Seminars In Arthritis And Rheumatism[JOURNAL]
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200 papers
Structural damage assessment in the spine of patients with axial spondyloarthritis - results from an international OMERACT multi-reader exercise using MRI-based synthetic CT.
Willesen ST, Lambert RGW, Maksymowych WP … +8 more , Pedersen SJ, Møller JM, Gosvig KK, Peterfy C, Bird P, Stoenoiu MS, Georgiadis S, Østergaard M
Semin Arthritis Rheum · 2026 Jun · PMID 42308963 · Publisher ↗
OBJECTIVE: To develop and perform preliminary cross-sectional validation of a magnetic resonance imaging (MRI)-based outcome measure for assessing spinal structural damage in spondyloarthritis clinical trials, with a spe...
OBJECTIVE: To develop and perform preliminary cross-sectional validation of a magnetic resonance imaging (MRI)-based outcome measure for assessing spinal structural damage in spondyloarthritis clinical trials, with a specific focus on MRI-based synthetic computed tomography (sCT) and related MRI-based techniques. METHODS: Consensus meetings within the Outcome Measures in Rheumatology (OMERACT) MRI in arthritis working group established consensus definitions for spinal new bone formation and scoring rules. Then, low-dose CT and sCT images of twenty patients with axial spondyloarthritis and five healthy controls were independently assessed by seven experienced readers using the agreed-upon definitions for: marginal syndesmophytes, non-marginal syndesmophytes, and osteophytes. sCT images were reconstructed using a deep learning algorithm (BoneMRI v1.8, MRIGuidance B.V., Utrecht, the Netherlands). Sensitivity and specificity of synthetic CT were calculated using low-dose CT as the reference standard, and inter-reader reliability was assessed. RESULTS: A total mean of 35.5 lesions was scored on both sCT and low-dose CT in all participants. sCT demonstrated an overall good sensitivity (0.77) and excellent specificity (≥ 0.94) with low-dose CT as reference standard. Inter-reader agreement was substantial for both low-dose CT and sCT, with an overall intra-class coefficient of 0.80 (low-dose CT) and 0.86 (sCT), and corresponding kappa values of 0.68 and 0.70, respectively. CONCLUSION: This OMERACT international multi-reader exercise established consensus definitions for spinal new bone formation and provided preliminary evidence that sCT meets key OMERACT criteria of domain match and feasibility. This MRI technique for generating CT-like images shows promise as a novel method for assessing spinal structural damage in spondyloarthritis clinical trials.
Efficacy and safety of belimumab and anifrolumab in systemic lupus erythematosus: A systematic review and network meta-analysis.
Martinez-Martinez MU, Tejada-Llacsa PJ, Prokop LJ … +3 more , Crowson CS, Murad MH, Duarte-García A
Semin Arthritis Rheum · 2026 Jun · PMID 42308962 · Publisher ↗
OBJECTIVES: To compare the efficacy and safety of belimumab and anifrolumab in adult patients with SLE. METHODS: We conducted a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) in...
OBJECTIVES: To compare the efficacy and safety of belimumab and anifrolumab in adult patients with SLE. METHODS: We conducted a systematic review and network meta-analysis (NMA) of randomized controlled trials (RCTs) in SLE. We included RCTs comparing belimumab or anifrolumab plus standard of care versus placebo plus standard of care. Outcomes included SRI-4, BICLA, selected BILAG organ-domain responses, and safety endpoints; belimumab BICLA data were derived from post hoc analyses. Odds ratios (ORs) with 95% confidence intervals (CIs) were estimated. Risk of bias was assessed with RoB 2; certainty in network estimates was evaluated using the GRADE approach as applied in the CINeMA framework. RESULTS: Eleven trials (n = 8607) were included (4 anifrolumab; 7 belimumab, including 2 safety-only trials). Both biologics were associated with higher odds of achieving an SRI-4 response than placebo: anifrolumab OR 1.78 (95% CI 1.41-2.24); belimumab OR 1.62 (95% CI 1.38-1.90), with no significant difference between active treatments. For BICLA, anifrolumab was superior to belimumab (OR 1.56, 95% CI 1.10-2.21). Mucocutaneous and musculoskeletal responses favored both biologics versus placebo, whereas renal and cardiovascular/respiratory effects were not statistically significantly different. In safety analyses, SAEs and serious infections were similar between biologics, whereas herpes zoster was higher with anifrolumab versus belimumab (OR 4.74, 95% CI 2.00-11.21). CONCLUSION: In this NMA, anifrolumab and belimumab achieved similar SRI-4 responses. Anifrolumab showed a higher BICLA response than belimumab, but this finding should be interpreted cautiously given reliance on indirect evidence and moderate certainty. Clinically, these data support individualized biologic selection, weighing potential benefit on BICLA against the consistently higher herpes zoster risk with anifrolumab.
Development and validation of the OMERACT juvenile idiopathic arthritis MRI- sacroiliac joint score (OMERACT JAMRIS-SIJ): Phase 3.
Maksymowych WP, Weiss PF, Francavilla ML … +6 more , Herregods N, Meyers AB, Stimec J, Paschke J, Lambert RG, Rumsey D
Semin Arthritis Rheum · 2026 Jun · PMID 42308961 · Publisher ↗
OBJECTIVE: The OMERACT JAMRIS working group has defined a spectrum of MRI lesions in the sacroiliac joint (SIJ) in pediatric cases with spondyloarthritis (SpA) that match domains for inflammation and structural damage. W...
OBJECTIVE: The OMERACT JAMRIS working group has defined a spectrum of MRI lesions in the sacroiliac joint (SIJ) in pediatric cases with spondyloarthritis (SpA) that match domains for inflammation and structural damage. We aimed to assess longitudinal construct validity using two available instruments, the Spondyloarthritis Research Consortium of Canada (SPARCC) and JAMRIS scores, in two longitudinal cohorts of youth with SpA treated with a tumor necrosis factor inhibitor (TNFi) according to the OFISA framework. METHODS: Two cohorts recruited 60 youth with SpA who had MRI prior to and after TNFi. MRI lesions were assessed blinded to timepoint by 7 readers (5 MSK radiologists, 2 rheumatologists). Analyses compared data from JAMRIS-all slice versus SPARCC selected slices for descriptive variables, reliability, and responsiveness. RESULTS: Pre- and post-treatment scans (mean (SD) duration between scans 46.6 (47.1) weeks) were available from 60 cases. The major contributor to change in inflammatory lesion scores was bone marrow edema (BME) followed by inflammation in an erosion cavity (IEC), though differences between the two instruments were minimal. For change in structural lesions, minimal differences were evident between SPARCC and JAMRIS-all slice instruments. Reliability for detection of change scores and responsiveness were comparable between SPARCC and JAMRIS-all slice methodologies. Combining scores for inflammatory lesions did not enhance responsiveness compared to BME alone. CONCLUSIONS: BME is the most responsive lesion to treatment with TNFi in axJSpA followed by IEC and then erosion. Validation according to the OFISA framework demonstrates that the JAMRIS-all slice and SPARCC instruments have comparable performance characteristics.
Multimodal imaging evaluation of pre-systemic sclerosis patients presenting with Raynaud's Phenomenon from a reference microcirculatory clinic versus healthy controls: a cross-sectional study.
Govender R, Hysa E, Campitiello R … +7 more , Wallaert S, Vandycke M, Gotelli E, Du Four T, Piette Y, Cutolo M, Smith V
Semin Arthritis Rheum · 2026 Jun · PMID 42296908 · Publisher ↗
OBJECTIVE: To determine whether multimodal imaging tools can detect dermal and microvascular abnormalities in pre-systemic sclerosis (pre-SSc) patients compared with matched healthy controls (HC). METHODS: Non-selected p...
OBJECTIVE: To determine whether multimodal imaging tools can detect dermal and microvascular abnormalities in pre-systemic sclerosis (pre-SSc) patients compared with matched healthy controls (HC). METHODS: Non-selected pre-SSc patients (n = 20, fulfilling LeRoy's criteria) from the Ghent University (hospital) Raynaud's clinic and age-, sex-, and BMI-matched HC (n = 20) were evaluated. Dermal thickness (DT) was measured using high-frequency ultrasound (HFUS, 18 MHz) at 17 sites. Nailfold videocapillaroscopy (NVC, 200x magnification) was assessed using standardized consensus. Peripheral blood perfusion (PBP) was quantified using laser speckle contrast analysis (LASCA). Group differences were analysed using generalised linear mixed models with group, location and their interaction as fixed effects, accounting for matching and within-subject clustering. RESULTS: HFUS showed an effect of group on mean DT (p = 0.011). Significant locations included the right and left fingers (0.80 ± 0.04 vs 0.68 ± 0.04 mm, p = 0.012; 0.81 ± 0.04 vs 0.67 ± 0.04 mm, p = 0.015) and left forearm (1.02 ± 0.05 vs 0.88 ± 0.05 mm, p = 0.035). LASCA demonstrated reduced (volar) fingertip PBP in pre-SSc (139 ± 12 vs 200 ± 12 perfusion units; mean difference = 61, 95% CI: 38-85; p < 0.001). NVC revealed lower capillary density (7.8 vs 9.8/mm, p < 0.001), increased microhaemorrhages (18%vs 7.4%, p = 0.032), and exclusivity of giant capillaries and scleroderma pattern. CONCLUSION: Dermal, functional and structural microvascular abnormalities are detectable in pre-SSc in the absence of clinical skin thickening or overt organ involvement. Future multicentric longitudinal studies are required to confirm multimodal differentiative value.
Perioperative management of biologic disease-modifying antirheumatic drugs in patients with inflammatory rheumatic diseases undergoing total joint arthroplasty: A nationwide population-based cohort study from Taiwan.
Chen JP, Chen PA, Peng SH … +4 more , Lee SH, Chang CH, Hu CC, Lin YC
Semin Arthritis Rheum · 2026 Jun · PMID 42287866 · Publisher ↗
BACKGROUND: The optimal perioperative management of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory rheumatic disease (IRD) patients undergoing total joint arthroplasty (TJA) remains debated, wit...
BACKGROUND: The optimal perioperative management of biologic disease-modifying antirheumatic drugs (bDMARDs) in inflammatory rheumatic disease (IRD) patients undergoing total joint arthroplasty (TJA) remains debated, with current guidelines based on low-to-moderate quality evidence. METHODS: Using the Taiwan National Health Insurance Research Database (NHIRD, 2004-2020), we identified IRD patients undergoing primary TJA and propensity score-matched them with non-IRD controls. Within the IRD cohort, patients were categorized by perioperative bDMARD strategy: continuation (n = 623) versus withholding (n = 631). Primary outcomes included surgical site infection (SSI), delayed wound healing, and disease flares within 30 days. RESULTS: Among 1254 propensity-matched IRD patients, SSI rates were comparable between continuation and withholding groups, consistent with prior studies [12,17] (2.91%vs 2.51%; OR 1.31, p = 0.39), as was delayed wound healing (2.21%vs 1.09%; OR 2.02, p = 0.43). Disease flares were significantly lower with continuation (6.12%vs 22.33%; OR 0.13, p = 0.03). Healthcare costs were lower in the continuation group. CONCLUSIONS: Perioperative bDMARD continuation was not associated with a significantly increased risk of SSI or wound complications but substantially reduced disease flares. Blanket bDMARD discontinuation may not be warranted, supporting individualized perioperative management.
Evaluation of physical function in patients with inflammatory myopathies using the health assessment questionnaire-II (HAQ-II).
Lee SK, Wipfler K, Ritz E … +3 more , Aydemir B, Michaud K, Saygin D
Semin Arthritis Rheum · 2026 Jun · PMID 42287865 · Publisher ↗
BACKGROUND: Idiopathic inflammatory myopathies (IIM) are autoimmune diseases characterized by chronic muscle inflammation leading to impaired physical function and strength. Despite the importance of functional assessmen...
BACKGROUND: Idiopathic inflammatory myopathies (IIM) are autoimmune diseases characterized by chronic muscle inflammation leading to impaired physical function and strength. Despite the importance of functional assessment, only few validated tools exist for this population. The Health Assessment Questionnaire-II (HAQ-II), a streamlined 10-item version of the HAQ, may provide an efficient instrument. This study aimed to evaluate the measurement properties of HAQ-II in patients with IIM. METHODS: Adults with IIM enrolled in Forward Databank (2005-2023) with available data on HAQ-II were included. Patients completed HAQ-II along with assessments of disease activity, pain, fatigue, quality of life (SF-36), and comorbidities. Internal consistency of HAQ-II was assessed using Cronbach's α. Floor and ceiling effects, discriminant and construct validity (based on a priori hypotheses), and responsiveness (via linear mixed models adjusted for age, sex, and obesity) were evaluated. RESULTS: A total of 192 IIM patients (mean age 54.8 years; 79.3% female) were included. HAQ-II demonstrated high internal consistency (α = 0.93), no significant floor or ceiling effects. Discriminant validity was supported by significant score differences across groups stratified by SF-36 physical function, pain, fatigue, and disease activity (all p < 0.0001). Fifteen of 17 a priori hypotheses for construct validity were met. Longitudinal changes in HAQ-II scores were significantly associated with changes in pain, fatigue, global disease activity, and SF-36 physical component scores. CONCLUSION: HAQ-II demonstrated high internal consistency, no significant floor or ceiling effects, adequate validity and responsiveness for assessing physical function in patients with IIM and could be appropriate for both clinical and research settings.
The OMERACT core domain sets for calcium pyrophosphate deposition disease.
Dalbeth N, Zhang Y, Hensey O … +19 more , Grossberg D, Cai K, Fuller A, McCarthy GM, Pascart T, Latourte A, Cipolletta E, Taylor WJ, Diaz-Torne C, Jansen TL, Hong LE, Sirotti S, Becce F, Filippou G, Shea B, Christensen R, Singh JA, Abhishek A, Tedeschi SK
Semin Arthritis Rheum · 2026 Jun · PMID 42284818 · Publisher ↗
OBJECTIVES: To develop OMERACT core domain sets for chronic and recurrent calcium pyrophosphate deposition (CPPD) disease and acute calcium pyrophosphate (CPP) crystal arthritis. METHODS: Following OMERACT methodology, t...
OBJECTIVES: To develop OMERACT core domain sets for chronic and recurrent calcium pyrophosphate deposition (CPPD) disease and acute calcium pyrophosphate (CPP) crystal arthritis. METHODS: Following OMERACT methodology, the CPPD Working Group (comprising of patient research partners, fellows, clinicians, and methodologists) defined the core domain sets. The development of the core sets occurred through a scoping review, qualitative study, Delphi surveys, and ranking exercises to identify the most relevant domains. A virtual e-module was developed to enable members of the OMERACT community to discuss and vote for endorsement of the OMERACT CPPD core domain sets. RESULTS: The core domains for chronic and recurrent CPPD are pain intensity, joint tenderness, joint swelling, acute CPP crystal arthritis flares, overall function, patient global assessment of disease activity, physician global assessment of disease activity, and adverse events including death. In voting, this core domain set was endorsed by 14/14 (100%) patient research partners and 85/87 (98%) other participants. The core domains for acute CPP crystal arthritis are pain intensity, joint tenderness, joint swelling, duration of acute CPP crystal arthritis flare, overall function, patient global assessment of disease activity, and adverse events including death. In voting, this core domain set was endorsed by 14/14 (100%) patient research partners and 83/86 (97%) other participants. Definitions for all core domains have been developed. CONCLUSION: These core domains provide a foundation for future clinical trials and longitudinal studies in CPPD by defining the minimum outcomes that should be assessed and reported to ensure relevance and comparability across studies.
The role of integrated gastro-rheumatological care in IBD-associated Spondyloarthritis in achieving joint-gut remission: Four-year outcomes from the real-world SPIB cohort.
Paci V, Marchionni G, Zabotti A … +20 more , Perini L, Marconi V, Agostinelli A, Cimaroli I, Fiorini F, Di Zio R, Massaccesi L, Sordillo R, Bartoli D, Manuale V, Balducci D, Montori M, Bolognini L, Bendia E, Benfaremo D, Benedetti A, Quartuccio L, Moroncini G, Poddubnyy D, Luchetti Gentiloni MM
Semin Arthritis Rheum · 2026 Jun · PMID 42276008 · Publisher ↗
BACKGROUND: Spondyloarthritis associated with inflammatory bowel disease (Spa-IBD) often requires a customised multidisciplinary approach. The aim of this study was to evaluate long-term outcomes of a cohort of SpA-IBD p...
BACKGROUND: Spondyloarthritis associated with inflammatory bowel disease (Spa-IBD) often requires a customised multidisciplinary approach. The aim of this study was to evaluate long-term outcomes of a cohort of SpA-IBD patients with a multidisciplinary management. METHODS: Consecutive patients with SpA-IBD were assessed at our multidisciplinary Gastro-Rheumatological Clinic and enrolled in the SPIB (SpA in Inflammatory Bowel Disease) cohort. The primary endpoint was the proportion of patients achieving remission in both intestinal and articular domains at four years. Secondary outcomes included the cohort's baseline clinical features, progressive improvement in disease activity scores, treatment patterns, and predictors of remission. RESULTS: The cohort includes 159 patients (58% Crohn's disease, 42% ulcerative colitis). At baseline, 56% of patients were diagnosed with axial SpA-IBD, and 44% with peripheral SpA-IBD. At baseline, 0.6% of patients were in combined intestinal and articular remission, and this proportion gradually increased to 5.7% at six months and 26.3% at four years. Clinical outcomes at 4 years included improvements in TJC (Δ-3.8), SJC (Δ-1.0), LEI score (Δ-0.3), DAPSA remission status (+36.0%), ASDAS inactive disease status (+38.0%), and remission status for CDAI (+19.3%) and pMayo (+26.2%) scores. At 2 years, bDMARD therapy increased by 36%, while corticosteroid use decreased by 35%. In multivariable analysis, male gender predicted remission during follow-up (OR 2.80, 95% CI 1.21-6.76), whereas axial disease (OR 0.41, 0.17-0.96) and enthesitis (OR 0.26, 0.11-0.59) were negative predictors. CONCLUSIONS: The long-term results of the SPIB cohort highlight the value of close collaboration between rheumatologists and gastroenterologists in the application of joint-gut remission strategies.
OMERACT- determining a core domain set for Sjögren's disease: International focus group series.
DiRenzo DD, Ang L, O'Brien C … +18 more , Lee A, Gordon RA, Franke K, Yang H, Baer A, Grader-Beck T, Pulukool S, Destro L, Hammitt K, Bouillot C, He J, Jin Y, Hoi A, Bowman SJ, Seror R, Rischmueller M, Arends S, McCoy SS
Semin Arthritis Rheum · 2026 Jun · PMID 42276007 · Publisher ↗
BACKGROUND: Sjögren's Disease (SjD) is a systemic autoimmune disease that is associated with a significant reduction in health-related quality of life (HRQoL). The goal of this study was to better understand HRQoL using...
BACKGROUND: Sjögren's Disease (SjD) is a systemic autoimmune disease that is associated with a significant reduction in health-related quality of life (HRQoL). The goal of this study was to better understand HRQoL using a multi-national and rigorously defined SjD population according to 2016 ACR/EULAR classification criteria. METHODS: The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Sjögren's Disease Working Group conducted three regionally based focus groups (United States, Australia/China, the Netherlands) for adult patients with SjD who met classification criteria. The focus groups were semi-structured and designed to elicit feedback regarding important life impact domains, or aspects of disease, that should be included in future research. Additionally, a brief demographic survey was administered. Focus group transcripts were coded and analyzed for theme saturation and interpretation. RESULTS: There were 29 participants with SjD who completed the focus groups (25 females, 4 males); 28 participants completed the surveys. Five codes and 19 subcodes were identified corresponding to the following relevant domains: pain interference, physical activity, dryness, fatigue, oral health, autonomic function, and sequelae of inflammation, brain fog, pregnancy/fertility, emotional health, social participation and engagement with others including medical providers, and worker productivity. CONCLUSION: These findings from a multi-national sample reaffirm the relevance of established symptoms such as pain, fatigue, and dryness while elucidating a broader spectrum of disease impact reported by individuals with SjD. Domains related to cognitive impairment, autonomic dysfunction, oral health, emotional well-being, and social and occupational functioning emerged as salient features of the patient experience. These data support the need to expand current outcome frameworks to better capture the multidimensional burden of SjD and inform the development of more comprehensive, patient-centered assessment tools.
Risk of disease flare and clinical reversibility following discontinuation versus dose reduction of biological DMARDs in Rheumatoid arthritis: A systematic review and meta-analysis.
Lee YH, Song GG
Semin Arthritis Rheum · 2026 Jun · PMID 42269230 · Publisher ↗
BACKGROUND: For patients with rheumatoid arthritis (RA) who achieve stable remission, a key clinical goal is the de-escalation of biological disease-modifying antirheumatic drugs (bDMARDs). However, the best approach-whe...
BACKGROUND: For patients with rheumatoid arthritis (RA) who achieve stable remission, a key clinical goal is the de-escalation of biological disease-modifying antirheumatic drugs (bDMARDs). However, the best approach-whether to completely discontinue treatment or to gradually reduce the dose-remains a topic of debate. This systematic review and meta-analysis aimed to compare the risks of flare, clinical reversibility, and radiographic safety associated with these two strategies. METHODS: We conducted a search of PubMed, Embase, and the Cochrane Library for randomized controlled trials (RCTs) published from inception until February 1, 2026. Eleven studies (including 10 RCTs and one 10-year extension study) involving 2861 patients were included. The primary outcome was the risk ratio (RR) of disease flare. Secondary outcomes included the re-treatment success rate (capture rate) and radiographic progression (vSHS). All analyses employed a random-effects model. The study protocol was registered in the PROSPERO database (Registration No CRD420261331554) RESULTS: The pooled meta-analysis revealed that complete discontinuation of bDMARDs significantly increases the risk of flare compared to dose reduction or maintenance strategies (Pooled RR: 2.13; 95% CI: 1.74-2.61; P < 0.00001). Subgroup analysis based on disease duration indicated a significant interaction (P = 0.007); the risk of flare was lower in patients with early RA (<2 years; RR 1.62; 95% CI: 1.25-2.10) compared to those with established RA (RR 2.31; 95% CI: 1.89-2.82). Despite the increased flare risk, the pooled capture rate upon re-initiating therapy was 87.5% (95% CI: 82.4-91.6), with clinical recovery achieved within a median of 12.4 weeks. Radiographic progression was minimal and primarily driven by cumulative disease activity during flares rather than the tapering strategy itself. No significant publication bias was detected (Egger's test, P = 0.456). CONCLUSION: Gradual dose reduction is a safer initial de-escalation strategy than complete discontinuation for maintaining remission in RA. Although stopping bDMARDs more than doubles the risk of flare, the clinical consequences are largely reversible. A stepwise tapering approach, supported by strict monitoring and immediate re-treatment protocols, should be prioritized to balance treatment-free remission with structural safety.
Beyond co-occurrence: Age, sex, and the temporal progression of autoimmune overlap syndromes in a 23-year nationwide cohort.
Chan TM, Li PR, Luo SF … +2 more , Kuo CF, See LC
Semin Arthritis Rheum · 2026 Jun · PMID 42269229 · Publisher ↗
OBJECTIVES: This study aimed to elucidate the epidemiological features and temporal progression patterns of overlapping autoimmune rheumatic diseases (ARDs), with a particular focus on how age and sex influence the overl...
OBJECTIVES: This study aimed to elucidate the epidemiological features and temporal progression patterns of overlapping autoimmune rheumatic diseases (ARDs), with a particular focus on how age and sex influence the overlap. METHODS: We conducted a nationwide historical cohort study using Taiwan's National Health Insurance Research Database (NHIRD), including patients newly diagnosed with one of nine common ARDs between 2000 and 2022. Overlap syndrome was classified as "co-occurring" (second ARD diagnosis ≤3 months after the first) or "sequential" (second ARD diagnosis >3 months after the first). Joinpoint regression analysis was used to assess the trends in annual incidence rate of developing a second ARD. RESULTS: Among 235,592 patients with an incident ARD, 22.2% developed an overlapping syndrome. Younger age at onset (46.0 vs. 51.1 years) and female sex were significantly associated with sequential overlap. Co-occurring overlaps were most observed in combinations of Sjögren's syndrome (SS) with systemic lupus erythematosus (48.2% of co-occurring cases). In sequential overlaps, rheumatoid arthritis was the most frequent first diagnosis (36.1%), and SS emerged as the most frequent second autoimmune diagnosis overall. The risk of a second ARD was highest in the first three years after initial diagnosis and then declined sharply, defining a critical 3-4-year high-risk period. CONCLUSIONS: Overlapping ARDs affected nearly one-quarter of Taiwanese patients, with most emerging within 3 years of the initial diagnosis. Younger age and female sex were strongly associated with overlap, underscoring a critical 3-4-year window for intensified surveillance.
Identifying candidate core domains for clinical trials in systemic sclerosis-associated Raynaud's phenomenon and digital ulcers.
Proudman SM, Hughes M, Maltez N … +9 more , Brown E, Hickey V, Quinn KA, Christensen R, Shea B, Herrick AL, Pauling JD, Merkel PA, OMERACT Scleroderma Vascular Disease Working Group
Semin Arthritis Rheum · 2026 Jun · PMID 42269228 · Full text
BACKGROUND: The OMERACT Scleroderma Vascular Disease Working Group sought to identify essential core outcome domains for inclusion in clinical trials focusing on Raynaud's phenomenon (RP) and/or digital ulcers (DUs) rela...
BACKGROUND: The OMERACT Scleroderma Vascular Disease Working Group sought to identify essential core outcome domains for inclusion in clinical trials focusing on Raynaud's phenomenon (RP) and/or digital ulcers (DUs) related to systemic sclerosis (SSc). METHODS: Candidate domains identified from previous qualitative work and systematic literature reviews were included in separate Delphi exercises for SSc-RP and SSc-DUs. Patients with SSc and other participants (clinicians with experience in treating patients with SSc and/or conducting clinical trials) were invited to participate through international patient advocacy groups and clinical networks. Core domains were defined as the domains reaching group consensus agreement (≥ 70% ratings of 'critical' in both patient and other participant groups) after three rounds of the Delphi. RESULTS: The 3-round Delphi exercises were completed by 78 patients and 116 others from 39 countries for SSc-RP, and by 26 patients and 99 others from 36 countries for SSc-DUs. For SSc-RP, nine domains reached consensus agreement as critically important: three domains in the Pathophysiological Manifestations core area and six in the Life Impact core area. For SSc-DUs, 16 domains reached consensus: five domains in the Pathophysiological Manifestations core area, seven in the Life Impact core area, and four in the Resource Use area. CONCLUSION: Patients with SSc and clinicians identified core domains for use in clinical trials in SSc-associated RP and DUs, with several Life Impact domains common to both vascular manifestations of disease. These results will inform development of a final Core Domain Set for use in clinical trials.
Spanish multicenter registry of belimumab in systemic lupus erythematosus: Data from daily clinical practice.
Aldasoro V, Laiño M, Enguita M … +50 more , Loricera J, Moriano C, Lasa C, Calvo V, Narváez FJ, Navarro P, Casafont I, Font J, Gállego A, Carrión I, Quiroga P, Castañeda S, García Á, Belzunegui J, López M, de Dios JR, Hernández S, Heredia S, Fariña A, Navarro F, Fragio J, Escudero C, Ortega R, Olmo LD, Pinillos V, Labrador E, Ortega MC, Castro P, Blanco J, Paulino M, Matías MÁ, Peralta C, García S, Camins J, Garijo M, Fábregas D, Urruticoechea A, Medina M, Cossio P, Pérez-Pampín E, Varas B, Vázquez C, Balsalobre J, Vegas N, Rusinovich O, Giner E, Lamúa JR, Abascal IB, Moreno MJ, Pérez P
Semin Arthritis Rheum · 2026 Jun · PMID 42269227 · Publisher ↗
INTRODUCTION: The monoclonal antibody belimumab (BLM) is the first biologic drug approved for the treatment of systemic lupus erythematosus (SLE). While the efficacy and safety profile of BLM has been well documented in...
INTRODUCTION: The monoclonal antibody belimumab (BLM) is the first biologic drug approved for the treatment of systemic lupus erythematosus (SLE). While the efficacy and safety profile of BLM has been well documented in clinical trials, both in SLE in general and in lupus nephritis (LN) in particular, it is necessary to obtain data from daily clinical practice. OBJECTIVES: To describe Spanish experience with BLM for treatment of SLE in daily clinical practice from 2011 until May 2024. METHODS: We performed a descriptive, observational, retrospective, and multicenter study of patients diagnosed with SLE based on the classification criteria of EULAR/ACR 2019, SLICC, and/or ACR 1997 who were starting treatment with BLM. Data were collected from the clinical history at 44 hospitals throughout Spain. The primary objective was to analyze laboratory and clinical data, effectiveness and safety. We also assessed the reduction in use of prednisone (or equivalent) and persistence of treatment. The analyses were performed overall and by differentiating between 2 periods (2011-2016 [period 1] and 2017-2024 [period 2]) and according to the subpopulation of patients with LN. Early BLM initiators, patients in monotherapy (HCQ allowed) and patients with prior biologic disease-modifying antirheumatic drugs (bDMARD) treatment were also analyzed. RESULTS: The registry contains 533 patients (85.7% women, 14.3% men). Mean duration of follow-up was 22.6 months (SD: 21.2). Significant decreases were observed for the dose of prednisone, SLEDAI-2 K score, and anti-dsDNA antibody levels, whereas increases were observed for complement C3 and C4. Kidney biopsy, performed in 114 patients, revealed class IV and class III nephritis to be the most common types (44.7% and 21.2%, respectively). Three-quarters of patients (75%) started treatment in period 2, where the less frequently used drugs were bDMARD, conventional synthetic disease-modifying antirheumatic drugs (csDMARD), and prednisone. In addition, drug persistence was greater than for period 1. Patients treated after bDMARD had a worse survival (p < 0.001) while no differences were observed in patients treated in monotherapy (p = 0.06); in early BLM patients drug survival was similar to those after at least 1 csDMARD (findings were consistent in adjusted multivariable models). A total of 151 patients (28.3%) interrupted treatment, mainly owing to lack of efficacy (56.7%) and infections (12.1%). CONCLUSIONS: We present data on the effectiveness and safety of the largest series to date of SLE patients treated with BLM in daily clinical practice in Spain. Our results show that BLM use was associated with improvements in disease activity and serologic markers, along with prednisone dose reductions, and showed an acceptable safety profile.
Corrigendum to "Development and validation analysis of a corrected axial spondyloarthritis metrology index (CASMI)" [Seminars in Arthritis and Rheumatism 78 (2026) 152981].
Capelusnik D, Gardiner P, Boonen A … +5 more , Nikiphorou E, van der Heijde D, Landewé R, van Tubergen A, Ramiro S
Semin Arthritis Rheum · 2026 Jun · PMID 42250405 · Publisher ↗
Abstract loading — click title to view on PubMed.
Long-term rheumatologic comorbidities in familial Mediterranean fever.
Magen E, Aamar S, Magen I … +5 more , Merzon E, Green I, Golan-Cohen A, Vinker S, Israel A
Semin Arthritis Rheum · 2026 Jun · PMID 42250404 · Publisher ↗
OBJECTIVES: Familial Mediterranean fever (FMF) is characterized by pyrin inflammasome dysregulation and chronic subclinical inflammation. Whether FMF carries an increased long-term burden of rheumatologic and autoimmune...
OBJECTIVES: Familial Mediterranean fever (FMF) is characterized by pyrin inflammasome dysregulation and chronic subclinical inflammation. Whether FMF carries an increased long-term burden of rheumatologic and autoimmune inflammatory disease is unclear. We evaluated baseline and long-term occurrence of rheumatologic and selected autoimmune comorbidities in FMF. METHODS: This was a nationwide, retrospective, population-based matched-cohort study using electronic health records from Leumit Health Services in Israel (2001-2024). Patients with confirmed FMF were matched 1:4 with controls by age, sex, and socioeconomic status. Rheumatologic and selected autoimmune comorbidities, including inflammatory bowel disease and autoimmune thyroid disease, were identified using International Classification of Diseases, 9th Revision (ICD-9) codes. Baseline prevalence and cumulative occurrence over up to 20 years were assessed, with a 12-month washout. A composite endpoint of any prespecified rheumatologic or autoimmune diagnosis was evaluated. Multivariable logistic regression was adjusted for demographic and clinical covariates, with false discovery rate correction. RESULTS: The cohort included 3324 FMF patients and 13,296 controls (mean age 24.5 years; 51% female). At baseline, FMF was associated with Behçet disease, rheumatoid arthritis, fibromyalgia, gout, osteoarthritis, and connective tissue disease (all q < 0.05). During follow-up, FMF was further associated with ankylosing spondylitis, lupus, vasculitis, psoriatic arthritis, and Crohn's disease (adjusted odds ratios 1.31-12.7; all q < 0.05). Amyloidosis was markedly more frequent in FMF (1.26%vs. 0.015%; q < 0.001). The composite endpoint was higher in FMF (17.0%vs. 7.4%; adjusted odds ratio 2.18). CONCLUSION: FMF is associated with a selective, persistent excess of rheumatologic and autoimmune diseases despite colchicine, supporting long-term rheumatologic surveillance.
Lessons from an early rheumatoid arthritis incident cohort.
Bykerk VP, Bartlett SJ, Schieir O … +12 more , Boire G, Hitchon CA, Thorne C, Tin D, Haraoui B, Bessette L, Hazlewood G, Allard-Chamard H, Kuriya B, Valois MF, Pope JE, CATCH Investigators and Participants
Semin Arthritis Rheum · 2026 May · PMID 42247732 · Publisher ↗
BACKGROUND: The Canadian Early Arthritis Cohort (CATCH) study, a pioneering national registry established in 2007, has generated robust real-world evidence that has significantly advanced early rheumatoid arthritis (ERA)...
BACKGROUND: The Canadian Early Arthritis Cohort (CATCH) study, a pioneering national registry established in 2007, has generated robust real-world evidence that has significantly advanced early rheumatoid arthritis (ERA) care in Canada and internationally. METHODS: Data have been collected from over 3800 patients across 25 sites and >35,000 study visits. RESULTS: This paper synthesizes 15 key learnings from CATCH that span early diagnosis, treatment strategies, patient-reported outcomes, and health equity. Findings underscore the importance of standardized data collection, early methotrexate use, and treat-to-target approaches, while also highlighting challenges such as persistent disease activity, treatment adherence, and disparities linked to sex, comorbidities, and social determinants of health. CATCH has contributed to the development and validation of novel outcome measures, supported the training of future rheumatology leaders, and informed national and international guidelines. Its infrastructure enabled continuity of research during the COVID-19 pandemic and supports pragmatic trials and innovations in care delivery. CONCLUSIONS: As real-world incident cohort, CATCH has helped to answer questions that impact clinical and policy decisions, and CATCH exemplifies the enduring value of well-curated patient registries in generating actionable insights to improve outcomes for people living with ERA.
Adherence to dietary recommendations and the risk of developing giant cell arteritis: A nested Case-Control study.
Kwanyuen P, Wadström K, Sonestedt E … +5 more , Fors C, Bäcklund R, Mohammad AJ, Jacobsson L, Turesson C
Semin Arthritis Rheum · 2026 May · PMID 42247731 · Publisher ↗
OBJECTIVES: To investigate the relation between adherence to dietary recommendations, the quantified intake of the components of these recommendations, and the risk of developing giant cell arteritis (GCA). METHODS: Part...
OBJECTIVES: To investigate the relation between adherence to dietary recommendations, the quantified intake of the components of these recommendations, and the risk of developing giant cell arteritis (GCA). METHODS: Participants in the Malmö Diet and Cancer Study cohort who subsequently developed GCA were identified through register linkage and validated in a structured review. Four controls, matched for age, sex, and year of inclusion, were selected per case. Diet quality was assessed using the Swedish Dietary Guidelines Score (SDGS, range 0-5). The relations for the SDGS, adherence to recommendations for each component and total intake of each component with development of GCA were assessed using logistic regression, adjusted for total energy intake, leisure-time physical activity and alcohol intake. Potential misreporters of total energy intake were excluded. RESULTS: There were 193 incident cases of GCA. High adherence to dietary guidelines (SDGS 4-5 vs 0-1) was associated with subsequent development of GCA (adjusted odds ratio 2.70; 95% CI 1.43-5.10). In adjusted models, adherence to recommended intake of added sugar, fish and shellfish and vegetables and fruit was associated with an increased risk of GCA. A reduced risk was seen with higher quantified consumption of added sugar, and an increased risk with higher intakes of fiber and fish and shellfish. CONCLUSIONS: An overall high diet quality was independently associated with an increased risk of GCA. This is compatible with the concept of an increased risk of GCA in subjects with a healthy metabolic profile, and of metabolic regulation of early disease mechanisms in GCA.
Editorial policies for ethical use of artificial intelligence in rheumatology journals.
Fedorchenko Y, Usen A, Seiil B … +2 more , Zimba O, Korkosz M
Semin Arthritis Rheum · 2026 Jun · PMID 42241773 · Publisher ↗
BACKGROUND: The integration of artificial intelligence (AI) into research and publishing poses ethical challenges. Global editorial associations, including the International Committee of Medical Journal Editors (ICMJE),...
BACKGROUND: The integration of artificial intelligence (AI) into research and publishing poses ethical challenges. Global editorial associations, including the International Committee of Medical Journal Editors (ICMJE), have updated their recommendations to safeguard transparency and accountability for AI use. The extent to which these recommendations have been enforced in specialist journals remains unknown. OBJECTIVE: The aim of our study was to analyze the extent to which indexed rheumatology journals have adopted AI-related editorial policies, the scope of these policies, and their alignment with ICMJE recommendations. METHODS: A total of 58 impact-factor rheumatology journals were analyzed in view of their AI-related editorial policies. Author instructions, ethics statements, and publisher guidelines were overviewed for (1) AI-related instructions; (2) alignment with ICMJE recommendations; (3) provisions regulating AI use by authors, peer reviewers, and editors; and (4) regulations concerning generative text, images, data, and analytical outputs. RESULTS: Of the 58 journals, 45 (77.6%) presented explicit AI editorial policies, while 13 (22.4%) lacked any AI-related guidance. The majority of journals (98.2%) endorsed ICMJE points on AI. High-impact journals-Nature Reviews Rheumatology, The Lancet Rheumatology, and Annals of the Rheumatic Diseases-demonstrated the most stringent governance, prohibiting AI use for analytical and creative roles, mandating detailed disclosure of AI tools and prompts, and banning AI use for peer review and editorial decision-making. The guidance on AI use by peer reviewers and editors was present in 45 journals (77.6%). Permissive uses of AI were largely confined to language editing under human supervision. Generative or substantive uses-such as producing figures, conceptual contents, or data-were broadly restricted. CONCLUSIONS: Indexed rheumatology journals demonstrate variable editorial policies of enforcing AI guidance. While the adoption of AI-related policies is mostly improving, a marked heterogeneity still exists, particularly between top-tier and lower-tier journals. Upgrades of editorial policies are warranted to safeguard the integrity and transparency of rheumatology sources.
Suitability of the Oxford Shoulder Score for measuring pain in clinical trials evaluating interventions for people with shoulder disorders according to the OMERACT filter 2.2.
Haas R, Marmura H, Furtado R … +10 more , Ramiro S, Gagnier JJ, Verhagen A, Whittle S, Beaton D, Shea B, Richards P, Berkovic D, Firth A, Buchbinder R
Semin Arthritis Rheum · 2026 May · PMID 42235149 · Publisher ↗
BACKGROUND: Pain is a mandatory domain in Outcome Measures in Rheumatology (OMERACT) core outcome sets for shoulder disorder trials. We evaluated the Oxford Shoulder Score (OSS), a composite measure comprising four pain...
BACKGROUND: Pain is a mandatory domain in Outcome Measures in Rheumatology (OMERACT) core outcome sets for shoulder disorder trials. We evaluated the Oxford Shoulder Score (OSS), a composite measure comprising four pain and eight function items but no separate subscales for these domains, for measuring pain using the OMERACT Filter 2.2. METHODS: Following the OMERACT Handbook, we assessed domain match and feasibility, then systematically reviewed OSS measurement properties in shoulder disorders (rotator cuff disease, adhesive capsulitis, instability, osteoarthritis, dislocation, humeral head fractures and unspecified pain). MEDLINE, EMBASE and CINAHL were searched to June 2023. Reviewers independently screened, appraised methodological quality and extracted data. Measurement properties were synthesised and rated (green, amber, red or white). Results were summarised in a Summary of Measurement Properties (SOMP) table and discussed at the OMERACT 2025 workshop. RESULTS: The OSS was rated amber for feasibility and domain match, reflecting concerns about its multidimensional nature while acknowledging interrelatedness of pain and function. Twenty-three studies were included in the systematic review: eleven examined construct validity, three test-retest reliability, ten responsiveness, five clinical trial discrimination and five thresholds of meaning. Thirty of 34 components were judged suitable to proceed (eight green; 22 amber). All studies assessed the OSS total score (pain and function); one assessed a 4-item pain subscale. For the total OSS score, construct validity and responsiveness were green and reliability, trial discrimination and thresholds of meaning were amber. Two studies reported no floor/ceiling effects, one was equivocal. At OMERACT 2025, 95% of respondents agreed multidimensional instruments should not be used to measure single domains without validated subscales. CONCLUSION: The OSS total score shows adequate construct validity and responsiveness, but its combined assessment of pain and function makes it unsuitable for measuring pain alone.
Tophus measurement as an outcome measure in gout: an updated systematic literature review.
Murdoch R, Pearcy Q, Schauer C … +1 more , Dalbeth N
Semin Arthritis Rheum · 2026 May · PMID 42190485 · Publisher ↗
OBJECTIVE: To conduct an updated review of methods of tophus measurement in gout and evaluate each method according to the Outcome Measures in Rheumatology (OMERACT) Filter 2.2. METHODS: A systematic search for methods o...
OBJECTIVE: To conduct an updated review of methods of tophus measurement in gout and evaluate each method according to the Outcome Measures in Rheumatology (OMERACT) Filter 2.2. METHODS: A systematic search for methods of tophus assessment from 2010 to 2024 was conducted. Publications before 2010 were identified from a previous review published in 2011. Instruments were assessed according to the OMERACT 2.2, a framework for evaluating three key pillars of measurement instruments: their feasibility, truth, and discrimination. RESULTS: Ten methods were identified: counting the number of tophi, tape measurement, Vernier callipers, digital photography, ultrasound (US), computed tomography (CT), dual-energy computed tomography (DECT), magnetic resonance imaging (MRI), plain radiography and the Tophus Impact Questionnaire (TIQ-20), a patient-reported outcome measure. Vernier callipers correlated well with other physical measurement techniques, had good to excellent reliability, and demonstrated responsiveness to treatment and discrimination. US and DECT had excellent reliability and showed responsiveness to treatment but have not yet demonstrated a difference in tophus size in a randomized controlled trial (RCT) and have higher cost and training requirements. The TIQ-20 had high feasibility and demonstrated responsiveness, but further research is required regarding its discrimination. CONCLUSION: There is evidence to support the feasibility, truth and discrimination of Vernier callipers. US, DECT and the TIQ-20 fulfil many aspects of the Filter but have not yet demonstrated a difference between arms of a RCT. Overall, Vernier callipers have evidence for each pillar of the Filter and are a strong candidate for endorsement as an instrument of tophus measurement.
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