Adding nemolizumab to topical corticosteroid treatment improves prurigo nodularis

Key takeaways:

• The highest mean percentage change from baseline in itch scores occurred in the 30 mg group with a reduction of 61.1%.
• This was followed by the 60 mg group at 56% and the placebo group at 18.6%.

Nemolizumab doses of 30 mg and 60 mg with topical corticosteroid treatment yielded positive results in adolescent patients with prurigo nodularis, according to a study.

“Currently, there are few treatment options for [prurigo nodularis (PN)] in Japan, and many of those available are insufficiently effective,” Hiroo Yokozeki, MD, PhD, professor and chair of the department of dermatology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, and colleagues wrote. “Nemolizumab, an investigational monoclonal antibody, binds to [interleukin]-31 receptor A, blocking IL-31 signaling, decreasing IL-31-mediated inflammatory responses and normalizing epidermal differentiation in skin samples from patients with PN.”

In this double-blind, phase 2/3 study, the researchers evaluated the optimal dose of nemolizumab to ensure efficacy and safety long-term in patients aged 13 years and older with PN. Patients were randomly assigned 1:1:1 to receive treatment every 4 weeks for a total of 16 weeks. All treatments included concomitant topical corticosteroids and dosages included: nemolizumab 30 mg with an initial dose of 60 mg (n = 77); nemolizumab 60 mg (n = 76); or placebo (n = 76).

Results showed the highest mean percentage change from baseline in Peak Pruritus Numerical Rating Scale scores occurred in the 30 mg group with a reduction of 61.1% followed by the 60 mg group at 56% and the placebo group at 18.6%.

The least-squares mean differences between the nemolizumab and placebo groups were significant with the 30 mg and 60 mg groups seeing 42.5% (95% CI, –51.9 to –33.1) and 37.4% (95% CI, –46.7 to –28.1) greater reductions in PP-NRS scores vs. the placebo group.

IGA 1 or 0 was achieved by 41.6%, 39.5% and 3.9% of patients in the nemolizumab 30 mg, nemolizumab 60 mg and placebo groups, respectively. The number of prurigo nodularis nodules also decreased by week 16 with the nemolizumab 30 mg group consistently outperforming the other two groups. Sleep and quality of life outcomes also greatly improved by the end of the study in nemolizumab-treated patients.

Adverse events were reported at similar rates in each group with a frequency of 66.2% in the 30 mg group, 64.5% in the 60 mg group and 53.9% in the placebo group. Severe events occurred in two patients in the placebo group; however, there were no serious events or deaths reported. The most common events deemed treatment-related in the nemolizumab groups vs. the placebo group were vaccination complication, eczema, erythema, dermatitis and folliculitis.

“Both doses of nemolizumab resulted in a greater reduction in pruritus than placebo over a period of 16 weeks in patients with PN who had not had an adequate response to topical agents and antihistamines,” the authors concluded.