NEJM Publishes Positive Phase 2 Results for Biogen’s Litifilimab Lupus Treatment


Part A results from the 2-part LILAC study show that the therapy significantly reduced disease activity based on active joint count in individuals compared with the placebo.

Biogen Inc published a second manuscript in The New England Journal of Medicine, detailing positive results from the 2-part phase 2 LILAC (NCT01901146) study, which evaluated litifilimab (BIIB059) as treatment for cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE).

The findings from the SLE part of the study showed that litifilimab met the study’s primary endpoint by significantly reducing total active joint count compared with the placebo.

“Litifilimab has been shown to inhibit the production of type 1 interferons, as well as other inflammatory mediators produced by plasmacytoid dendritic cells. Strong evidence has accumulated that these mediators contribute to disease activity in lupus,” Richard Furie, MD, The Marilyn and Barry Rubenstein Chair in Rheumatology and chief of the division of rheumatology at Northwell Health, said in a statement.

The SLE part of the LILAC study evaluated individuals who had SLE with active joint and skin manifestations, while the CLE part evaluated individuals with moderate to severe active CLE with active subacute and chronic subtypes, with or without systemic manifestations.

Both parts of the study met their respective primary endpoints. Litifilimab demonstrated superior efficacy in reducing total active joint count in SLE and improving skin disease activity in CLE.

In the SLE part of that study, litifilimab significantly reduced the total number of swollen and tender joints in individuals from the baseline compared with the placebo over 24 weeks, and there were no secondary endpoints.

Furthermore, litifilimab was generally well tolerated, with most adverse events being mild or moderate in severity, including diarrhea, falls, headaches, nasopharyngitis, and urinary-tract infection.

“This second NEJM manuscript shows the totality of data from the phase 2 LILAC program, reinforcing our belief in the potential of litifilimab as a first-in-class therapy for both systemic and cutaneous lupus,” Nathalie Franchimont, MD, PhD, head of the multiple sclerosis and immunology development unit at Biogen, said in the statement.

“Our goal is to discover and develop new treatment options that not only reduce lupus disease activity but also decrease clinical manifestations that impact patients the most,” she said. “We look forward to continuing our evaluation of litifilimab in phase 3 studies and sharing additional data when available.”

Biogen is enrolling individuals in the phase 3 TOPAZ-1 (NCT03875235) and TOPAZ-2 (NCT04961567) studies, which will evaluate the efficacy and safety of litifilimab in individuals with active SLE at 269 clinical trial sites across the world.

The company plans to achieve appropriate representation of the Black and Hispanic communities.

Positive data from the CLE portion were published on July 28, 2022. Biogen also plans to initiate a pivotal study of litifilimab in CLE in 2022.

Litifilimab is a humanized igG1 monoclonal antibody, targeting blood dendritic cell antigen 2. When litifilimab binds to the receptor, it has been shown to reduce production of pro-inflammatory molecules by plasmacytoid dendritic cells, including type-1 interferon and other cytokines and chemokines.


The New England Journal of Medicine publishes second manuscript reporting positive phase 2 results for Biogen’s litifilimab in lupus. News release. Biogen Inc. September 7, 2022. Accessed September 9, 2022.

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