Jonathan Silverberg, MD, PhD: New Phase 3 Findings on Nemolizumab for Atopic Dermatitis

Nemolizumab was shown to be effective and safe on moderate-to-severe atopic dermatitis (AD) patients after 48 weeks of treatment, according to late-breaking data presented at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego.

These new findings were the result of 2 global phase 3 pivotal studies titled ARCADIA-1 and ARCADIA-2, both of which were randomized, double-blind, placebo-controlled trials assessing subcutaneous nemolizumab 30 mg administered every 2 weeks.

In a new interview at AAD, Jonathan Silverberg, MD, PhD, director of clinical research at the George Washington University School of Medicine and Health Sciences, discussed his team’s findings in this study.

“The primary data readouts were presented a few months ago at the European Academy of Dermatology and Venereology meeting in Berlin in October of 2023,” Silverberg said. “Those primary readouts were Week 16. This phase of the study, the maintenance phase of the study, examined the maintenance of response for an additional 32 weeks beyond that initial 16 week period.”

Silverberg noted that the participants who had been responders at the 16-week mark were then re-randomized to receive either ongoing nemolizumab every 4 weeks, a maintenance dose every 8 weeks, or placebo every 4 weeks for another 32 weeks. This was done with participants having a background with topical corticosteroids and/or topical calcineurin inhibitors, as per the investigators’ discretion.

“What they found was that at Week 48, there were a high proportion of patients who maintained their response based on Investigator Global Assessment score of clear, almost clear, EASI75 responses, or even 4 point responses in itch,” Silverberg explained. “Even improvements in terms of sleep quality, etc. So overall, seeing very nice durability across all treatment arms. The most effective arm maintenance of response was the continuous every 4 week dosing, but there was a subset of patients who did fantastic with the every 8 week dosing as well, suggesting that there may be an opportunity for…a more spread out maintenance dose.”

He did add that there were strong responses even amongst subjects who were randomized to placebo, suggesting that for some individuals, there may be a durable response in an ongoing manner. Silverberg was also asked about how the efficacy of nemolizumab compared to existing treatments for atopic dermatitis.

“It's important to just recognize we don't have any head-to-head data at this point and it may be years till we do,” he said. “So the best we can do is really try to do this sort of cross-trial comparison between comparable study designs. I think the big challenge we face here is this is a unique study design, which is not exactly comparable in several ways. In particular, because this study had this stable topical corticosteroid running period prior to that initial dosing of nemolizumab or placebo. So we don't we don't really have exactly the same feature in any of the studies out there.”

For further information, view Silverberg’s full interview segment posted above.

The quotes used in this summary were edited for clarity.