Prurigo nodularis improvement seen with nemolizumab monotherapy

Key takeaways:

• Patients with prurigo nodularis showed significant improvements in itch, sleep disturbance and lesions after nemolizumab treatment.
• Nemolizumab is an interleukin-31 receptor alpha antagonist.

NEW ORLEANS — Symptoms of prurigo nodularis were significantly improved after 16 weeks of monotherapy with nemolizumab, according to a presenter at the American Academy of Dermatology Annual Meeting.

“Prurigo nodularis, PN, is characterized by these intensely itchy nodules that are commonly on the extremities and the trunk,” Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins University School of Medicine and director of the Johns Hopkins Itch Center, said during his presentation. “In terms of pathophysiology, we believe this is a neuroimmune mediated skin disease, and it actually also has inducement of not only type 2 inflammation but also elements of type 17 and type 22 inflammation.

Nemolizumab is an interleukin-31 receptor alpha antagonist that also can modulate both type 2 and type 17 helper T cells, he continued.

The OLYMPIA 2 phase 2 trial randomly assigned 274 patients aged 18 years and older with prurigo nodularis to receive nemolizumab (n = 183; mean age, 53.7 years; 61.7% women) or placebo (n = 91; mean age, 50.8 years; 60.4% women) every 4 weeks for 16 weeks to assess the efficacy of the drug.

A 4-point or greater improvement in Peak Pruritis Numerical Rating Scale (PP-NRS) was reported in 56.3% of those in the treatment group compared with 20.9% of those in the placebo group.

IGA success was achieved by 37.7% of the treatment group and 11% of the placebo group.

Secondary endpoints, including itch, sleep disturbance and skin lesion improvement at week 4, were also statistically significant in the treatment group. PP-NRS scores improved by at least 4 points in 41% of nemolizumab-treated patients at week 4, compared with 7.7% of those in the placebo group.

Sleep Disturbance Numerical Rating Scale improvements of at least 4 points were reported by 37.2% at 4 weeks and 51.9% at 16 weeks in the treatment population, compared with 9.9% and 20.9% of the placebo group.

“Nemolizumab monotherapy, which is Q4 weeks — monthly — was associated with really significant improvements in pruritus, skin lesions and sleep disturbance at week 16, and these improvements were as early as week 4,” Kwatra said.

“The results of this study extend the efficacy and safety findings from phase 2 studies of nemolizumab in patients with prurigo nodularis.”