Treatment with an investigational antibody therapy known as BIIB059 was well-tolerated and decreased disease activity in people with cutaneous lupus erythematosus (CLE) — lupus affecting the skin — with or without systemic lupus erythematosus (SLE), which affects other organs and systems, top-line results of a Phase 2 study show.
BIIB059, developed by Biogen, is a monoclonal antibody that binds to BDCA2, a receptor specific to plasmacytoid dendritic cells. These immune cells produce large amounts of type I interferon (IFN-I), an inflammatory molecule that plays a central role in SLE disease processes. Importantly, these cells can travel throughout the body, promoting inflammation and lesions.
CLE refers to manifestations specifically in the skin. It can be divided into several subtypes, such as acute, subacute, and chronic, based on the severity of the disease and where inflammation occurs.
Data from a Phase 1 SLE trial showed that BIIB059 was well-tolerated and effectively reduced IFN-I levels, inflammation, and skin lesions in people with systemic lupus.
LILAC (NCT02847598) was a Phase 2 study that included 264 adults, ages 18-75, split into groups of 132 participants for each of its two parts. Part A was designed to evaluate whether BIIB059 reduces disease activity in SLE patients with active skin manifestations and joint involvement. In turn, Part B assessed the therapy’s benefits in 132 people with active CLE — subacute or chronic — with or without systemic manifestations.
The study’s secondary goals were to evaluate the efficacy of BIIB059 using other parameters of disease activity, as well as to assess the antibody’s safety, tolerability, and pharmacokinetics. Pharmacokinetics examines how a compound is absorbed, distributed, metabolized, and excreted by the body.
In this double-blind trial, participants were randomly assigned to receive either BIIB059 — in doses of 50, 150, or 450 mg — or a placebo subcutaneously, or under the skin, for 12 to 20 weeks. Treatment was given at the study’s start, and at every 4 weeks until week 20, with an additional dose at week 2.
The results at 16 weeks of treatment showed that BIIB059 significantly reduced skin disease activity in people with CLE, as measured by the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score.
Specifically, the three doses of the therapy led to a 40.9-48% reduction in the CLASI-A score. In contrast, the participants on placebo showed only 14.5% less disease activity.
For people with CLE and SLE, BIIB059 450 mg reduced the number of joints with active disease at week 24, in comparison with placebo. Less skin disease and overall disease activity were consistently observed across multiple secondary measures, the team said.
Treatment with BIIB059 was safe and well-tolerated.
“We are excited by the LILAC study results, and the potential for BIIB059 to be a meaningful new treatment option for patients living with lupus,” Nathalie Franchimont, MD, PhD, vice president of the lupus and multiple sclerosis potfolio at Biogen, said in a press release.
“We also believe these results support Biogen’s goal of continuing to build a multi-franchise portfolio by bringing potential new treatment options to people with great unmet medical need,” Franchimont added.
LILAC study’s results will be made available at an upcoming scientific forum, according to the company.