Translating Treatment Effects Between Rheumatoid Arthritis Activity Measures and American College of Rheumatology Responses in Direct Comparison Trials.

ABSTRACT:

Objective

Direct comparison trials in rheumatoid arthritis (RA) increasingly use changes in continuous disease activity measures as endpoints. However, the between-arm differences in these scores that are clinically meaningful are uncertain. To aid interpretation of clinical trials that use the Disease Activity Score in 28 joints (DAS28) or Simplified Disease Activity Index (SDAI) as endpoints, we developed statistical equivalences between changes in these measures and American College of Rheumatology (ACR) responses.

Methods

For superiority trials, we computed the minimal detectable difference in DAS28 changes and SDAI changes that correspond to the ACR criteria for 20% improvement (ACR20) and 50% improvement (ACR50) responses at the same type I and type II errors and same

SUBMITTER: Dasgupta A 

PROVIDER: S-EPMC6620166 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature