Nemolizumab, a biologic that blocks interleukin-31 signaling, showed sustained benefits for patients with prurigo nodularis over 68 weeks of treatment, according to findings from a multicenter clinical trial in Japan.
The study followed 226 patients aged 13 years and older with moderate-to-severe prurigo nodularis (PN), characterized by at least 20 prurigo nodules and severe itching at baseline.
Patients were randomized to receive subcutaneous nemolizumab 30 mg, 60 mg, or placebo every 4 weeks for 16 weeks, along with medium-potency topical corticosteroids (TCS). During the subsequent 52-week extension, nemolizumab treatment continued, and those initially assigned to placebo were switched to one of the nemolizumab arms.
At week 68, patients in the 30 mg group showed a 78.6% (SD 19.0) reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) scores, while the 60 mg group reported a 76.5% (SD 25.9) reduction. These improvements were greater than those at week 16, which were 60.5% (SD 29.2) and 55.1% (SD 31.1), respectively.
In the 30 mg group, 45 of 77 patients (58%) achieved a PP-NRS score below 3, and in the 60 mg group, 47 of 76 patients (62%) reached the same threshold. Additionally, 32 of 77 patients (42%) in the 30 mg group and 45 of 76 patients (59%) in the 60 mg group achieved a score of 1 or lower on the 5-level itch scale.
Reductions in prurigo nodules were also observed. At baseline, most patients had more than 100 nodules. By week 68, the mean number of nodules had decreased by 93.0% (SD 12.6) in the 30 mg group and 89.7% (SD 25.4) in the 60 mg group.
Quality-of-life outcomes improved over the course of treatment. In the 30 mg group, 35 of 61 patients (57%) had an Insomnia Severity Index (ISI) score ≤7 at week 68, compared with 38 of 66 patients (58%) in the 60 mg group. In terms of Dermatology Life Quality Index (DLQI), 54 of 72 patients (75%) in the 30 mg group and 53 of 70 patients (76%) in the 60 mg group achieved at least a 4-point improvement.
Use of TCS also declined. Daily average usage decreased from 2.3 g to 1.2 g in the 30 mg group and from 2.5 g to 1.3 g in the 60 mg group. By week 68, 7 of 77 patients (9%) in the 30 mg group and 12 of 76 patients (16%) in the 60 mg group were no longer using TCS.
Treatment-emergent adverse events (TEAEs) were reported in 103 of 112 patients (92.0%) in the 30 mg group and 103 of 113 patients (91.2%) in the 60 mg group. Most events were mild or moderate. Two patients in the 60 mg group experienced serious TEAEs that were considered related to treatment.
“Nemolizumab treatment continued to provide improvements in pruritus, PN severity and QoL after week 16,” wrote lead author Hiroo Yokozeki, of the Department of Dermatology at Tokyo Medical and Dental University.
These results suggest sustained efficacy and tolerability of nemolizumab over 68 weeks in patients with prurigo nodularis.
Full disclosures can be found in the published study.
Source: BJD