OLYMPIA 1: Nemolizumab Shows Improvements in Prurigo Nodularis Symptoms

Key Takeaways

• Nemolizumab reduced pruritus (58.4% vs. 16.7%) and skin nodules (26.3% vs. 7.3%) at week 16 compared to placebo.
• Improvements were present at week 24, with 58.3% reporting itch relief and 30.5% achieving near-clear skin.
• Most adverse events in patients treated with nemolizumab were mild to moderate.

Results from a multicenter phase 3 clinical trial indicated that nemolizumab monotherapy significantly reduces pruritus and nodular lesions in adults with moderate to severe prurigo nodularis (PN).

Researchers for the OLYMPIA 1 trial evaluated the efficacy and safety of nemolizumab in 286 patients over a 24-week treatment period, randomly assigning patients (2:1) to either nemolizumab 30 mg or 60 mg or placebo every four weeks for 24 weeks, with primary endpoints assessed at week 16. The primary outcome of interest was the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and Investigator’s Global Assessment (IGA) success (score of 0/1 and 2-grade or more improvement from baseline) at week 16.

According to the results, nemolizumab-treated patients showed significant improvement (58.4% achieved ≥4-point reduction in itch severity vs. 16.7% in the placebo group (P < 0.001). Near-clear skin by 26.3% achieved near-clear skin (IGA score of 0/1) compared to 7.3% in the placebo group (P = 0.003). Ad hoc analyses at week 24 confirmed sustained benefit. Regarding safety, researchers reported adverse events in 71.7% of patients receiving nemolizumab and 65.3% of those on placebo, with most events being characterized as mild or moderate.

"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 concluded in the study, published in JAMA Dermatology. "During the treatment period, headache and eczema were reported in more patients in the nemolizumab vs placebo group. The results were consistent with results of previous study."

Source:  Stander S, et al. JAMA Dermatology. 2024. Doi:10.1001/jamadermatol.2024.4796