Part A of the LILAC study of litifilimab for systemic lupus erythematosus: a plain language summary
- PMID: 39995062
- PMCID: PMC11951715
- DOI: 10.1080/1750743X.2025.2459054
Part A of the LILAC study of litifilimab for systemic lupus erythematosus: a plain language summary
Plain language summary
What is this summary about?The LILAC study was performed in two separate parts, to see how litifilimab, an antibody, worked for two distinct forms of lupus. In Part A, summarized in this manuscript, litifilimab was evaluated in participants diagnosed with systemic lupus erythematosus (SLE) with active joint and skin disease. 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 A, which were published in the New England Journal of Medicine in 2022. Part A of the LILAC study analyzed the treatment effects of litifilimab compared with placebo, a nonactive control treatment that looks like and is taken the same way as the study drug. Side effects (undesirable secondary effects) were monitored to evaluate the safety of the treatment.What were the results?A total of 120 participants received litifilimab or placebo. The primary measure (main objective) was assessed at Week 24 of the study. A 28-joint clinical assessment (28 specified joints) was used to measure the specific treatment effects on the joints, and the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity (CLASI–A) scale was used to assess its effects on the skin. The SLE Responder Index (SRI)–4 combined score was used to measure SLE disease activity across the entire body.The results demonstrated that, on average, participants who received litifilimab had a lower total number of swollen and tender joints after 24 weeks than those who received placebo. Also, compared with participants who received placebo, more participants who received litifilimab had a reduction of at least 7 points in their CLASI-A score, meaning their skin disease reduced, and had reductions in SRI-4 responses, meaning their SLE disease activity was reduced across multiple organ systems. The side effects observed (e.g., diarrhea, the common cold, urinary tract infections, falls and headaches) were mostly mild or moderate in severity, without any major differences between the groups.What do the results of the study mean?SLE has no cure and, although there are medications used to manage symptoms, new treatments are needed. The results summarized here show that litifilimab may be a treatment option for patients with SLE that affects their joints and skin. Larger studies are continuing to evaluate litifilimab in patients with SLE.[Box: see text].
Conflict of interest statement
Richard Furie is an investigator and consultant for AstraZeneca, Biogen, Bristol Myers Squibb, Genentech, and GlaxoSmithKline. He has received speaker honoraria from AstraZeneca and GlaxoSmithKline, and has participated in Data Safety Monitoring Board and Advisory Board meetings by AstraZeneca, Biogen, Bristol Myers Squibb, Genentech, GlaxoSmithKline, and Remegen. Ronald van Vollenhoven has received consulting fees from AbbVie, AstraZeneca, Biogen, Biotest Pharmaceuticals Corporation, Bristol Myers Squibb, Galapagos, Gilead Sciences, GlaxoSmithKline, Instituto Científico Pfizer, Janssen, Miltenyi Biotec, Sanofi, Servier, UCB, and Viela Bio, and has received research grants from Roche. He has also received educational grants to his institution from Merck. Kenneth Kalunian has received consulting fees from Biogen. Sandra Navarra has received advisory board/consulting fees from AstraZeneca, Biogen, Boehringer Ingelheim, and Idorsia, and speaker honoraria from AstraZeneca, GlaxoSmithKline, and Pfizer. She has received educational grants to her institution from Astellas Pharma, Boehringer Ingelheim, and Johnson & Johnson Health Care Systems Inc. Juanita Romero-Diaz has received consulting fees from Biogen and travel support from Boehringer Ingelheim. Victoria Werth has received consulting fees from AbbVie, Akari Therapeutics, Amgen, AnaptysBio, argenx, AstraZeneca, Bayer, Beacon Bioscience, Biogen, Bristol Myers Squibb, Cabaletta Bio, Calyx, Chrysalis, Corcept Therapeutics, CSL Behring, Cugene, Eli Lilly and Company, EMD Serono, Galderma, Gilead Sciences, GlaxoSmithKline, Horizon Therapeutics, Incyte, Janssen, Kezar Life Sciences, Kyowa Kirin, Merck, Nektar, Novartis, Nuvig Therapeutics, Octapharma, Pfizer, Regeneron, Rome Therapeutics, Sanofi, Takeda Pharmaceuticals, UCB, Viela Bio, and Xencor. She has received research grants from Amgen, argenx, AstraZeneca, Biogen, Bristol Myers Squibb, Celgene, Corbus Pharmaceuticals, CSL Behring, Genentech, Gilead Sciences, Horizon Therapeutics, Janssen, Lupus Research Alliance/Bristol Myers Squibb, Pfizer, Priovant Therapeutics, Q32 Bio, Regeneron, Rome Therapeutics, Syntimmune, Ventus Therapeutics, and Viela Bio. The University of Pennsylvania owns the copyright for CLASI. Xiaobi Huang and Cristina Musselli are former employees of Biogen and may hold Biogen stock. Hua Carroll, Adam Meyers, and Catherine Barbey are employees of Biogen and may hold Biogen stock. Nathalie Franchimont is a former employee of Biogen and may hold Biogen stock. She is a current employee and Chief Medical Officer of Nimbus*, and an equity holder of Nimbus Therapeutics. She serves on the Board of Directors and owns stocks and shares in OMass Therapeutics. She has received consulting fees from Atara Biotherapeutics and Bain Capital and is a consultant for Rome Therapeutics. She is a past member of the Lupus Industry Council. *Nimbus refers to the group of entities including Nimbus Therapeutics LLC, Nimbus Discovery, Inc., and Nimbus subsidiaries. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Writing and editorial support for the preparation of this publication was provided by Sara Henriques, PhD, and Megan Thomas, MSc, of Selene Medical Communications (Alderley Park, Cheshire, UK), and was funded by Biogen.
Patient reviewers on this PLSP have received honorarium from Immunotherapy for their review work but have no other relevant financial relationships to disclose.
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