Nemolizumab shows high success rates in prurigo nodularis

Nemolizumab achieved the 2 primary endpoints in the phase 3 OLYMPIA 1 study for itch and Investigator’s Global Assessment (IGA) success in prurigo nodularis (PN) after 16 weeks. Statistically significant differences compared with placebo in itch reduction were already evident at week 4.

The phase 3 randomised-controlled OLYMPIA 1 study (NCT04501666) randomised 286 participants with PN to receive a sole treatment of either placebo or the first-in-class IL-31 receptor alpha antagonist nemolizumab at a dosage of 30 mg (<90 kg) or 60 mg (≥90 kg) once every 4 weeks [1]. Prof. Sonja Ständer (Münster University Hospital, Germany) pointed out that this study together with the 560 participants with PN from the OLYMPIA 2 trial (NCT04501679) form the globally largest completed phase 3 programme in this indication.

The 2 primary endpoints of OLYMPIA 1 were treatment response after 16 weeks, defined as an at least 4-point itch reduction in the Peak Pruritus Numerical Rating Scale (PP NRS), and the proportion of participants with an IGA success in terms of an IGA of 0/1 (i.e. clear to almost clear skin). The mean age of the participants was 57.5 and 58% were women. In this population with moderate-to-severe PN, 60% had a baseline IGA of 3 and the mean weekly average itch by PP NRS was 8.5. Of note, the rate of severe cases was higher in the nemolizumab group than in the placebo group (43.7% vs 35.4%).
At week 16, 58.4% achieved an itch reduction in PP NRS on nemolizumab compared with 16.7% on placebo (P<0.0001). “We see a significant separation of both groups with over 40% of patients achieving this endpoint already at week 4, and this means they received only 1 injection of nemolizumab,” Prof. Ständer highlighted. The amelioration of sleep disturbance followed similar responses over time with 49.8% versus 12.1% reaching a ≥4-point improvement on the sleep disturbance NRS at week 16.

Furthermore, 26.3% of participants on the study drug achieved IGA 0/1 compared with 7.3% in the placebo arm (P=0.0001). The inter-group differences in IGA success demonstrated significant superiority of nemolizumab as of week 8. Also, the proportion of participants with >75% healed lesions on nemolizumab was already significant at week 8 (P≤0.0001) with 47.9% versus 15.6% (P≤0.0001) at week 24. “With the conventional therapies we never saw something like this before in the moderate-to-severe PN population,” Prof. Ständer stated.

She further pointed out that nemolizumab was overall well-tolerated. Adverse events related to treatment were reported for 71.7% in the nemolizumab group and 65.3% on placebo. Study discontinuations due to treatment were 4.8% and 4.2%, respectively.

“These results confirm the results of the OLYMPIA 2 study, the other phase 3 study, and now I hope you can understand why we are so excited,” Prof. Ständer concluded.

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   1. Ständer S. Nemolizumab monotherapy improves itch and skin lesions in patients with moderate-to-severe prurigo nodularis: results from a global phase 3 trial (OLYMPIA 1). D1T01.1D, EADV Congress 2023, 11–14 October, Berlin, Germany.

 

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Posted on 28 November, 202328 November, 2023