For patients with moderate-to-severe prurigo nodularis (PN), nemolizumab is associated with improvement in itch and sleep disturbance, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.
Shawn Kwatra, M.D., from the Johns Hopkins University School of Medicine in Baltimore, conducted a phase 3 trial in adults with PN presenting with ≥20 nodules, an Investigator's Global Assessment (IGA) score ≥3, and a Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥7.0. Participants were randomly assigned to receive nemolizumab or matching placebo (183 and 91, respectively); they received 30 or 60 mg every four weeks for 16 weeks, following an initial 60-mg subcutaneous dose.
The researchers found that compared with placebo-treated patients, significantly more nemolizumab-treated patients achieved a ≥4-point improvement from baseline in the PP-NRS and IGA success at week 16 (56.3 versus 20.9 percent and 37.7 versus 11.0 percent, respectively); a ≥4-point improvement in the PP-NRS at week 4 (41.0 versus 7.7 percent); and a ≥4-point improvement in the Sleep Disturbance Numerical Rating Scale at weeks 4 and 16 (37.2 versus 9.9 percent and 51.9 versus 20.9 percent, respectively). Overall, 61.2 and 52.7 percent of nemolizumab- and placebo-treated patients, respectively, had treatment-emergent adverse events.
"Nemolizumab monotherapy demonstrated significant improvements in both primary and key secondary end points compared with placebo in patients with moderate-to-severe PN; the safety profile was consistent with that previously observed," the authors write.
The study was sponsored by Galderma, the manufacturer of nemolizumab.