New research shows that cendakimab is safe and efficacious at certain dosing levels over a 16-week study period in patients with moderate-to-severe atopic dermatitis (AD).
The study authors for the phase 2 trial included 221 adult patients with moderate-to-severe AD from the United States, Japan, Canada, Poland, and the Czech Republic. Patients were randomized into four groups: 360 mg cendakimab every two weeks, 720 mg every two weeks, 720 mg once weekly, and placebo. The endpoint of interest was the mean percentage change in Eczema Area and Severity Index (EASI) scores from baseline to week 16.
According to the results, there was a significant reduction in EASI scores for the group receiving 720 mg once weekly vs. placebo (−84.4 vs. −62.7; P = 0.003). Patients in the 720 mg arm did not achieve statistical significance vs. placebo (−76.0 vs. −62.7; P = 0.06). Those in the 360 mg group trended toward improvement, but it did not statistical significance due to the hierarchical testing sequence being interrupted.
Relatively high placebo response rates due to the possible use of other topicals during the study was cited as a limitation, as was the limited number of countries patients were drawn from.
"In this randomized clinical trial, treatment with cendakimab was well-tolerated and efficacious in patients with moderate to severe AD, demonstrating improvements in skin clearance (ie, body surface area affected), pruritus, and the extent and severity of AD (ie, EASI, vIGA-AD) after 16 weeks compared with treatment with placebo," the authors concluded. "The primary end point was reached for the highest dose. Cendakimab demonstrated progressive AD improvement at all doses during 16 weeks of treatment."
Source: Baluvelt A, et al. JAMA Dermatology. 2024. Doi:10.1001/jamadermatol.2024.2131