SynthesisArthritis care & research2025
Sex-Related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta-Analysis.
Synthesis in Arthritis care & research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed.
- Sex differences in axial spondyloarthritis: biological mechanisms, clinical phenotypes, and therapeutic implications - a narrative review.Medicine and pharmacy reports · 2026Review
- Sex Differences in Medication Discontinuation in Axial Spondyloarthritis.Arthritis care & research · 2026Article
- Observational
- Fatigue in Middle-Aged and Older Adults with Axial Spondyloarthritis: A Sex-Stratified Case-Control Study.Journal of clinical medicine · 2026Article
- Real-world clinical experience with upadacitinib in a cohort of Italian patients with axial spondyloarthritis.Frontiers in pharmacology · 2026Article
- Sex- and gender-based personalized medicine in rheumatology.Nature reviews. Rheumatology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
objectiveWe aimed to assess differences in baseline characteristics, efficacy, and safety of advanced therapies between male and female patients with axial spondyloarthritis (axSpA) in randomized controlled trials (RCTs).
methodsWe conducted a systematic literature search for RCTs assessing the efficacy of advanced therapies in patients with axSpA until March 19, 2023. We extracted the following outcomes by sex: baseline participant characteristics, Assessment in Spondylarthritis International Society (ASAS) 20/40 criteria, and Axial Spondyloarthritis Disease Activity Score low disease activity or inactive disease (ASDAS-LDA/ID). Random-effects models were used to calculate pooled effects for responses in men versus women for different medication classes.
resultsWe included 79 RCTs (n = 23,748 patients, 69.7% male). Only 9 trials (11.4%), 22 trials (28%), and 9 trials (11.4%) reported baseline characteristics, efficacy end points, and safety end points by sex, respectively. At baseline, women were significantly older and had higher pain scores, whereas men had higher C-reactive protein levels. Overall, male patients were more likely to achieve an ASAS40 response compared to female patients for all advanced therapies (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.44-2.46) and for interleukin-17A (IL-17A) inhibitors (IL-17Ai) (OR 1.82) and tumor necrosis factor inhibitor (TNFi) (OR 2.42), and male patients had numerically higher values for IL-17A/Fi. Male patients were also more likely to achieve an ASDAS-LDA/ID (OR 2.19, 95% CI 1.47-3.26) across all advanced therapies and for IL-17Ai (OR 2.08) and TNFi (OR 2.42) individually.
conclusionFemale patients with axSpA are less likely to achieve efficacy outcomes on advanced therapies compared to their male counterparts, with similar differences across medication classes. Future studies should study the biologic (sex-related) and sociocultural (gender-related) mechanisms underlying these differences.
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