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The FDA recently approved roflumilast 0.3% foam for the treatment of plaque psoriasis of the scalp and body in both adolescents and adults. To better understand how this newly approved therapy fits into clinical practice, what the data show and which patients are likely to benefit, we spoke with Dr Jennifer Soung (Harbor University of California, Los Angeles and Southern California Dermatology, Santa Ana, CA, USA), a key investigator on the phase 3 ARRECTOR trial.

FDA approval of nemolizumab gives new treatment option for prurigo nodularis

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Published Online: Aug 14th 2024

The FDA has approved nemolizumab-ilto (Nemluvio; Galderma) for treating prurigo nodularis, a chronic skin condition characterized by intensely itchy nodules. Nemolizumab is the first approved monoclonal antibody specifically inhibiting the signaling of IL-31, a neuroimmune cytokine that drives multiple disease mechanisms in prurigo nodularis

The efficacy of nemolizumab was demonstrated in two pivotal phase 3 trials, OLYMPIA 1 and OLYMPIA 2. The key efficacy measures included the proportion of patients who achieved at least a 4-point reduction in itch intensity, the proportion with an Investigator Global Assessment (IGA) score of 0 (clear) or 1 (almost clear), and those who responded positively in both measures.

In OLYMPIA 1, 22% of patients treated with nemolizumab achieved both a significant reduction in itch intensity and an IGA score of 0 or 1, compared to just 2% of the placebo group. Additionally, 56% of nemolizumab patients saw a 4-point improvement in itch intensity and 32% had a Peak-Pruritus Numerical Rating Scale (PP-NRS) score of less than 2, compared to 16% and 4% in the placebo group, respectively.

OLYMPIA 2 yielded similar results, with 25% of nemolizumab patients achieving the combined itch and IGA outcome, compared to 4% of the placebo group. The study also showed that 49% of nemolizumab patients achieved at least a 4-point improvement in itch, and 31% had a PP-NRS score below 2, compared to 16% and 7% in the placebo group, respectively.

The most common adverse reactions reported with nemolizumab were headache, atopic dermatitis, eczema, and nummular eczema. This approval provides a promising new treatment option for those suffering from prurigo nodularis, addressing an unmet need in dermatology.

Disclosures: This article was created by the touchDERMATOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.

 

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