Nemolizumab efficacy in prurigo nodularis: onset of action on itch and sleep disturbances. (4th July 2022)

• Record Type: Journal Article
• Authors: Ständer, S.; Yosipovitch, G.; Lacour, J.‐P.; Legat, F.J.; Paul, C.; Reich, A.; Chaouche, K.; Ahmad, F.; Piketty, C.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 36:Number 10(2022)
• Page Start: 1820
• Page End: 1825
• Publication Date: 2022-07-04
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.18377
• Languages: English
• ISSNs: 0926-9959

Abstract

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.