Investigational IL-13 inhibitor shows therapeutic potential in atopic dermatitis

The IL-13 inhibitor cendakimab appears to be beneficial in the treatment of atopic dermatitis (AD), with the results of a phase II study showing that a dosing schedule of 720 mg once weekly helps reduce the severity of the said condition.

A total of 221 patients with moderate-to-severe AD and inadequate response to topical medications were randomly assigned to receive one of three subcutaneous cendakimab dosing schedules—360 mg every 2 weeks; 720 mg every 2 weeks; 720 mg once weekly—or placebo for 16 weeks.

Of the patients, 220 received the study drug (mean age 37.7 years, 43 percent women), of which 54 were in the 720-mg once-weekly group, 55 in the 720-mg every-2-weeks group, 55 in the 360-mg every-2-weeks group, and 56 in the placebo group.

The primary efficacy endpoint was met for the cendakimab, 720-mg once-weekly dosing. Specifically, the mean percentage change in Eczema Area and Severity Index (EASI) score at week 16 was significantly higher with the said dosing schedule than with placebo (–84.4 vs –62.7; p=0.003). No significant between-group difference was observed for the 720-mg every-2-weeks dosing schedule vs placebo (–76.0 vs –62.7; p=0.06).

The treatment effect observed with the 360-mg every-2-weeks dosing schedule was greater than with placebo (p=0.03) and comparable with 720 mg once weekly, but significance was not established due to hierarchical testing sequence interruption.

In terms of safety, the rates of treatment-emergent adverse events leading to discontinuation were 7.4 percent in the 720-mg once-weekly group, 3.6 percent in the 720-mg every-2-weeks group, 1.8 percent in the 360-mg every-2-weeks group, and 3.6 percent in the placebo group.