- 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.
The phase 3 randomised-controlled OLYMPIA 1 study (NCT04501666) enrolled 286 participants with prurigo nodularis (PN) to receive either placebo or nemolizumab once every 4 weeks as sole treatment1. The 2 primary endpoints were defined as treatment responses after 16 weeks: 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.
The mean age of the participants was 57.5 and 58% were women. In this population with moderate-to-severe PN, overall 60% had a baseline IGA of 3 and the mean weekly average itch by PP NRS was 8.5.
At week 16, 58.4% achieved an itch reduction in PP NRS on nemolizumab versus 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. Sonja Ständer (Münster University Hospital, Germany) highlighted.
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 highly 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, also pointing out that nemolizumab was overall well-tolerated.
“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.