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Objective: To test trial and longitudinal known group discrimination of thresholds of meaning for improvement and health states of the ASAS Health Index (ASAS HI) in patients with active axSpA treated in a randomized study., Methods: Data from baseline and week 48 from the tight-controlled, treat-to-target trial TICOSPA study were used. The performance of different thresholds to assess change or health states of the ASAS HI were evaluated between arms and against changes in patients' relevant outcomes and various external responder criteria. Analyses were performed by comparing the mean values t-tests or proportion of responders of continuous and dichotomous external criteria respectively. Trial discrimination of the ASAS HI thresholds were assessed by odds ratios and Phi coefficient in a large number of potential ASAS HI thresholds. Differences in health states in relevant external outcomes between ASAS HI responders and non-responders was assessed by comparing the best performing improvement and state thresholds by using t-tests and chi-square, as appropriate. Missing data on outcomes was handled by non-responder imputation (NRI)., Results: All 160 patients had available ASAS HI data. Trial discrimination was larger for absolute ASAS HI change of ≥2.0, ≥2.5, and ≥3.0 points followed by ASAS HI 20 % improvement. Odds ratio ranged between 1.27 and 1.75 for absolute and between 1.0 and 1.64 for relative improvement outcomes. Longitudinal discrimination of ASAS HI improvement ≥30 % or ≥ 3.0 points had a larger reduction in patient global and disease activity and reached more often remission compared to patients with no significant improvement in global functioning. Patients who achieved ASAS HI ≤ 5.0 compared with patients who did not achieve such states were more likely to have ASAS partial remission, ASDAS inactive disease or ASDAS low activity at week 48., Conclusions: The data-driven thresholds of the ASAS HI identified in a longitudinal observational setting perform well in the context of a randomized trial., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. UK is the chair of the quality of care Committee at EULAR. AM has received consulting fees from Abbvie, Lilly, BMS, Biogen, Celltrion, Pfizer, UCB, Janssen, Novartis and research grant from Biogen. AM is a Chair of the Epidemiology subcommittee from the EULAR Research Committee, DvdH has received consulting fees AbbVie, Argenx, BMS, Galapagos, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, Takeda, UCB Pharma. Associate editor Annals Rheumatic Diseases, editorial board member Journal of Rheumatology and RMD Open, Advisor Assessment Axial Spondyloarthritis international Society and director of Imaging Rheumatology bv, CLM has received consulting/speaker fees AbbVie, UCB, Novartis, Lilly, Janssen and MSD. Research grants AbbVie, Lilly, UCB and Novartis, MD has received consulting fees from Pfizer, Abbvie, Novartis and UCB and research grants from Pfizer, Abbvie and UCB. Member of a DSMB of Galapagos. AB has received consulting fees AbbVie, Galapagos, Novartis, Pfizer, and UCB Pharma. Research grants AbbVie, Lilly. FvdB has received consulting fees AbbVie, Amgen, Fresenius, Galapagos, Janssen, Lilly, Novartis, UCB Pharma. JB reported no conflict of interest., (Copyright © 2024. Published by Elsevier Inc.)

Objectives: In axial spondyloarthritis (axSpA), early diagnosis is crucial, but diagnostic delay remains long and diagnostic criteria do not exist. We aimed to identify a diagnostic model that distinguishes patients with axSpA from patients without axSpA with chronic back pain based on clinical data in routine care., Methods: Clinical data from patients with chronic back pain were used, with information on rheumatological examinations based on clinical indications. The total dataset was randomly divided into training and test datasets at a 7:3 ratio. A machine learning-based model was built to distinguish axSpA from non-axSpA using the random forest algorithm. Overall accuracy, sensitivity, specificity and the area under the receiver operating characteristic curve-area under the curve (ROC-AUC) in the test dataset were calculated. The contribution of each variable to the accuracy of the model was assessed., Results: Data from 939 randomly selected patients were available: 659 diagnosed with axSpA and 280 with non-axSpA. In the test dataset, the model reached an accuracy of 0.9234, a sensitivity of 0.9586, a specificity of 0.8438 and a ROC-AUC of 0.9717. Human leucocyte antigen B27 (HLA-B27) contributed most to the accuracy of the model; that is, the accuracy would suffer most from not using HLA-B27, followed by insidious onset of back pain and erosions in the sacroiliac joint., Conclusions: We provide a machine learning-based model that reveals high performance in diagnosing patients with chronic back pain with axSpA versus without axSpA based on information from a tertiary rheumatology practice. This model has the potential to improve diagnostic delay in patients with axSpA in daily routine settings., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Since the publication of the 2011 European Alliance of Associations for Rheumatology (EULAR) recommendations for patient research partner (PRP) involvement in rheumatology research, the role of PRPs has evolved considerably. Therefore, an update of the 2011 recommendations was deemed necessary., Methods: In accordance with the EULAR Standardised Operational Procedures, a task force comprising 13 researchers, 2 health professionals and 10 PRPs was convened. The process included an online task force meeting, a systematic literature review and an in-person second task force meeting to formulate overarching principles (OAPs) and recommendations. The level of agreement of task force members was assessed anonymously (0-10 scale)., Results: The task force developed five new OAPs, updated seven existing recommendations and formulated three new recommendations. The OAPs address the definition of a PRP, the contribution of PRPs, the role of informal caregivers, the added value of PRPs and the importance of trust and communication in collaborative research efforts. The recommendations address the research type and phases of PRP involvement, the recommended number of PRPs per project, the support necessary for PRPs, training of PRPs and acknowledgement of PRP contributions. New recommendations concern the benefits of support and guidance for researchers, the need for regular evaluation of the patient-researcher collaboration and the role of a designated coordinator to facilitate collaboration. Agreements within the task force were high and ranged between 9.16 and 9.96., Conclusion: The updated EULAR recommendations for PRP involvement are more substantially based on evidence. Together with added OAPs, they should serve as a guide for researchers and PRPs and will ultimately strengthen the involvement of PRPs in rheumatology research., Competing Interests: Competing interests: MdW: over the last 3 years, Stichting Tools has received fees for lectures or consultancy provided by Maarten de Wit from UCB, not related to this project. LG reports grants from AbbVie, Biogen, Lilly, Novartis, UCB, personal fees from AbbVie, Amgen, BMS, Celltrion, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, non-financial support from AbbVie, Amgen, Galapagos, Janssen, MSD, Novartis, Pfizer, UCB, outside the submitted work. KA: funded by EULAR grant RES005 this project; research grants: UCB; consulting fees: Novartis. ME: congress travel support from Janssen and AstraZeneca outside of the submitted work. DB: Speakers bureau: AbbVie, BMS, Galapagos, Janssen, Lilly, MSD. Research grants: Novartis. Consultancy: Sandoz, UCB. Part-time work in Savana Research. EFM has received consultancy fees from Boehringer Ingelheim Portugal outside of the submitted work, LPCDR has received fees for lectures or consultancy provided by Elsa Mateus from Lilly Portugal, GSK and Novartis, outside of the submitted work. SWT has received research funding, consultancy and/ or speaker fees from: Abbvie, Arthrogen, AstraZeneca, BMS, Celgene, Galapagos, Galvani bioelectronics, GSK, Lilly, MSD, Pfizer, Roche, and Sanofi-Genzyme, all outside the submitted work. WT has received research funding, consultancy and/ or speaker fees from: AbbVie, Amgen, BMS, Celgene, Eli-Lilly, GSK, Janssen, MSD, Novartis, Ono-Pharma, Pfizer and UCB all outside of the submitted work. HB, SB, PB, JP, CD, MF, SK, UK, DPR, JR-C, JS, RS, SRS, AV, T-CW, CZ and JP report no competing interests for this project., (© European Alliance of Associations for Rheumatology, EULAR 2024. Re-use permitted under CC BY-NC-ND. No commercial re-use. No derivatives. See rights and permissions. Published by BMJ on behalf of EULAR.)

Objectives: To analyse clinical outcomes of a non-medical switch from originator adalimumab (ADA) to its ABP501 biosimilar (ABP) over 6 months in patients with inflammatory rheumatic musculoskeletal diseases (RMD) in relation to comorbidity as a risk factor for therapy discontinuation., Methods: RMD patients switching from originator ADA to ABP were identified from a large routine database from October 2018 onwards. Documented clinical data at the time of non-medical switching (baseline), and at 3 and 6 months were collected. Comorbidities were represented by the Charlson Comorbidity Index (CCI) at baseline and patients were categorized based on CCI > 0. Differences in the ABP retention rate over 6 months between patients with CCI = 0 and patients with CCI > 0 were analysed using Bayesian exponential regression., Results: A total of 111 patients with axial spondyloarthritis (n = 68), rheumatoid arthritis (n = 23) and psoriatic arthritis (n = 15), were identified, 74.8% of whom had continued treatment with ABP after 6 months, while a smaller proportion had either switched to another ADA biosimilar (10.8%), switched back to originator ADA (7.2%), switched to a different biologic (3.6%), or dropped out (3.6%). At baseline, a CCI > 0 was found in 38% of patients. Cardiovascular comorbidities (40%) were most prevalent followed by diseases of the skin (33%), the gastrointestinal tract (20%) and the eye (20%). ABP treatment was continued after 6 months in 74% of patients with CCI = 0 and in 76% with CCI > 0. Bayesian analysis showed only a small difference (months) in the APB continuation rate between groups (estimate 0.0012, 95% credible interval (CrI) -0.0337 to 0.0361). Adjusting for age, sex, and disease subtype revealed somewhat shorter retention rates for patients with CCI > 0, but the distribution of the difference included 0 (estimate -0.0689, 95% CrI -0.2246 to 0.0234)., Conclusion: In a non-medical switch scenario of RMD patients, there was no evidence for a considerable difference in ABP retention rates over 6 months between comorbidity groups., (© 2024. The Author(s).)

Global health (GH) and health-related quality of life are patient priorities in axial spondyloarthritis (axSpA). Our objective was to assess the relative importance of disease-related factors including disease activity, and patient-related factors including comorbidities, to explain GH in axSpA. Post hoc cross-sectional analyses of 4 sets (COMOSPA, PERSPA, COMEDSPA, and DESIR) of patients fulfilling ASAS criteria for axSpA. GH was assessed through the ASAS Health Index (ASAS-HI) or the EuroQoL-5D-3L (EQ-5D). Disease-related factors included disease activity (ASDAS, psoriasis, arthritis, enthesitis, and CRP), disease duration, diagnostic delay, bamboo spine, and treatment. Non-disease-related factors included sociodemographic characteristics, comorbidities and chronic widespread pain. Multivariable logistic and linear regressions and partial variances (R 2 ) were applied to identify independent determinants of GH. In 6064 patients (range 284-2756 across datasets), mean age ranged 38.9-45.8 years, 51-68% were male. GH was generally moderate: median ASAS-HI ranged 5.0-7.0. GH was explained by ASDAS (range of odds ratios, OR, 2.60-4.48) and chronic widespread pain (range of OR 2.19-8.39); other determinants included comorbidities and sociodemographic characteristics. Only 47-57% of the total variance in GH could be explained by the models; disease activity (partial variance, 16-26%) and chronic widespread pain (partial variance 12-15%) were the key contributing variables. A wide range of disease and non-disease-related variables usually collected in studies could only explain 47-57% of the variability in GH. Among these, disease activity and chronic widespread pain were most relevant and of similar magnitude of importance. These findings will be helpful for shared decision-making., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Spinal radiographic progression is an important outcome in radiographic axial spondyloarthritis (SpA). The objective of the phase IIIb SURPASS study was to compare spinal radiographic progression in patients with radiographic axial SpA treated with secukinumab (interleukin-17A inhibitor) versus adalimumab biosimilar (Sandoz adalimumab [SDZ-ADL]; tumor necrosis factor inhibitor)., Methods: Biologic-naive patients with active radiographic axial SpA, at high risk of radiographic progression (high-sensitivity C-reactive protein [hsCRP] ≥5 mg/L and/or ≥1 syndesmophyte[s] on spinal radiographs), were randomized (1:1:1) to secukinumab (150/300 mg) or SDZ-ADL (40 mg). The proportion of patients with no radiographic progression (change from baseline [CFB] in modified Stoke Ankylosing Spondylitis Spinal Score [mSASSS] ≤0.5) on secukinumab versus SDZ-ADL at week 104 (primary endpoint), mean CFB-mSASSS, proportion of patients with ≥1 syndesmophyte(s) at baseline with no new syndesmophyte(s), and safety were evaluated., Results: Overall, 859 patients (78.5% male, mSASSS 16.6, Bath Ankylosing Spondylitis Disease Activity Index 7.1, hsCRP 20.4 mg/L, and 73.0% with ≥1 syndesmophyte[s]) received secukinumab 150 mg (n = 287), secukinumab 300 mg (n = 286), or SDZ-ADL (n = 286). At week 104, the proportion of patients with no radiographic progression was 66.1%, 66.9%, and 65.6% (P = not significant, both secukinumab doses) and mean CFB-mSASSS was 0.54, 0.55, and 0.72 in secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL arms, respectively. Overall, 56.9%, 53.8%, and 53.3% of patients on secukinumab 150 mg, secukinumab 300 mg, and SDZ-ADL, respectively, with ≥1 syndesmophyte(s) at baseline did not develop new syndesmophyte(s) by week 104. There were no unexpected safety findings., Conclusion: Spinal radiographic progression over two years was low with no significant difference between secukinumab and SDZ-ADL arms. The safety of both treatments was consistent with previous reports., (© 2024 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Background: In spondyloarthritides (SpA) and fibromyalgia (FM), patients suffer from generalized pain. The impact of FM on PRO validated in SpA has not been systematically studied., Objective: Study the performance of PROs developed for SpA in patients with primary (p) FM without chronic inflammatory-rheumatic disease vs. SpA without and with concomitant (c) FM., Methods: Patients with pFM, axSpA or PsA and indication for treatment adaptation were prospectively included. Standardized PROs were assessed: BASDAI, ASDAS-CRP, DAPSA, patient´s global assessment, BASFI, LEI, MASES, SPARCC Enthesitis Score and FIQ., Results: 300 patients were included (100/diagnosis). More males were found in axSpA vs. PsA and pFM group (67, 33 and 2/100, respectively), while 12 axSpA (axSpA+) and 16 PsA (PsA+) patients had cFM. pFM patients showed significantly higher scores in all assessments vs. axSpA or PsA, with exception of ASDAS-CRP (3.3 ± 0.6 in FM vs. 3.1 ± 1.0 in axSpA) and duration of low lumbar morning stiffness. Similar results were also found in the subanalysis of female patients only. In addition, patients with axSpA + or PsA + showed no differences to patients with pFM, while significantly higher scores were found for FM, axSpA + and PsA + for almost all FIQ items compared to axSpA- or PsA-., Conclusions: PROs originally developed for axSpA or PsA need to be interpreted differently in the presence or absence of cFM. ASDAS-CRP and duration of lumbar morning stiffness were not affected by cFM. FM-specific questionnaires also showed high scores in patients with SpA with cFM but not in those without., (© 2024. The Author(s).)

Objective: Define the prevalence and location of inflammatory and structural lesions on magnetic resonance imaging (MRI) in patients with rheumatoid arthritis (RA) and radiographic axial spondyloarthritis (r-axSpA) with neck pain as leading clinical symptom., Methods: Patients with diagnosis of RA and r-axSpA were consecutively included if they had chronic (> 3 months) neck pain. Clinical assessment, neck pain questionnaires and MRIs of the cervical spine (CS) were performed., Results: 107 patients (59 RA and 48 r-axSpA) were included. While there was no difference in the Northwick-Park-Neck-Pain-questionnaire, patients with RA reported higher neck pain compared to r-axSpA on a numeric rating scale (5.0 ± 3.6 vs. 3.0 ± 3.1; p = 0.003). Inflammatory lesions occurred predominantly in the craniocervical area in RA and in the lower CS segments in r-axSpA. Bone marrow edema (BME) was more frequent in axSpA (BME-score axSpA/RA: 0.35vs0.17; p < 0.001) while synovitis was visible in both but was more prevalent in RA (synovitis-score axSpA/RA: 0.02vs0.1; p < 0.001). BME was found in 8 (13.6%) vertebral corner vs. 9 (18.8%), in 2 (3.4%) facet joints vs. 7 (14.6%) and in 1 (1.7%) spinous processes vs. 9 (18.8%) in patients with RA/r-axSpA. In contrast, more patients with RA (30.5% vs6.3%) showed erosive osteochondrosis with endplate BME (p = 0.002)., Conclusion: While involvement of upper cervical inflammation was typically present in RA, r-axSpA patients showed more BME in lower CS segments, vertebral corners, facet joints and spinous processes. Neck pain is linked to upper and lower inflammatory and structural lesions of the CS in both diseases., (© 2024. The Author(s).)

Objectives: We aimed to study remission rates in patients with RA in a tertiary care centre over a long-term observation period., Methods: In a monocentric cohort study with a prospective and a retrospective part, adult RA patients were included. Patient's characteristics and outcome parameters were documented prospectively (clinical visit). Data of the initial visit (index visit) and date of first occurrence of remission were taken retrospectively from the hospital information system. Remission was defined as DAS28 <2.6 and sustained remission (SR) was defined as remission lasting >6 months. Logistic regression analysis was used to analyse factors associated with remission and SR., Results: A total of 136 RA patients were included with retrospective data available over a period of 47.9 (18.9) months. One third already had erosions and severe limitations in physical function at baseline. The vast majority (n=109) of patients achieved a state of remission at least once over time (80.1%). At the clinical visit, 40 patients (29.4%) were in remission. Remission was achieved 14.9 months (13.8) after the index visit and by 54.1%, 23.9%, 13.8%, and 8.3% of patients within the first, second, third, and fourth year, respectively. SR was achieved by 65 patients (47.8%) within the observation period., Conclusions: Most patients achieved remission at least once within the observation period and almost 50% of patients also achieved SR. This study shows that the target of achieving remission should be constantly pursued, as we were able to show that even in the fourth year of treatment, patients still achieved remission.

Objective: European Alliance of Associations for Rheumatology (EULAR) task forces (TF) requires participation of ≥2 junior members, a health professional in rheumatology (HPR) and two patient research partners for the development of recommendations or points to consider. In this study, participation of these junior and representative members was compared with the one of traditional TF members (convenor, methodologist, fellow and expert TF members)., Methods: An online survey was developed and emailed to previous EULAR TF members. The survey comprised multiple-choice, open-ended and 0-100 rating scale (fully disagree to fully agree) questions., Results: In total, 77 responded, 48 (62%) women. In total, 46 (60%) had participated as a junior or representative TF member. Most junior/representative members reported they felt unprepared for their first TF (10/14, 71%). Compared with traditional members, junior/representative members expressed a significantly higher level of uncertainty about their roles within the TF (median score 23 (IQR 7.0-52.0) vs 7 (IQR 0.0-21.0)), and junior/representative members felt less engaged by the convenor (54% vs 71%). Primary factors that facilitated interaction within a TF were experience, expertise and preparation (54%), a supportive atmosphere (42%) and a clear role (12%)., Conclusion: Juniors, patients and HPR experience various challenges when participating in a EULAR TF. These challenges differ from and are generally less pronounced than those experienced by traditional TF members. The convenor should introduce the participants to the tasks, emphasise the value of their contributions and how to prepare accordingly for the TF meeting., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Radiographic axial spondyloarthritis (r-axSpA), formerly known as ankylosing spondylitis (AS), is a chronic, inflammatory rheumatic disease associated with symptoms such as inflammatory back pain, morning stiffness, and arthritis. First-line recommendations for patients with AS include treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for reducing pain and stiffness., Objectives: The objective of our study is to evaluate the efficacy and short-term NSAID-sparing effect of secukinumab in patients with AS currently treated with NSAIDs., Design: We assessed the clinical Assessment of SpondyloArthritis International Society (ASAS20) response to secukinumab and evaluated the extent to which the use of concomitant NSAID can be reduced between weeks 4 and 12 in r-axSpA patients treated with secukinumab 150 mg compared with placebo., Methods: ASTRUM was a prospective 24-week randomized controlled trial of adult patients with active r-axSpA [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ⩾4] who had a documented inadequate response to ⩾2 NSAIDs. Patients were randomized (1:1:1) to initiate treatment with subcutaneous secukinumab 150 mg from either week 0 (group 1), week 4 (group 2), or week 16 (group 3). From week 4 onward, tapering of NSAIDs was allowed in all groups., Results: This study included 211 patients ( n  = 71, 70, and 70 in groups 1, 2, and 3, respectively). ASAS20 response at week 12 for pooled groups 1 and 2 versus group 3 was 51.1% versus 44.3% ( p  = 0.35). A higher proportion of patients in groups 1 and 2 achieved ASAS40 and BASDAI50 and showed improvements in other secondary clinical outcomes as compared to group 3 at week 16. More patients in groups 1 and 2 versus group 3 stopped their NSAID intake from baseline through week 16., Conclusion: Treatment with secukinumab improved clinical outcomes and showed a short-term NSAID-sparing effect in patients with r-axSpA, even though the primary endpoint was not met., Trial Registration: ClinicalTrials.gov; NCT02763046, EudraCT 2015-004575-74., Competing Interests: Uta Kiltz has received consultancy and speaker honoraria from AbbVie, Biocad, Chugai, Eli Lilly, Fresenius, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, and grant/research support (unrestricted grant) from AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer; Xenofon Baraliakos has received consultancy honoraria and research grants from AbbVie, Biocad, Chugai, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Roche, and UCB; Jan Brandt-Jürgens has received consultancy and speaker honoraria from AbbVie, Pfizer, Roche, Sanofi-Aventis, Novartis, Eli Lilly, MSD, UCB, BMS, Janssen, and Medac; Ulf Wagner has received research support from Roche, Novartis, BMS, and Pfizer and has received consultancy and speaker honoraria from Pfizer, Novartis, and Roche; Sebastian Lieb, Christian Sieder, and Christian Mann are employees of Novartis; Jürgen Braun has received grant/research support and speaker honoraria from and served as a consultant for AbbVie, Amgen, Celltrion, Chugai, Medac, MSD, Novartis, Pfizer, Roche, and UCB., (© The Author(s), 2024.)

Objectives: The study aimed to evaluate the effect of adding a non-steroidal anti-inflammatory drug (NSAID), celecoxib (CEL), to a tumour necrosis factor inhibitor (TNFi), golimumab (GOL), compared with TNFi monotherapy on radiographic spinal progression in patients with radiographic axial spondyloarthritis (r-axSpA) over 2 years., Methods: R-axSpA patients, having risk factors for radiographic progression (high disease activity plus C reactive protein >5 mg/L and/or ≥1 syndesmophyte(s)), underwent a 12-week run-in phase with GOL 50 mg every 4 weeks. In the core phase (96 weeks), only patients with a good clinical response at week 12 were randomised (1:1) to GOL+CEL 200 mg two times per day (combination therapy) or GOL monotherapy. The primary endpoint was radiographic progression assessed by modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) change at week 108 in the intent-to-treat population., Results: A total of 128 patients were enrolled in the run-in phase; and 109 patients were randomised at week 12 to monotherapy (n=55) or combination therapy (n=54). At week 108, 97 (52 vs 45) patients completed the study. The change in mSASSS at week 108 was 1.7 (95% CI 0.8 to 2.6) in the monotherapy vs 1.1 (95% CI 0.4 to 1.8) in the combination therapy groups (p=0.79). New syndesmophytes occurred in 25% of patients in the monotherapy vs 11% of patients in the combination therapy groups (p=0.12). During the study, no significant differences in adverse events and serious adverse events were observed between the groups., Conclusions: Combination therapy with GOL+CEL did not demonstrate statistically significant superiority over GOL monotherapy in retarding radiographic spinal progression over 2 years in r-axSpA., Competing Interests: Competing interests: FP reports grants and personal fees from Novartis, Eli Lilly and UCB and personal fees from AbbVie, AMGEN, BMS, Celgene, Janssen, Hexal, Medscape, MSD, Pfizer and Roche outside the presented work. MT reports grants and personal fees from Abbvie and UCB. BM reports personal fees from Alexion, Amgen, Galapagos Biopharma, Novartis, Stadapharm and UCB outside the presented work. VRR, JL, LS, AKW, MV, JBJ, MS and SJ: nothing to disclose. MP: reports consulting fees from Novartis and support for attending meetings and/or travel from Janssen, UCB Pharma, Abbvie and Pfizer outside the presented work. JR: reports financial support for attending meetings and/or travel from Abbvie, Novartis, UCB and Janssen outside the presented work. HH: reports personal fees from Novartis, Abbvie, Janssen, Pfizer, Roche, Novartis and UCB and grants and personal fees from SOBI outside the presented work. UK: reports grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. JS: reports personal fees from AbbVie, Merck, Novartis, UCB and UpToDate outside the presented work. DP: reports grants and personal fees from AbbVie, Eli Lilly, MSD, Novartis and Pfizer, and personal fees from AbbVie, Biocad, Bristol-Myers Squibb, Canon, DKSH, Eli Lilly, Janssen, Moonlake, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB outside the presented work., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Background: Individuals with anti-citrullinated protein antibodies (ACPAs) and subclinical inflammatory changes in joints are at high risk of developing rheumatoid arthritis. Treatment strategies to intercept this pre-stage clinical disease remain to be developed. We aimed to assess whether 6-month treatment with abatacept improves inflammation in preclinical rheumatoid arthritis., Methods: The abatacept reversing subclinical inflammation as measured by MRI in ACPA positive arthralgia (ARIAA) study is a randomised, international, multicentre, double-blind, placebo-controlled trial done in 14 hospitals and community centres across Europe (11 in Germany, two in Spain, and one in the Czech Republic). Adults (aged ≥18 years) with ACPA positivity, joint pain (but no swelling), and signs of osteitis, synovitis, or tenosynovitis in hand MRI were randomly assigned (1:1) to weekly subcutaneous abatacept 125 mg or placebo for 6 months followed by a double-blind, drug-free, observation phase for 12 months. The primary outcome was the proportion of participants with any reduction in inflammatory MRI lesions at 6 months. The primary efficacy analysis was done in the modified intention-to-treat population, which included participants who were randomly assigned and received study medication. Safety analyses were conducted in participants who received the study medication and had at least one post-baseline observation. The study was registered with the EUDRA-CT (2014-000555-93)., Findings: Between Nov 6, 2014, and June 15, 2021, 139 participants were screened. Of 100 participants, 50 were randomly assigned to abatacept 125 mg and 50 to placebo. Two participants (one from each group) were excluded due to administration failure or refusing treatment; thus, 98 were included in the modified intention-to-treat population. 70 (71%) of 98 participants were female and 28 (29%) of 98 were male. At 6 months, 28 (57%) of 49 participants in the abatacept group and 15 (31%) of 49 participants in the placebo group showed improvement in MRI subclinical inflammation (absolute difference 26·5%, 95% CI 5·9-45·6; p=0·014). Four (8%) of 49 participants in the abatacept group and 17 (35%) of 49 participants in the placebo group developed rheumatoid arthritis (hazard ratio [HR] 0·14 [0·04-0·47]; p=0·0016). Improvement of MRI inflammation (25 [51%] of 49 participants in the abatacept group, 12 [24%] of 49 in the placebo group; p=0·012) and progression to rheumatoid arthritis (17 [35%] of 49, 28 [57%] of 49; HR 0·14 [0·04-0·47]; p=0·018) remained significantly different between the two groups after 18 months, 12 months after the end of the intervention. There were 12 serious adverse events in 11 participants (four [8%] of 48 in the abatacept group and 7 [14%] of 49 in the placebo group). No deaths occurred during the study., Interpretation: 6-month treatment with abatacept decreases MRI inflammation, clinical symptoms, and risk of rheumatoid arthritis development in participants at high risk. The effects of the intervention persist through a 1-year drug-free observation phase., Funding: Innovative Medicine Initiative., Competing Interests: Declaration of interests JR reports receiving an unrestricted research grant from Sobi and Novartis, and speakers' honoraria and consulting fees from Bristol-Myers Squibb, Novartis, and Sobi. KT reports receiving speakers' honoraria and consulting fees from Novartis and Union Chimique Belge, and travel support from Celltrion. MØ reports receiving grants from AbbVie, Bristol-Myers Squibb, Merck, Novartis, and Union Chimique Belge, consulting fees from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, MEDAC, Merck, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and Union Chimique Belge, and honoraria for lectures, presentations, and speakers' bureaus from AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Merck, Novartis, Pfizer, Regeneron, Roche, Sandoz, Sanofi, and Union Chimique Belge. AK reports receiving honoraria for lectures and presentations, honoraria for participation on a data safety monitoring board (IIT TOLERA study), and honoraria for drug supply (IIT TOLERA study) from Bristol-Myers Squibb. BM reports receiving honoraria for lectures from Gilead, AbbVie, Janssen, and Pfizer. AJH reports receiving payment for a conditional grant from Galapagos and Novartis, consulting fees from AbbVie, Amgen, Galapagos, Janssen, Eli Lilly, Novartis, and Union Chimique Belge, and payment for lectures and presentations from AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Galapagos, GlaxoSmithKline, Janssen, Eli Lilly, Medupdate, Novartis, Pfizer, Rheumaakademie, and Union Chimique Belge. XB reports receiving consulting fees from AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Sanofi, and Union Chimique Belge, honoraria for lectures and presentations from AbbVie, Bristol-Myers Squibb, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz, Sanofi, and Union Chimique Belge, and payment for participation on a data safety monitoring board or an advisory board from AbbVie, Eli Lilly, Galapagos, Janssen, Merck Sharp & Dohme, Novartis, Pfizer, and Union Chimique Belge. MFl reports receiving honoraria for presentations and lectures from AbbVie, Actelion, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Chugai, Janssen, Medac, Menarini, Merck Sharp & Dohme, Novartis, Pfizer, Rheumaakademie, Roche, and Sobi. AR-R reports receiving consulting fees from Bristol-Myers Squibb, AbbVie, Pfizer, and Eli Lilly, payment for lectures and presentations from AbbVie, Bristol-Myers Squibb, Pfizer, Galapagos, Eli Lilly, Merck Sharp & Dohme, Union Chimique Belge, Sanofi, and Roche, payment for expert testimony from AbbVie and Galapagos, support for attending meetings or travel (or both) from Pfizer and Sanofi, participating on a data safety monitoring board for R-Pharm, and having a leadership or fiduciary role in the Swiss Rheumatology Society. RV reports receiving payment for lectures and presentations from AbbVie, AstraZeneca, Galapagos, GlaxoSmithKline, Novartis, Janssen–Cilag, and Pfizer, institutional support for attending meetings or travel (or both) from AbbVie, Galapagos, and Janssen–Cilag, institutional grants from Novartis and Pfizer, and participating on a data safety monitoring board or advisory board for AbbVie, AstraZeneca, Novartis, GlaxoSmithKline, and Union Chimique Belge. NV reports receiving honoraria for lectures and presentations and support for attending scientific meetings and congresses (congress fee and travel expenses) from Bristol-Myers Squibb. JT reports receiving an unrestricted research grant from Bristol-Myers Squibb, consulting fees from AbbVie, AstraZeneca, Novartis, GlaxoSmithKline, Eli Lilly, and Vifor, support for attending a meeting from Galapagos and Bristol-Myers Squibb, and participating on an advisory board for Novartis. EF reports receiving honoraria for lectures and presentations from AbbVie, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer, and Sobi, support for attending meetings from Novartis, and institutional grants from Eli Lilly, Novartis, and Galapagos. KK reports receiving honoraria from Union Chimique Belge for participation in an advisory board and reports payment for presentations from AbbVie, Novartis, and Union Chimique Belge. JS reports receiving honoraria for lectures and presentations from AbbVie, Bristol-Myers Squibb, Union Chimique Belge, Pfizer, Novartis, and Amgen, support for attending meetings from Union Chimique Belge and Janssen, and participating on an advisory board from AbbVie, Novartis, and Union Chimique Belge. EN reports receiving institutional payment from Pfizer and Eli Lilly, and payment for lecturing from AbbVie, Pfizer, and Eli Lilly. GS reports receiving speakers' honoraria and consulting fees from Bristol-Myers Squibb, Cabaletta, Janssen, Kyverna, Miltenyi, and Novartis. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Objectives: To translate the Assessment of SpondyloArthritis international Society (ASAS) Health Index (HI) Environmental Factors Item Set (EFIS) into Swedish and culturally adapt it for a Swedish context, and to assess the construct validity of the Swedish version of the ASAS HI and test-retest reliability in ASAS HI and EFIS in Swedish patients with ankylosing spondylitis (AS)., Method: Translation and cross-cultural adaptation of the EFIS were carried out according to a forward-backward procedure consisting of five steps. The construct validity of the ASAS HI was tested using Spearman correlation with standard health outcomes for axial spondyloarthritis (axSpA). Reliability was analysed by internal consistency with the Cronbach's alpha coefficient for ASAS HI, and test-retest reliability with intraclass correlation coefficients (ICCs) for ASAS HI and kappa agreement for the individual items of EFIS., Results: The translation of EFIS showed acceptable face and content validity. ASAS HI showed an acceptable internal consistency (Cronbach's alpha 0.79), and excellent test-retest reliability (ICC 0.87). Test-retest reliability for EFIS showed varied results, with kappa agreement for the individual items ranging from poor (-0.027) to good (0.80)., Conclusions: The Swedish version of ASAS HI proved to be valid and reliable and is recommended for assessing the impact of AS on global functioning and health. A Swedish version of EFIS has been produced and uploaded on the ASAS website. The EFIS proved to have acceptable face and content validity, and may contribute to the contextual interpretation of the ASAS HI.

The aim of this study is to present the current care situation of patients with giant cell arteritis (GCA), Takayasu arteritis (TAK), ANCA-associated vasculitis (AAV) and Behçet's disease (BD). Trends over the last 15 years will reflect improvements and remaining deficits in the management of vasculitides. Consecutive cross-sectional data from patients with vasculitides from the German National Database (NDB) of the Collaborative Arthritis Centres between 2007 and 2021 were included. Medication, physician- and patient-reported outcomes on disease activity and disease burden, inpatient stays and occupational participation are compared for different vasculitis entities and over time. Employment rates were compared to German population rates. Between 502 and 854 vasculitis patients were annually documented. GCA and AAV were the most common vasculitides. Median disease duration ranged from 2 to 16 years. Over the years, glucocorticoids decreased in proportion and dose, most markedly in GCA and TAK, while biologic therapies increased up to 27%. Physicians rated disease activity as low for the vast majority of patients, while patients-reported moderate outcomes in many dimensions. PROs remained largely unchanged. The proportion of employed patients (< 65 years) increased from 47 to 57%. In recent years, biologics are increasingly used in patients with vasculitides, while glucocorticoids decreased significantly. PRO's have not improved. Work participation increased but remains lower than that in the German population., (© 2023. The Author(s).)

Objectives: We investigated whether the effectiveness of upadacitinib in rheumatoid arthritis (RA) treatment is affected by baseline CRP levels in a real-world setting., Methods: UPwArds was a prospective, non-interventional study. Patients had moderate-to-severe RA and an inadequate response or intolerance to ≥1 disease-modifying anti-rheumatic drug (DMARD). The primary endpoint was clinical remission (Clinical Disease Activity Index [CDAI] ≤2.8) at 6 months. Secondary endpoints at 12 months included clinical remission and low disease activity assessed by CDAI and Simple Disease Activity Index criteria, DAS28-CRP <2.6/≤3.2, and patient-reported outcomes. The impact of baseline CRP levels (normal vs. above the upper limit of normal [ULN]) on primary and secondary endpoints was evaluated. The effect of concomitant MTX and prior inadequate response to biologic or targeted synthetic DMARDs (b/tsDMARD-IR) on the effectiveness of upadacitinib was also assessed. Safety was evaluated through 12 months., Results: 518 patients were included in the effectiveness analyses. At 6 months, 24.4% of patients achieved the primary endpoint (CDAI ≤2.8). At 12 months, similar proportions of patients with normal CRP and CRP above the ULN at baseline achieved CDAI ≤2.8 (27.3% and 29.1%) and other key secondary endpoints. The effectiveness of upadacitinib was comparable with and without concomitant MTX and in b/tsDMARD-naive and b/tsDMARD-IR patients. The safety results were consistent with the known safety profile of upadacitinib; no new safety signals were identified., Conclusions: Upadacitinib therapy was effective for RA in a real-world setting. Baseline CRP levels had no significant impact on the effectiveness of upadacitinib.

Background: Patients with axial spondyloarthritis (axSpA) are often compromised by impaired function and mobility. The standardized 2-week inpatient program 'multimodal rheumatologic complex treatment' (MRCT) was designed for patients with axSpA. The Epionics SPINE (ES) is an objective tool validated to assess mobility., Objective: To investigate the impact of MRCT on physical function and mobility including range of motion (RoM) and kinematics (RoK)., Design: Single-center interventional, observational trial., Methods: Patients with axSpA presenting with high disease activity and impaired physical function were consecutively recruited to undergo MRCT. Assessments performed before (V1) and after (V2) the intervention included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis functional index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), the ankylosing spondylitis physical performance index (ASPI), the Short Physical Performance Battery (SPPB), and ES measurements., Results: At baseline, the 80 patients included had: BASDAI 5.5 ± 1.5, BASFI 5.6 ± 2.0, BASMI 4.2 ± 1.8, SPPB 13.8 ± 1.8, and ASPI 37.3 ± 18.1 s. Clinically relevant improvements between V1 versus V2 were noted for BASFI, BASMI, and all other assessments ( p  < 0.001), and also for ES measures of RoK (all p  < 0.003) and RoM (all p  < 0.04), while a positive trend was seen for flexion and extension (RoM). There was no significant effect of changes in medication (all p  > 0.05)., Conclusion: The 2-weeks MRCT was associated with definite improvements of function and mobility. Importantly, the effect of this extensive physical activity was confirmed by using the ES as an objective tool to assess spinal mobility. The ES demonstrated for the first time that the RoK of spinal mobility can significantly improve related to an exercise intervention., Trial Registration: Ethical Committee: Ruhr-Universität (reference-number: 19-6735-BR)., Competing Interests: The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DK has received grant and research support and consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JB has received honoraria for talks, advisory boards, paid consultancies, and rants for studies from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi Aventis, and UCB. UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. NK: None. LS: None. IA has received research support, consultancy fees, and honoraria from Abbvie, Amgen, BMS, Chugai, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sobi, Takkeda, and UCB. ST: None. BB has received honoraria for talks, advisory boards, paid consultancies, and/or travel support from Abbvie, Alexion, Amgen, Biogen, Boehringer Ingelheim, Gilead/Galapagos, Janssen, MSD, Theramex, Sanofi-Genzyme, and UCB. PS has received grant and research support and consultancy fees from AXIOM Health, AMGEN, AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Chugai Pharma Marketing Ltd/Chugai Europe, Deutscher Psoriasis-Bund, Gilead Sciences, Hexal Pharma, Janssen-Cilag, Johnson & Johnson, Lilly/Lilly Europe/Lilly Global, medi-login, Mediri GmbH, Novartis Pharma, Onkowissen GmbH, Pfizer, Roche Pharma, Rheumazentrum Rhein-Ruhr, Sanofi-Genzyme, Spirit Medical Communication, Swedish Orphan Biovitrum, UCB Pharma. SH: Has received consultancy fees of AbbVie and Novartis. XB has received grant and research support and consultancy fees from AbbVie, Amgen, Chugai, Galapagos, Hexal, Lilly, MSD, Novartis, Pfizer, and UCB., (© The Author(s), 2024.)

Objectives: To determine if there were differences in the Assessment of SpondyloArthritis international Society Health Index (ASAS HI) scores between patients classified as radiographic axial spondyloarthritis (r-axSpA) and non-radiographic axSpA (nr-axSpA), and to identify factors associated with higher ASAS HI scores in both disease phenotypes., Methods: This study was an ancillary analysis of the ASAS HI international validation project performed in 23 countries. Patients were included if they were ≥18 years of age and diagnosed with axSpA. Univariable and multivariable analysis were performed to determine if ASAS HI scores differed between the axSpA phenotypes, and to identify other variables associated with ASAS HI scores. We also tested for potential interactions between the axSpA phenotype and significant variables identified through the multivariable regression., Results: A total of 976 patients were included, with 703 having r-axSpA and 273 nr-axSpA. Patients with r-axSpA reported higher (worse) ASAS HI scores compared with those with nr-axSpA (6.8 (4.4) vs 6.0 (4.0), p=0.02), but the axSpA phenotype was not associated with ASAS HI scores in the multivariable regression (β: -0.19, 95% CI: -0.56 to 0.19). Female gender, having worse physical function (Bath Ankylosing Spondylitis Functional Index), disease activity (Ankylosing Spondylitis Disease Activity Score) and anxiety and depressive symptoms (Hospital Anxiety and Depression Scale) were associated with higher ASAS HI scores. No interactions were found to be significant., Conclusion: Overall health and functioning are similarly affected in patients with r-axSpA and nr-axSpA. Female patients, having worse physical function, disease activity, anxiety and depressive symptoms were independently associated with higher ASAS HI scores., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The ASSIST study investigated prescribing in routine psoriatic arthritis (PsA) care and whether the patient reported outcome: PsA Impact of Disease questionnaire (PsAID-12), impacted treatment. This study also assessed a range of patient and clinician factors and their relationship to PsAID-12 scoring and treatment modification., Methods: Patients with PsA were selected across the UK and Europe between July 2021-March 2022. Patients completed the PsAID questionnaire, with the results shared with their physician. Patient characteristics, disease activity, current treatment methods, treatment strategies, medication changes and patient satisfaction scores were recorded., Results: 503 patients recruited. 36.2% had changes made to treatment, 88.8% of this had treatment escalation. Overall, the mean PsAID-12 score was higher for patients with treatment escalation; the PsAID-12 score was associated with odds of treatment escalation (OR: 1.58; p< 0.0001). However, most clinicians reported PsAID-12 did not impact their decision to escalate treatment, instead supporting treatment reduction decisions. Physician's assessment of disease activity had the most statistically significant effect on likelihood of treatment escalation, (OR = 2.68, per 1-point score increase). Escalation was more likely in patients not treated with biologic therapies. Additional factors associated with treatment escalation included: patient characteristics, physician characteristics, disease activity and disease impact., Conclusion: This study highlights multiple factors impacting treatment decision making for individuals with PsA. PsAID-12 scoring correlates with multiple measures of disease severity and odds of treatment escalation. However, most clinicians reported the PsAID-12 did not influence treatment escalation decisions. PsAID scoring could be used to increase confidence in treatment de-escalation., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: Patients with axial spondyloarthritis (axSpA) suffer from clinical symptoms like morning stiffness and back pain. Mobility of patients with axSpA is often impaired. The aim of this study is to compare the performance of patients with axSpA regarding mobility measures including performance-based tests and objective electronic assessments with the Epionics SPINE device (ES) at different times of the day compared with healthy controls (HC)., Methods: Observational trial, consecutive inpatients with axSpA (n=100) and 20 HCs were examined in the morning (V1: before 10:00 am) and in the afternoon (V2: after 02:00 pm) by the Bath Ankylosing Spondylitis Metrology Index (BASMI), the AS physical performance index (ASPI), the Short Physical Performance Battery (SPPB) and ES measurements, including range of motion (RoM) and range of kinematics (RoK)., Results: The assessments of patients with axSpA performed in the morning clearly differed from those in the afternoon, especially regarding performance-based tests. Significant improvements were seen for BASMI (4.0±3.8 to 3.8±1.9; p<0.001), ASPI (36.2±18.3 to 28.8±11.9 s; p<0.001), SPPB (10.1±1.5 to 10.7±1.4 points; p<0.001) and for ES measures of speed (RoK; p<0.018) but not for RoM, except for lateral flexion (13.3±7.4 to 14.7±8.2°; p=0.002). This time of assessment-related variability was not observed in HC., Conclusion: The spinal mobility of patients with axSpA was worse in the morning but significantly improved in the afternoon. This was captured best by performance-based measures and was not seen in HC. The diurnal variation of mobility has implications for clinical studies, suggesting that the time of assessments needs to be standardised., Competing Interests: Competing interests: The authors declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: Dr DK has received grant and research support and consultancy fees from AbbVie, BMS, Boehringer Ingelheim, Chugai, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche and UCB. Dr JB has received honoraria for talks, advisory boards, paid consultancies and rants for studies from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi Aventis and UCB. Dr UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, Pfizer, Roche and UCB. NK, LS and ST: none. Dr IA has received research support, consultancy fees and honoraria from Abbvie, Amgen, BMS, Chugai, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sobi, Takkeda and UCB. Dr BB has received honoraria for talks, advisory boards, paid consultancies and/or travel support from Abbvie, Alexion, Amgen, Biogen, Boehringer Ingelheim, Gilead/Galapagos, Janssen, MSD, Theramex, Sanofi-Genzyme and UCB. Dr PS has received grant and research support and consultancy fees from AXIOM Health, AMGEN, AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Chugai Pharma Marketing/Chugai Europe, Deutscher Psoriasis-Bund, Gilead Sciences, Hexal Pharma, Janssen-Cilag, Johnson & Johnson, Lilly/Lilly Europe/Lilly Global, medi-login, Mediri GmbH, Novartis Pharma, Onkowissen GmbH, Pfizer, Roche Pharma, Rheumazentrum Rhein-Ruhr, Sanofi-Genzyme, Spirit Medical Communication, Swedish Orphan Biovitrum, UCB Pharma. SH has received consultancy fees of AbbVie and Novartis. Dr XB has received grant and research support and consultancy fees from AbbVie, Amgen, Chugai, Galapagos, Hexal, Lilly, MSD, Novartis, Pfizer and UCB., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The objective of this study is to build a structural model visualising and quantifying the interrelationships of different disease outcomes with the Assessment of SpondyloArthritis International Society Health Index (ASAS HI) in patients with axial spondyloarthritis (axSpA)., Methods: Cross-sectional data collected at month 72 of the Devenir des Spondylarthropathies Indifferénciées Récentes cohort was analysed. Combining prior knowledge and observed data, probabilistic Bayesian network modelling was used to study how the interplay of different disease outcomes affects the ASAS HI, which measures disease-specific overall functioning and health. Disease outcomes comprised, among others, the Ankylosing Spondylitis (AS) Disease Activity Score (ASDAS) and the Bath AS Functional Index (BASFI)., Results: Data of 384 patients were analysed. The obtained structure suggests that ASAS HI is determined by both patient-reported physical function (BASFI) and disease activity (ASDAS). The parameters of the structural model show that an increase of ASDAS or BASFI by 1 unit corresponds to an increase of ASAS HI by 0.70 or 1.25 units, respectively. Moreover, the model suggests that disease activity has an indirect impact on ASAS HI via BASFI. No relationship between spinal mobility or structural damage and ASAS HI was found., Conclusions: This is the first structural model developed to better understand the construct and the interplay between clinically relevant outcomes related to ASAS HI in axSpA patients. It shows that disease activity and physical function have a strong impact on ASAS HI, confirming it to be a valid construct of overall functioning and health in axSpA patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The influence of sex on treatment outcomes during interleukin-12/23 therapy in patients with psoriatic arthritis (PsA) has not been explored., Objective: To conduct exploratory post hoc analyses of sex-stratified data from the MUST trial, an investigator-initiated, multicentre, phase 3b study in which patients with active PsA initiating treatment with open-label ustekinumab were randomised to treatment with placebo or methotrexate (MTX)., Methods: We evaluated baseline characteristics, key treatment outcomes and adverse events stratified by sex, with a focus on outcomes that did not include erythrocyte sedimentation rate (ESR) as a component due to the known elevation of ESR in females., Results: A total of 166 patients were treated with ustekinumab+MTX (37 female, 50 male) or ustekinumab+placebo (32 female, 47 male). At baseline, females had a significantly longer time since PsA diagnosis and greater impairment in physical function, but similar joint counts. At week 24, both females and males showed marked improvements to ustekinumab with or without MTX. Females generally had numerically reduced treatment responses compared with males, although differences did not achieve statistical significance. MTX did not show an overall effect on treatment outcomes, but was associated with faster enthesitis responses in males only. Adverse events were generally comparable, but females in the ustekinumab+MTX group had higher levels of gastrointestinal disorders., Conclusion: Females and males with PsA had differences in baseline characteristics, treatment responses and adverse events during therapy. A better understanding of sex-based differences in PsA may help optimise treatment., Competing Interests: Competing interests: MK received consulting fees or honoraria from Amgen, Janssen-Cilag, Lilly, Novartis and UCB and received travel support from UCB. UK received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, BMS, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche, UCB and Viatris and participated on a data safety monitoring or advisory board for the COPAGO trial, conducted by the German Ministry of Health. GRB received fees or honoraria for serving as a speaker and/or consultant from Abbvie, Galapagos, Janssen, Lilly, Novartis and UCB, meeting or travel support from Abbvie and Lilly and is the editor-in-chief of RMD Open. DMK received honoraria for serving as a speaker for Sanofi-Aventis. SF received scientific grants from Novartis, honoraria or fees for serving as a speaker and/or consultant from Abbvie, AstraZeneca, Chugai, Galapagos, Novartis, NovoNordisc and UCB, and travel or meeting support from Abbvie, Galapagos, Janssen Cilag, Novartis, SOBI and UCB. RB received honoraria or fees for serving as a speaker and/or consultant from Abbvie, BMS, Chugai, GSK, Galapagos, Novartis, Roche and Vifor and meeting or travel support from Chugai and Galapagos. MS received research support from Charité. FB received research support for this study from Janssen Cilag, consulting fees or honoraria from Abbvie, Acelyrin, Amgen, Janssen Cilag, Lily, Novartis, Pfizer and UCB, and meeting or travel support from Abbvie and UCB. ACF, TR, HK and JB have no competing interests to declare., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Baricitinib, an orally available small-molecule inhibitor of Janus kinase (JAK)1 and JAK2, is indicated to treat active moderate-to-severe rheumatoid arthritis (RA)., Objective: This systematic review described the real-world clinical characteristics of baricitinib-treated patients with RA, prescription patterns, effectiveness, drug persistence, patient-reported outcomes (PROs; physical function, pain, health-related quality of life [HRQoL]), patient global assessment (PGA), and safety of baricitinib., Methods: A PRISMA systematic review of real-world studies was conducted to identify relevant literature published between January 2016 and September 2022 using MEDLINE®, EMBASE®, and evidence-based medicine review databases. Websites or online repositories of the American College of Rheumatology and the European Alliance of Associations for Rheumatology were searched manually to include relevant abstracts from conferences held between January 2016 and November 2022., Results: A total of 11,472 records were identified by searching online databases. Seventy studies were included in the study, of which 40 were abstracts. Most patients were older (51-71 years), female, and with mean RA duration of 4-19 years. Baricitinib was mostly used after the failure of one or more bDMARDs, and 4 mg dosing was prevalent in patients with RA (range 22-100%). Clinical effectiveness of baricitinib was reported in real-world settings regardless of prior biologic/targeted synthetic disease-modifying antirheumatic drug (DMARD) use and concomitant conventional synthetic DMARD use. Achievement of Clinical Disease Activity Index (CDAI) remission was reported in 8.7-60% of patients at week 12 and CDAI low disease activity (LDA) in 20.2-81.6% at week 24. The proportion of patients attaining Simple Disease Activity Index (SDAI) remission was reported in 12% at week 4 to 45.4% at 24 weeks. Drug persistence was high, similar, or equal to anti-tumor necrosis factor drugs. No new safety signals were identified., Conclusion: Baricitinib demonstrated effectiveness in the real-world setting with a consistent safety profile observed in clinical studies. Better persistence rates for baricitinib compared to bDMARDs with improvement in PROs were reported, although baricitinib-treated patients had RA with poor prognostic characteristics., (© 2023. The Author(s).)

Objectives: Shared decision-making (SDM) is advocated to improve patient outcomes in Psoriatic arthritis (PsA). We analysed current prescribing practices and the extent of SDM in PsA across Europe., Methods: The ASSIST study was a cross-sectional observational study of PsA patients aged ≥18 years attending face-to-face appointments between July 2021-March 2022. Patient demographics, current treatment and treatment decisions were recorded. SDM was measured by the clinician's effort to collaborate (CollaboRATE questionnaire) and patient communication confidence (PEPPI-5 tool)., Results: 503 patients were included from 24 centres across the UK, France, Germany, Italy and Spain. Physician- and patient-reported measures of disease activity were highest in the UK. Conventional synthetic DMARDs constituted a higher percentage of current PsA treatment in UK than continental Europe (66.4% vs 44.9%), which differed from biologic DMARDs (36.4% vs 64.4%). Implementing treatment escalation was most common in the UK. CollaboRATE and PEPPI-5 scores were high across centres. Of 31 patients with low CollaboRATE scores (<4.5), no patients with low PsAID-12 scores (<5) had treatment escalation. However, of 465 patients with CollaboRATE scores ≥4.5, 59 patients with low PsAID-12 scores received treatment escalation., Conclusions: Higher rates of treatment escalation seen in the UK may be explained by higher disease activity and a younger cohort. High levels of collaboration in face-to-face PsA consultations suggests effective implementation of the SDM approach. Our data indicate that, in patients with mild disease activity, only those with higher perceived collaboration underwent treatment escalation. Prospective studies should examine the impact of SDM on PsA patient outcomes., Trial Registration: clinicaltrials.gov, NCT05171270., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: Axial spondyloarthritis (axSpA) is associated with decreased function and mobility of patients as a result of inflammation and radiographic damage. The Epionics SPINE device (ES), an electronic device that objectively measures spinal mobility, including range of motion (RoM) and speed (ie, range of kinematics [RoK]) of movement, has been clinically validated in axSpA. We investigated the performance of the ES relative to radiographic damage in the axial skeleton of patients with axSpA., Methods: A total of 103 patients with axSpA, 31 with nonradiographic axSpA (nr-axSpA) and 72 with radiographic axSpA (r-axSpA), were consecutively examined. Conventional radiographs of the spine (including presence, number, and location of syndesmophytes) and the sacroiliac joints (SIJs; rated by the modified New York criteria) were analyzed with the ES. Function and mobility were assessed using analyses of covariance and Spearman correlation., Results: The number of syndesmophytes correlated positively with Bath Ankylosing Spondylitis Metrology Index scores ( r 0.38, P = 0.02) and correlated negatively with chest expansion ( r -0.39, P = 0.02) and ES measurements (-0.53 ≤ r ≤ -0.34, all P < 0.03), except for RoM and RoK regarding rotation and RoK for extension of the lumbar and thoracic spines. In the radiographic evaluation of the SIJs, the extent of damage correlated negatively with ES scores and metric measurements (-0.49 ≤ r ≤ -0.33, all P < 0.001). Patients with r-axSpA, as compared to those with nr-axSpA, showed significantly worse ES scores for RoM, RoK, and chest expansion., Conclusion: The ES scores, in accordance with mobility measurements, correlated well with the presence and extent of radiographic damage in the spine and the SIJs. As expected, patients with r-axSpA had more severe impairments than those with nr-axSpA., (Copyright © 2023 by the Journal of Rheumatology.)

Background: Previous experiences with non-medical switching of adalimumab (ADA) in patients with chronic inflammatory rheumatic diseases (CIRD) come mainly from phase III extension of randomised clinical trials and little from routine care., Objectives: To analyse treatment trajectories over 2 years in patients with CIRD conducting a non-medical switch from originator to biosimilar ADA., Design: A retrospective observational cohort study was conducted with data from a third-level rheumatology centre in Germany. CIRD patients on originator ADA who switched to ADA biosimilar from October 2018 onwards were identified and followed until September 2020., Methods: Patients' characteristics were compared between the four a priori defined treatment trajectories 'continued biosimilar ADA therapy', 'back-switch to originator ADA therapy', 'switch to another biological disease-modifying anti-rheumatic drug (bDMARD) therapy' and 'stopped bDMARD therapy/death/drop out'. Factors associated with continuing biosimilar ADA therapy were analysed using Cox proportional hazards regression analyses., Results: A total of 121 CIRD patients were included. Most patients (66.9%) continued therapy with biosimilar ADA over 2 years, with a treatment retention rate of 73.1%. Whereas 21 patients (17.4%) switched back to originator ADA, mainly due to adverse events, and 8 patients (6.6%) switched to a different bDMARD, mainly due to lack of effect. The estimated risk of withdrawal was lower for longer prior duration on originator ADA [hazard ratio (HR): 0.82; 95% CI: 0.69-0.97] and higher for higher C-reactive protein levels at baseline (HR: 1.18; 95% CI: 1.00-1.39). Male patients, older patients and those for whom originator ADA was their first bDMARD tended to have a lower risk of withdrawal., Conclusion: Our results indicated that three of four patients continue biosimilar ADA over 2 years with lower risks of withdrawal for male sex, older age, longer prior duration on originator ADA and originator ADA as first bDMARD., Competing Interests: IR, SM and ST: none. XB has received grant and research support and consultancy fees from AbbVie (Abbot), Amgen, Centocor, Chugai, MSD, Novartis, Pfizer, UCB and Wyeth. IA has received research support, consultancy fees and honoraria from AbbVie, Amgen, AstraZeneca, Chugai, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sobi, Takeda and UCB. BB has received research support, consultancy fees and honoraria from GE/Lunar, Kinemed, Janssen, UCB, Lilly, AbbVie and Gilead. JB has received honoraria for talks, advisory boards, paid consultancies and grants for studies from Abbvie (Abbott), Amgen, Baxter, Biogen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, Fresenius, GlaxoSmithKline, Gilead, Hexal, Janssen, Lilly, Medac, MSD (Schering-Plough), Mylan, Mundipharma, Novartis, Pfizer (Wyeth, Hospira), Roche, Sanofi-Aventis and UCB. UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche, UCB and Viatris., (© The Author(s), 2023.)

The treatment of patients with axial spondyloarthritis (axSpA) is characterized by non-pharmacological and pharmacological treatment options. It may depend on the type and extent of musculoskeletal and extramusculoskeletal manifestations. Recent data on non-pharmacological treatment options, such as physical activity, physiotherapy, and modification of lifestyle factors, are summarized in this review. Moreover, we have provided an overview on non-steroidal anti-inflammatory drugs and the ever-expanding number of biological and targeted synthetic disease-modifying antirheumatic drugs (bDMARDs and tsDMARDs, respectively). In addition to data on efficacy and safety, the review also encompasses data on switching/cycling, tapering, and treatment selection for specific patient subgroups to optimize treatment outcomes., Competing Interests: Conflict of interest Dr. Baraliakos: Research Support: Abbvie, Novartis, and MSD; Consultant, Speakers Bureau, Scientific Advisory Board and Honoraria: Abbvie, Amgen, BMS, Chugai, Galapagos, Gilead, Lilly, MSD, Novartis, Pfizer, Roche, Sandoz, and UCB. Dr. Kiltz has received a grant, research support, and consultancy fees from AbbVie, Amgen, Biocad, Biogen, BMS, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche, UCB, and Viatris. Dr. Ciurea received honoraria for educational lectures from Abbvie and Novartis. Iuliia Kononenko declares no conflicts of interest or funding., (Copyright © 2023. Published by Elsevier Ltd.)

Introduction: The course of axial spondyloarthritis (axSpA) is often characterized by impairments in physical function and mobility. Regular physical activity (PA) is a cornerstone of axSpA management. Recent European League Against Rheumatism (EULAR) recommendations for PA have stressed the importance of their implementation., Objective: Cohort study to investigate the awareness on and individual implementation of axSpA patients towards PA., Methods: Patients with axSpA and impaired physical function (Bath AS Functional Index [BASFI] score≥2.0) were recruited consecutively. All patients underwent a clinical examination including assessments of disease activity, physical function, mobility and global functioning. Patients also had to fill out structured questionnaires on knowledge, awareness and individual attitudes to PA., Results: Out of a total of 100 patients enrolled, 96 were included. Most respondents (n=82, 85.4%) were aware that PA has significant health benefits for patients with axSpA. Even though less than half of the patients (n=44, 42.7%) were aware that actual EULAR recommendations do exist, 45 patients (46.9%) did already fulfill these in terms of frequency/week. The majority of patients (n=61, 67.7%) had been informed about the benefits of PA by their physician, and physiotherapy had often been prescribed (n=61, 63.3%). Many patients (n=51, 53.1%) reported to perform individual exercise programs, and some (n=22, 22.9) supervised PA., Conclusion: Even though the majority of axSpA patients are not aware of the recent EULAR recommendations for PA, many understand and agree that PA is beneficial for their health status. Health care providers should concentrate on the patients who are not active and do not know about the benefits of PA., (Copyright © 2023 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Objectives: We aimed to evaluate whether obese patients with psoriatic arthritis (PsA) were less likely to be in remission/low disease activity (LDA)., Methods: We used data from the ReFlaP, an international multi-centre cohort study (NCT03119805), which recruited consecutive adults with definite PsA (disease duration ≥ 2 years) from 14 countries. Demographics, clinical data, comorbidities, and patient-reported outcomes were collected. Remission/LDA was defined as Very Low Disease Activity (VLDA)/minimal disease activity (MDA), Disease Activity in PSoriatic Arthritis (DAPSA) ≤4/≤14, or by patients' opinion. Obesity was defined as physician-reported and/or body mass index ≥30 kg/m 2 . We evaluated the association between obesity and the presence of remission/LDA, with adjustment in multivariable regression models., Results: Among 431 patients (49.3% women), 136 (31.6%) were obese. Obese versus non-obese patients were older, more frequently women, had higher tender joint and enthesitis counts and worse pain, physical function and health-related quality of life. Obese patients were less likely to be in VLDA; DAPSA remission and MDA, with adjusted ORs of 0.31 (95% CI 0.13 to 0.77); 0.39 (95% CI 0.19 to 0.80) and 0.61 (95% CI 0.38 to 0.99), respectively. Rates of DAPSA-LDA and patient-reported remission/LDA were similar for obese and non-obese patients., Conclusion: PsA patients with comorbid obesity were 2.5-3 folds less likely to be in remission/LDA by composite scores compared with non-obese patients; however, remission/LDA rates were similar based on the patients' opinion. PsA patients with comorbid obesity may have different disease profiles and require individualised management., Competing Interests: Competing interests: YYL has received consulting fee and speaking fees from AbbVie, DKSH, Janssen, Novartis and Pfizer. LCC is an Editorial Board Member of RMD Open, she has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer and UCB; worked as a paid consultant for AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Moonlake, Novartis, Pfizer and UCB; and has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Medac, Novartis, Pfizer and UCB. MdW has received fees for lectures or consultancy from Celgene, Eli Lilly, Pfizer and UCB. JSS received Research Grants for his institution from Abbvie, AstraZeneca, Lilly, Novartis and Roche, and honoraria for consultancies and/or speaking engagements from AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Lilly, Merck Sharp & Dohme, Novartis- Sandoz, Pfizer, R-Pharm, Samsung, Sanofi, and UCB. UK has received grants and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowoessen.de, Pfizer, Roche, UCB and Viatris. AB has received speakers’ fees and consulting fees from Abbvie, Amgen, Akros, Astra-Zeneca, Angellini, AlphaSigma, BMS, Berlin-Chemie, Biogen, Lilly, Mylan, MSD, Novartis, Pfizer, Roche, Sandoz, Teva, UCB, Zentiva; and was investigator in clinical trials sponsored by Akros, MSD, Sanofi, Pfizer, Astra-Zeneca, Novartis, BMS, GSK, Roche, UCB, Sandoz. LG has received research grants from Sandoz, UCB; consulting fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)

Introduction: To evaluate the effect of upadacitinib vs. placebo on health-related quality of life (HRQoL) and work productivity in patients with active non-radiographic axial spondyloarthritis (nr-axSpA) enrolled in the SELECT-AXIS 2 phase 3 randomized controlled trial., Methods: Adult patients with active nr-axSpA and an inadequate response to non-steroidal anti-inflammatory drugs were randomized 1:1 to receive upadacitinib 15 mg once daily or placebo. Mean changes from baseline in measures of HRQoL (Ankylosing Spondylitis QoL [ASQoL], Assessment of SpondyloArthritis international Society Health Index [ASAS HI], Short-Form 36 Physical Component Summary [SF-36 PCS] score) and Work Productivity and Activity Impairment (WPAI) were assessed through 14 weeks based on mixed-effects repeated measures or analysis of covariance models. The proportions of patients with improvements ≥ minimum clinically important differences (MCID) were assessed in HRQoL measures at week 14 using non-responder imputation with multiple imputation., Results: At week 14, upadacitinib- vs. placebo-treated patients reported greater improvements from baseline in ASQoL and ASAS HI (ranked, P < 0.001) and in SF-36 PCS and WPAI overall work impairment (nominal P < 0.05). Improvements were observed as early as week 2 in ASAS HI. Greater proportions of upadacitinib vs. placebo-treated patients reported improvements ≥ MCID in ASQoL (62.6 vs. 40.9%), ASAS HI (44.8 vs. 28.8%), and SF-36 PCS (69.3 vs. 52.0%), with numbers needed to treat < 10 for all (nominal P ≤ 0.01). Improvements ≥ MCID were consistently observed irrespectively of prior exposure to tumor necrosis factor inhibitors., Conclusions: Upadacitinib provides clinically meaningful improvements in HRQoL and work productivity in patients with active nr-axSpA., Clinical Registration Number: NCT04169373, SELECT-AXIS 2., (© 2023. The Author(s).)

Objective: To assess the prevalence of foot insufficiency fractures (IF) in patients with rheumatic musculoskeletal disease (RMD) with foot pain., Methods: In a retrospective design, 1752 magnetic resonance imaging (MRI) scans of consecutive patients presenting with foot pain in 2 time periods between 2016 and 2018 were evaluated. The group with IF was matched with controls with foot pain without IF. Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry. Multivariate analyses were performed., Results: A total of 1145 MRI scans of patients (median age 59 yrs, 82.9% female) with an inflammatory (65.4%) and of 607 with no inflammatory (34.6%) RMD (median age 58 yrs, 80.8% female) were available. Most patients had rheumatoid arthritis (RA; 42.2%), and others had psoriatic arthritis (22.4%), axial spondyloarthritis (11.1%), or connective tissue disease (CTD; 7.6%). Foot IF were found in 129 MRI scans of patients (7.5%). There was no difference between time periods. The prevalence of IF was highest in CTD (23%) and RA (11.4%). More patients with an inflammatory than a noninflammatory RMD had IF (9.1% vs 4.1%, respectively; P < 0.001). Using conventional radiography, IF were only detected in 25%. Low BMD and a history of fractures were more frequent in patients with IF than without (42.6% vs 16.2% and 34.9% vs 8.6%, respectively; P < 0.001)., Conclusion: A high prevalence of foot fractures was found in MRI scans of patients with RMD, many without osteoporosis. MRI was more sensitive than radiographs to detect IF., (Copyright © 2023 by the Journal of Rheumatology.)

Objective: The Assessment of Spondyloarthritis International Society Health Index (ASAS HI) is a validated patient-reported outcome (PRO) for global functioning of patients with axial spondyloarthritis (axSpA). The Epionics SPINE (ES) is an electronic device for assessment of axial mobility that provides an objective measure of spinal mobility by assessing range of motion (RoM) and range of kinematics (RoK). The aim of this study is to investigate the relationship between global functioning and clinical measures of disease activity, physical function, spinal mobility, and radiographic damage., Methods: In a cross-sectional study design, consecutive patients with radiographic and nonradiographic axSpA were included, and the following established tools were assessed: Bath ankylosing spondylitis (AS) disease activity index (BASDAI), Bath AS functional index (BASFI), Bath AS metrology index (BASMI), ASAS HI, and RoM and RoK using ES. Structural damage of spine and sacroiliac joints (SIJ) were assessed by counting the number of syndesmophytes and by New York grading of sacroiliitis. Kendall's tau correlation coefficients were calculated., Results: In 103 patients with axSpA, ASAS HI scores correlated significantly with PRO scores (BASDAI, r = 0.36; BASFI, r = 0.48; and back pain, r = 0.41; all P < 0.001). In contrast, no significant correlation between ASAS HI and RoM and RoK (r between -0.08 and 0.09) and radiographic damage in SIJ and spine (all r between 0.03 and 0.004) were seen, respectively. BASMI scores correlated weakly (r = 0.14; P = 0.05)., Conclusion: This study shows that axSpA disease-specific PROs have an impact on global functioning, whereas spinal mobility scores, even if objectively assessed by the ES, have limited impact on patient reported-global functioning. The results also suggest that global functioning is, in this cohort, not much dependent on the degree of structural damage in the axial skeleton., (© 2023 The Authors. Arthritis Care & Research published by Wiley Periodicals LLC on behalf of American College of Rheumatology.)

Objectives: Despite the increasing number of female medical students and fellows in Europe, women are still under-represented in higher academic careers and positions in medicine. The aim of this survey was to assess the 'status quo' on gender distribution among rheumatologists in Germany., Methods: A web-based anonymous survey (21 questions with multiple answers and free text) using QuestionPro ® was distributed among rheumatologists in Germany via newsletters, social media and personal contact, including questions regarding hierarchical positions and work characteristics., Results: Among the total of 170 respondents (72% women, 28% men, 1% diverse), 48% were rheumatologists in training, 35% were trained rheumatologists and 7% were heads of rheumatology departments. Regarding the gender ratio at different hierarchical levels, 74% of respondents reported more men than women in leadership positions. Part-time work was possible in the departments of 86% of respondents, with more women working part-time (56%) compared to men (29%). Most respondents stated their impression that employees working part-time did not have the same career chances as full-time workers in their departments. In total, 66% agreed that activities to improve gender equity are necessary. The highest need was seen in reconciling work and family through, e.g., part-time models, flexible childcare options at work and a higher acceptance of part-time work in leadership positions., Conclusions: According to our results, a gender imbalance is prevalent among rheumatologists in Germany, with lower numbers of women evident at higher hierarchical levels. Traditional role assignments are still represented by a higher proportion of part-time work in women. The establishment of structural changes to achieve better gender equity is needed.

Objective: To investigate the effect of pharmacological treatment of SpA on depressive symptoms and explore whether this effect differs between drug classes., Methods: Data from the observational Assessment of SpondyloArthritis international Society Health Index Validation Study were used. Patients were assessed at baseline and after initiation of NSAIDs/conventional synthetic DMARDs (csDMARDs)/TNF inhibitors (TNFis). Depressive symptoms were assessed with the Hospital Anxiety and Depression Scale depression subscale [HADS-D; 0-21 (best-worst)]. Covariables included demographics and disease characteristics, including disease activity [Ankylosing Spondylitis Disease Activity Score (ASDAS)/BASDAI]. The change in HADS-D from baseline was compared between treatments (NSAIDs/csDMARDs/TNFis) with analysis of variance and multivariable regression analysis., Results: A total of 304 patients were included; 102/45/157 initiated NSAIDs/csDMARDs/TNFis and 260 (85%) / 44 (15%) had axial/peripheral SpA. At baseline, the mean HADS-D was 6.9 (s.d. 4.2); 126 (42%) were possibly depressed (HADS-D ≥8) and 66 (22%) were probably depressed (HADS-D ≥11). At follow-up, depressive symptoms significantly improved in all treatment groups. In multivariable regression without disease activity measures, initiating TNFis compared with NSAIDs was associated with greater improvement in depressive symptoms [β = -1.27 (95% CI -2.23, -0.32)] and lower odds of possible depression at follow-up [odds ratio 0.47 (95% CI 0.23, 0.94)]. This association was attenuated after additional adjustment for disease activity (ASDAS/BASDAI) but not CRP. csDMARDs did not differ from NSAIDs regarding their effect on HADS-D. Between-drug class results were confirmed in axial SpA (axSpA), although less clear in peripheral SpA., Conclusion: Treatment of active SpA also improves depressive symptoms. Especially in axSpA, TNFis have a greater effect than NSAIDs, which is mainly explained by a stronger effect on disease activity. We found no evidence for a direct link between CRP-mediated inflammation and depressive symptoms in SpA., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objective: To assess test-retest reliability, construct validity, known groups discrimination, and responsiveness of the Assessment of the SpondyloArthritis international Society Health Index (ASAS HI) to evaluate functioning, disability, and health in patients with radiographic axial spondyloarthritis (r-axSpA)., Methods: Data were generated from 2 randomized, placebo-controlled, active-controlled phase III ixekizumab studies (COAST-V, N = 341; COAST-W, N = 316). Assessments included the following: test-retest reliability (ie, intraclass correlation coefficients [ICCs] between ASAS HI scores at screening and baseline), construct validity (ie, Spearman correlation with standard r-axSpA outcome measures), known groups discrimination (ie, 1-way ANOVA comparing the ASAS HI with different disease activity categories, measured by the Ankylosing Spondylitis Disease Activity Score [ASDAS]), and responsiveness (ie, Spearman correlation between changes in the ASAS HI and changes in the Bath Ankylosing Spondylitis Functional Index [BASFI], the Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], the ASDAS, and the Patient Global Assessment [PtGA] as well as ANOVA comparing changes in the ASAS HI with various responder categories)., Results: The ICC for test-retest reliability was 0.78 for COAST-V and 0.76 for COAST-W, indicating adequate agreement. Moderate-to-large correlations ( r = 0.40-0.61) were observed between the ASAS HI and the BASDAI. Statistically significant differences (all P < 0.001) between mean ASAS HI scores were observed for subgroups based on ASDAS-defined disease activity categories at baseline and week 16. Moderate-to-large correlations existed between changes in the ASAS HI and the BASFI, BASDAI, ASDAS, and PtGA from baseline to week 16. The ASAS HI differentiated statistically ( P < 0.001) between ASAS, BASDAI, and ASDAS response groups., Conclusion: The ASAS HI demonstrated reliability, construct validity, known groups discrimination, and responsiveness in adults with r-axSpA in 2 clinical trials., (Copyright © 2023 by the Journal of Rheumatology.)

Introduction: To identify facilitators and barriers towards vaccination in general and specifically against pneumococci, influenza and SARS-CoV-2 in patients with rheumatic musculoskeletal diseases (RMD)., Methods: Between February and April 2021, consecutive patients with RMD were asked to complete a structured questionnaire on general knowledge about vaccination, personal attitudes and perceived facilitators and barriers towards vaccination. General facilitators (n=12) and barriers (n=15) and more specific ones for vaccination against pneumococci, influenza and SARS-CoV-2 were assessed. Likert scales had four response options: from 1 (completely disagree) to 4 (completely agree). Patient and disease characteristics, their vaccination records and attitudes towards vaccination against SARS-CoV-2 were assessed., Results: 441 patients responded to the questionnaire. Knowledge about vaccination was decent in ≥70% of patients, but <10% of patients doubted its effectiveness. Statements on facilitators were generally more favourable than on barriers. Facilitators for SARS-CoV-2 vaccination were not different from vaccination in general. Societal and organisational facilitators were more often named than interpersonal or intrapersonal facilitators. Most patients indicated that recommendations of their healthcare professional would encourage them to be vaccinated-without preference for general practitioner or rheumatologists. There were more barriers towards SARS-CoV-2 vaccination than to vaccination in general. Intrapersonal issues were most frequently reported as a barrier. Statistically significant differences in response patterns to nearly all barriers between patients classified as definitely willing, probably willing and unwilling to receive SARS-CoV-2 vaccines were noted., Discussion: Facilitators towards vaccination were more important than barriers. Most barriers against vaccination were intrapersonal issues. Societal facilitators identified support strategies in that direction., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To define the instruments for the Assessment of SpondyloArthritis international Society-Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA)., Methods: An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments' psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS., Results: The updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments., Conclusions: The selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials., Competing Interests: Competing interests: VN-C: grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer and UCB. ABoonen: grants from AbbVie ad Novartis and honoraria for boards or lectures form Abbvie, Galapagos and Lilly. PJM: research grants, consultation fees and/or speaker honoraria from Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma and UCB. MD: consulting fees Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma. UK: grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. RBML: honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli-Lilly, Novartis, Pfizer and UCB Pharma; Director of Rheumatology Consultancy BV. XB: consulting fees AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB. WB-M: research speaker's fees from Janssen, Lilly, Novartis, Pfizer and Biopas. PC: research grants/honoraria from Novartis, Pfizer, Zuellig Pharma and Janssen. LF: employee and shareholder of Pfizer. MG-C: research collaboration with and provides services to Novartis Pharma AG. LG: research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer and UCB. BKE: consultancy, research grants and speaker's fees from AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis and Servier. NH: consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PMM: consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WM: consulting fees Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer and UCB; research and/or educational grants from Abbvie, Novartis and Pfizer; Chief Medical Officer CARE Arthritis Limited. AM: speaker honoraria for lectures, presentations from Abbvie, UCB, Novartis, Pfizer, Gilead, Janssen, MSD, BMS, Biogen and Lilly. NdP: employee of UCB Pharma. DP: research support from AbbVie, Lilly, MSD, Novartis and Pfizer, consulting fees from AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis and UCB and speaker fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer and UCB. MP: speaker honoraria for lectures, presentations from Novartis and UCB. SR: research grants from Galapagos, MSD, Novartis and Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. I-HS: employee of AbbVie, Immunology Clinical Development, USA. DvdH: consulting fees AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology bv. ABoel, HD, YHK and SvW: no competing interests to declare., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: Refusal to receive SARS-CoV-2 vaccination poses a threat to fighting the COVID-19 pandemic. Little is known about German cancer patients' attitude towards and experience with SARS-CoV-2 vaccination., Methods: Patients were enrolled between 04-11/2021. They completed a baseline questionnaire (BLQ) containing multiple choice questions and Likert items ranging from 1 ("totally disagree") to 11 ("totally agree") regarding their attitude towards vaccination and COVID-19. A follow-up questionnaire (FUQ) was completed after vaccination., Results: 218 patients (43% female) completed BLQ (110 FUQ; 48% female). Most patients agreed to "definitely get vaccinated" (82%) and disagreed with "SARS-CoV-2 vaccination is dispensable due to COVID-19 being no serious threat" (82%; more dissent among men, p = 0.05). Self-assessment as a member of a risk group (p = 0.03) and fear of COVID-19 (p = 0.002) were more common among women. Fear of side effects was more common among women (p = 0.002) and patients with solid or GI tumors (p = 0.03; p < 0.0001). At FUQ, almost all (91%) reported their vaccination to be well tolerated, especially men (p = 0.001). High tolerability correlated with confidence in the vaccine being safe (r = 0.305, p = 0.003). Most patients would agree to get it yearly (78%). After vaccination, patients felt safe meeting friends/family (91%) or shopping (62%). Vacation (32%) or work (22%) were among others considered less safe (less frequent among men, p < 0.05)., Conclusion: Acceptance of SARS-CoV-2 vaccination is high and it is well tolerated in this sensitive cohort. However, concerns about vaccine safety remain. Those and gender differences need to be addressed. Our results help identify patients that benefit from pre-vaccination consultation., (© 2022. The Author(s).)

Objectives: To explore patient-defined flares in psoriatic arthritis (PsA), compared to an increase in disease activity in psoriatic arthritis (DAPSA) and to analyze the validity of a patient-reported flare question., Methods: ReFlap (NCT03119805) was a longitudinal study in 14 countries of consecutive patients with definite PsA. Patients were seen twice in the context of usual care, 4.5±2.2 months apart. Flares were reported by patients and physicians at the second visit using a single question. DAPSA worsening was defined as a change to a higher DAPSA category. Agreement between the definitions of worsening was calculated by prevalence adjusted bias adjusted kappa (PABAK). Validity of patient-reported flare was assessed by comparing patients with versus without flare and transition to flares., Results: In 222 patients, mean disease duration 10.8±8.3 years, 127 (58.8%) males: disease activity was low (mean DAPSA 11.5±14.0); 63.3% received a bDMARD. Patient-reported flares between the 2 visits were seen in 27% patients (for these patients, mean 2.2±3.7 flares per patient, mean duration 12.6±21.0 days per flare). Physician- reported flares were seen in 17.6% and worsening in DAPSA in 40.1% of patients. Agreement between definitions was moderate (PABAK=0.32-0.59). Patients in flare had significantly more active disease than patients not in flare for all outcomes (all P<0.001). At the patient-level, transition to flare state was associated to a worsening in disease activity and impact outcomes., Conclusions: Patient flares were frequent and were associated with active and symptomatic disease. These findings provide preliminary validation for patient-reported flares in PsA., (Copyright © 2022 Société française de rhumatologie. Published by Elsevier Masson SAS. All rights reserved.)

Objectives: To compare the influence of age on inflammatory (bone marrow oedema [BME]) and structural (fat lesions [FL], erosions and ankylosis) MRI lesions in the sacroiliac joints (SIJ) of patients with and without axial spondyloarthritis (axSpA)., Methods: In a retrospective study, SIJ MRI (STIR/T1 sequences) of consecutive patients with chronic back pain diagnosed with axSpA or non-SpA were evaluated based on SIJ quadrants (SIJ-Q). Two blinded readers evaluated BME and structural lesions. Reader agreement was evaluated for prevalence of MRI lesions related to age., Results: MRIs of 309 (175 axSpA, 134 non-SpA) patients were evaluated. Their mean age was 38.5 (11.4) and 43.4 (13.8) years, 67% and 36% were male, CRP was 1.6 (2.4) and 1.1 (2.1) mg/dl and median symptom duration was 48 and 60 months for axSpA and non-SpA, respectively. SIJ-Q with BME and erosions were significantly more frequent in axSpA vs non-SpA patients independent of age, while this difference was seen for FL only in patients ≥50 years. The proportion of patients with ≥1 or ≥3 BME or chronic lesions except for FL increased with age in both groups, and was constantly higher in axSpA vs non-SpA. In univariate analyses, only female sex was significantly associated with more FL., Conclusions: The proportion of patients with MRI lesions was high in both axSpA and non-SpA patients. However, the prevalence of BME and erosions was significantly more frequent in patients with axSpA, was independent of age and also allowed for discrimination. FL occurred more frequently only in older age groups and were less reliable for discrimination vs non-SpA patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To assess the association between self-reported and performance-based physical functioning and to evaluate which performance tests are most frequently impaired in patients with axial spondyloarthritis (axSpA)., Methods: Consecutive patients with axSpA underwent standardized assessments including patient and disease characteristics; patient-reported outcomes for disease activity, functioning, depression, mobility, and physical activity; and performance tests. Patients were defined as being impaired if they were not able to perform ≥ 1 of the performance tests. Validated cut-offs were used to define impaired physical performance. Impairment of performance tests as well as discrimination between subgroups were analyzed., Results: A total of 200 patients (radiographic axSpA 66.5%, nonradiographic axSpA 33.5%) were included: 69% males, mean age 44.3 (SD 12.5) years, and mean symptom duration 17.9 (SD 12.6) years. The 2 most frequently impaired performance tests were the repeated chair stand test (n = 75, 37.5%) and putting on socks (n = 44, 22%). An impairment in ≥ 1 performance test was seen in 91 patients (45.5%). Patients with impairments were older (49.1 yrs vs 40.3 yrs); had a higher BMI (28.9 kg/m 2 vs 25.8 kg/m 2 ); a more active disease (Ankylosing Spondylitis Disease Activity Score, 3.0 vs 2.1); higher Bath Ankylosing Spondylitis Functional Index (BASFI; 5.8 vs 2.7), Bath Ankylosing Spondylitis Metrology Index (BASMI; 4.4 vs 2.7), and Assessment of Spondyloarthritis international Society Health Index scores (9.5 vs 4.9); and higher depression screen values (9-item Patient Health Questionnaire, 11.6 vs 6.5; all P < 0.01)., Conclusion: Many patients with axSpA had impairments in physical performance tests. Importantly, this was frequently seen in tasks requiring coordination and muscle power of the lower extremity. Performance tests provide qualitatively different information than BASFI and BASMI assessments in patients with axSpA., (Copyright © 2023 by the Journal of Rheumatology.)

Introduction: Axial spondyloarthritis (axSpA) is a chronic inflammatory disease that typically affects people in their second and third decades of life, which are important years for establishing a professional career. We aim to study outcomes of work participation (WP) and their associations with demographic and clinical confounders, in addition to prevalence of negative workplace experiences in axSpA., Methods: In total, 770 patients with axSpA participated in the multicentre, observational ATTENTUS-axSpA survey in Germany. Demographic information, clinical parameters and patient-related outcomes (including disease activity and function) with a focus on WP were prospectively recorded., Results: A high prevalence of negative workplace experiences was reported among the 770 patients analysed. Overall, 23.4% of patients were not employed and 6.5% received disability pensions. Current work cessation was prevalent in 120 patients, and 28 of those were out of work for 10 years or longer. Of the 590 currently employed patients, 31.9% reported absenteeism and 35.9% reported presenteeism for >1 month within the past year. Multivariate logistic regression identified low disease activity (Bath Ankylosing Spondylitis Disease Activity Index), better physical function (Bath Ankylosing Spondylitis Functional Index) and better global functioning (Assessment of SpondylAarthritis International Society-Health Index) as the main predictors for unimpaired WP (n=242). Importantly, biological treatment, disease duration, age, sex, education level and body mass index were not reliable predictors., Discussion: Despite improvements in pharmacological treatment options, we still observed substantially impaired WP in patients with axSpA. These data emphasise the high unmet need for targeted strategies to provide improved medical and social care., Competing Interests: Competing interests: The study was sponsored by Novartis Pharma GmbH, Germany. UK received consultancy and speaker honoraria from AbbVie, Biocad, Chugai, Eli Lilly, Grünenthal, Janssen, MSD, Novartis, Pfizer, Roche and UCB; and grant/research support (unrestricted grant) from Abbvie, Amgen, Biogen, Fresenius, GSK, Novartis and Pfizer. DM-O received consultancy and speaker honoraria from 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. KH received consultancy and speaker honoraria from Abbvie, Chugai, Gilead, Lilly, Novartis, Sandoz Hexal and Sanofi. LH has no disclosures. SL and AH are employees of Novartis., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Spondyloarthritides (SpA) such as axial spondyloarthritis (axSpA) including ankylosing spondylitis (AS) and psoriatic arthritis (PsA) including psoriasis are chronic immune-mediated disorders with involvement of tumor necrosis factor (TNF), interleukin (IL)-17 cytokines, and janus kinases (JAK) in their pathogenesis, with IL-23 clearly also playing a role in psoriasis, PsA, and chronic inflammatory bowel diseases., Areas Covered: In this narrative review, we focus on a biologic disease modifying anti-rheumatic drug (bDMARD), the bispecific IL-17A and IL-17 F inhibitor bimekizumab, and a targeted synthetic (ts) DMARD, the JAK inhibitor (i) filgotinib - emerging agents for the treatment of axSpA. Upadacitinib, another JAKi that has recently been reviewed intensively by us is already approved for axSpA and PsA in Europe., Expert Opinion: In contrast to inhibition of IL-17, JAKi also work in rheumatoid arthritis (RA), while agents inhibiting IL-17 are not, even though some effect may be there. Indeed, 4 JAKi including filgotinib are approved for RA. There are several head-to-head trials with bimekizumab in plaque psoriasis. The last one showed that the bispecific inhibition of IL-17A and IL-17 F with bimekizumab may indeed be superior to inhibition of IL-17A alone with 300 mg secukinumab (usual dosage). Whether this is also the case for treatment of axSpA and PsA remains to be shown.

Objective: The Assessment of Spondyloarthritis international Society Health Index (ASAS HI) measures global functioning and health in patients with axial spondyloarthritis (axSpA) covering domains of physical, emotional, and social functioning. The main aim of this study was to investigate the sensitivity to change of ASAS HI in comparison with established variables of disease activity, function, and mental health., Methods: Patients with axSpA from the disease register RABBIT-SpA with follow-up time of at least 12 months and available ASAS HI questionnaires were included. Patients received questionnaires addressing disease activity (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS]), physical function (Bath Ankylosing Spondylitis Functional Index [BASFI]), mental health (5-item World Health Organization Well-Being Index [WHO-5]), and global functioning (ASAS HI). Standardized response means (SRMs) were calculated to compare the sensitivity to change of different variables., Results: Six hundred and sixty-seven patients were included, 552 treated with biologic disease-modifying antirheumatic drugs (bDMARDs) and 115 with conventional synthetic DMARDs and/or nonsteroidal antiinflammatory drugs (control group). Between baseline and month 12, the mean ASAS HI declined from 6.9 to 5.1 in the bDMARD group and from 5.9 to 5.6 in the conventionally treated group. In the bDMARD group, the SRM of ASAS HI was 0.52, compared to 0.59 for BASFI, 0.65 for WHO-5, 0.73 for BASDAI, and 0.90 for ASDAS. The following ASAS HI domains were most frequently affected: pain (78% agreed), maintaining body position (75%), and energy/drive (73%). In the patients receiving bDMARDs, there was an improvement in all items. In the control group, the largest improvement was seen in pain., Conclusion: As expected, ASDAS and BASDAI as disease activity scores showed high sensitivity to change, whereas changes in physical function (BASFI), mental health (WHO-5), and the broader concept of functioning and health (ASAS HI) were moderate., (Copyright © 2023 by the Journal of Rheumatology.)

Background: The role of methotrexate in combination with biological agents in patients with psoriatic arthritis remains unclear. The MUST phase 3b trial aimed to compare the efficacy of ustekinumab plus placebo with ustekinumab plus methotrexate in patients with active psoriatic arthritis., Methods: In this investigator-initiated, randomised, multicentre, placebo-controlled, phase 3b non-inferiority trial done in 22 centres in Germany, patients with active psoriatic arthritis received open-label ustekinumab and were randomly assigned (1:1) to masked concomitant therapy with placebo or methotrexate (ongoing or new). The primary outcome was non-inferiority of mean Disease Activity Score-28 joints (DAS28) at week 24 for ustekinumab monotherapy (ustekinumab plus placebo) versus ustekinumab combination therapy (ustekinumab plus methotrexate), stratified by previous methotrexate treatment. The key secondary analysis was non-inferiority of DAS28 at week 52. The primary analysis was based on a stratified van Elteren test with an α of 2·5% and a non-inferiority margin of 12·5% by Mann-Whitney estimator. Adverse events and serious adverse events were assessed. This study is registered with ClinicalTrials.gov, NCT03148860., Findings: Between Jan 24, 2017, and April 12, 2021, 186 patients with active psoriatic arthritis were screened, of whom 173 (93%) patients were enrolled and randomly assigned (1:1) to receive concomitant methotrexate therapy (n=88) or placebo (n=85). 84 patients were receiving methotrexate at baseline, and 89 patients had no previous methotrexate treatment. 166 (96%) patients (87 in the ustekinumab plus methotrexate group and 79 in the ustekinumab plus placebo group) were included in the safety and efficacy analyses at week 24 (69 [42%] female; 97 [58%] male; mean age 48·2 years [SE 1·1]). Ustekinumab plus placebo was non-inferior to ustekinumab plus methotrexate in DAS28 at week 24 (2·9 [SD 1·31] vs 3·1 [1·42]); the stratified Mann-Whitney estimator for treatment comparison was 0·5426 (95% CI 0·4545-0·6307). Non-inferiority for ustekinumab plus placebo was also observed in DAS28 at week 52. Serious adverse events occurred in seven (9%) patients in the ustekinumab plus placebo group and eight (9%) patients in the ustekinumab plus methotrexate group. No specific serious adverse events affected more than one patient, and there were no deaths., Interpretation: Interleukin (IL)-12 and IL-23 inhibition with ustekinumab is an effective treatment for psoriatic arthritis independent of methotrexate use; concomitant methotrexate did not increase efficacy of ustekinumab (based on DAS28). On the basis of these data, there is no evidence to support the addition or maintainance of methotrexate when initiating ustekinumab in patients with active psoriatic arthritis., Funding: Janssen Cilag., Competing Interests: Declaration of interests MK received grants or contracts from BMS, Bionorica, Iron4u, Janssen-Cilag, LEO, Novartis, and Pfizer and received travel support or honoraria or fees for serving as a speaker, consultant and/or advisory board member from Abbvie, Lilly, Janssen-Cilag, Novartis, Pfizer, and UCB. GRB received honoraria or fees for serving as a speaker and/or consultant from Abbvie, Amgen, BMS, Galapagos, Lilly, MSD, Pfizer, Roche, and Sanofi. UK received scientific grants from AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, Pfizer and honoraria or fees for serving as a speaker and/or consultant from Abbvie, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB. JR received scientific grants from Novartis and Sobi, and honoraria or fees for serving as a speaker and/or consultant from Abbvie, Biogen, BMS, Chugai, GSK, Janssen, Lilly, MSD, Novartis, Roche, Sanofi, Sobi, and UCB. SM-P received honoraria or fees for serving as a speaker and/or consultant from AstraZeneca, Bristol Myers Squibb, GlaxoSmithKline, Janssen, and Novartis. HB received travel support or honoraria or fees for speaking from Janssen Cilag and research support from the Fraunhofer Cluster of Excellence for Immune-mediated diseases (CIMD). FB received research support from Janssen Cilag, the Fraunhofer Cluster of Excellence for Immune-mediated diseases (CIMD), and LOEWE Zentrum Translational Medicine and Pharmacology, grants or contracts from BMS, Bionorica, Iron4u, Janssen-Cilag, LEO, Novartis, and Pfizer, and meeting support or honoraria or fees for serving as a speaker, consultant, and/or advisory board member from Abbvie, Affibody, Amgen, Boehringer Ingelheim, Galapagos, GSK, Janssen Cilag, Lilly, MoonLake, MSD, Novartis, Pfizer, Sandoz, Sanofi, and UCB. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Objectives: To update the Assessment of SpondyloArthritis international Society (ASAS)-EULAR recommendations for the management of axial spondyloarthritis (axSpA)., Methods: Following the EULAR Standardised Operating Procedures, two systematic literature reviews were conducted on non-pharmacological and pharmacological treatment of axSpA. In a task force meeting, the evidence was presented, discussed, and overarching principles and recommendations were updated, followed by voting., Results: Five overarching principles and 15 recommendations with a focus on personalised medicine were agreed: eight remained unchanged from the previous recommendations; three with minor edits on nomenclature; two with relevant updates (#9, 12); two newly formulated (#10, 11). The first five recommendations focus on treatment target and monitoring, non-pharmacological management and non-steroidal anti-inflammatory drugs (NSAIDs) as first-choice pharmacological treatment. Recommendations 6-8 deal with analgesics and discourage long-term glucocorticoids and conventional synthetic disease-modifying antirheumatic drugs (DMARDs) for pure axial involvement. Recommendation 9 describes the indication of biological DMARDs (bDMARDs, that is, tumour necrosis factor inhibitors (TNFi), interleukin-17 inhibitors (IL-17i)) and targeted synthetic DMARDs (tsDMARDs, ie, Janus kinase inhibitors) for patients who have Ankylosing Spondylitis Disease Activity Score ≥2.1 and failed ≥2 NSAIDs and also have either elevated C reactive protein, MRI inflammation of sacroiliac joints or radiographic sacroiliitis. Current practice is to start a TNFi or IL-17i. Recommendation 10 addresses extramusculoskeletal manifestations with TNF monoclonal antibodies preferred for recurrent uveitis or inflammatory bowel disease, and IL-17i for significant psoriasis. Treatment failure should prompt re-evaluation of the diagnosis and consideration of the presence of comorbidities (#11). If active axSpA is confirmed, switching to another b/tsDMARD is recommended (#12). Tapering, rather than immediate discontinuation of a bDMARD, can be considered in patients in sustained remission (#13). The last recommendations (#14, 15) deal with surgery and spinal fractures., Conclusions: The 2022 ASAS-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA., Competing Interests: Competing interests: SR received research grants from AbbVie, Galapagos, Novartis, Pfizer and UCB, and consulting fees from AbbVie, Eli Lilly, Novartis, MSD, Pfizer, UCB and Sanofi. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. AS has received speaker/consulting fees from UCB and Novartis. AO has nothing to declare. CW has nothing to declare. XB received consulting fees and research grants from AbbVie, BMS, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi and UCB. XB is an editorial board member of Annals of Rheumatic Diseases. RBML received consulting fees from AbbVie, Bristol Myers Squibb, Celgene, Jansen, Galapagos, GlaxoSmithKline, Novartis, Pfizer, and UCB, and is director of Rheumatology Consultancy. FEVdB received consulting and/or speaker fees from AbbVie, Amgen, Eli Lilly, Galapagos, Janssen, MoonLake, Novartis, Pfizer and UCB. BB has nothing to declare. AB has nothing to declare. PC received consulting/speaker’s fees from Eli Lilly, Pfizer, AbbVie, Sanofi, Galapagos, Fresenius Kabi, Biogen, MSD, UCB and Novartis. AC received honoraria for lectures from AbbVie, Merck Sharp & Dohme and Novartis. FAvG received grants from Stichting ASAS, and consulting/speaker’s fees from Novartis, UCB, Pfizer, AbbVie, Eli Lilly, Bristol Myers Squibb and Celgene. PG received speaker’s fees from AbbVie. LG received consulting fees and research grants from AbbVie, Eli Lilly, Galapagos, Janssen, MoonLake, Novartis, Pfizer and UCB. JH has received speaker honoraria and participated in advisory boards for AbbVie, Lilly, Novartis and Janssen. MdH has nothing to declare. MH has received speaker’s fees from Novartis. UK has received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. CL-M has received speaker/consulting fees from UCB, Novartis, Janssen, Eli Lilly, MSD and AbbVie. PMM has received honoraria from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, and UCB, and is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). HM-O received grants from Janssen, Novartis and UCB, and consultancy/speaker's fees from AbbVie, Biogen, Eli Lilly, Janssen, MoonLake, Novartis, Pfizer and UCB. AM received research grants from UCB and consulting fees from AbbVie, Biogen, BMS, Eli Lilly, Gilead, Novartis, MSD, Pfizer and UCB. VN-C received grants/honoraria from AbbVie, Galapagos, Janssen, Lilly, MoonLake, Novartis, Pfizer and UCB. MJN received grant from Novartis and consultancy/speaker's fees from AbbVie, Eli Lilly, Janssen, Novartis and Pfizer. FMP-S received research grants from AbbVie, Janssen, and Novartis, and consulting fees from AbbVie, Bial, Biogen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Pharma Kern, UCB and Tecnimed. DP received research support from AbbVie, Eli Lilly, MSD, Novartis, and Pfizer, and consulting fees from AbbVie, Biocad, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Janssen, MSD, MoonLake, Novartis, Pfizer, Samsung Bioepis, and UCB, and speaker's fees from AbbVie, Bristol Myers Squibb, Eli Lilly, Janssen, MSD, Medscape, Novartis, Peervoice, Pfizer and UCB. FP reports grants and personal fees from Novartis, Lilly and UCB, and personal fees from AbbVie, Amgen, BMS, Celgene, Janssen, Hexal, MSD, Pfizer and Roche. MR received consulting fees from AbbVie, Janssen, Eli Lilly, Novartis, Pfizer and UCB Pharma. MT has nothing to declare. SSZ has received consulting fees from UCB. NZ received research grants from AbbVie, Celgene, NewBridge and Pfizer; consulting fees from AbbVie, Eli Lilly, Pfizer, Gilead, Janssen, Novartis, NewBridge and Roche; and speaker's fees from AbbVie, Apotex, Eli Lilly, Janssen, Novartis, Pfizer, Pierre Fabre, Pharmaline, Roche and Sanofi-Aventis. DvdH received consulting fees from AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer and UCB Pharma, and is director of Imaging Rheumatology., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)