
Targeting interleukin-31 signalling with nemolizumab appears to produce substantial improvements in core signs and symptoms of prurigo nodularis (PN), as shown in the phase III OLYMPIA 1 trial.
OLYMPIA 1 included 286 patients (mean age 57.5 years, 58.0 percent female, mean body weight 85.0 kg) with moderate to severe PN (at least 20 nodules and an Investigator’s Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0.
The patients were randomly assigned to receive nemolizumab monotherapy at 30 mg if baseline weight was <90 kg or at 60 mg if baseline weight was at least 90 kg (n=190), or matching placebo (n=96) administered every 4 weeks for 24 weeks.
The primary endpoints were itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.
At week 16, significantly more patients in the nemolizumab group than in the placebo group achieved an itch response (58.4 percent vs 16.7 percent; p<0.001) and IGA success (26.3 percent vs 7.3 percent; p=0.003).
Similar results were observed at week 24. Compared with the placebo group, the nemolizumab group had higher itch response rate (58.3 percent vs 20.4 percent) and IGA success rate (30.5 percent vs 9.4 percent).
Adverse events occurred in 71.7 percent of nemolizumab-treated patients and in 65.3 percent of placebo-treated patients. Most events were mild to moderate in severity.