Part B of the LILAC study of litifilimab for cutaneous lupus erythematosus: a plain language summary
Year: 2025
Type: article
Abstract: Plain Language SummaryWhat is this summary about?LILAC was a Phase 2 study performed in two separate parts which ran in parallel, designed to see how litifilimab worked against two distinct types of lupus. In Part A, litifilimab was used by participants diagnosed with systemic lupus erythematosus (SLE). In Part B, litifilimab was administered to participants with moderate-to-severe cutaneous lupus erythematosus (CLE) with or without SLE. This is a summary of the main results from Part B. These results were published in the New England Journal of Medicine in 2022.The study tested the effect of three different litifilimab doses compared with placebo, a non-active control treatment that looks the same and is taken in the same way as the study treatment. The safety of the treatment was also monitored during the study.What were the results?The 132 participants, most with moderate-to-severe CLE disease (with or without SLE), were divided randomly into four treatment groups to receive, for 12 weeks, litifilimab 50 milligrams (mg), litifilimab 150 mg, litifilimab 450 mg, or placebo every four weeks, with an additional dose at Week 2. The primary measure was assessed at Week 16 of the study.The results of LILAC showed that, for the primary study measure,litifilimab at all three doses was better than placebo at reducing CLE skin disease. This reduction was measured using Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI–A) scores, a measurement of skin disease in CLE. Most participants experienced side effects (undesirable secondary effects, e.g., headaches, joint pain, and itchiness), which were mainly of mild or moderate severity.What do the results of the study mean?Overall, Part B of the LILAC study showed that litifilimab could be a promising treatment option for patients with CLE, with or without SLE. Larger litifilimab studies, including more patients with CLE, are ongoing.This is an abstract of the Plain Language Summary of Publication article.View the full Plain Language Summary PDF of this article to read the full-text
Source: Immunotherapy
Authors: Victoria P Werth, Richard A Furie, Juanita Romero-Diaz, Sandra Navarra, Kenneth Kalunian, Ronald F van Vollenhoven, Filippa Nyberg, Benjamin H Kaffenberger, Saira Z Sheikh, Goran Radunovic, Xiaobi Huang, Hua Carroll, Himanshu Naik, Francois Gaudreault, Adam Meyers, Cristina Musselli, Nathalie Franchimont, Catherine Barbey
Institutions: Philadelphia VA Medical Center, University of Pennsylvania, Northwell Health, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, University of Santo Tomas, University of California San Diego, Amsterdam University Medical Centers, Karolinska University Hospital, The Ohio State University, University of North Carolina at Chapel Hill, University of Belgrade, Biogen (United States)
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Funder: Biogen
OpenAlex ID: W4407929643