Detectable safety gestalt of rheumatoid arthritis treatments from pivotal clinical drug trials
Authors' conclusion
Standardized safety reporting and profiling of bDMARDs and tsDMARDs from pivotal clinical drug trials provides an overview of safety outcomes of commonly used RA therapies, supports safety-oriented treatment selection in individual patients, and provides essential context for safety evaluation of novel therapies during periods before long-term safety data become available.
Study context
- Population
- RCTs of rheumatoid arthritis (RA) drug approval for bDMARDs and tsDMARDs64 RCTs
- Comparison
- Licensed bDMARDs and tsDMARDs vs placebo: safety profiles by compound and drug class
- TNF-α inhibitorsn = 25
- IL-6 receptor inhibitorsn = 10
- Rituximabn = 5
- Abataceptn = 7
- Janus kinase inhibitorsn = 18
- Outcome
- Total AEs and SAEs; organ classes and AESIs
Methodological detailsrandom-effects meta-analyses, Medical Dictionary for Regulatory Activities (MedDRA) hierarchy, placebo-controlled drug approval trials, Searched EMBASE, Medline and the Cochrane Library, Serious AEs (SAEs) and AEs of special interest (AESIs) studied descriptively
- Random-effects meta-analyses
- MedDRA hierarchy
- Placebo-controlled drug approval trials
- Searched EMBASE, Medline and the Cochrane Library
- SAEs and AESIs studied descriptively
Pooled result
As reported in the abstract
- Comparable overall safety and tolerability (total adverse events (AEs) and SAEs)
- Differences between compounds and drug classes in distinct organ classes and AESIs
Original publication
Detectable safety gestalt of rheumatoid arthritis treatments from pivotal clinical drug trials. Rheumatology (Oxford). Published 26 June 2026. doi:10.
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