Safety considerations and data sources are crucial to consider when designing studies for rheumatology treatments, according to presenters at the 2022 ACR-FDA Summit.
For best safety and efficacy outcomes, trials in psoriatic arthritis should use active comparators and stricter remission criteria, with outcome measures that are important to patients.
Clinical trials in rheumatoid arthritis (RA) should use the new ACR/EULAR remission definition rather than the Disease Activity Score-28-CRP, which does not sufficiently reflect patient outcomes, according to an ACR/EULAR committee.