IL-31 inhibition with nemolizumab demonstrated improvement of various symptoms of prurigo nodularis in the phase 3 OLYMPIA 2 trial. After 16 weeks of treatment, the pruritus decreased by 4 or more points on the Peak Pruritus Numerical Rating Scale (PP-NRS) in 56.3% of patients who were administered the study drug.
Shawn Kwatra, MD, presented the results of the OLYMPA 2 trial at 2023 American Academy of Dermatology annual meeting. The trial was designed to assess the IL-31 receptor α antagonist nemolizumab for its potential in treating prurigo nodularis1.
A total of 274 adults with prurigo nodularis were randomized 2:1 and treated with either subcutaneous nemolizumab at a dosage of 30mg (bodyweight <90 kg) or 60 mg (bodyweight ≥90 kg) every 4 weeks or placebo. The coprimary endpoints were defined as an at least 4-point improvement in the PP-NRS at week 16 and the percentage of patients with Investigator’s Global Assessment (IGA) success, measured by a score of 0-1 plus a 2-grade or greater reduction at the same time point.
The cohort had a mean age of 52.7, just over 60% were women, and 43% presented with severe itch on the average weekly PP-NRS. Of total patients, 37.2% had a nodule count of greater than 100. Compared with baseline, 56.3% of those on nemolizumab and 20.9% on placebo reached a 4-point or greater PP-NRS improvement (P<0.0001). Significant differences were observed as of week 4. Furthermore, in the nemolizumab arm, a greater proportion of IGA success was noted (37.7% vs 11.0%; P<0.0001). A significant decrease in sleep disturbance of 4-point or greater was noted on the NRS (51.9% vs 20.9%; P<0.0001).
Treatment-emergent events occurred in 61.2% on nemolizumab and 52.7% on placebo, with a fraction of any serious events in 2.2% and 5.5%.
All in all, the monotherapy with nemolizumab involved significant benefits in itch, lesions, and sleep impairments, while showing a consistent safety profile.
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