Cendakimab effective, generally safe for moderate to severe atopic dermatitis

Key takeaways:

• The cendakimab group dosed at 720 mg once weekly met the primary efficacy endpoint.
• Adverse events were experienced by 7.4% of patients in this group.

Cendakimab was effective and generally safe in the treatment of moderate to severe atopic dermatitis in adults, according to a study.

“Cendakimab is a monoclonal, high-affinity, selective antibody that binds to interleukin-13, blocking the interaction of IL-13,” Andrew Blauvelt, MD, MBA, lead study author and investigator at the Oregon Medical Research Center, and colleagues wrote. “IL-13 is a primary cytokine involved in the type 2 inflammation that is associated with AD.”

To evaluate the efficacy and safety of cendakimab treatment in patients with moderate to severe AD, the researchers conducted a randomized, double-blind, phase 2 clinical trial. A total of 221 patients (mean age, 37.7 years; 43% women) from 69 sites across five countries were randomly assigned to receive 720 mg once weekly (24%), 720 mg every 2 weeks (25%), 360 mg every 2 weeks (25%) or placebo (26%).

Results showed that the cendakimab group dosed at 720 mg once weekly met the primary efficacy endpoint of a mean percentage change in EASI score from baseline to week 16 vs. placebo (–84.4 vs. –62.7; P = .003).

On the other hand, the 720 mg every 2 weeks group did not attain statistical significance (–76 vs. –62.7). Because the hierarchical testing sequence was interrupted, the treatment effect for 360 mg every 2 weeks, while comparable to the 720 mg once weekly group, also did not attain statistical significance.

The highest rates of discontinuation occurred in the 720 mg once weekly group at 7.4% followed by the 720 mg every 2 weeks and placebo groups at 3.6% and the 360 mg every 2 weeks group at 1.8%.

“Safety findings from this study were similar to findings in other phase 2 studies of biologic agents targeting IL-4 and IL-13 for treating moderate to severe AD,” the authors wrote. “Treatment with cendakimab was well tolerated and efficacious in patients with moderate to severe AD, demonstrating improvements in skin clearance, pruritus and the extent and severity of AD after 16 weeks compared with treatment with placebo.”