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Background: Inception cohorts aim to describe chronic diseases from diagnosis and over years of follow-up. Axial spondyloarthritis (axSpA) diagnosis might be challenging during the first years of the disease. Thus, identifying the features that will be associated with a confirmed diagnosis over time is key., Objectives: To assess the frequency and the predisposing factors for a change of an initial diagnosis in an inception axSpA cohort., Methods: DESIR is an ongoing national multicentre inception axSpA cohort with currently 12.5 years of follow-up. At the entry visit and confirmed at each visit, the diagnosis of axSpA was based on the opinion of the treating rheumatologist. Follow-up was interrupted in case of a change in this initial diagnosis. Multiple imputation was used to estimate the probability of a change in the initial diagnosis of axSpA for each patient lost to follow-up. Factors predisposing to an unchanged diagnosis of axSpA were then assessed using a multivariate logistic regression model on the imputed data sets., Results: Of the 708 patients included, over 10 years of follow-up, 45 (6.4%) were excluded due to a diagnosis change and 300 (42.4%) patients were lost to follow-up. Based on the imputation of these 300 patients, a change in their initial axSpA diagnosis was estimated in 42 (14.0%). Factors predisposing to an unchanged initial axSpA diagnosis during follow-up were (ORs (95% CIs)): radiographic sacroiliitis: 17.0 (4.1 to 71.0); psoriasis: 5.3 (2.0 to 14.3); CRP≥6 mg/L: 2.7 (1.3 to 5.3); good NSAID response: 2.5 (1.5 to 4.2); HLA B27+: 2.0 (1.3 to 3.3); anterior chest wall pain: 2.0 (1.2 to 3.3) and female sex: 1.9 (1.2 to 3.0)., Conclusion: These data suggest that a change in diagnosis in recent onset axSpA exists, but is not frequent, and is less likely to occur in the presence of objective features at baseline., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Objective: Subjects with subclinical psoriatic arthritis (PsA), defined as the presence of arthralgia in psoriasis (PsO), are at higher risk of PsA but scant real-world data exist. Our aims were to (1) estimate the probability of PsA development in subclinical PsA, (2) characterise subclinical PsA symptoms and (3) determine the clinical patterns at PsA diagnosis., Methods: Patients with PsO, mainly subclinical PsA, were evaluated longitudinally in two European cohorts. The key outcome was new-onset PsA. Musculoskeletal symptoms including inflammatory and non-inflammatory symptoms before PsA diagnosis were collected. Occurrence of PsA was analysed with survival analysis and cumulative incidence functions (CIFs)., Results: 384 patients with PsO were included with a mean follow-up of 33.0 (±20.9) months. 311 of 384 (80.9%) had subclinical PsA with a PsA incidence rate of 7.7 per 100 patient-years. Subclinical PsA displayed a higher risk of PsA development compared with PsO (HR=11.7 (95% CI 1.57 to 86.7), p=0.016). The probability of new-onset PsA estimated by the CIF was 9.4% (95% CI 4.7% to 10.6%) at month 12 and 22.7% (95% CI 17.2% to 28.6%) at month 36. 58.9% of cases reported inflammatory symptoms in the months immediately prior to PsA diagnosis but prior non-inflammatory symptoms were evident in 83.9% prior to PsA diagnosis. Peripheral joint swelling was the predominant PsA presentation pattern (82.1%)., Conclusions: The probability of PsA development among subclinical PsA was relatively high, emphasising the importance of emergent musculoskeletal symptoms when aiming for PsA prevention. Joint swelling was the dominant feature in new-onset PsA, likely reflecting clinical confidence in recognising joint swelling., Competing Interests: Competing interests: AZ—speakers bureau: AbbVie, Novartis, Janssen, Lilly, UCB, Amgen; paid instructor for: AbbVie, Novartis, UCB. FF—none declared. LG—consultant of: AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB; grant/research support from: Sandoz, UCB. IG—none declared. MS—none declared. AT—none declared. XB—speakers bureau: AbbVie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly; paid instructor for: AbbVie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly; consultant of: AbbVie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly; grant/research support from: AbbVie, MSD, Novartis; leadership or fiduciary role in other board, society, committee or advocacy groups, paid or unpaid; editorial board member of Annals of Rheumatic Diseases; ASAS president. GDM—none declared. SDV—none declared. EE—consultant of: AbbVie, Janssen, Novartis, Amgen. LQ—none declared. ES—none declared. JSS—consulting fees: AbbVie, Galapagos/Gilead, Novartis-Sandoz, BMS, Samsung Sanofi, Chugai R-Pharma, Lilly; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Samsung, Lilly, R-Pharma, Chugai, MSD, Janssen Novartis-Sandoz; editor-in-chief of Annals of Rheumatic Diseases. IT—none declared. AW—none declared. GS—none declared. DGM—speakers bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB; consultant of: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB; grant/research support from: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer. DS—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.)

Objective: Evaluate long-term guselkumab effectiveness across Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-recognised domains/related conditions of psoriatic arthritis (PsA)., Methods: Post hoc analyses used data from DISCOVER-2 (NCT03158285) biologic/Janus-kinase inhibitor-naïve participants with active PsA (≥5 swollen/≥5 tender joints, C-reactive protein ≥0.6 mg/dL), randomised (1:1:1) to guselkumab every 4 or 8 weeks (Q4W/Q8W) or placebo with crossover to guselkumab. Outcomes aligned with key GRAPPA-recognised domains of overall disease activity, peripheral arthritis, axial disease, enthesitis/dactylitis and skin psoriasis (nail psoriasis was not evaluated). PsA-related conditions (inflammatory bowel disease (IBD)/uveitis) were assessed via adverse events through W112. Least squares mean changes from baseline through W100 in continuous outcomes employed repeated measures mixed-effects models adjusting for baseline scores. Binary measure response rates were determined with non-responder imputation for missing data., Results: 442/493 (90%) of guselkumab-randomised patients completed treatment through W100. Following early reductions in disease activity with guselkumab, durable improvements were observed across key PsA domains (swollen/tender joints, psoriasis, spinal pain, enthesitis/dactylitis) through W100. Response rates of therapeutically relevant targets generally increased through W100 with guselkumab Q4W/Q8W: Disease Activity Index for PsA low disease activity (LDA) 62%/59%, enthesitis resolution 61%/70%, dactylitis resolution 72%/83%, 100% improvement in Psoriasis Area and Severity Index 59%/53%, Psoriatic Arthritis Disease Activity Score LDA 51%/49% and minimal disease activity 38%/40%. Through W112, no cases of IBD developed among guselkumab-randomised patients and one case of uveitis was reported., Conclusion: In biologic-naïve patients with active PsA, guselkumab provided early and durable improvements in key GRAPPA-recognised domains through 2 years, with substantial proportions achieving important treatment targets., Competing Interests: Competing interests: LCC: 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, GlaxoSmithKline, Janssen, Medac, Novartis, Pfizer and UCB. LCC is supported by the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. LCC is an associate editor at RMD Open. LG: received research grants from AbbVie, Biogen, Eli Lilly, Novartis, UCB; consulting fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sandoz and UCB. MZ: employee of Janssen EMEA Medical Affairs Immunology, LLC, Zug, Switzerland; owns stock or stock options in Johnson & Johnson. MS: employee of Janssen Research & Development, LLC; owns stock or stock options in Johnson & Johnson. ER: employee of JSS Medical Research; paid consultant of Janssen. NJS: employee of Janssen Scientific Affairs, LLC; owns or has owned stock in AbbVie, Gilead, Iovance, Johnson & Johnson, Novo-Nordisk and Pfizer within the past 3 years. Current stock ownership: AbbVie, Gilead, Iovance, Jazz, Johnson & Johnson, Novavax and Viatris. APK: employee of Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson, and own stocks in Johnson & Johnson. XLX: employee of Janssen Research & Development, LLC, a wholly owned subsidiary of Johnson & Johnson; owns stock in Johnson & Johnson. PN: received funding for research and clinical trials and honoraria for advice and lectures on behalf of AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sun Pharma and UCB. PN is an editorial board member at RMD Open. PJM: received research grants from AbbVie, Acelyrin, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer, SUN Pharma and UCB; consulting fees from AbbVie, Acelyrin, Aclaris, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, GlaxoSmithKline, Immagene, Janssen, Novartis, Pfizer, SUN, UCB, Ventyx; and speaker fees from AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB. PSH: received consulting fees from Eli Lilly and fees for educational services from AbbVie, Amgen, Janssen and Novartis., (© 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: To assess which definition of remission best predicts good radiographic outcome (GRO) and good functional outcome (GFO) in rheumatoid arthritis, focusing the updated American College of Rheumatology/European Alliance of Associations for Rheumatology criteria., Material and Methods: Meta-analyses of individual patient data (IPD) from randomised controlled trials (RCTs). Six definitions of remission were considered: (1) Boolean with Patient Global Assessment (PGA)≤1 (Boolean); (2) Simplified Disease Activity Index (SDAI)≤3.3; (3) Clinical Disease Activity Index (CDAI)≤2.8; (4) Boolean with PGA≤2 (Updated-Boolean); (5) Boolean with Physician Global Assessment (PhGA≤1) replacing PGA (Boolean-PhGA) and (6) Boolean excluding PGA (3VBoolean). GRO was defined as a worsening ≤0.5 units in radiographic score and GFO as a no worsening in Health Assessment Questionnaire (HAQ), that is, ∆HAQ-DI≤0.0 units. Relationships between each remission definition at 6 and/or 12 months and GRO and GFO during the second year were analysed. Pooled probabilities for each outcome for each definition and their predictive accuracy were estimated., Results: IPD from eight RCTs (n=4423) were analysed. Boolean, SDAI, CDAI, Updated-Boolean, Boolean-PhGA and 3VBoolean were achieved by 24%, 27%, 28%, 32%, 33% and 43% of all patients, respectively. GRO among patients achieving remission ranged from 82.4% (3VBoolean) to 83.9% (SDAI). 3VBoolean showed the highest predictive accuracy for GRO: 51.1% versus 38.8% (Boolean) and 44.1% (Updated-Boolean). The relative risk of GFO ranged from 1.16 (Boolean) to 1.05 (3VBoolean). However, the proportion of GFO correctly predicted was highest for the 3VBoolean (50.3%) and lowest for the Boolean (43.8%)., Conclusion: 3VBoolean definition provided the most accurate prediction of GRO and GFO, avoiding the risk of overtreatment in a substantial proportion of patients without increment in radiographic damage progression, supporting the proposal that 3VBoolean remission is preferable to guide immunosuppressive treatment. The patient's perspective, which must remain central, is best served by an additional patient-oriented target: a dual-target approach., Competing Interests: Competing interests: RJOF reports a research grant from Medac, Consulting fees from Sanofi Genzyme, and support for attending meetings from Medac and speaker fees from Sanofi Genzyme, unrelated with this work LG reports grants from AbbVie, Biogen, Lilly, Novartis, Sandoz, UCB, personal fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, non-financial support from AbbVie, Janssen, MSD, Novartis, Pfizer, UCB, Viatris, outside the submitted work PM: reports consulting/speakers fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB Pharma and is supported by NIHR, UCLH and BRC; unrelated with this work. DvdH is Director of Imaging Rheumatology BV and reports speaker fees from AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda and UCB Pharma, unrelated with this work. JAPdS reports a research grant from Medac, Consulting fees from Amgen, MSD and Abbvie, speaker fees from Amgen, MSD and Abbvie and Support for attending meetings from Amgen, Abbvie and Pfizer, unrelated with this work., (© 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: To assess 52-week safety and efficacy of bimekizumab in patients with active psoriatic arthritis (PsA) and prior inadequate response/intolerance to tumour necrosis factor inhibitors., Methods: Patients completing the 16-week phase III double-blind, placebo-controlled BE COMPLETE (NCT03896581) study entered the open-label extension, BE VITAL (NCT04009499). All patients in BE VITAL received 160 mg bimekizumab every 4 weeks. Safety and efficacy are reported to week 52., Results: A total of 347/400 (86.8%) patients completed week 52. To week 52, the exposure-adjusted incidence rate/100 patient-years for ≥1 treatment-emergent adverse event (TEAE) was 126.0, and was 7.0 for serious TEAEs. The most frequent TEAEs were SARS-CoV-2 (COVID-19), oral candidiasis, nasopharyngitis and urinary tract infection. All fungal infections were mild or moderate in severity and localised; two patients discontinued the study due to oral candidiasis. No cases of active tuberculosis, uveitis or inflammatory bowel disease were reported. One sudden death occurred. Sustained efficacy was observed with bimekizumab from week 16 to ‍52 across clinical and patient-reported outcomes. At week 52, 51.7% bimekizumab-randomised and 40.6% placebo/bimekizumab patients (receiving bimekizumab from week 16 to 52) had ≥50% improvement in the American College of Rheumatology criteria. Complete skin clearance (Psoriasis Area and Severity Index 100) was achieved by 65.9% bimekizumab and 60.2% placebo/bimekizumab patients at week 52. Minimal disease activity was achieved by 47.2% bimekizumab and 33.1% placebo/bimekizumab patients at week 52., Conclusions: Bimekizumab demonstrated a safety profile consistent with previous reports; no new safety signals were identified. Sustained efficacy was observed from week 16 to 52., Competing Interests: Competing interests: LCC: Grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Galapagos, Gilead, Janssen, Moonlake Pharma, Novartis, Pfizer and UCB Pharma; speaking fees from AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, medac, Novartis, Pfizer and UCB Pharma. Associate Editor of RMD Open. RL: Consultancy fees from AbbVie, AstraZeneca, BMS, Eli Lilly, Novartis, Pfizer and UCB Pharma; research grants from AbbVie, Pfizer, Novartis, and UCB Pharma; owner of Rheumatology Consultancy BV, an AMS company under Dutch law. On the Editorial Board of RMD Open. IBM: Consulting fees and honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Cabaletta, Causeway Therapeutics, Celgene, Eli Lilly, Evelo, Janssen, Moonlake Pharma, Novartis and UCB Pharma; research support from BMS, Boehringer Ingelheim, Celgene, Janssen, Novartis and UCB Pharma. On the Editorial Board of RMD Open. PJM: Research grants from AbbVie, Amgen, BMS, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Sun Pharma and UCB Pharma; consultancy fees from AbbVie, Acelyrin, Aclaris, Amgen, BMS, Boehringer Ingelheim, Eli Lilly, Galapagos, Gilead, GSK, Janssen, Moonlake Pharma, Novartis, Pfizer, Sun Pharma and UCB Pharma; speakers’ bureau for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Pfizer and UCB Pharma. CTR: Research for AbbVie; consultant for AbbVie, Amgen, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. YT: Speaking fees and/or honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Chugai, Eisai, Eli Lilly, Gilead, GSK, Pfizer, Taiho and Taisho; received grants from Chugai, Eisai, Mitsubishi-Tanabe and Taisho. On the Editorial Board of RMD Open. AA: Honoraria and/or research grants from AbbVie, Amgen, BMS, Boehringer Ingelheim, Eisai, Eli Lilly, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Tanabe Pharma, Novartis, Pfizer, Sun Pharma, Taiho Pharma, Torii Pharmaceutical Co. and UCB Pharma. FB: Consultant and/or speaker and/or investigator for AbbVie, Affibody, Amgen, BMS, Boehringer Ingelheim, Celgene, Chugai, Eli Lilly, Genzyme, GSK, Janssen, MoonLake Pharma, MSD, Novartis, Pfizer, Roche, Sandoz and Sanofi. DDG: Consultant and/or received grant support from AbbVie, Amgen, BMS, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer and UCB Pharma. LG: Grants from AbbVie, Biogen, Eli Lilly, Novartis, Sandoz and UCB Pharma; personal fees from AbbVie, Amgen, BMS, Celltrion, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Pfizer, Sandoz and UCB Pharma. AMO: Research grants to Johns Hopkins University from AbbVie, Amgen, and Janssen; consulting fees from BMS, Janssen, Sanofi and UCB Pharma. ABG: Received research/educational grants from AnaptypsBio, BMS, Highlights Therapeutics, Janssen, Moonlake Immunotherapeutics AG, Novartis and UCB Pharma, (all paid to Mount Sinai School of Medicine); Received honoraria as an advisory board member and consultant for Amgen, AnaptypsBio, Avotres Therapeutics, BMS, Boehringer Ingelheim, Dice Therapeutics, Eli Lilly, Highlights Therapeutics, Janssen, Novartis, Sanofi, UCB and Xbiotech. RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, GSK, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi and UCB Pharma; research grants to his institution from AbbVie, Almirall, Janssen, LEO Pharma, Novartis and UCB Pharma; honoraria from Astellas, DICE Therapeutics, GSK and Union Therapeutics. BI: Shareholder of AbbVie, GSK and UCB Pharma; employee of UCB Pharma. RB and JC: Employees and shareholders of UCB Pharma. VS: Employee of UCB Pharma. JFM: Consultant and/or investigator for AbbVie, Amgen, Biogen, BMS, Dermavant, Eli Lilly, Janssen, LEO Pharma, Pfizer, Novartis, Regeneron, Sanofi, Sun Pharma and UCB Pharma., (© 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: To investigate psychometric performance of the 12-item Psoriatic Arthritis Impact of Disease (PsAID-12) total and individual item scores in patients with psoriatic arthritis (PsA) and to estimate score change thresholds and scores corresponding to different levels of symptom/impact severity., Methods: Data up to week 16 from 1252 patients with active PsA enrolled in two randomised controlled trials of bimekizumab (BE OPTIMAL (NCT03895203) and BE COMPLETE (NCT03896581)) were used to assess construct validity (correlations with other patient-reported outcomes), known-groups validity (based on Minimal Disease Activity index, Disease Activity Index for Psoriatic Arthritis and Psoriatic Arthritis Disease Activity Score), reliability (Cronbach's alpha and intraclass correlation coefficients (ICCs)) and responsiveness (sensitivity to change). Clinically meaningful within-patient improvement thresholds were estimated by anchor-based and distribution-based analyses, and symptom/impact severity thresholds were estimated by receiver operating characteristic curve analyses., Results: The mean (SD) PsAID-12 total score at baseline was 4.19 (1.94). PsAID-12 scores demonstrated good convergent validity and good known-groups validity. Internal consistency reliability (Cronbach's alpha 0.95) and test-retest reliability (ICC ≥ 0.70) were also good. Responsiveness was acceptable (correlations ≥0.30 for most scores). Improvement thresholds were estimated at 1.5-2 points for the PsAID-12 total score and 2 or 3 points for item scores. Thresholds for different levels of symptom/impact severity could be derived for most PsAID-12 items., Conclusions: The PsAID-12 demonstrated robust psychometric properties in a large sample of patients with active PsA, supporting its use as a fit-for-purpose patient-reported outcome in this population. Furthermore, thresholds for score interpretation were derived., Competing Interests: Competing interests: LG: Grants from AbbVie, Biogen, Eli Lilly, Novartis, Sandoz and UCB Pharma; consulting fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Sandoz and UCB Pharma. A-MO: Research grants to Johns Hopkins University from AbbVie, Amgen and Janssen; consulting fees from BMS, Janssen, Sanofi and UCB Pharma. LCC: Grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer and UCB Pharma; consultant for AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Domain, Eli Lilly, Galapagos, Gilead, Janssen, Moonlake Pharma, Novartis, Pfizer, and UCB Pharma; speaking fees from AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, GSK, Janssen, medac, Novartis, Pfizer, and UCB Pharma. DG: Consultant and/or received grant support from Abbvie, Amgen, BMS, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB Pharma. AO: Grant/research support from AbbVie, Amgen, Janssen, Novartis and Pfizer, consultant of AbbVie, Amgen, BMS, Celgene, CorEvitas, Eli Lilly, GSK, Gilead, Janssen, Novartis, Pfizer, Takeda and UCB Pharma. CGP: Employed by Evidera, a part of Thermo Fisher Scientific, which received funding for this research from UCB Pharma. VC, VT and JL: Employees and stockholders of UCB Pharma. BI: Employee of UCB Pharma; shareholder of AbbVie, GlaxoSmithKline and UCB Pharma. MdW: Over the last five years Stichting Tools has received fees for lectures or consultancy provided by MdW from Celgene, Eli Lilly, Janssen-Cilag, Pfizer and UCB Pharma., (© 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 inclusion of patient research partners (PRPs) in research projects is increasingly recognised and recommended in rheumatology. The level of involvement of PRPs in translational research in rheumatology remains unknown, while in randomised clinical trials (RCTs), it has been reported to be 2% in 2020. Therefore, we aimed to assess the involvement of PRPs in recent translational studies and RCTs in rheumatology., Methods: We conducted a scoping literature review of the 80 most recent articles (40 translational studies and 40 RCTs) from four target diseases: rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus and lower extremity osteoarthritis. We selected 20 papers from each disease, published up until 1 March 2023, in rheumatology and general scientific journals. In each paper, the extent of PRP involvement was assessed. Analyses were descriptive., Results: Of 40 translational studies, none reported PRP involvement. Of 40 RCTs, eight studies (20%) reported PRP involvement. These trials were mainly from Europe (75%) and North America (25%). Most of them (75%) were non-industry funded. The type of PRP involvement was reported in six of eight studies: six studies reported PRP participation in the study design or design of the intervention and two of them in the interpretation of the results. All the trials reporting the number of PRPs (75%), involved at least two PRPs., Conclusion: Despite a worldwide movement advocating for increased patient involvement in research, PRPs in translational research and RCTs in rheumatology are significantly under-represented. This limited involvement of PRPs in research highlights a persistent gap between the existing recommendations and actual practice., Competing Interests: Competing interests: ME: congress support Astrazeneca and Janssen outside of the submitted work. DB: speakers bureau: Janssen, UCB, Abbvie, Galapagos, Lilly, BMS. Grant/research support from: Novartis. Part-time work as medical expert as Savana Research. KA, PS, HB, JP, CZ and LG: none relevant to this paper. MdW: over the last 3 years Stichting Tools has received fees for lectures or consultancy provided by MdW from UCB., (© 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: 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.)

Background: Identifying subjects at risk of imminent psoriatic arthritis (PsA) would allow these subjects to participate in therapeutic interventions to delay or prevent PsA development., Methods: A systematic literature review (SLR) was conducted in 2021 in Medline, Embase, PubMed, Central databases and international congress abstracts (PROSPERO CRD42022255102). All articles reporting the characteristics of patients transitioning from psoriasis (PsO) to PsA and from undifferentiated arthritis (UA) to PsA were included. Clinical and imaging characteristics were collated before PsA onset and at time of PsA diagnosis., Results: Eighteen of 23 576 references evaluated for PsO/PsA transition were analysed; 14 were cohort studies, 2 case-control studies. Two SLRs were used to enrich the project but were not analysed per se. Of 7873 references focusing on UA to PsA, 3 studies were included. Meta-analysis was not possible due to excessive data heterogeneity. Patients with PsO who developed PsA often reported joint pain, joint tenderness and functional limitations. Arthralgia (PsO, n=669; incident PsA, n=99) was associated with subsequent PsA development. On imaging, subclinical enthesopathy (PsO=325; Incident PsA=39) appeared linked to later PsA development. At the time of PsA onset (incident PsA, N=214), peripheral arthritis, mainly oligo-arthritis (ie, the mean number of swollen joints ranged from 1.5 to 3.2), was the most frequent pattern of clinical presentation., Conclusions: Joint pain, arthralgia and entheseal involvement detected by imaging were frequent in individuals with PsO at risk for imminent PsA. Very early PsA was mainly oligoarticular. This review informed a EULAR taskforce on transition to PsA., Competing Interests: Competing interests: AZ: Speakers bureau: AbbVie, Novartis, Janssen, Lilly, UCB, Amgen, Paid instructor for: AbbVie, Novartis, UCB. GDM: Speakers bureau: Novartis, Janssen. LG: Consultant of: AbbVie, Amgen, BMS, Celltrion, Galapagos, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, Grant/research support from: Sandoz, UCB. XB: Speakers bureau: Abbvie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly, Paid instructor, for: Abbvie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly, Consultant of: Abbvie, BMS, MSD, Sandoz, Novartis, Pfizer, Galapagos, UCB, Lilly, Grant/research support from: Abbvie, MSD, Novartis, Editorial Board Member of Annals of Rheumatic Diseases, ASAS President DA received grants, speaker fees, or consultancy fees from Abbvie, Gilead, Galapagos, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sandoz and Sanofi. AI: Speakers bureau: Abbvie, MSD, Alfasigma, Celltrion, BMS, Celgene, Eli-Lilly, Sanofi Genzyme, Pfizer, Galapagos, Gilead, Novartis, SOBI, Janssen, Grant/research support from: Pfizer, Abbvie; Leadership or fiduciary role in other board, society, committee or advocacy group, Novartis, EULAR President, Member of the EULAR Board, Member of EULAR Advocacy Committee. PG: Speakers bureau Abbvie, Almirall, Amgen, UCB, Sanofi, Pfizer, Novartis, Eli Lilly, Jannsen, Leo pharma. JSS: Consulting fees: Abbvie, Galapagos/Gilead, Novartis-Sandoz, BMS, Samsung Sanofi, Chugai R-Pharma, Lilly; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Samsung, Lilly, R-Pharma, Chugai, MSD, Janssen Novartis-Sandoz. DGM: Speakers bureau: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB, Consultant of: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Celgene, Janssen, Merck, Novartis, Pfizer., (© 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 investigate factors associated with severe COVID-19 in people with idiopathic inflammatory myopathy (IIM)., Methods: Demographic data, clinical characteristics and COVID-19 outcome severity of adults with IIM were obtained from the COVID-19 Global Rheumatology Alliance physician-reported registry. A 3-point ordinal COVID-19 severity scale was defined: (1) no hospitalisation, (2) hospitalisation (and no death) and (3) death. ORs were estimated using multivariable ordinal logistic regression. Sensitivity analyses were performed using a 4-point ordinal scale: (1) no hospitalisation, (2) hospitalisation with no oxygen (and no death), (3) hospitalisation with oxygen/ventilation (and no death) and 4) death., Results: Of 348 patients, 48% were not hospitalised, 39% were hospitalised (and did not die) and 13% died. Older age (OR=1.59/decade, 95% CI 1.31 to 1.91), high disease activity (OR=3.50, 95% CI 1.25 to 9.83; vs remission), ≥2 comorbidities (OR=2.63, 95% CI 1.39 to 4.98; vs none), prednisolone-equivalent dose >7.5 mg/day (OR=2.40, 95% CI 1.09 to 5.28; vs no intake) and exposure to rituximab (OR=2.71, 95% CI 1.28 to 5.72; vs conventional synthetic disease-modifying antirheumatic drugs only) were independently associated with severe COVID-19. In addition to these variables, in the sensitivity analyses, male sex (OR range: 1.65-1.83; vs female) was also significantly associated with severe outcomes, while COVID-19 diagnosis after 1 October 2020 (OR range: 0.51-0.59; vs on/before 15 June 2020) was significantly associated with less severe outcomes, but these associations were not significant in the main model (OR=1.57, 95% CI 0.95 to 2.59; and OR=0.61, 95% CI 0.37 to 1.00; respectively)., Conclusions: This is the first large registry data on outcomes of COVID-19 in people with IIM. Older age, male sex, higher comorbidity burden, high disease activity, prednisolone-equivalent dose >7.5 mg/day and rituximab exposure were associated with severe COVID-19. These findings will enable risk stratification and inform management decisions for patients with IIM., Competing Interests: Competing interests: S-AY is supported by vs Arthritis, Royal College of Physicians, Rosetrees Trust, University College London Hospitals Biomedical Research Centre and University College London Hospitals Charity, all unrelated to this manuscript. MG is a Pfizer employee as of March 2022. KLH has received support from EULAR for database maintenance and data extraction related to this manuscript, KLH has received grants from Pfizer and BMS for work unrelated to this manuscript, honoraria from Abbvie unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. LC participates on a Data Safety Monitoring Board or Advisory Board of Lilly, and has a leadership or fiduciary role in EULAR, unrelated to this manuscript. CR receives consulting fees from AbbVie, Astra Zeneca, GSK, Novartis, Pfizer, honoraria from AbbVie, Amgen, Astra Zeneca, GSK, Pfizer, Biogen, BMS, Galapagos, Lilly, travel support from Amgen, Celltrion, Galapagos, patents planned, issued or pending by Astra Zeneca, and receipt of equipment, materials, drugs, medical writing, gifts or other services by Biogen and Lilly, all unrelated to this manuscript. GJP-E has received grants from Janssen, consulting fees and honoraria from GSK, Janssen, Pfizer, Werfen, travel support from GSK, Montpellier, Boehringer Ingelheim, and participates on a Data Safety Monitoring Board or Advisory Board of Pfizer, GSK and Janssen, and has received equipment, materials, drugs, medical writing, gifts or other services from Janssen, all unrelated to this manuscript. REV has received grants from BMS, Novartis, Pfizer and honoraria from Hexal, all unrelated to this manuscript. EV has received honoraria from AbbVie, Novartis, Janssen and travel support from AbbVie, Janssen, Pfizer, and participates on a Data Safety Monitoring Board or Advisory Board of AbbVie, Novartis, Janssen, and is President of Asociacion de Rumatologia del Noreste Argentino, all unrelated to this manuscript. ES receives honoraria from the COVID-19 Global Rheumatology Alliance and non-financial support from Canadian Arthritis Patient Alliance, unrelated to this manuscript. JH receives grants from the Rheumatology Research Foundation, salary support from the Childhood Arthritis and Rheumatology Research Alliance, consulting fees from Novartis, Pfizer, Sobi and Biogen, all unrelated to this manuscript. MGM is a patient consultant for Aurinia Pharmaceuticals, Boehringer Ingelheim, Johnson & Johnson, Bristol-Myers Squibb, all unrelated to this manuscript, and receives honoraria from Aurinia Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, all unrelated to this study. RG has received honoraria from Janssen, Pfizer, AbbVie, Cornerstones, Novartis, travel support from Pfizer and Janssen, and is a member of the New Zealand Rheumatology Association executive and ACR Global Engagement Special Committee, all unrelated to this manuscript. SB is a Pfizer employee and has received honoraria from AbbVie, Horizon, Novartis, Pfizer, has received travel support from Pfizer, and owns restricted stock units with Pfizer as a Pfizer employee, all unrelated to this manuscript. PCR has received grants from Pfizer, Novartis, UCB, Janssen, all unrelated to this manuscript, consulting fees from AbbVie, Janssen, UCB, Roche, Lilly, Novartis, Atom Biosciences, Gilead, Kukdong, GSK, all unrelated to this manuscript, honoraria from AbbVie, UCB, Janssen, Novartis, Lilly, GSK, Pfizer, all unrelated to this manuscript, travel support from BMS, UCB, Pfizer, Novartis, all unrelated to this manuscript. PCR reports participation on a Data Safety Monitoring Board or Advisory Board of Atom Biosciences, unrelated to this manuscript, and leadership role in the Australian Rheumatology Association and Arthritis Queensland, unrelated to this manuscript. JY has received support from NIH/NIAMS (grants to UCSF) for the present manuscript, grants from Gilead, Astra Zeneca, BMS Foundation, all unrelated to this manuscript, consulting fees from Astra Zeneca, Aurinia, Pfizer, all unrelated to this manuscript. PMM is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC) and has received consulting fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche, UCB, all unrelated to this manuscript., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Evidence on the current status of gender equity in academic rheumatology in Europe and potential for its improvement is limited. The EULAR convened a task force to obtain empirical evidence on the potential unmet need for support of female rheumatologists, health professionals and non-clinical scientists in academic rheumatology., Methods: This cross-sectional study comprised three web-based surveys conducted in 2020 among: (1) EULAR scientific member society leaders, (2) EULAR and Emerging EULAR Network (EMEUNET) members and (3) EULAR Council members. Statistics were descriptive with significance testing for male/female responses assessed by χ 2 test and t-test., Results: Data from EULAR scientific member societies in 13 countries indicated that there were disproportionately fewer women in academic rheumatology than in clinical rheumatology, and they tended to be under-represented in senior academic roles. From 324 responses of EULAR and EMEUNET members (24 countries), we detected no gender differences in leadership aspirations, self-efficacy in career advancement and work-life integration as well as the share of time spent on research, but there were gender differences in working hours and the levels of perceived gender discrimination and sexual harassment. There were gender differences in the ranking of 7 of 26 factors impacting career advancement and of 8 of 24 potential interventions to aid career advancement., Conclusions: There are gender differences in career advancement in academic rheumatology. The study informs a EULAR task force developing a framework of potential interventions to accelerate gender-equitable career advancement in academic rheumatology., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To investigate patient characteristics predictive of response to secukinumab in patients with psoriatic arthritis (PsA) with axial manifestations., Methods: In a post-hoc analysis from the MAXIMISE trial (NCT02721966) in patients with PsA and axial manifestations, we tested the hypothesis that the OR of the effect of treatment on the primary endpoint of the trial (Assessment of SpondyloArthritis international Society (ASAS) 20 responder status at week 12) would be different depending on 12 prespecified predictor variables. We applied a two-model logistic regression approach, a main effects and an interaction model., Results: The OR (95% CI) for ASAS20 response for the presence of nail dystrophy was 3.2 (95% CI 0.93 to 10.99) in the secukinumab 150 mg group and 5.0 (95% CI 1.47 to 17.19) in the secukinumab 300 mg group compared with the placebo group (p=0.029). Odds of being a responder were similar in men and women in the secukinumab groups, though men fared worse than women in the placebo group (p=0.039). Current smokers were less likely to be ASAS20 responders compared with never smokers regardless of the treatment group (p=0.589)., Conclusion: Nail dystrophy was identified as a predictor of response to secukinumab in patients with PsA with axial manifestations in the MAXIMISE trial. These findings may be explained by the nail-entheseal concept as part of the axial phenotype in PsA ., Competing Interests: Competing interests: XB: grant/research support from: AbbVie, and Novartis; consulting fees: AbbVie, BMS, Celgene, Chugai, Galapagos, Gilead, MSD, Novartis, Pfizer and UCB; speakers bureau: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer and UCB. EP: employee of Novartis with Novartis stock. LG: research grants: Amgen, Lilly, Janssen, Pfizer, Sandoz, Sanofi and Galapagos; consulting fees: AbbVie, Amgen, BMS, Biogen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB. PJM: grant/research support: AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, SUN and UCB; consulting fees: AbbVie, Amgen, BMS, Boehringer Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma and UCB; speaker/honoraria: AbbVie, Amgen, Janssen, Lilly, Novartis, Pfizer and UCB. RW: employee of Novartis with Novartis stock. EO: employee of Novartis with Novartis stock. BS: employee of Novartis. HM-O: grants and/or consulting fees from AbbVie, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Takeda and UCB. LCC: grant/research support: AbbVie, Amgen, Gilead, Janssen, Lilly, Novartis, Pfizer; consultant/speaker for: AbbVie, Amgen, Biogen, Celgene, Pfizer, UCB, Boehringer Ingelheim, Novartis, Lilly, Janssen, Gilead and Medac., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: There is a lack of data on SARS-CoV-2 vaccination safety in children and young people (CYP) with rheumatic and musculoskeletal diseases (RMDs). Current vaccination guidance is based on data from adults with RMDs or CYP without RMDs., Objectives: To describe the safety of SARS-COV-2 vaccination in adolescents with inflammatory RMDs and adults with juvenile idiopathic arthritis (JIA)., Methods: We described patient characteristics, flares and adverse events (AEs) in adolescent cases under 18 with inflammatory RMDs and adult cases aged 18 or above with JIA submitted to the European Alliance of Associations for Rheumatology COVAX registry., Results: A total of 110 cases were reported to the registry. Thirty-six adolescent cases were reported from four countries, most with JIA (42%). Over half (56%) reported early reactogenic-like AEs. One mild polyarthralgia flare and one serious AE of special interest (malaise) were reported. No CYP reported SARS-CoV-2 infection postvaccination.Seventy-four adult JIA cases were reported from 11 countries. Almost two-thirds (62%) reported early reactogenic-like AEs and two flares were reported (mild polyarthralgia and moderate uveitis). No serious AEs of special interest were reported among adults with JIA. Three female patients aged 20-30 years were diagnosed with SARS-CoV-2 postvaccination; all fully recovered., Conclusions: This is an important contribution to research on SARS-CoV-2 vaccine safety in adolescents with RMDs and adults with JIA. It is important to note the low frequency of disease flares, serious AEs and SARS-CoV-2 reinfection seen in both populations, although the dataset is limited by its size., Competing Interests: Competing interests: SL-T and BR have nothing to disclose. PMM reports consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript, and is supported by the National Institute for Health Research (NIHR), University College London Hospitals (UCLH), Biomedical Research Centre (BRC). AS reports personal fees from lectures for AbbVie, MSD, Roche, BMS, and Pfizer. EM reports LPCDR received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal S.A., MSD, Celgene, Medac, Pharmakern, GAfPA; grants and non-financial support from Pfizer; non-financial support from Grünenthal, outside the submitted work. LG reports Amgen, Galapagos, Lilly, Pfizer, Sandoz; consulting fees: AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, all unrelated to this manuscript. LC reports fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal, and UCB Pharma. IB reports speaker fees from AbbVie, Pfizer, Janssen, Boehringer Ingelheim, all unrelated to this manuscript. DC reports speakers fees from Novartis, GSK, all unrelated to this manuscript. JZ reports speaker fees from Abbvie, Novartis, Janssen/Johnson & Johnson, all unrelated to this manuscript. AR reports research grants and consultant fees from Amgen and Pfizer, all unrelated to this manuscript. KLH reports non-personal speaker’s fees from Abbvie and grant income from BMS, UCB, and Pfizer, all unrelated to this manuscript, and is supported by the NIHR Manchester Biomedical Research Centre. XM is an Associate Editor for this journal., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: Patient care can vary substantially by country. The objective was to explore differences in psoriatic arthritis (PsA) across countries for disease activity, impact and treatments., Methods: A cross-sectional analysis of 13 countries from the Remission/Flare in PsA study (NCT03119805) of consecutive adult patients with definite PsA was performed. Countries were classified into tertiles by gross domestic product (GDP)/capita. Disease activity (Disease Activity in PsA, DAPSA and Minimal Disease Activity, MDA) and their components, disease impact (patient-reported outcomes) and biological disease-modifying antirheumatic drugs (bDMARDs) were analysed per country and compared between the three tertiles of GDP/capita by parametric and non-parametric tests. We also explored the percentage of patients with significant disease activity (DAPSA >14) and no ongoing bDMARD prescription., Results: In 439 patients (50.6% male, mean age 52.3 years, mean disease duration 10.1 years), disease activity and disease impact were higher in the lowest GDP/capita countries. DAPSA remission and MDA were attained in the lowest tertile in 7.0% and 18.4% patients, vs 29.1% and 49.5% in the middle tertile and 16.8% and 41.3% in the high tertile, respectively (all p<0.001). bDMARDs use was similar in the tertiles (overall mean 61%). The overall rate of patients with DAPSA >14 and no bDMARDs was 18.5%, and was higher in lower GDP/capita countries (p=0.004)., Conclusion: PsA patients from countries with the lowest GDP/capita, despite similar use of bDMARDs, were more likely to have high disease activity and worse disease impact. There is a need for more equity in healthcare., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objective: While COVID-19 vaccination prevents severe infections, poor immunogenicity in immunocompromised people threatens vaccine effectiveness. We analysed the clinical characteristics of patients with rheumatic disease who developed breakthrough COVID-19 after vaccination against SARS-CoV-2., Methods: We included people partially or fully vaccinated against SARS-CoV-2 who developed COVID-19 between 5 January and 30 September 2021 and were reported to the Global Rheumatology Alliance registry. Breakthrough infections were defined as occurring ≥14 days after completion of the vaccination series, specifically 14 days after the second dose in a two-dose series or 14 days after a single-dose vaccine. We analysed patients' demographic and clinical characteristics and COVID-19 symptoms and outcomes., Results: SARS-CoV-2 infection was reported in 197 partially or fully vaccinated people with rheumatic disease (mean age 54 years, 77% female, 56% white). The majority (n=140/197, 71%) received messenger RNA vaccines. Among the fully vaccinated (n=87), infection occurred a mean of 112 (±60) days after the second vaccine dose. Among those fully vaccinated and hospitalised (n=22, age range 36-83 years), nine had used B cell-depleting therapy (BCDT), with six as monotherapy, at the time of vaccination. Three were on mycophenolate. The majority (n=14/22, 64%) were not taking systemic glucocorticoids. Eight patients had pre-existing lung disease and five patients died., Conclusion: More than half of fully vaccinated individuals with breakthrough infections requiring hospitalisation were on BCDT or mycophenolate. Further risk mitigation strategies are likely needed to protect this selected high-risk population., Competing Interests: Competing interests: KLH reports she has received non-personal speaker’s fees from AbbVie and grant income from BMS, UCB and Pfizer, all unrelated to this manuscript; KLH is supported by the NIHR Manchester Biomedical Research Centre. LG reports personal consultant fees from AbbVie, Amgen, BMS, Biogen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB, and grants from Amgen, Lilly, Janssen, Pfizer, Sandoz, Sanofi and Galapagos, all unrelated to this manuscript. AS reports research grants from a consortium of 14 companies (among them AbbVie, BMS, Celltrion, Fresenius Kabi, Gilead/Galapagos, Lilly, Mylan/Viatris, Hexal, MSD, Pfizer, Roche, Samsung, Sanofi-Aventis and UCB) supporting the German RABBIT register and personal fees from lectures for AbbVie, MSD, Roche, BMS, Lilly and Pfizer, all unrelated to this manuscript. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as AbbVie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi-Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal and UCB Pharma. EF-M reports personal consultant fees from Boehringer Ingelheim Portugal and that LPCDR received support for specific activities: grants from AbbVie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal, MSD, Celgene, Medac, Pharmakern and GAfPA; grants and non-financial support from Pfizer; and non-financial support from Grünenthal, outside the submitted work. IB reports personal consultant fees from AbbVie, Novartis, Pfizer and Janssen, all unrelated to this manuscript. JZ reports speaker fees from AbbVie, Novartis and Janssen/Johnson & Johnson, all unrelated to this manuscript. GR-C reports personal consultant fees from Eli Lilly and Novartis, all unrelated to this manuscript. JS is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (grant numbers: R01 AR077607, P30 AR070253 and P30 AR072577), and the R Bruce and Joan M Mickey Research Scholar Fund. JS has received research support from Amgen and Bristol Myers Squibb and performed consultancy for Bristol Myers Squibb, Gilead, Inova, Janssen and Optum, unrelated to this work. LW receives speaker’s bureau fees from Aurinia Pharma, unrelated to this manuscript. SB reports no competing interests related to this work. He reports non-branded consulting fees for AbbVie, Horizon and Novartis (all <$10 000). MGM has no competing interests related to this work. She serves as a patient consultant for BMS, BI JNJ and Aurinia (all <$10 000). RG reports no competing interests related to this work. Outside of this work she reports personal and/or speaking fees from AbbVie, Janssen, Novartis, Pfizer and Cornerstones and travel assistance from Pfizer (all <$10 000). JH reports no competing interests related to this work. He is supported by grants from the Rheumatology Research Foundation and has salary support from the Childhood Arthritis and Rheumatology Research Alliance. He has performed consulting for Novartis, Sobi and Biogen, all unrelated to this work (<$10 000). ESi reports non-financial support from Canadian Arthritis Patient Alliance, outside the submitted work. PS reports personal fees from the American College of Rheumatology/Wiley Publishing, outside the submitted work. ZW reports grant support from Bristol Myers Squibb and Principia/Sanofi and performed consultancy for Viela Bio and MedPace, outside the submitted work. His work is supported by grants from the National Institutes of Health. PMM has received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this study. PMM is supported by the National Institute for Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre (BRC). PCR reports no competing interests related to this work. Outside of this work PCR reports personal fees from AbbVie, Atom Bioscience, Eli Lilly, Gilead, GlaxoSmithKline, Janssen, Kukdong, Novartis, UCB, Roche and Pfizer; meeting attendance support from BMS, Pfizer and UCB; and grant funding from Janssen, Novartis, Pfizer and UCB Pharma (all <$10 000). JY reports no competing interests related to this work. Her work is supported by grants from the National Institutes of Health (K24 AR074534 and P30 AR070155). Outside of this work, she has received research grants or performed consulting for Gilead, BMS Foundation, Pfizer, Aurinia and AstraZeneca., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To evaluate the effect of a nurse-led patient education on safety skills of patients with inflammatory arthritis treated with biologic disease-modifying antirheumatic drugs (bDMARDs)., Methods: This is a multicentre, open-labelled, randomised controlled trial comparing an intervention group (face-to-face education by a nurse at baseline and 3 months later) with a control group (usual care) at the introduction of a first subcutaneous bDMARD. The primary outcome was score on the BioSecure questionnaire at 6 months (0-100 scale), a validated questionnaire assessing competencies in dealing with fever, infections, vaccination and daily situations. The secondary outcomes were disease activity, coping, psychological well-being, beliefs about medication, self-efficacy and severe infection rate., Results: 129 patients with rheumatoid arthritis and spondyloarthritis were enrolled in nine rheumatology departments; 122 completed the study; 127 were analysed; and 64 received the intervention (mean duration: 65 min at baseline and 44 min at 3 months). The primary outcome was met: the BioSecure score was 81.2±13.1 and 75.6±13.0 in the education and usual care groups (difference: +6.2, 95% CI 1.3 to 11.1, p=0.015), demonstrating higher safety skills in the education group. Exploratory analyses showed better skills regarding infections, greater willingness for vaccinations and greater adherence-related behaviours in the education group. Coping was significantly more improved by education; other secondary outcomes were improved in both groups, with no difference., Conclusions: Educating patients was effective in promoting patient behaviours for preventing adverse events with bDMARDs. An education session delivered to patients starting a first bDMARD can be useful to help them self-manage safety issues., Trial Registration Number: NCT02855320., Competing Interests: Competing interests: CB reports research grants from BMS, Fresenius Kabi, Lilly and Mylan, and was an occasional speaker for BMS, AbbVie, MSD, Mylan, Pfizer, Roche, Sanofi and UCB. LG reports research grants from Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz and Sanofi, and consulting fees from AbbVie, Amgen, BMS, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB. CSo reports occasional consulting fees from AbbVie, UCB, Lilly, Nordic, GSK, Roche Chugaï and BMS., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objectives: To obtain an overview of gender equity at European rheumatology conferences., Methods: The proportion of women invited as either moderators or speakers to the European Alliance of Associations for Rheumatology (EULAR) annual congresses and national conferences in Europe was calculated from the published congress materials from EULAR annual congresses (2015-2019) and the 2019 national conferences of France, Germany, Italy, Spain and the UK. Data from EULAR congresses were further categorised by type of session. Significance testing was conducted using χ 2 tests with the level of statistical significance set at p<0.05., Results: The proportion of combined women moderators and speakers at EULAR varied from 40% to 43% between 2015 and 2019 with no obvious trend over time. There were higher proportions of women in the Health Professionals in Rheumatology and People with Arthritis and Rheumatism sessions (>50% consistently). However, these sessions represent <25% of EULAR congress invitations. Representation of women at the EULAR congress in 2019 (39.6%) was significantly higher than at the national congresses in France (28.6%) and Germany (29.6%) but similar to that observed in Italy (33.7%), Spain (41.7%) and the UK (42%)., Conclusion: Women account for less than half of invited moderators and speakers at the conferences reviewed. Compared with historical EULAR data in 2003 (16%) and in 2004 (19%), the gender gap at EULAR congresses has narrowed considerably, but there remains a need to monitor and improve women's representation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: The consequences of psoriasis associated to axial spondyloarthritis (axSpA) are unclear. The objectives were to determine the prevalence and the consequences of psoriasis in recent axSpA over 6 years of follow-up., Methods: The multicentric prospective cohort DESIR (NCT01648907) of adult patients with recent inflammatory back pain suggestive of axSpA was analysed over 6 years. Psoriasis was recorded at each visit and cumulative prevalence and incidence were calculated. Patients with vs without psoriasis at any time point were compared. Outcomes included disease activity (Ankylosing Spondylitis Disease Activity Score-C reactive protein (ASDAS-CRP), joint and enthesitis count, CRP), patient-reported outcomes for function (Health Assessment Questionnaire for axSpA, HAQ-AS) and quality of life, and treatment use over 6 years. Outcomes were compared through univariable and multivariable analyses, as well as linear mixed effect models., Results: In 589 patients, mean age 40.5±8.7 years, 45.8% men and baseline mean symptom duration 1.5±0.9 years, the cumulative prevalence of psoriasis increased from 16.8% (99/589) at baseline to 26.8% (158/589) at 6 years, leading to an incidence of 2.1/100 patient-years. Over 6 years of follow-up, patients with psoriasis developed more synovitis (p=0.008), and received more methotrexate (cumulative use, 25.5% vs 11.8%, p<0.001) and biological disease-modifying drugs (55.7% vs 38.5%, p<0.001). There were no significant consequences of psoriasis on other outcomes, including disease activity (ASDAS-CRP), functional capacity (HAQ-AS) and quality of life., Conclusion: Psoriasis is frequent in early axSpA. AxSpA patients with psoriasis had more swollen joints over time and received more biologics; they did not have worse outcomes related to axSpA in terms of activity and severity., Trial Registration Number: NCT01648907., Competing Interests: Competing interests: PR: personal fees from Amgen, Galapagos, Lilly, Pfizer, Sanofi; Abbvie, BMS, Galapagos, Janssen, Novartis, UCB, outside the submitted work. DW: personal fees from AbbVie, BMS, MSD, Pfizer, Roche Chugai, Amgen, Nordic Pharma, UCB, Novartis, Janssen, Celgene, Lilly, Sandoz, Grünenthal, Galapagos, outside the submitted work. BF: grants from AbbVie, Lilly, MSD, Pfizer; personal fees from AbbVie, Amgen, Biogen, BMS, Celltrion, Fresenius Kabi, Galapagos, Gilead, Janssen, Lilly, Medac, MSD, Mylan, NORDIC Pharma, Novartis, Pfizer, Roche, Sandoz, Sanofi-Genzyme, SOBI, UCB, outside the submitted work. LG: grants from Amgen, Galapagos, Lilly, Pfizer, Sandoz, Sanofi; personal fees from AbbVie, Amgen, BMS, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, outside the submitted work., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.)

Objective: The rheumatoid arthritis impact of disease (RAID) questionnaire comprises seven patient-important domains of disease impact (pain, function, fatigue, sleep disturbance, emotional well-being, physical well-being, coping). RAID was validated as a pooled-weighted score. Its seven individual items separately could provide a valuable tool in clinical practice to guide interventions targeting the patient's experience of the disease. The aim was to separately assess the psychometric properties of each of the seven numeric rating scale (NRS) of the RAID (RAID.7)., Material and Methods: Post hoc analyses of data from the cross-sectional RAID study and from the Rainbow study, an open-label 12-week trial of etanercept in patients with RA. Construct validity of each NRS was assessed cross-sectionally in the RAID data set by Spearman's correlation with the respective external instrument of reference. Using the rainbow data set, we assessed reliability through intraclass correlation coefficient between the screening and the baseline visits and responsiveness (sensitivity to change) by standardised response mean between baseline and 12 weeks., Results: A total of 671 patients with RA with features of established disease were analysed, 563 and 108 from RAID and Rainbow, respectively. The NRS correlated moderately to strongly with the respective external instrument of reference (r=0.62-0.81). Reliability ranged from 0.64 (0.51-0.74) (pain) to 0.83 (0.76-0.88) (sleep disturbance) and responsiveness from 0.93 (0.73-1.13) (sleep disturbance) to 1.34 (1.01-1.64) (pain)., Conclusion: The separate use of the individual NRS of RAID (RAID.7) is valid, feasible, reliable and sensitive to change, representing an opportunity to improve the assessment and treatment of disease impact with minimal questionnaire burden., Trial Registration Number: NCT00768053., Competing Interests: Competing interests: MD and JAPS have received consultancy fees from Pfizer (advisory board) and their departments have received research grants from Pfizer. TKK has received fees for speaking and/or consulting from Abbvie, Biogen, Celgene, Celltrion, Egis, Evapharma, Ewopharma, Eli Lilly, Gilead, Hikma, Hospira, MSD, Mylan, Novartis, Oktal, Orion Pharma, Pfizer, Roche, Sandoz, Sanofi and UCB and received research funding to Diakonhjemmet Hospital from Abbvie, BMS, MSD, Pfizer, Roche and UCB., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Although patient-reported outcome measures (PROMs) are increasingly used in clinical practice and research, it is unclear whether these instruments cover the perspective of young people with inflammatory arthritis (IA). The aims of this study were to explore whether PROMs commonly used in IA adequately cover the perspective of young people from different European countries., Methods: A multinational qualitative study was conducted in Austria, Croatia, Italy and the Netherlands. Young people with either rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), Still's disease, psoriatic arthritis (PsA) or spondyloarthritis (SpA), aged 18-35 years, participated in semistructured focus group interviews. Thematic analysis was used and data saturation was defined as no new emergent concepts in at least three subsequent focus groups., Results: Fifty-three patients (21 with RA/JIA/Still's, 17 with PsA, 15 with SpA; 72% women) participated in 12 focus groups. Participants expressed a general positive attitude towards PROMs and emphasised their importance in clinical practice. In addition, 48 lower level concepts were extracted and summarised into 6 higher level concepts describing potential issues for improvement. These included: need for lay-term information regarding the purpose of using PROMs; updates of certain outdated items and using digital technology for data acquisition. Some participants admitted their tendency to rate pain, fatigue or disease activity differently from what they actually felt for various reasons., Conclusions: Despite their general positive attitude, young people with IA suggested areas for PROM development to ensure that important concepts are included, making PROMs relevant over the entire course of a chronic disease., Competing Interests: Competing interests: PS reports grants from AbbVie, outside the submitted work; IP reports personal fees from Abbvie, personal fees from Novartis, personal fees from Roche, personal fees from Sandoz, personal fees from Sanofi, outside the submitted work; SR reports personal fees from AbbVie, personal fees from Eli Lilly, personal fees from MSD, personal fees from Novartis, personal fees from Sanofi, personal fees from UCB, outside the submitted work; LG reports grants and personal fees from Amgen, grants from Galapagos, grants and personal fees from Janssen, grants and personal fees from Lilly, grants and personal fees from Pfizer, grants from Sandoz, grants from Sanofi, personal fees from AbbVie, personal fees from BMS, personal fees from Biogen, personal fees from Celgene, personal fees from Gilead, personal fees from Novartis, personal fees from Samsung Bioepis, personal fees from Sanofi-Aventis, personal fees from UCB, outside the submitted work; EN reports personal fees from Abbvie, personal fees from Celltrion, personal fees from Gilead, personal fees from Lilly, personal fees from Pfizer, personal fees from Sanofi, outside the submitted work; SS reports personal fees from Actelion, personal fees from CISCRP, personal fees from Janssen, personal fees from Parexel, outside the submitted work; TAS reports grants from AbbVie, grants and personal fees from Roche, personal fees from Sanofi Genzyme, personal fees from Takeda, outside the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To analyse how non-adherence to prescribed treatments might be prevented, screened, assessed and managed in people with rheumatic and musculoskeletal diseases (RMDs)., Methods: An overview of systematic reviews (SR) was performed in four bibliographic databases. Research questions focused on: (1) effective interventions or strategies, (2) associated factors, (3) impact of shared decision making and effective communication, (4) practical things to prevent non-adherence, (5) effect of non-adherence on outcome, (6) screening and assessment tools and (7) responsible healthcare providers. The methodological quality of the reviews was assessed using AMSTAR-2. The qualitative synthesis focused on results and on the level of evidence attained from the studies included in the reviews., Results: After reviewing 9908 titles, the overview included 38 SR on medication, 29 on non-pharmacological interventions and 28 on assessment. Content and quality of the included SR was very heterogeneous. The number of factors that may influence adherence exceed 700. Among 53 intervention studies, 54.7% showed a small statistically significant effect on adherence, and all three multicomponent interventions, including different modes of patient education and delivered by a variety of healthcare providers, showed a positive result in adherence to medication. No single assessment provided a comprehensive measure of adherence to either medication or exercise., Conclusions: The results underscore the complexity of non-adherence, its changing pattern and dependence on multi-level factors, the need to involve all stakeholders in all steps, the absence of a gold standard for screening and the requirement of multi-component interventions to manage it., Competing Interests: Competing interests: VR, PB, FEL, JBN, AI, MN, AM, EM, KV and AdT did not have competing interest to declare. TS has received grant/research support from AbbVie and Roche, has been consultant for AbbVie, Sanofi Genzyme, and has been paid speaker for AbbVie, Roche and Sanofi. DA has received grant/research support from AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme and UCB, has been consultant for AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme and UCB, and has been paid speaker for AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme and UCB. JB has received grant/research support from Roche, and has been paid speaker for Roche and Lilly. RD has been paid speaker for MSD, AbbVie, Novartis, Roche, Pfizer, Mylan and Sandoz. ED has received grant/research support from Independent Learning, Pfizer, combined funding for a research fellow from Celgene, Abbvie and Novartis, and has been paid instructor for Novartis to deliver training to nurses. LG has received grant/research support from Fresenius, Lilly, Pfizer and Sandoz, and has been consultant for AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Sandoz, Sanofi-Aventis and UCB Pharma. BvdB has been paid speaker for MSD, Abbvie and Biogen. MV has been paid speaker for Pfizer. LC has received grant/research support through her institute from Novartis, Pfizer, MSD, Roche, Sanofi Aventis, AbbVie and Gebro Pharma., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Mobile health applications (apps) are available to enable people with rheumatic and musculoskeletal diseases (RMDs) to better self-manage their health. However, guidance on the development and evaluation of such apps is lacking., Objectives: The objective of this EULAR task force was to establish points to consider (PtC) for the development, evaluation and implementation of apps for self-management of RMDs., Methods: A systematic literature review of app content and development strategies was conducted, followed by patient focus group and an online survey. Based on this information and along with task force expert opinion, PtC were formulated in a face-to-face meeting by a multidisciplinary task force panel of experts, including two patient research partners. The level of agreement among the panel in regard to each PtC was established by anonymous online voting., Results: Three overarching principles and 10 PtC were formulated. Three PtC are related to patient safety, considered as a critical issue by the panel. Three are related to relevance of the content and functionalities. The requirement for transparency around app development and funding sources, along with involvement of relevant health professionals, were also raised. Ease of app access across ages and abilities was highlighted, in addition to considering the cost benefit of apps from the outset. The level of agreement was from 8.8 to 9.9 out of 10., Conclusion: These EULAR PtC provide guidance on important aspects that should be considered for the development, evaluation and implementation of existing and new apps., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the current use of big data and artificial intelligence (AI) in the field of rheumatic and musculoskeletal diseases (RMDs)., Methods: A systematic literature review was performed in PubMed MEDLINE in November 2018, with key words referring to big data, AI and RMDs. All original reports published in English were analysed. A mirror literature review was also performed outside of RMDs on the same number of articles. The number of data analysed, data sources and statistical methods used (traditional statistics, AI or both) were collected. The analysis compared findings within and beyond the field of RMDs., Results: Of 567 articles relating to RMDs, 55 met the inclusion criteria and were analysed, as well as 55 articles in other medical fields. The mean number of data points was 746 million (range 2000-5 billion) in RMDs, and 9.1 billion (range 100 000-200 billion) outside of RMDs. Data sources were varied: in RMDs, 26 (47%) were clinical, 8 (15%) biological and 16 (29%) radiological. Both traditional and AI methods were used to analyse big data (respectively, 10 (18%) and 45 (82%) in RMDs and 8 (15%) and 47 (85%) out of RMDs). Machine learning represented 97% of AI methods in RMDs and among these methods, the most represented was artificial neural network (20/44 articles in RMDs)., Conclusions: Big data sources and types are varied within the field of RMDs, and methods used to analyse big data were heterogeneous. These findings will inform a European League Against Rheumatism taskforce on big data in RMDs., Competing Interests: Competing interests: RC is an employee of Orange Healthcare, and HS is an employee of Sanoïa, a Digital CRO providing clinical research services including data science. There are no competing interests for the other authors.

Background/purpose: Cardiovascular (CV) risk, cancer, infections and osteoporosis should be screened for in rheumatoid arthritis (RA). The objective was to assess 3-year effects of a nurse visit for comorbidity counselling., Methods: This was an open long-term (3 years) extension of the Comorbidities and Education in Rheumatoid Arthritis 6-month randomised controlled trial in which patients with definite, stable RA were visiting a nurse for comorbidity counselling. Comorbidity status was assessed and nurses provided advice on screening and management, at baseline and 3 years later. A score was developed to quantify comorbidity screening and management: 0-100, where lower scores indicate better screening and management. The score was compared between baseline and 3-year assessment using a Wilcoxon test for paired data., Results: Of the 970 recruited patients, 776 (80%) were followed-up at 2-4 years and 769 (79%) had available data for comorbidities at both time points: mean (±SD) age 58 (±11) years and mean disease duration 14 (±10) years; 614 (80%) were women, the mean Disease Activity Score 28 was 3.0±1.3, and 538 (70%) were receiving a biologic. At baseline, the mean comorbidity screening score was 36.6 (±19.9) and it improved at 3 years to 24.3 (±17.8) (p<0.0001), thus with a relative improvement of 33% (improvement of 12 points). CV risk screening, vaccination status and bone densitometry performance improved the most., Conclusions: Comorbidity screening was suboptimal but improved notably over 3 years, after a nurse-led programme aiming at checking systematically for comorbidity screening and giving patient advice. This long-term efficacy pleads in favour of nurse-led interventions to better address comorbidities in RA., Trial Registration Number: NCT01315652., Competing Interests: Competing interests: None declared.

Objective: To evaluate the prevalence and performance as axial Spondyloarthritis (axSpA) diagnostic feature of radiographic and MRI lesions 'typical' of axSpA of the sacroiliac joint (SIJ) and spine in a mechanical chronic back pain (CBP) population and in an axSpA cohort., Methods: Cross-sectional multicentre study. Patients: (1) recent onset axSpA (DESIR cohort) and (2) mechanical non-axSpA CBP matched for age and gender (ILOS study). Imaging: radiographs and MR scans were performed identically in both groups. All images were centrally read, blinded for diagnosis and for other imaging findings in the same patient. Statistical analysis: prevalence of lesions 'typical of axSpA' were compared in both groups. Sensitivity, specificity and positive likelihood ratios (LR+) of each lesion (and combination of lesions) were calculated., Results: A total of 98 patients with CBP were included, and compared with 100 patients with recent onset axSpA. SIJ lesions were consistently more frequent in the axSpA group (35.0% vs 11.8% p<0.001, 35.0% vs 8.4% p<0.001% and 32.0% vs 10.0%. p<0.001 for modified New York criteria, MRI sacroiliitis and ≥3 erosions of the SIJ on MRI, respectively), and performed well (LR+ for ≥3 erosions 3.0 (95% CI 1.6 to 5.8)). Spine lesions were comparable across groups: radiographic lesions were rare, while all MRI lesions were frequent., Conclusion: Our study confirms that 'typical' lesions can also be observed in patients with non-axSpA CBP but that SIJ lesions by all modalities remain the most valuable for diagnosis, including structural lesions of the SIJ. This suggests the potential interest of adding MRI SIJ structural lesions in the definition of MRI abnormalities for axSpA classification., Competing Interests: Competing interests: AM received an ASAS (Assessment of SpondyloArthritis International Society) research grant and an unrestricted grant from Pfizer (Passerelle) to conduct this study. There are no other benefits from commercial sources for the work reported on in the manuscript, and no other financial interests that any of the authors may have, which could create a potential conflict of interest or the appearance of a conflict of interest with regard to the work.

Objective: Current methods used for forecasting workforce requirements in rheumatology are disparate, as are the parameters incorporated into workforce projection studies. The objective of these European League Against Rheumatism (EULAR points to consider (PTC) is to guide future workforce studies in adult rheumatology in order to produce valid and reliable manpower estimates., Methods: The EULAR Standardised Operating Procedures were followed. A multidisciplinary task force with experts including patients with rheumatic diseases from 11 EULAR countries and the USA was assembled. A systematic literature review (SLR) was conducted to retrieve workforce models in rheumatology and other medical fields. PTC were based on expert opinion informed by the SLR, followed by group discussions with consensus obtained through informal voting. The level of agreement with the PTC was voted anonymously., Results: A total of 10 PTC were formulated. The task force recommends models integrating supply (=workforce available in rheumatology), demand (=health services requested by the population) and need (=health services that are considered appropriate to serve the population). In general, projections of workforce requirements should consider all factors relevant for current and future workload in rheumatology inside and outside of direct patient care. Forecasts of workforce supply should consider demography and attrition of rheumatologists, as well as the effects of new developments in healthcare. Predictions of future need/demand should take demographic, sociocultural and epidemiological development of the population into account., Conclusion: These EULAR-endorsed PTC will provide guidance on the methodology and the parameters to be applied in future national and international workforce requirement studies in rheumatology., Competing Interests: Competing interests: None declared.

Objective: To summarise the available information on physician workforce modelling, to develop a rheumatology workforce prediction risk of bias tool and to apply it to existing studies in rheumatology., Methods: A systematic literature review (SLR) was performed in key electronic databases (1946-2017) comprising an update of an SLR in rheumatology and a hierarchical SLR in other medical fields. Data on the type of workforce prediction models and the factors considered in the models were extracted. Key general as well as specific need/demand and supply factors for workforce calculation in rheumatology were identified. The workforce prediction risk of bias tool was developed and applied to existing workforce studies in rheumatology., Results: In total, 14 studies in rheumatology and 10 studies in other medical fields were included. Studies used a variety of prediction models based on a heterogeneous set of need/demand and/or supply factors. Only two studies attempted empirical validation of the prediction quality of the model. Based on evidence and consensus, the newly developed risk of bias tool includes 21 factors (general, need/demand and supply). The majority of studies revealed high or moderate risk of bias for most of the factors., Conclusions: The existing evidence on workforce prediction in rheumatology is scarce, heterogeneous and at moderate or high risk of bias. The new risk of bias tool should enable future evaluation of workforce prediction studies. This review informs the European League Against Rheumatism points to consider for the conduction of workforce requirement studies in rheumatology., Competing Interests: Competing interests: None declared.

Objective: Lack of adherence to treatment is frequent in chronic inflammatory rheumatic diseases and is associated with poorer outcomes. The objective of this study was to describe and evaluate interventions that have been proposed to enhance medication adherence in these conditions., Methods: A systematic literature review was performed in Pubmed, Cochrane, Embase and clinicaltrials.gov databases completed by the rheumatology meeting (ACR, EULAR and SFR) abstracts from last 2 years. All studies in English or French evaluating an intervention to improve medication adherence in chronic inflammatory rheumatic diseases (rheumatoid arthritis (RA), spondyloarthritis (SpA), crystal related diseases, connective tissue diseases, vasculitis and Still's disease) were included. Interventions on adherence were collected and classified in five modalities (educational, behavioural, cognitive behavioural, multicomponent interventions or others)., Results: 1325 abstracts were identified and 22 studies were finally included (18 studies in RA (72%), 4 studies in systemic lupus erythematosus (16%), 2 studies in SpA (8%) and 1 study in gout (4%)). On 13 randomised controlled trials (RCT) (1535 patients), only 5 were positive (774 patients). Educational interventions were the most represented and had the highest level of evidence: 8/13 RCT (62%, 1017 patients) and 4/8 were positive (50%). In these studies, each patient was individually informed or educated by different actors (physicians, pharmacists, nurses and so on). Supports and contents of these educational interventions were heterogenous., Conclusion: Despite the importance of medication adherence in chronic inflammatory rheumatic disorders, evidence on interventions to improve medication adherence is scarce., Competing Interests: Competing interests: None declared.

Objectives: To describe the prevalence of degenerative changes on MRI and conventional radiographs of the spine in a young population with suspicion of axial spondyloarthritis (axSpA) and assess whether it is possible to discriminate between degenerative changes and lesions associated with axSpA., Methods: Whole spine MRI and cervical and lumbar radiographs of patients ≥18 years with chronic back pain (≥3 months, ≤3 years, onset <50 years) were assessed for degeneration by two readers, and for SpA lesions by two other readers, all blinded for clinical information and results of the other readers. Degenerative scores were adjudicated in case of disagreement (by a third reader). Patients fulfilling and not fulfilling the Assessment of SpondyloArthritis international Society axSpA criteria were compared for prevalence of degenerative lesions. Scores for degenerative and SpA lesions were compared, and overlap was defined as the presence of both types of lesions in a single vertebral unit (VU)., Results: In 456/648 (70.4%) patients (46.8% men, mean age 33.6), degenerative lesions were found with similar percentages in patients with no axSpA and with axSpA (72.4% and 69.2%, p=0.45). Modic changes were found more often in patients with no axSpA (29/239, 12.1%) versus patients with axSpA (19/409, 4.6%, p=0.01). Other lesions were evenly distributed. Overlap was minimal in 19 patients (3.0%) and 32/14 674 (0.2%) VUs for SpA reader 1 and in 23 patients (3.6%) and 34/14 674 VUs (0.2%) for SpA reader 2., Conclusion: The prevalence of degeneration is high in an early inflammatory back pain cohort. Discrimination between degeneration and axSpA lesions is very well possible with little overlap between degenerative and axSpA readings., Competing Interests: Competing interests: None declared.

Although peer review plays a central role in the maintenance of high standards in scientific research, training of reviewing skills is not included in the common education programmes. The Emerging EULAR (European League Against Rheumatism) Network (EMEUNET) developed a programme to address this unmet need. The EMEUNET Peer Review Mentoring Program for Rheumatology Journals promotes a systematic training of reviewing skills by engaging mentees in a 'real world' peer review experience supervised by experienced mentors with support from rheumatology journals. This viewpoint provides an overview of this initiative and its outcomes, and discusses its potential limitations. Over 4 years, 18 mentors and 86 mentees have participated. Among the 33 participants who have completed the programme, 13 (39.3%) have become independent reviewers for Annals of the Rheumatic Diseases after the training. This programme has been recently evaluated by a survey and qualitative interviews, revealing a high interest in this initiative. The main strengths (involvement of a top journal and learning opportunities) and weaknesses of the programme (limited number of places and insufficient dissemination) were identified. Overall, this programme represents an innovative and successful approach to peer review training. Continuous evaluation and improvement are key to its functioning. The EMEUNET Peer Review Mentoring Program may be used as a reference for peer review training in areas outside rheumatology., Competing Interests: Competing interests: TKK was Editor-in-Chief of the Annals of the Rheumatic Diseases from 2008 to 2017.

In recent years, the evolution of healthcare challenged the management of people with rheumatic and musculoskeletal diseases (RMDs). From disease-centred care to person-focused care, a holistic approach along with patient empowerment about their disease, improved the physician-patient relationship and allowed to achieve better outcomes with lower healthcare costs. Nevertheless, RMDs may occur from childhood to the old age and to date very few studies have addressed the needs and priorities of young people with RMDs. However, the image of RMDs is still associated with the elderly population. In this regard, the group of young people with arthritis and rheumatism in Europe (PARE) was recently developed within European League Against Rheumatism to represent the voice of the young affected and to carry out projects aiming for a better understanding of these specific aspects. This viewpoint discusses the needs and priorities of young people compared with adult people with RMDs, based on the available literature and on the results of the PARE Youth research project, aiming to identify the next steps of actions that need to be taken to improve the current situation., Competing Interests: Competing interests: None declared.

Introduction: We have limited data on the sustainability of tumour necrosis factor (TNF)-blocker tapering in rheumatoid arthritis (RA) in remission over the long term in real-life settings. This study aimed to assess the probability of sustained dose reduction of TNF-blockers in an observational 3-year extended follow-up of the Spacing of TNF-blocker injections in Rheumatoid ArthritiS Study (STRASS), a randomised controlled trial comparing progressive TNF-blocker injections (spacing arm (S-arm) to maintenance arm (M-arm)) in patients with RA in stable remission., Methods: In 2015, clinical data for the completer population were retrospectively collected at 1, 2 and 3 years after the end of the trial. The endpoints were the proportion of patients free of a biological disease-modifying antirheumatic drug (bDMARD) treatment, a sustainably spaced injection of TNF-blockers and a full-dose regimen as well as the mean dose of bDMARD intake and treatment switch rate., Results: Overall, 96 patients (76.8% of the completers) had data available up to 3 years; 11.5% discontinued TNF-blockers (5.8% vs 18.2% in the M-arm and S-arm, p=0.06), 30.2% had a tapered regimen (28.8% vs 31.8%, p=0.76) and 37.5% retained a full dose (44.2% vs 29.5%, p=0.14). The mean TNF-blocker dose quotient was 66% of the full dose (74% vs 58% in the M-arm and S-arm, p=0.06); 20.8% switched to another bDMARD (21.2% vs 20.5%, p=0.94)., Conclusion: Sustained TNF-blocker de-escalation or withdrawal is achievable in 41% of patients over 3 years with limited dose reduction. Optimal strategies remain to be determined to maintain remission after TNF-blocker tapering or discontinuation., Competing Interests: Competing interests: The authors declare a potential conflict of interest having received grant support and/or honoraria for consultations and/or for presentations as indicated: JS: BMS, MSD; XM: BMS, Celgene, GSK, Lilly, MSD, Novartis, Pfizer, Sanofi, UCB; JM: Abbvie, Pfizer, MSD, UCB; FT: research grants from Abbvie, Pfizer, Janssen, MSD, AstraZeneca, Lundbeck; LG: Abbvie, BMS, Celgène, Chugai, Janssen, MSD, Novartis, Pfizer, Roche, UCB; BF: AbbVie, BMS, Celgène, Hospira, Janssen, Lilly, MSD, Nordic, Novartis, Pfizer, R-Pharm, Roche-Chugai, UCB.

Background: The evolution of rheumatoid arthritis (RA) and axial spondyloarthritis (axSpA) is marked by flares, although their frequency is unclear. Flares may impact physical activity. Activity can be assessed objectively using activity trackers. The objective was to assess longitudinally the frequency of flares and the association between flares and objective physical activity., Methods: This prospective observational study (ActConnect) included patients with definite clinician-confirmed RA or axSpA, owning a smartphone. During 3 months, physical activity was assessed continuously by number of steps/day, using an activity tracker, and disease flares were self-assessed weekly using a specific flare question and, if relevant, the duration of the flare. The relationship between flares and physical activity for each week (time point) was assessed by linear mixed models., Results: In all, 170/178 patients (91 patients with RA and 79 patients with axSpA; 1553 time points) were analysed: mean age was 45.5±12.4 years, mean disease duration was 10.3±8.7 years, 60 (35.3%) were men and 90 (52.9%) received biologics. The disease was well-controlled (mean Disease Activity Score 28: 2.3±1.2; mean Bath Ankylosing Spondylitis Disease Activity Index score: 3.3±2.1). Patients self-reported flares in 28.2%±28.1% of the weekly assessments. Most flares (78.9%±31.4%) lasted ≤3 days. Persistent flares lasting more than 3 days were independently associated with less weekly physical activity (p=0.03), leading to a relative decrease of 12%-21% and an absolute decrease ranging from 836 to 1462 steps/day., Conclusion: Flares were frequent but usually of short duration in these stable patients with RA and axSpA. Persistent flares were related to a moderate decrease in physical activity, confirming objectively the functional impact of patient-reported flares., Competing Interests: Competing interests: None declared.