Prurigo nodularis: long-term treatment decreases relapse events

A phase 3b withdrawal trial revealed that discontinuing nemolizumab significantly heightened the risk of prurigo nodularis (PN) relapse. Flare-ups in 75% of the previous responders suggests benefit from maintained treatment.

Patients with the chronic neuroimmune skin disease PN suffer from a debilitating itch and numerous pruriginous skin lesions [1]. “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. 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 in 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). Upon relapse, participants were allowed to re-enter the long-term extension study. 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 primary endpoint was time from baseline to relapse.

The primary endpoint results 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. In the withdrawal arm, 12 out of 16 participants (75%) relapsed, compared with 3 out of 18 participants (16.7%) continuing nemolizumab. “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. “I want to highlight here that no patient actually relapsed with an increase of PP-NRS to 9 or 10, indicating that there is obviously no rebound effect of itch,” Prof. Legat added. The study defined relapse as ≥4 points increase in PP-NRS score or ≥2 points increase in IGA score. 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.

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   1. 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.

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Posted on 6 November 20246 November 2024