Nemolizumab Shows Significant Efficacy in Treating Signs, Symptoms of Prurigo Nodularis in OLYMPIA 1 Trial

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Galderma recently announced¹ that data from its phase 3 OLYMPIA 1 (NCT04501666) trial was published in JAMA Dermatology.²

The data demonstrated the efficacy of nemolizumab (Nemluvio) in treating adults with moderate to severe prurigo nodularis, with significant reductions reported in signs and symptoms of the condition.

The study, conducted at 77 centers across 10 countries, included 286 patients with at least 20 nodules and a Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0. A total of 286 patients were enrolled in the trial, with 190 receiving nemolizumab and 96 receiving placebo. The average age of participants was 57.5 years, and the average body weight was 85.0 kg (187.39 lb).

Participants were randomly assigned to receive either nemolizumab monotherapy or a placebo for 24 weeks, with doses of 30 mg or 60 mg depending on body weight.

At week 16, significantly more patients receiving treatment with nemolizumab demonstrated improvement in both itch severity and skin lesions compared to the placebo group.

Specifically, 58.4% of patients on nemolizumab achieved a ≥4-point improvement from baseline in their weekly average PP-NRS score compared to just 16.7% of those on placebo. Additionally, 26.3% of patients receiving nemolizumab achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear/almost clear) and a 2-grade improvement from baseline, compared to only 7.3% in the placebo group.

"The full phase III OLYMPIA 1 trial results add to the extensive body of evidence supporting nemolizumab’s potential to significantly and safely improve some of the most debilitating symptoms for people with prurigo nodularis – chronic itch, skin nodules, and poor sleep quality – which can be all consuming and have a knock-on effect on patients’ overall quality of life and mental health," said professor Sonja Ständer, lead OLYMPIA investigator and professor of dermatology at University Hospital Münster, in a news release.¹

These improvements were maintained at week 24.

In an ad hoc analysis, 58.3% of patients in the nemolizumab treatment group showed a ≥4-point improvement in the PP-NRS, compared to 20.4% in the placebo group, and 30.5% of the nemolizumab group achieved IGA success versus 9.4% in the placebo group.

Regarding safety, nemolizumab was generally well tolerated.

During the treatment period, 71.7% of patients receiving nemolizumab experienced at least one adverse event, compared to 65.3% of patients receiving placebo. The most common events in the nemolizumab group were mild to moderate, including headache and eczema.

Nemolizumab was approved by the US Food and Drug Administration in August of this year.³

"These results, alongside the OLYMPIA 2 trial data, formed the basis of nemolizumab’s recent US Food and Drug Administration approval for the treatment of adults with prurigo nodularis," said Baldo Scassellati Sforzolini, MD, PhD, global head of R&D at Galderma.¹ "They demonstrate the potential of this treatment to rapidly and significantly provide relief from the most burdensome symptom for people with prurigo nodularis – itch. We are committed to bringing this treatment option to patients in other parts of the world as soon as possible."

References

1. Galderma’s phase III OLYMPIA 1 data published in JAMA Dermatology demonstrate that nemolizumab improves core signs and symptoms of prurigo nodularis. News release. Galderma. November 28, 2024. Accessed November 27, 2024. https://www.galderma.com/newsroom-new
2. Ständer S, Yosipovitch G, Legat FJ, et al. Efficacy and safety of nemolizumab in patients with moderate to severe prurigo nodularis: the OLYMPIA 1 randomized clinical phase 3 trial. JAMA Dermatol. Published online November 27, 2024. doi:10.1001/jamadermatol.2024.4796
3. Galderma receives U.S. FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed November 27, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo#:~:text=Zug%2C%20Switzerland%20%E2%80%93%20August%2013%2C,of%20adults%20with%20prurigo%20nodularis