Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis
Pooled result · ACR20 responseResult — go to the resultRelative risk 1.01 95% CrI 0.98–1.04Authors' conclusion
In this systematic review and meta-analysis, biosimilars of adalimumab, infliximab, and etanercept were associated with clinically equivalent treatment effects compared with their reference biologics for the treatment of RA.
Study context
- Population
- Patients with moderate to severe rheumatoid arthritis (RA) in head-to-head randomized clinical trials (RCTs); databases searched from inception to September 2021
- Participants
- 10,642 patients25 head-to-head trials
- Comparison
- Biosimilars of adalimumab, etanercept and infliximab vs their reference biologics
- Outcome
- Equivalence for ACR20 (margin RR, 0.94 to 1.06) and HAQ-DI (margin SMD, −0.22 to 0.22)
Methodological detailshead-to-head RCTs, bayesian random effects, trial sequential analysis, prespecified equivalence margins, PRISMA
- Head-to-head RCTs
- Bayesian random effects
- Trial sequential analysis
- Prespecified equivalence margins
- PRISMA
Pooled result
ACR20 response
Relative risk
1.01
95% CrI 0.98–1.04
Biosimilarsvs Reference biologics
RR 1.01 (95% CrI 0.98–1.04)
As reported in the abstract
Further pooled results
| Outcome | SMD (95% CrI) | |
|---|---|---|
| Change of HAQ-DI scores (co-primary equivalence outcome)14 RCTs with 5579 patients; τ2 = 0.002 · CrI | −0.04 (−0.11 to 0.02) | |
| −0.15−0.1−0.0500.05Difference (linear scale) |
- Change of Health Assessment Questionnaire-Disability Index (HAQ-DI) scores (co-primary equivalence outcome): equivalence met (prespecified margin SMD, −0.22 to 0.22)
- Change of HAQ-DI scores (co-primary equivalence outcome): Trial sequential analysis: evidence for equivalence since 2016
Safety
Safety and immunogenicity (14 secondary items)
- Biosimilars associated with similar safety and immunogenicity profiles vs reference biologics
Original publication
Therapeutic Equivalence of Biosimilar and Reference Biologic Drugs in Rheumatoid Arthritis: A Systematic Review and Meta-analysis. JAMA Netw Open. Published 1 May 2023. doi:10.
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