Treatment efficacy seen in primary end points of itch response and Investigator’s Global Assessment response
By Elana Gotkine HealthDay Reporter
THURSDAY, Oct. 26, 2023 (HealthDay News) — For patients with moderate-to-severe prurigo nodularis, nemolizumab improves symptoms, according to a study published in the Oct. 26 issue of the New England Journal of Medicine.
Shawn G. Kwatra, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a phase 3, double-blind, randomized trial involving adults with moderate-to-severe prurigo nodularis. Participants were assigned to receive an initial 60-mg dose of nemolizumab followed by subcutaneous injections of 30 or 60 mg every four weeks for 16 weeks or matching placebo (183 and 91 patients, respectively).
The researchers found that at week 16, treatment efficacy was shown with respect to both primary end points (itch response and Investigator’s Global Assessment [IGA] response); a greater proportion of patients in the nemolizumab group than in the placebo group had an itch response (56.3 versus 20.9 percent) and an IGA response (score of 0 [clear] or 1 [almost clear]; 37.7 versus 11.0 percent). For the five key secondary end points, benefits were also observed: itch response at week 4, Peak Pruritus Numerical Rating Scale score of less than 2 at weeks 4 and 16, and improvement of 4 or more points on the sleep disturbance numerical rating scale at weeks 4 and 16.
“The results of this trial extend the efficacy and safety findings of nemolizumab from the phase 2 study in patients with prurigo nodularis,” the authors write.
The study was funded by Galderma, the manufacturer of nemolizumab.
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