FDA Updates Dupilumab Label Supporting Use Among Atopic Dermatitis Patients with Hand, Foot Involvement

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The updated labeling for dupilumab’s use resulted from the first phase 3 trial assessing a biologic within this subgroup of eczema patients.

An announcement was made by Regeneron Pharmaceuticals, Inc. and Sanofi that an update had been made by the US Food and Drug Administration (FDA) for dupilumab (Dupixent) treatment of patients with atopic dermatitis (AD).1

The January 16 announcement indicated that the FDA revised effectiveness and safety information specifically with regard to AD patients aged 12 years and up dealing with AD that is known to be uncontrolled and characterized by moderate-to-severe hand and/or foot involvement.

This was the result of new phase 3 data indicating that twice as many such individuals treated with the drug reported clear or almost clear skin and around 4 times as many of these patients saw pruritus improvement compared to those given a placebo. This was both the first and only phase 3 study assessing biologic use in this subgroup.

“Dupixent has been used to treat hundreds of thousands of patients with moderate-to-severe atopic dermatitis around the world since its initial U.S. approval in 2017, and we are pleased that (dupilumab) is now the first biologic with data in the label supporting its use in this particularly challenging subset of the disease,” George D. Yancopoulos, MD, PhD, principal investigator and Chief Scientific Officer for Regeneron, said in a statement.

The FDA’s decision to revise the labelin for dupilumab followed the phase 3 findings from the LIBERTY-AD-HAFT study. In this trial, 67 subjects had been treated with the drug every 2 weeks.

Specifically, the investigators gave 300 mg of dupilumab to adult participants, they gave 200 mg or 300 mg to participants who were adolescents based upon their body weight, or they gave a placebo to participants. Following a treatment course of 16 weeks, several results were found by the research team.

The major finding from LIBERTY-HD-HAFT was that 40% of subjects were shown by the team to have gotten clear or nearly clear skin on both their hands and feet. This contrasted with the 17% of individuals treated with the placebo, and the primary endpoint was consequently met for enough of the study participants.

The investigators also noted that 52% were found to have experienced a clinically meaningful diminishment in itch on both the hands and feet. This contrasted with the 14% who reported such an effect in the placebo arm, meeting the team’s key secondary endpoint.

The research team lastly reported that safety outcomes among subjects generally aligned with those of the established safety profile of dupilumab for AD patients. They found that the most common adverse events (AEs) linked to the drug (≥1%) for AD encompassed injection site reactions, keratitis, dry eye, blepharitis, conjunctivitis, oral herpes, other herpes simplex virus infections, eye pruritus, and eosinophilia.

“Unfortunately, treating atopic dermatitis on the hands and feet has historically been difficult and there have been no Phase 3 trials evaluating a biologic in this population of patients,” Naimish Patel, MD, the head of global development, immunology and inflammation for Sanof, said in a statement. “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of (dupilumab) in atopic dermatitis overall.”

References

  1. Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement. GlobeNewswire. January 16, 2024. https://www.globenewswire.com/news-release/2024/01/16/2809695/0/en/Dupixent-dupilumab-U-S-Label-Updated-with-Data-Further-Supporting-Use-in-Atopic-Dermatitis-with-Moderate-to-Severe-Hand-and-Foot-Involvement.html. Date accessed: January 16, 2024.
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