Lupus Accelerating Breakthroughs Consortium Announces Milestone in Advancing Drug Development for Cutaneous Lupus Clinical Trials

Consensus on CLASI as Outcome Measure for the evaluation of efficacy in Cutaneous Lupus Clinical Trials Published in Nature Reviews Rheumatology  

A major step in lupus drug development has been reached with an alignment around how to measure treatment response in cutaneous lupus erythematosus (CLE). A chronic autoimmune skin disease, CLE greatly impacts quality of life yet has no approved medications and no endorsed outcome measure for assessing treatment response in clinical trials. The lack of an approved instrument has posed a significant challenge for CLE drug development. 

Nature Reviews Rheumatology published important results of a collaborative effort by Lupus ABC, a public-private partnership that brings together the U.S. Food and Drug Administration (FDA), people with lupus, advocacy groups, experts from industry, academia, and professional societies, with the mission to overcome barriers in lupus drug development through collaboration.  

Recognizing the urgent need for a validated outcome tool for CLE clinical trials, Lupus ABC convened an exploratory meeting in late 2023 to identify the instrument with the highest potential to be refined and accepted as a primary outcome measure for CLE. Although Cutaneous Lupus Disease Area and Severity Index (CLASI) is widely viewed as a validated, reliable measurement tool for evaluating skin disease activity and damage, it has not been endorsed in the USA for use in CLE clinical trials. 

Given the extensive data supporting CLASI, Lupus ABC launched a Working Group on CLASI to evaluate the evidence for its suitability as a primary outcome measure for this indication. The Working Group systematically addressed previously identified challenges with CLASI through the review and discussion of published and unpublished patient data. After rigorous deliberations, the working group reached consensus that CLASI is an appropriate instrument for assessing CLE disease activity in clinical trials. This consensus marks a turning point in drug development for CLE – one that can accelerate the development of much-needed therapies. 

“The impact of this consensus for CLE drug development could remove a major barrier in the process and provide a clear path for the approval of urgently needed therapies for CLE, furthering the mission of Lupus ABC to accelerate lupus drug development in a collaborative, pre-competitive setting,” said Janet Woodcock, MD, former Acting Commissioner of the FDA and Lupus ABC member.