Influence of study characteristics on harm estimates from randomised controlled trials in patients with inflammatory arthritis receiving biological or synthetic antirheumatic drugs: a meta-epidemiological study
Authors' conclusion
Most study characteristics do not affect the reported harm measures. However, a trend was observed where trials selecting patients with higher baseline disease activity found a higher risk ratio of WDdtAEs and SAEs, but also a lower risk of WDs, compared with trials not selecting patients with a high disease activity.
Study context
- Population
- Randomised controlled trials (RCTs) of patients with inflammatory arthritis (IA) receiving b/tsDMARD vs any comparator arm, from Cochrane reviews and systematic reviews published since April 2015 (MEDLINE)284 trials (245 reviews)
- Participants
- 97,607 participants
- Comparison
- Trial characteristics (48 trial/patient characteristics) related to the relative risk ratio (RRR) of harms in RCTs of b/tsDMARDs vs any comparator
- Outcome
- Withdrawals due to adverse events (WDdtAEs), RRR
Methodological detailsmeta-regression
- Meta-regression
Main finding
As reported in the abstract
RRR (95% CI)
Active comparator trialslower relative risk of WDdtAEs
0.74(0.58–0.94)
Raised inflammatory markers requiredhigher relative risk of WDdtAEs
1.25(1.01–1.55)
Further findings
Total withdrawals (WDs)
- Eligibility criteria for minimum tender/swollen joint count and maximum disease duration decreased the risk of WDs
Serious adverse events (SAEs)
- Previous b/tsDMARDs use at enrolment increased the risk of SAEs
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Influence of study characteristics on harm estimates from randomised controlled trials in patients with inflammatory arthritis receiving biological or synthetic antirheumatic drugs: a meta-epidemiological study. Ann Rheum Dis. Published 8 November 2024. doi:10.
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