Dermatology: Practical and Conceptual Letter to the Editor | Dermatol Pract Concept. 2025;15(4):5967 1 The Efficacy and Safety of Nemolizumab in Patients with Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials Hicham Titou1 1 Department of Dermatology-Venereology, Avicenne Military Hospital, Faculty of Medicine and Pharmacy, Cadi Ayyad University, Marrakech, Morocco Citation: Titou H. The Efficacy and Safety of Nemolizumab in Patients with Prurigo Nodularis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Dermatol Pract Concept. 2025;15(4):5967. DOI: https://doi.org/10.5826/dpc.1504a5967 Accepted: April 9, 2025; Published: October 2025 Copyright: ©2025 Titou. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (BY-NC-4.0), https://creativecommons.org/licenses/by-nc/4.0/, which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original authors and source are credited. Funding: None. Competing Interests: None. Authorship: All authors have contributed significantly to this publication. Corresponding Author: Hicham Titou, Dermatologist, Department of Dermatology-Venereology, Avicenne Military Hospital, Cadi Ayyad University, Marrakech, Morocco. ORCID: 0000-0001-9290-7627. Email: titou.medic@gmail.com To the Editor, Recent advancements in the understanding of Prurigo nodu- laris (PN) immunopathogenesis have led to more treatment choices. Since August 2024, nemolizumab has been ap- proved by the US Food and Drug Administration [1]. We systematically reviewed the efficacy and safety of nemoli- zumab among existing randomized, double-blinded, and placebo-controlled clinical trials. We performed every step according to the Preferred Re- porting Items for Systematic Reviews and Meta-Analyses guidelines. We searched electronic databases (Embase, Sco- pus, PubMed, and Cochrane) from their inception to 01 Jan- uary 2025. The search strategies and methods are provided in Supplementary Figure A1 and Materials (Available via Men- deley at https://data.mendeley.com/datasets/tghtskv98w/1). Finally, this study included four studies involving 560 pa- tients in experimental groups and 299 patients in control groups. We summarized the primary and second endpoints of each study in Supplementary Table 1 (Available via Men- deley at https://data.mendeley.com/datasets/tghtskv98w/1). Overall, compared with placebos, the use of nemoli- zumab treatment showed a significant improvement in the lesion score and pruritus from week 4: Peak Pruritus Nu- merical Rating Scale (PP-NRS) improvement ≥4 points (odds ratio (OR): 9.27; 95% confidence interval (CI): 5.08– 16.90; P<0.00001) and Investigators’ Global Assessment score (IGA 0/1) (OR: 3.24; 95% CI: 0.45–23.49; P=0.02) (Figures 1 and 2). The intense itching associated with PN significantly af- fects patients’ quality of life, leading to sleep disturbances, particularly during the evening [2]. The results of the meta-analysis indicated that nemolizumab has better per- formance than does the placebo on the Sleep Disturbance Numerical Rating Scale (SD-NRS) (OR: 6.33; 95% CI: 3.51–11.41; P<0.00001). (Supplementary Figure A2, avail- able via Mendeley at https://data.mendeley.com/datasets/ tghtskv98w/1). 2 Letter to the Editor | Dermatol Pract Concept. 2025;15(4):5967 The safety profile and efficacy of nemolizumab were similar to dupilumab [3]. Nemolizumab demonstrated the highest risk of AEs, and the incidence was significantly higher than that of the placebo. Twenty-nine patients in the nemolizumab-treated group experienced serious AEs, and 22 of them discontinued the treatment. The most commonly reported serious AEs of nemolizumab were infection (OR: 0.81; 95% CI: 0.53–1.24; P=0.52), atopic dermatitis (OR: 2.68; 95% CI: 0.54–13.24; P=0.21), peripheral or facial edema (OR: 1.83; 95% CI: 0.50–6.69; P=0.70), and asthma (OR: 1.35; 95% CI: 0.35–5.16; P=0.77), all of which were mild-to-moderate in severity (Supplementary Figure A3, available via Mendeley at https://data.mendeley.com/ datasets/tghtskv98w/1). In conclusion, this meta-analysis showed that nemoli- zumab is a promising treatment option for PN. Further stud- ies with long follow-up will be needed to fully elucidate the safety profile of nemolizumab. Figure 1. Forest plot of effect of nemolizumab treatment on PP-NRS improvement ≥4 points in prurigo nodularis patients. Figure 2. Forest plot of effect of nemolizumab treatment on Investigator’s Global Assessment score (IGA 0/1) in prurigo nodularis patients. Letter to the Editor | Dermatol Pract Concept. 2025;15(4):5967 3 References 1. Galderma receives U.S. FDA approval for Nemluvio (nemoli- zumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed January 1, 2025. 2. Ständer S, Fofana F, Dias-Barbosa C, et al. The Sleep Distur- bance Numerical Rating Scale: Content Validity, Psychometric Validation, and Meaningful Within-Patient Change in Prurigo Nodularis. Dermatol Ther (Heidelb). 2023;13(7):1587-1602. DOI:10.1007/s13555-023-00962-8. PMID: 37329468. 3. Brooks SG, Yosipovitch G. A critical evaluation of nemoli- zumab for prurigo nodularis. Expert Rev Clin Immunol. 2024;20(6):577-587. DOI:10.1080/1744666X.2024.2306225. PMID: 38217530.