Nemolizumab delivers ‘incredibly encouraging’ results for patients with prurigo nodularis

Key takeaways:

• By week 16, 58% of nemolizumab-treated patients vs. 16.7% of placebo-treated patients achieved itch response.
• 26.3% of the nemolizumab group vs. 7.3% of placebo reached IGA success by week 16.

Nemolizumab monotherapy improved the signs and symptoms of prurigo nodularis, according to new data published in JAMA Dermatology.

The newly published results are from the randomized phase 3 OLYMPIA 1 study where researchers assessed the efficacy and safety of nemolizumab for the treatment of moderate to severe prurigo nodularis (PN).

“Patients suffering from PN need a therapeutic solution allowing for long-term disease control,” Christophe Piketty, MD, PhD, global program head of Galderma and an investigator in the trial, told Healio. “The OLYMPIA 1 data add to the already extensive body of evidence supporting nemolizumab’s potential in PN where symptoms including chronic itch and poor sleep quality, together with numerous nodular skin lesions, can be debilitating, impacting patients’ overall quality of life and potentially mental health significantly.”

The study included 286 adults (mean age, 57.5 years; 58% women) who were randomly assigned 2:1 to receive nemolizumab monotherapy (n = 190) 30 mg or 60 mg, depending on baseline weight, or placebo (n = 96) every 4 weeks for 24 weeks.

Results showed that significantly more nemolizumab-treated patients achieved a 4-point or higher improvement from baseline in weekly average Peak Pruritus Numerical Rating Scale scores compared with placebo-treated patients by week 16 (58.4% vs. 16.7%; strata-adjusted difference, 40.1%; 95% CI, 29.4%-50.8%). At week 24, this difference remained significant (58.3% vs. 20.4%; strata-adjusted difference, 38.7%; 95% CI, 27.5%-49.9%).

According to Piketty, researchers saw rapid itch response in the nemolizumab group as early as week 4.

“The speed of onset we saw in OLYMPIA 1 was incredibly encouraging, given the massive burden that prurigo nodularis’ symptoms place on those affected, with robust improvements in itch and sleep disturbance,” Piketty told Healio.

The nemolizumab group also saw a higher proportion of IGA success, defined as a score of 0/1 with at least a 2-grade improvement from baseline, compared with the placebo group by week 16 (26.3% vs. 7.3%; strata-adjusted difference, 14.6%; 95% CI, 6.7%-22.6%), which was maintained at week 24 (30.5% vs. 9.4%; strata-adjusted difference, 19.2%; 95% CI, 10.3%-28.1%).

More than half of patients experienced at least one adverse event in both the nemolizumab and placebo groups (71.7% vs. 65.3%). While most were mild to moderate in severity, 16 nemolizumab-treated patients and 10 placebo-treated patients reported a serious adverse event, with one in the nemolizumab group (Campylobacter colitis) considered related to the study drug.