Nemolizumab Rapidly Relieves Itch and Sleep Disturbances in Patients with Prurigo Nodularis - European Medical Journal
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Nemolizumab Rapidly Relieves Itch and Sleep Disturbances in Patients with Prurigo Nodularis

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EMJ Dermatology 9.1 Feature Image
Authors:
*Sonja Ständer,1 Gil Yosipovitch,2 Jean-Philippe Lacour,3 Franz J. Legat,4 Carle Paul,5 Adam Reich,6 Kamel Chaouche,7 Faiz Ahmad,8 Christophe Piketty7
Disclosure:

Ständer has served as a member of an advisory board and/or received consulting fees from Almirall, Bayer, Beiersdorf, Bellus, Bionorica, Cara Therapeutics, Celgene, Clexio, DS Biopharma, Galderma, Menlo Therapeutics, Novartis, Perrigo, and Trevi Therapeutics; and has served as an investigator for Dermasence, Galderma, Kiniksa, Menlo Therapeutics, Novartis, Sanofi, Trevi Therapeutics, and Vanda Therapeutics. Yosipovitch has served as an advisory board member, investigator, and/or received consulting fees from Galderma, Pfizer, Sanofi Regeneron, Novartis, Eli Lilly, Kiniksa, Vellus, and Celldex. Lacour has received grants/research support as an investigator from AbbVie, BMS, Boehringer-Ingelheim, Celgene, Dermira, Galderma, Janssen, Eli Lilly and Company, Merck, Novartis, Regeneron Pharmaceuticals Inc, and Roche; honoraria, advisory board, or consulting fees from AbbVie, BMS, Celgene, Galderma, Eli Lilly and Company, Novartis, and Sanofi; funding for medical writing from Galderma; and has received consulting fees from Eli Lilly and Sanofi. Legat is/was an investigator for DS Biopharma, Eli Lilly, Galderma, Pfizer, Menlo Therapeutics, Trevi Therapeutics; a consultant for Galderma; and a member of advisory boards and/or has received speaker honoraria/travel fees from AbbVie, Almirall, Celgene, Eli Lilly, Janssen, Leo Pharma, Menlo Therapeutics, Novartis, Pfizer, Trevi Therapeutics, and Vifor Fresenius Medical Care Renal Pharma. Paul has received grants and has been a consultant for Almirall, Amgen, AbbVie, Bristol Myers Squibb, Boehringer, Celgene, Eli Lilly, Janssen, Leo Pharma, Merck, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi, and UCB Pharma; and has been an investigator for Eli Lilly, Leo Pharma, Pierre Fabre, Regeneron, and Sanofi. Reich has served as an investigator for AbbVie, Drug Delivery Solutions Ltd, Genentech, Janssen-Cilag, Kymab Ltd, Leo Pharma, Menlo Therapeutics, MetrioPharmAG, Merck Sharp and Dohme, Novartis, Pfizer, and Trevi therapeutics; and has received consulting fees and/or honoraria from AbbVie, Bioderma, Celgene, Chema-Elektronet, Eli Lilly, Galderma, Jansse-Cilag, Leo Pharma, Medac, Menlo Therapeutics, Novartis, Pierre Fabre, Sandoz, and Trevi Therapeutics. Chaouche, Ahmad, and Piketty are employees of Galderma.

Acknowledgements:

The authors would like to thank the Nemolizumab Study Team and all investigators in Europe who participated in this clinical trial. The study was funded by Galderma.

Citation
EMJ Dermatol. ;9[1]:63-64. Abstract Review No. AR7.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

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BACKGROUND AND AIMS

Patients with prurigo nodularis (PN) have intensely itchy nodular skin lesions resulting in a markedly impaired quality of life and frequent sleep deprivation. Nemolizumab is an IL-31A–receptor inhibitor that modulates the neuroimmune response to IL-31. Phase II trial data showed that nemolizumab significantly improves PN skin lesions and reduces itch compared to placebo with a favorable safety profile. A secondary analysis was conducted to determine the onset of significant reductions in pruritus and sleep disturbance.

MATERIALS AND Methods

Nemolizumab was studied in a 12-week Phase II randomised, double-blind, placebo-controlled trial of PN. Patients had moderate-to-severe PN with lesions on upper limbs and ≥20 nodules on the body and severe pruritus (peak pruritus numerical rating scale [PP-NRS] ≥7 over the previous week, scale 0–10). Nemolizumab 0.5mg/kg was administered subcutaneously at baseline, Week 4, and Week 8, and safety assessments were performed through to Week 18. In this secondary analysis, time to onset of significant reduction was assessed for pruritus and sleep disturbance (NRS). Changes in scratching time during sleep (ratio of scratch duration versus sleep duration in minutes per hour) as captured by actigraphy data were also assessed.

RESULTS

A total of 70 patients were randomised (nemolizumab n=34; placebo n=36) with a baseline PP-NRS of 8.4 in both groups. The groups were comparable in baseline itch, but there were more patients with severe disease (IGA 4) in the nemolizumab group (n=18 [53%] versus n=14 [39%] in placebo group). Baseline sleep disturbance NRS (SD-NRS) was 7.4 and 6.8 in the nemolizumab and placebo group, respectively.

By Day 2, reduction of itch in patients treated with nemolizumab was significantly greater than in patients receiving placebo (PP-NRS -19.5% versus -5.8%, respectively; p=0.014). A significant difference between nemolizumab and placebo in the response criteria for itch (PP-NRS ≥4) was achieved at Day 3 (23.5% versus 0.0%; p<0.001). A significant difference in SD-NRS was reported by Day 4 (-19.8% versus -4.3% with placebo; p=0.012).

Sleep continued improving through Week 4 (last data capture), when there was a 56.0% reduction in sleep disturbance NRS compared with -22.9% in the placebo group (Δ33.1; p<0.001).

Actigraphy data showed significant differences in scratch/sleep duration for nemolizumab versus placebo, respectively, at Week 1 (-32.15 versus +28.15 min/hour; Δ-60.3; p=0.001), Week 2 (-41.23 versus +35.92 min/hour; Δ-77.2; p<0.001), and Week 4 (-42.32 versus +0.68 min/hour; Δ-43.0; p=0.049).

CONCLUSION

Nemolizumab has a very rapid onset of action in patients with moderate-to-severe PN demonstrating a significant itch reduction as early as Day 2 and a significant improvement in sleep as early as Day 4.