The efficacy and safety of Janus kinase inhibitors in adults with rheumatoid arthritis: a systematic review and cumulative meta-analysis
Authors' conclusion
JAK inhibitors are more effective than placebo and active treatment in improving symptoms of RA including DAS, ACR response, and HAQ-DI.
Study context
- Population
- Randomised controlled trials (RCTs) of adults with rheumatoid arthritis (RA) treated with a JAKi, placebo or active treatment (csDMARDs or bDMARDs); Medline, Embase, Cochrane Library to June 11, 202446 reports (of 31 unique trials)
- Comparison
- JAKi vs placebo or active treatment
- Outcome
- Co-primary: DAS28-ESR and DAS28-CRP
Methodological detailsrandom-effects model, heterogeneity assessed (I² statistic), Risk of bias considered 'low' across the trials
- Random-effects model
- Heterogeneity assessed (I² statistic)
- Risk of bias considered 'low' across the trials
Pooled result
As reported in the abstract
MD (95 % CI)
JAKivs PlaceboDAS28-CRP
−1.06(−1.17 to −0.95)
MD
- Between JAKi and Placebo · Disease Activity Score Erythrocyte Sedimentation Rate (DAS28-ESR)
- 1.03 (95 % CI −1.21 to −0.85)
- Between JAKi and csDMARDs · DAS28 C-reactive protein (DAS28-CRP)
- 0.79 (95 % CI −1.05 to −0.53)
- Between JAKi and csDMARDs · DAS28-ESR
- 0.54 (95 % CI −0.73 to −0.36)
- Between JAKi and bDMARDs · DAS28-CRP
- 0.35 (95 % CI −0.48 to −0.23)
- Between JAKi and bDMARDs · DAS28-ESR
- 0.33 (95 % CI −0.65 to −0.01)
Further pooled results
Health Assessment Questionnaire-Disability Index (HAQ-DI) and American College of Rheumatology (ACR) response
- Similar efficacy improvements with JAKi vs placebo or active treatment
Safety
- Statistically significant increased risk with JAKi of adverse events (AEs), treatment-related AEs (TRAEs) and serious infections (vs placebo), serious infections (vs csDMARDs) and serious adverse events (SAEs) and major adverse cardiac events (MACE) (vs bDMARDs)
Original publication
The efficacy and safety of Janus kinase inhibitors in adults with rheumatoid arthritis: a systematic review and cumulative meta-analysis. Semin Arthritis Rheum. Published 22 November 2025. doi:10.
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