Clinical trial outcomes for SLE: what we have and what we need.

ABSTRACT: The paradigm of drug approval in SLE currently relies on successful large phase III randomised controlled trials and a set of primary, secondary and additional end points. Taken together, these outcomes offer a nuanced understanding of the efficacy and safety of the investigational agent. In this review, we thoroughly examine the main outcomes used in SLE trials and highlight unmet requirements as well as potential venues for future trial design in SLE. Disease activity indices can be broadly categorised into global-specific and organ-specific indices, in particular for skin, joints and kidneys, but there is no universal consensus about their use in clinical trials. Because each of these instruments has its own intrinsic strengths and weaknesses, the assessment of treatment response has pr

SUBMITTER: Arnaud L 

PROVIDER: S-EPMC10875561 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature