Comparison of treatment effects between ACR response criteria and target-based outcomes for contemporary rheumatoid arthritis drug approval trials: A meta-epidemiological study.
Wengliang Dong, Gengchen Wang, Xiaowen Hu et al.
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In 30 seconds
This meta-epidemiological study analyzed 53 randomized placebo-controlled trials involving 30,778 rheumatoid arthritis patients to compare treatment effects between ACR response criteria and target-based outcomes. The findings revealed that ACR20 significantly overestimates treatment effects compared to target-based outcomes, with a risk of odds ratio (ROR) of 0.65 for remission outcomes and 0.78 for low disease activity (LDA) outcomes.
Key findings
- ACR20 showed significantly greater treatment effects than remission outcomes (ROR = 0.65, 95% CI 0.52-0.81).
- ACR20 also overestimated effects compared to LDA outcomes (ROR = 0.78, 95% CI 0.69-0.89).
- Higher ACR thresholds (ACR50 and ACR70) demonstrated better alignment with target-based outcomes.
- Discordance between ACR20 and target-based outcomes was consistent across various drugs and treatment histories.
Why it matters
Understanding the discrepancies between ACR response criteria and target-based outcomes is crucial for clinicians involved in rheumatoid arthritis treatment, as it impacts the interpretation of trial results and regulatory approvals, ultimately influencing patient care and treatment decisions.