Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis
Authors' conclusion
Placebo controlled trials lead to smaller effect sizes of active compounds in RCTs compared with the same compound in head-to-head trials.
Study context
- Population
- Randomised controlled trials (RCTs) in rheumatoid arthritis (RA) investigating DMARD therapies (Medline, EMBASE, CENTRAL until December 2021)40 studies
- Comparison
- Same compounds' responses in active comparator trials vs in placebo-controlled trials
- Outcome
- OR for achieving ACR20/50/70 response
- Follow-up
- Weeks 12 and 24
Methodological detailsmatched active treatment arms, mixed-model logistic regression, Cochrane risk of bias tool, 8328 studies screened; 590 manuscripts reviewed in detail
- Matched active treatment arms
- Mixed-model logistic regression
- Cochrane risk of bias tool
- 8328 studies screened; 590 manuscripts reviewed in detail
Pooled result
As reported in the abstract
ACR20/50/70 response · week 12
Each group vs placebo controlled trialsEstimate (95% CI)P value
Active comparator trials
OR (ACR20) 1.67(1.46–1.91)
P < 0.001Active comparator trials
OR (ACR50) 1.50(1.29–1.75)
P < 0.001Active comparator trials
OR (ACR70) 1.65(1.30–2.10)
P < 0.001Further pooled results
| Outcome | Estimate | P value | |
|---|---|---|---|
| ACR20/50/70 response · week 24Active comparator trialsvs Placebo controlled trials | OR (ACR20) 1.93 (95% CI 1.50–2.48) | P < 0.001 | |
| ACR20/50/70 response · week 24Active comparator trialsvs Placebo controlled trials | OR (ACR50) 1.75 (95% CI 1.32–2.33) | P < 0.001 | |
| ACR20/50/70 response · week 24Active comparator trialsvs Placebo controlled trials | OR (ACR70) 1.68 (95% CI 1.21–2.34) | P < 0.001 | |
| 0.512Ratio (log scale) |
Sensitivity analyses
- Sensitivity analyses showed consistent results
Original publication
Influence of active versus placebo control on treatment responses in randomised controlled trials in rheumatoid arthritis. Ann Rheum Dis. Published 10 January 2023. doi:10.
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