Phase 3 data show nemolizumab rapidly improves itch in prurigo nodularis treatment
Key takeaways:
- 19.7% of nemolizumab-treated patients achieved an itch-free state by week 4 compared with only 2.2% of placebo-treated patients.
- Nemolizumab may also improve sleep disturbances caused by itch.
A greater proportion of patients treated with nemolizumab for prurigo nodularis achieved an itch-free state than those treated with placebo, according to phase 3 results presented at the 25th World Congress of Dermatology.
Galderma announced the latest results of its pivotal, 16-week, phase 3 Olympia 2 trial, which evaluated the efficacy and safety of nemolizumab, an investigational drug that targets interleukin (IL)-31 signaling, for the treatment of prurigo nodularis in adults.
“It’s important to consider the latest Olympia 2 trial results firstly in the context of the patient experience — 100% of adults living with prurigo nodularis report intense itching as their top complaint,” Baldo Scassellati Sforzolini, MD, PhD, MBA, global head of research and development at Galderma, told Healio. “The data presented at the World Congress of Dermatology demonstrate the potential of nemolizumab, with a significant percentage of patients achieving a statistically significant itch reduction as early as week 4, after just one dose. Furthermore, these results solidify our understanding of the neuroimmune cytokine IL-31 as a key driver of itch and other symptoms in prurigo nodularis.”
In the study, patients were randomly assigned to receive nemolizumab (n = 183) or placebo (n = 91). Nemolizumab-treated patients weighing less than 90 kg received a loading dose of 60 mg followed by 30 mg every 4 weeks. Patients weighing 90 kg or more received 60 mg every 4 weeks.
Results showed that a significantly greater proportion of nemolizumab-treated patients than placebo-treated patients achieved the primary endpoints. Of those treated with nemolizumab, 19.7% achieved an itch-free state by week 4 compared with only 2.2% of placebo-treated patients.
By week 16, 56.3% achieved a greater than or equal to 4-point improvement from baseline on the peak pruritus numerical rating scale compared with 20.9% of those treated with placebo.
IGA success was also much higher in the nemolizumab group (37.7%) than the placebo group (11%), and the rate of treatment-emergent adverse events was comparable between groups (61.2% vs. 52.7%).
According to a Galderma press release, the ability of nemolizumab to improve itchiness may help solve other issues this population faces, such as sleep disturbances.
Reference:
- Galderma @ WCD 2023: Late-breaking phase III results for nemolizumab monotherapy in prurigo nodularis show a significant proportion of itch-free patients by week 4. https://www.galderma.com/news/galderma-wcd-2023-late-breaking-phase-iii-results-nemolizumab-monotherapy-prurigo-nodularis. Presented at: 25th World Congress of Dermatology; July 3-8, 2023; Singapore.