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New phase 3 data shared at Fall Clinical Dermatology show the IL-13 inhibitor maintained skin clearance observed at 16 weeks.
Data presented last week at the Fall Clinical Dermatology 2022 Meeting showed interleukin-13 (IL-13) inhibitor lebrikizumab was associated with “maintained robust efficacy” in patients with moderate-to-severe atopic dermatitis treated over 1 year after previously achieving efficacy endpoints through a 16-week induction period.
Patients treated with the Lilly investigational systemic therapy in the randomized, double-blind, phase 3 ADvocate1 and ADvocate2 trials reported maintained response rates across various atopic dermatitis outcomes versus placebo at 52 weeks, including Investigator’s Global Assessment (IGA) scores of 0 or 1, Eczema Area Severity Index (EASI) scores of 75 or 90, Pruritus Numerical Rating Scale (NRS) improvements of ≥4 points, and quality of life measures.
Investigators additionally observed that patients in the lebrikizumab arms reported significantly reduced need for topical rescue therapy, a consistent safety profile from 16 to 52 weeks, and a“slow” loss of clinical response following treatment withdrawal when switched to placebo.
The latest phase 3 data for the high binding-affinity, significantly potent pathway-targeting biologic is a promising development for Lilly, who could submit application for US Food and Drug Administration (FDA) approval for atopic dermatitis in the near future.
In an interview with HCPLive during the Fall Clinical 2022, Jonathan Silverberg, MD, PhD, MPH, director of clinical research at the George Washington University School of Medicine and Health Sciences, shared what he said is a consistent message across all the observed treatment endpoints of the ADvocate trials.
“There’s a high rate of maintenance of clinical response overall, for those who initially had done well,” he said. “But in addition…it was found that a high proportion of patients maintained that response out to week 52 with even a lowered, every 4 weeks dosing.”
Though the FDA has not received nor decided on an atopic dermatitis indication for lebrikizumab, Silverberg noted that—with the exception of head-to-head trial data—the agent has built a substantial clinical profile relative to other marketed systemic therapies.
“We see that patients are at high rates of efficacy that puts it at least comparable, if not potentially better than other agents in this class,” Silverberg said. “And now with the 52-week data, we’re seeing this really high maintenance of response—these are some of the best numbers we’ve seen in this class of medications.”
“It really raises some interesting prospects or value propositions, that lebrikizumab could establish itself as one of the best-in-class medications out there.”
The study, “Efficacy and Safety of Lebrikizumab in Moderate-to-Severe Atopic Dermatitis: 52-Week Results of Two Randomized, Double-Blinded, Placebo-Controlled Phase 3 Trials (ADvocate1 and ADvocate2),” was presented at Fall Clinical 2022.