Managing Itching and Lesions in Patients with Prurigo Nodularis with Nemolizumab
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on March 31st, 2025
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Prurigo nodularis is an inflammatory skin disorder driven by interleukin-31, characterized by severe itching that leads to scratching, which can result in bleeding and sleep disturbances. Funded by Galderma, a study was conducted to evaluate the effectiveness of nemolizumab, an IL-31 receptor antagonist, in managing prurigo nodularis.
The phase 3 clinical trial enrolled 286 participants with a mean age of 57.5 years who had been diagnosed with prurigo nodularis for at least 6 months. Patients had severe disease, as evidenced by a baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score of 8.5 out of 10, and only those with more than 20 lesions were included—35% of whom had over 100 lesions. The Investigator’s Global Assessment (IGA) indicated that 59.1% of participants had a score of 3, while 40.9% had a score of 4, representing the most severe form of the disease. In terms of prior treatments, 55.9% of patients had received topical therapy, and 39.6% had been treated with systemic therapy. The most commonly used medication was oral antihistamines (20.6%), followed by systemic corticosteroids (13.6%) and nonsteroidal immunosuppressants (12.2%).
Patients were randomly assigned to receive a subcutaneous injection of either a placebo or nemolizumab every 4 weeks. Those receiving nemolizumab started with an initial dose of 60 mg; for patients weighing over 90 kg, this dose was maintained, while for those under 90 kg, the dose was reduced to 30 mg. After 24 weeks of treatment, the researchers found that nemolizumab significantly reduced itching, as measured by the PP-NRS. In addition, the treatment resulted in a greater number of healed lesions and a marked decrease in disease severity according to the IGA. The researchers noted that future studies should compare the efficacy of nemolizumab with dupilumab—an IL-4 and IL-13 receptor antagonist already approved for managing prurigo nodularis.
The phase 3 clinical trial enrolled 286 participants with a mean age of 57.5 years who had been diagnosed with prurigo nodularis for at least 6 months. Patients had severe disease, as evidenced by a baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score of 8.5 out of 10, and only those with more than 20 lesions were included—35% of whom had over 100 lesions. The Investigator’s Global Assessment (IGA) indicated that 59.1% of participants had a score of 3, while 40.9% had a score of 4, representing the most severe form of the disease. In terms of prior treatments, 55.9% of patients had received topical therapy, and 39.6% had been treated with systemic therapy. The most commonly used medication was oral antihistamines (20.6%), followed by systemic corticosteroids (13.6%) and nonsteroidal immunosuppressants (12.2%).
Patients were randomly assigned to receive a subcutaneous injection of either a placebo or nemolizumab every 4 weeks. Those receiving nemolizumab started with an initial dose of 60 mg; for patients weighing over 90 kg, this dose was maintained, while for those under 90 kg, the dose was reduced to 30 mg. After 24 weeks of treatment, the researchers found that nemolizumab significantly reduced itching, as measured by the PP-NRS. In addition, the treatment resulted in a greater number of healed lesions and a marked decrease in disease severity according to the IGA. The researchers noted that future studies should compare the efficacy of nemolizumab with dupilumab—an IL-4 and IL-13 receptor antagonist already approved for managing prurigo nodularis.