Litifilimab superior to placebo in patients with cutaneous lupus erythematosus
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Litifilimab is superior to placebo in improving CLASI-A scores among patients with cutaneous lupus erythematosus over 16 weeks, according to data published in the New England Journal of Medicine.
“This phase 2 study — LILAC — was designed to evaluate the safety and efficacy of litifilimab in reducing disease activity in participants with systemic lupus erythematosus with active cutaneous manifestations and joint involvement — in part A — and in participants with active cutaneous lupus erythematosus (CLE), specifically subacute CLE and/or chronic CLE, including discoid lupus erythematosus, with or without systemic manifestations in part B,” Nathalie Franchimont, MD, PhD, senior vice president of the multiple sclerosis and immunology development unit at Biogen, told Healio.
“Based on the results from LILAC, Biogen is advancing litifilimab into late-stage development to further evaluate its potential,” Franchimont added.
To investigate the impact of litifilimab (BIIB059, Biogen) in patients with cutaneous lupus erythematosus (CLE), the authors enrolled patients with CLE who were aged 18 to 75 years at the time of enrollment. In order to be eligible, the diagnosis has to be histologically confirmed through a biopsy. Additionally, disease needed to be active, with patients scoring at least an eight on the Cutaneous Lupus Erythematosus Disease Area and Severity Index–Activity scale (CLASI-A), but SLE was not a requirement for enrollment.
The authors randomized enrolled patients 1:1:1:1 to receive a 50 mg, 150 mg or 450 mg litifilimab dose, or a placebo, at 0, 2, 4, 8 and 12 weeks. Changes made to the study protocol resulted in more patients being randomized to the 450 mg and placebo groups, the authors wrote.
The primary endpoint of the phase 2 study was the change from baseline to week 16 in the CLASI-A score in the groups receiving 50 mg, 150 mg and 240 mg doses, compared with the placebo group. Secondary endpoints included a decrease of at least 50% from baseline in the CLASI-A score at weeks 12 and 16, as well as the percent change from baseline at week 12. Additionally, adverse events, serious adverse events, changes in laboratory variables, vital signs and electrocardiograms were monitored by investigators.
In total, the trial enrolled 132 participants, among whom 26 were randomized to the 50 mg group, 25 to the 150 mg group, 48 to the 450 mg group and 33 to the placebo group. The difference from placebo in CLASI-A scores at week 16 was –24.3 percentage points (95% CI, –43.7 to –4.9) in the 50 mg group, –33.4 percentage points (95% CI, –52.7 to –14.1) in the 150 mg group and –28 percentage points (95% CI, –44.6 to –11.4) in the 450 mg group, the authors wrote. Litifilimab was associated with three instances of hypersensitivity and oral herpes infections, as well as a single case of herpes zoster.
“In LILAC part B, litifilimab significantly reduced skin disease activity in participants with CLE compared to placebo as measured by the primary endpoint,” Franchimont said. “CLE can have lasting negative outcomes on skin with irreversible skin damage and negative emotional aspects of people’s lives, leading to a decrease in quality of life.”
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