WEDNESDAY, Nov. 27, 2024 -- Nemolizumab monotherapy leads to significant improvements in the signs and symptoms of moderate-to-severe prurigo nodularis (PN), according to a study published online Nov. 27 in JAMA Dermatology.

Sonja Ständer, M.D., from the University Hospital Münster in Germany, and colleagues examined the efficacy and occurrence of adverse events in adults with moderate-to-severe PN treated with nemolizumab versus placebo in a multicenter, placebo-controlled, phase 3 randomized clinical trial conducted at 77 centers across 10 countries. Participants were randomly assigned to receive nemolizumab monotherapy, 30 mg or 60 mg, or matching placebo (190 and 96 participants, respectively).

The researchers found that at week 16, the proportion of patients who achieved itch response and Investigator's Global Assessment (IGA) success was higher among those assigned to nemolizumab versus placebo (58.4 versus 16.7 percent and 26.3 versus 7.3 percent, respectively). The proportion of patients with itch response and IGA success was 58.3 versus 20.4 percent and 30.5 versus 9.4 percent, respectively, in the nemolizumab- versus placebo-treated groups at week 24. Overall, 71.7 and 65.3 percent of those receiving nemolizumab and placebo, respectively, had at least one adverse event during the treatment period; most events were mild-to-moderate in severity.

"In this phase 3 randomized clinical trial, nemolizumab monotherapy demonstrated rapid and sustained clinically meaningful improvements in core signs (skin lesions) and symptoms (itch and sleep disturbance) of PN," the authors write.

Several authors disclosed ties to pharmaceutical companies, including Galderma, which manufactures nemolizumab and funded the study.