Phase 3 data confirm rapid efficacy of nemolizumab for prurigo nodularis treatment
Key takeaways:
- More of the nemolizumab group vs. placebo group achieved an itch response by week 16 (56.3% vs. 20.9%).
- Also by week 16, 37.7% of those treated with nemolizumab vs. 11% treated with placebo achieved IGA 0/1.
Nemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis, including sleep disturbance, according to results from a phase 3 study.
“Prurigo nodularis is an intensely pruritic disease that devastates sleep quality and overall quality of life for patients,” Shawn G. Kwatra, MD, director of the Johns Hopkins Itch Center, associate professor of dermatology at Johns Hopkins Medicine and lead investigator of this study, told Healio. “For many years, patients have had limited therapeutic options because of the lack of well-designed placebo-controlled clinical trials.”
“Nemolizumab, which blocks the IL-31 receptor, was shown in this global phase 3 trial to have rapid itch relief accompanied by improvements in sleep disturbance and nodule resolution,” Kwatra continued.
In this study, OLYMPIA 2, which is the second of two double-blind, multicenter, randomized, phase 3 trials, patients with moderate to severe prurigo nodularis were randomly assigned to placebo (n = 91) or nemolizumab (n = 183). After a 60 mg initial nemolizumab dose, baseline weight determined if patients would receive 30 mg or 60 mg subcutaneous injections dosed every 4 weeks for 16 weeks.
Efficacy was shown in both primary endpoints with a higher proportion of patients in the nemolizumab vs. placebo group achieving an itch response, defined as a reduction of 4 points or more on the Peak Pruritus Numerical Rating Scale (PP-NRS; 56.3% vs. 20.9%; P < .001) and an IGA score of 0/1 (37.7% vs. 11%; P < .001) by week 16.
Key secondary endpoints were also reached including a higher proportion of nemolizumab-treated vs. placebo-treated patients achieving an itch response at week 4 (41% vs. 7.7%; P < .001), and a PP-NRS score of less than 2 at week 4 (19.7% vs. 2.2%; P < .001) and week 16 (35% vs. 7.7%; P < .001).
A 4-point improvement in sleep was also achieved by 37.2% of nemolizumab-treated patients vs. 9.9% of placebo-treated patients by week 4. The proportion of patients that achieved improved sleep increased to 51.9% in the nemolizumab group vs. 20.9% in the placebo group by week 16.
At least one adverse event was experienced by 61.2% of nemolizumab-treated patients compared with 52.7% of placebo-treated patients, with the most common being headache (6.6% vs. 4.4%) and atopic dermatitis (5.5% vs. 0%).
Editor's note: On Oct. 27, the headline was corrected from "atopic dermatitis" to "prurigo nodularis." The editors regret the error.