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SHR Neuro Cancer Cardio Lipid Metab Microb

Ständer, S; Yosipovitch, G; Lacour, JP; Legat, FJ; Paul, C; Reich, A; Chaouche, K; Ahmad, F; Piketty, C.
Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances.
J Eur Acad Dermatol Venereol. 2022; 36(10): 1820-1825. Doi: 10.1111/jdv.18377 [OPEN ACCESS]
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Co-authors Med Uni Graz: Legat Franz
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Abstract:: BACKGROUND: Patients with prurigo nodularis (PN) have multiple itchy nodules, impaired quality of life and sleep deprivation. Prurigo nodularis patients have a high burden of disease, primarily due to the intensity of the itch. It is reasonable to expect that rapid relief of itch - and associated improvement of sleep - are highly valued clinical outcomes for patients. Nemolizumab is an IL-31A-receptor inhibitor that modulates the neuroimmune response with reported positive efficacy and safety data in a phase 2 study of PN. OBJECTIVES: To evaluate the onset of action of nemolizumab on itch and sleep disturbances. METHODS: Post hoc analysis of a phase 2 trial of nemolizumab 0.5 mg/kg SC vs. placebo in patients (n = 70) with moderate-to-severe PN (≥20 nodules) and severe pruritus (NRS ≥ 7). Time to significant reduction was assessed for peak pruritus (PP) and sleep disturbance (SD) using numerical rating scales (NRS), also assessed was scratching time during sleep. RESULTS: Nemolizumab significantly reduced itch vs. placebo within 48 h (PP NRS -19.5% vs. -5.8%, respectively, P = 0.014). Significant difference between nemolizumab and placebo in reducing itch by ≥4 on PP NRS was achieved at Day 3 (23.5% vs. 0%, P < 0.001). A significant difference in SD NRS was reported by Day 4 (-24.0% vs. -4.3% placebo, P = 0.012). In addition, there was a separation between groups in SD responders (decrease of ≥4 points) in favour of nemolizumab by Day 2 (8.8% vs. 0%, P = 0.037). Sleep continued improving through Week 4, when there was a -56.0% reduction in SD NRS vs. -22.9% placebo (P < 0.001). Actigraphy data showed improvement in scratch/sleep duration for nemolizumab vs. placebo, respectively, by Week 1 (-32.15 vs. +28.15 min/h, P = 0.001). CONCLUSION: Nemolizumab has a rapid and robust onset of action in PN with itch reduction and improvement of sleep within 48 h.
Find related publications in this database (using NLM MeSH Indexing): Antibodies, Monoclonal, Humanized - administration & dosage; Humans - administration & dosage; Prurigo - complications, drug therapy; Pruritus - drug therapy, etiology; Quality of Life - administration & dosage; Sleep - administration & dosage; Sleep Wake Disorders - drug therapy, etiology