Sex‐Related Differences in Efficacy and Safety Outcomes in Axial Spondyloarthritis Randomized Clinical Trials: A Systematic Literature Review and Meta‐Analysis
Bibliographic record
Abstract
OBJECTIVE: We 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). METHODS: We 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. RESULTS: We 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. CONCLUSION: Female 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.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.030 | 0.078 |
| Meta-epidemiology (narrow) | 0.003 | 0.001 |
| Meta-epidemiology (broad) | 0.021 | 0.034 |
| Bibliometrics | 0.005 | 0.007 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.004 | 0.002 |
| Open science | 0.002 | 0.002 |
| Research integrity | 0.003 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".