf diesem Grundkurs wurden ein Kurs „Stationare Pflege“ und ein „Refresher-Kurs“ entwickelt. Nach 8 Grundkursen wurde eine Evaluation vorgenommen. Der Rucklauf lag bei 51,6%. 95% gaben an, dass sich ihr Wissen zum Verstandnis rheumatologischer Erkrankungen „sehr deutlich“ bzw. „deutlich“ verbessert hat; 90% antworteten, dass sie „Akuttermine“ besser abschatzen konnten, und 86% gaben an, bei der Einschatzung einer Notfallsituation sicherer zu sein. 50% der Befragten bestatigten, dass sich ihr Arbeits- und Aufgabenfeld geandert habe. So wurden u. a. selbststandigeres Arbeiten, Erheben einer orientierenden Anamnese, Betreuung von Studien, Information und Anlegen von Infusionen als neue Bereiche genannt. Zusammenfassend zeigen die Ergebnisse, dass das Curriculum ein wirksamer Schritt in Richtung der Professionalisierung medizinischer Assistenzberufe ist.

Radiosynovectomy or radiosynoviorthesis (RSO), the intra-articular injection of beta-emitting radionuclides (e.g. colloidal preparations of 90-Yttrium, 186-Rhenium or 169-Erbium), is an approved, reliable and easily performed therapy for the treatment of chronic synovitis without harmful side effects. The best clinical results have been obtained in patients with predominantly inflammatory joint disease such as rheumatoid arthritis or reactive arthritis. But RSO is also established to treat pain and persistent effusions after total knee replacement. It also represents an adjuvant therapy in patients with pigmented villonodular synovitis to protect against recurrence following synovectomy. In patients with hemophilia and arthropathy a reduction in joint bleeding is seen and the use of coagulation factor is reduced. The indication for RSO should be made in close cooperation between the referring physician, the rheumatologist and the nuclear medicine expert in the context of a multimodal therapy concept. In this way, success rates of over 80%, with only few side effects, can be achieved, particularly in rheumatoid arthritis, reactive arthritis and hemophilic arthropathy.

Nowadays nitrided gears have been successfully introduced for applications such as steering gears in engines, internal gears in transmissions and other not very highly loaded applications. In future, the fast growing market for top performance gears in the vehicle industry with its high load demand, is a particularly promising expansion area. Especially here is a need for reliable fatigue data from optimized material-plasmanitriding combinations. To generate such fatigue data in a fast and cost effective way, a step by step approach with specially designed specimens and test procedures has been chosen. This paper discusses the results of the first steps and gives an outlook on the steps ahead. The first part of this investigation focuses on bending fatigue strength of the gear tooth, while other failure modes, such as pitting, will be tested in the second part of the project.

Objectives: To investigate remission rates in rheumatoid arthritis patients exposed to tocilizumab treatment in real life clinical practice and to test whether concomitant conventional and previous biological disease modifying anti-rheumatic drugs treatment affects the efficacy of tocilizumab to reach remission. Methods: Between January 2009 and December 2012 disease activity was analyzed in 272 rheumatoid arthritis patients exposed to tocilizumab at the onset of treatment and sequentially thereafter, i.e. every four weeks at the time of infusion. Aside from demographic and disease-specific variables, previous and concomitant conventional and biologic disease modifying anti-rheumatic drugs therapy was documented in all patients. Multivariate logistic regression analyses were conducted to identify factors influencing Disease Activity Score 28 remission and attrition to tocilizumab treatment. Results: 219 (80.5%) of all patients were female. Mean Age was 55.48 ± 13.23 years and our patients had mean disease duration of 12.48 ± 9.30 years. Disease Activity Score 28 significantly decreased from 5.00 ± 1.52 at baseline to 3.09 ± 1.49 at the latest infusion. Mean treatment period was 58.28 ± 43.95 weeks. A total of 101 patients (42.8%) achieved Disease Activity Score 28 remission, which was significantly associated to the length of tocilizumab exposure. Achievement of Disease Activity Score 28 remission was independent from the concomitant use of conventional disease modifying anti-rheumatic drugs. Previous exposure to tumour necrosis factor inhibitors but not rituximab significantly reduced the likelihood to achieve Disease Activity Score 28 remission. Two logistic regression analyses revealed baseline disease activity and duration of tocilizumab therapy as independent factors for Disease Activity Score 28 remission, whereas age and concomitant methotrexate therapy were linked to attrition to tocilizumab treatment. Conclusion: Remission rates found in this observational study are comparable to those of randomized controlled trials and those of big post-marketing surveillance studies. Remission rates of rheumatoid arthritis patients treated with tocilizumab in clinical practice are not influenced by concomitant disease modifying anti-rheumatic drugs use. Previous exposure to tumour necrosis factor inhibitors but not to rituximab decreases the chance to reach remission with tocilizumab.

O interesse em materiais dosimétricos opticamente estimulados (OSL) para aplicação em Radioterapia vem crescendo devido ao seu potencial uso em controle da qualidade. O uso desses dosímetros em dosimetria in vivo, entretanto, pode influenciar a dose na pele e em profundidade no paciente. O objetivo desse trabalho é a avaliação da influência do material OSL Al2O3, na dose depositada na pele e em profundidade em tratamentos radioterápicos. Simulação Monte Carlo foi utilizada para avaliar esse propósito, quando dosímetros OSL são utilizados na superfície da pele do paciente. Curvas de porcentagem de dose profunda para feixes clínicos de 6 e 10 MV foram simuladas com e sem a presença do dosímetro na superfície de um objeto simulador homogêneo de água. Os resultados obtidos evidenciaram uma diminuição nas doses em regiões próximas à superfície da pele. Na região de build-up, as máximas diminuições nas doses, produzidas pela presença dos dosímetros, foram de 52,5% e 47,5% para os feixes de 6 e 10 MV, respectivamente. Após a região de build-up, não há aumento significativo de dose para nenhum dos feixes utilizados. As diferenças de doses encontradas são devidas à influência do material dosimétrico na fluência relativa de elétrons em profundidade. Os resultados permitiram concluir que a presença do material dosimétrico na superfície interfere na dose na pele. Entretanto, esses dosímetros não provocam variações de dose em profundidades de interesse clínico, o que possibilita sua aplicação na rotina da dosimetria in vivo em Radioterapia.