Nemolizumab Delivers Rapid Itch Response in Patients with PN

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At Fall Clinical 2024 in Las Vegas, Nevada, from October 24 to 27, a poster from Galderma presented early efficacy data from the first 14 days of nemolizumab treatment for prurigo nodularis (PN).¹ Post hoc analyses were conducted from 2 phase 3 studies in adult patients with moderate to severe PN.

Background

Nemolizumab (Nemluvio) is a first-in-class IL-31 receptor alpha antagonist that targets itch, inflammation, altered epidermal differentiation, and fibrosis associated with PN. The pre-filled pen for subcutaneous injection was approved by the US Food and Drug Administration in August.²

In the OLYMPIA 1 (NCT04501666) and OLYMPIA 2 (NCT04501679) studies, the drug demonstrated significant clinical improvement in itch, sleep disturbance, and skin lesions compared to placebo. Itching is considered to be the most burdensome PN symptom, severely disrupting patients’ quality of life.³

“Because this patient population has suffered for a long time, anytime there's a hope of new therapeutics, it's very exciting for doctors and for patients; nemolizumab has the potential to be a very significant addition to our armamentarium against treating itch,” said OLYMPIA investigator, Shawn Kwatra, MD, in a previous interview with Dermatology Times.

Methods and Materials

All 560 patients from the phase 3 studies were included in the post hoc analysis. A majority of participants were white females with an Investigator’s Global Assessment (IGA) score of 3 or 4. Patients had previously used other PN medications including systemic therapy, biologics, non-steroidal immunosuppressants, oral antihistamines, and systemic steroids.

The post hoc analysis examined daily scores over the first 14 days of the OLYMPIA 1&2 trials. More specifically, researchers assessed the mean change in Peak Pruritus Numerical Rating Scale (NRS) from baseline. They also evaluated ≥4-point improvements from baseline in daily Sleep Disturbance NRS and Peak Pruritus NRS scores.

Results

Early ≥4-point improvements in Peak Pruritus NRS were first observed on day 2 of the OLYMPIA 1 trial (p ≤ 0.005) and day 1 of the OLYMPIA 2 trial (p ≤ 0.05). By day 14, around 40% of participants achieved a clinically significant itch response in the nemolizumab groups (p ≤ 0.0001).

Additionally, the mean change in itch response compared to baseline was first observed on Day 1 of both trials. This continued to decrease until day 14, with a mean reduction of 3.2 in OLYMPIA 1 and 3.1 in OLYMPIA 2 (p ≤ 0.0001).

Meaningful ≥4-point improvements in SleepDisturbance NRS score were recorded as early as day 2 in OLYMPIA 1 and at day 3 in OLYMPIA 2 (p ≤ 0.05). By day 14, 27% of OLYMPIA 1 patients (p ≤ 0.0001) and 34% of OLYMPIA 2 patients (p ≤ 0.001) noted significant improvement in sleep after being treated with nemolizumab.

Conclusion

Through this post hoc analysis, researchers confirmed that symptoms greatly improved with nemolizumab versus placebo, with rapid results occurring within the first 2 days. Over one-third of patients achieved significant clinical response in daily itch intensity and sleep disturbance. by day 14 of treatment.

"By targeting and blocking this neuroimmune cytokine signaling, which drives key symptoms of prurigo nodularis, nemolizumab has the potential to rapidly and effectively address the most burdensome symptom for people with prurigo nodularis – itch, as well as the appearance of skin nodules,” said Baldo Scassellati Sforzolini, MD, PhD, MBA, the global head of research and development at Galderma, in a previous interview with Dermatology Times.

References

1. Ständer S, Elmariah S, Kwatra SG, et al. Nemolizumab elicits an early and rapid itch response in prurigo nodularis within 2 days: A post hoc analysis of OLYMPIA 1&2 data. Poster presented at the 44th Annual Fall Clinical Dermatology Conference. Las Vegas, Nevada. October 24 to 27, 2024.

2. Galderma receives U.S. FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed August 13, 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.

3. Pereira MP, Hoffmann V, Weisshaar E, et al. Chronic nodular prurigo: clinical profile and burden. A European cross-sectional study. J EurAcad Dermatol Venereol. 2020;34(10):2373-2383. doi:10.1111/jdv.16309