Determination of the most appropriate American College of Rheumatology (ACR) response definition for contemporary drug approval trials in rheumatoid arthritis
Authors' conclusion
ACR20 remains the most powerful discriminator between active treatment and placebo, especially when early discrimination is of primary interest.
Study context
- Population
- Randomised controlled rheumatoid arthritis (RA) drug approval trials of biological and targeted synthetic disease-modifying antirheumatic drugs (DMARDs) reporting ACR response rates at multiple time points over a 24-week placebo-controlled period45 trials included
- Comparison
- Discriminant validity of ACR20, ACR50 and ACR70 at multiple time points
- Outcome
- Discriminant validity of ACR20, 50 and 70 responses at multiple time points
Methodological detailsmixed-effect logistic regression, placebo-controlled period of 24 weeks, 12 680 records screened
- Mixed-effect logistic regression
- Placebo-controlled period of 24 weeks
- 12 680 records screened
Pooled result
As reported in the abstract
- ACR20: discriminative capacity high across all time points
- ACR50 and ACR70: highest discrimination towards the end of the placebo-controlled periods
- Observed in all patient populations and compound groups
Further pooled results
Speed of response by patient population
- Faster response in DMARD-naïve populations vs DMARD insufficient responders
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Determination of the most appropriate ACR response definition for contemporary drug approval trials in rheumatoid arthritis. Ann Rheum Dis. Published 2 January 2024. doi:10.
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