- Legat F. Durability of response to nemolizumab in patients with moderate-to-severe prurigo nodularis: Results from a randomised placebo-controlled withdrawal phase 3b study. D1T01.1A, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.
In a phase 3b trial, 75% of participants with a prior clinical response experienced a flare-up of their disease when nemolizumab was suspended. “When we compare it with other skin diseases, it is one of the itchiest of all, it highly impacts the quality-of-life and physical, emotional, and psychological well-being,” Prof. Franz Legat (Medical University Graz, Austria) explained about PN1.
Prof. Legat presented the results of the phase 3b durability study on nemolizumab (NCT05052983), the first FDA-approved IL-31 receptor alpha antagonist. Eligible participants all had a clinical response at week 52 of the ongoing OLYMPIA-LTE trial (NCT04204616) defined by an Investigator Global Assessment (IGA) 0/1 and a ≥4-point improvement in Peak Pruritus Numerical Rating Scale (PP-NRS). Matching the entry requirements, 58.8% of participants had an IGA of 1, all others had an IGA of 0. The mean age was 59.5 years, 79.4% were women, and the mean PP-NRS was 0.7.
The results for the primary endpoint of time from baseline to relapse showed that participants with nemolizumab withdrawal had a median time to relapse of 112.5 days, while the time to relapse in those on continuous treatment was undetermined until week 24 because the event rate was too low.
“The hazard ratio of relapse was 0.125, which means that it was 8 times more likely to relapse in the nemolizumab withdrawal arm than in the nemolizumab continuous arm,” Prof. Legat specified. In the withdrawal arm, 12 out of 16 participants (75%) relapsed, compared with 3 out of 18 (16.7%) continuing nemolizumab. The safety data showed a profile that was in line with previous data.
“These findings support the continued use of nemolizumab beyond 52 weeks of treatment among patients who are clinical responders,” Prof Legat concluded.
Medical writing support was provided by Karin Drooff, MPH