Cendakimab Clears Skin in Adults With Atopic Dermatitis

TOPLINE:

Treatment with cendakimab, an investigational anti–interleukin-13 monoclonal antibody administered subcutaneously, is well tolerated and reduces the severity of atopic dermatitis (AD) and pruritus in adults with moderate to severe AD.

METHODOLOGY:

• In a multinational, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2 study of cendakimab, researchers evaluated 221 patients with moderate to severe AD (mean age, 37.7 years).
• Participants were randomly assigned to receive subcutaneous cendakimab at doses of 720 mg once weekly, 720 mg every 2 weeks, or 360 mg every 2 weeks or placebo for 16 weeks.
• The primary outcome was the mean percentage change in the Eczema Area and Severity Index (EASI) scores from baseline to week 16.
• Secondary outcomes included the proportion of patients achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear), a 75% or greater improvement in EASI (EASI-75) scores, a 4-point or greater reduction in Pruritus Numeric Rating Scale (P-NRS-4) scores, and safety at week 16.

TAKEAWAY:

• Those on cendakimab, at the 720 mg once weekly dose, had significantly reduced disease severity compared with those on placebo (mean difference in EASI scores from placebo, −21.8%; P = .003) at 16 weeks.
• For the primary outcome, cendakimab 720 mg every 2 weeks, did not reach statistical significance (P = .06); the 360 mg dose administered every 2 weeks showed a reduction in EASI scores compared with placebo (P = .03), but significance was not claimed because of hierarchical testing rules.
• Compared with those on placebo (9.4%), more patients on 720 mg cendakimab every week (33.3%) and 360 mg cendakimab every 2 weeks (38.2%) achieved a vIGA-AD score of 0 or 1 (P = .004 and P < .001, respectively). All three doses resulted in improvements in EASI-75 and P-NRS-4 scores in significantly higher proportions of treated patients vs those on placebo.
• Treatment-emergent adverse events ranged between 69.1% and 74.5% across the treatment groups, with most being mild to moderate, vs 73.2% among those on placebo.

IN PRACTICE:

In this study, “efficacy and safety of cendakimab…was established in patients with moderate to severe AD,” with treatment that was “was well tolerated and efficacious in patients…demonstrating improvements in skin clearance, pruritus, and the extent and severity of AD after 16 weeks” compared with placebo, the authors wrote.

SOURCE:

The study was led by Andrew Blauvelt, MD, MBA, Oregon Medical Research Center in Portland, Oregon, and published online on July 17, 2024, in JAMA Dermatology.

LIMITATIONS:

Relatively high placebo response rates were observed across the primary and secondary endpoints, which may have been influenced by the required use of a non-medicated topical emollient and rescue medications. The study included only adults, limiting the generalizability of the findings to pediatric patients, and was limited to a small number of countries, which may limit relevance of the results to the global population.

DISCLOSURES:

This study was supported by Bristol Myers Squibb. Many authors declared having financial ties outside this work. Two authors were employees of Bristol Myers Squibb. Other authors had no competing interests.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.