Nemolizumab 30mg powder and solvent for solution for injection pre-filled disposable devices

This meta-analysis evaluated the efficacy and safety of nemolizumab in treating prurigo nodularis through a systematic review of randomized controlled trials. A comprehensive literature search was conducted across multiple databases, including PubMed, Embase, Cochrane Library, and Web of Science, identifying relevant studies until January 5th 2025. Four randomized controlled trials involving 859 participants were included in the final analysis. The primary outcomes assessed were itching response measured by the Worst Itch Numeric Rating Scale (WI-NRS) and Investigator's Global Assessment (IGA) success. Nemolizumab demonstrated significant improvement in itch response compared to control, with a risk ratio of 3.52 (95% CI: 2.48 to 5.02, p < 0.00001) and low heterogeneity (I² = 28%). Similarly, IGA success rates were notably higher in the nemolizumab group, with a risk ratio of 4.40 (95% CI: 2.86 to 6.75, p < 0.00001) and low heterogeneity (I² = 11%). While adverse events were slightly more frequent in the nemolizumab group, the difference was not statistically significant (RR: 1.11, 95% CI: 0.99 to 1.24). The analysis was limited by the small number of included trials, relatively short follow-up periods, and lack of subgroup analysis. Despite these limitations, the findings suggest that nemolizumab is an effective and well-tolerated treatment for prurigo nodularis. Further research with longer follow-up periods and larger, more diverse patient populations is recommended to establish the long-term efficacy and safety profile of nemolizumab in treating this condition.

Abstract licence: CC BY

[This corrects the article DOI: 10.3389/fimmu.2022.825312.].

Abstract licence: CC BY 4.0

Prurigo nodularis (PN) is a chronic skin condition characterized by severe, persistent pruritus and impairment in health-related quality of life. Dupilumab and nemolizumab are the only treatments approved by the US Food and Drug Administration and the European Medicines Agency for PN. In the absence of head-to-head comparisons, this study evaluated the comparative clinical efficacy and safety of nemolizumab versus dupilumab in an indirect treatment comparison. A systematic literature review (SLR) identified clinical trials reporting efficacy and/or safety outcomes in PN. Searches were conducted on 1 December 2025 in Embase, MEDLINE and MEDLINE In-Process, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and PsycInfo. Evidence from the SLR was synthesized using a Bayesian network meta-analysis (NMA) to generate comparative estimates. Sensitivity analyses assessed robustness to assumptions regarding missing data and differences in concomitant topical corticosteroid or calcineurin inhibitor use. Five trials were included. In base-case analyses, nemolizumab generally demonstrated greater estimated efficacy than dupilumab across pruritus-related outcomes, with statistically significant differences for selected endpoints and time points. Estimated treatment differences significantly favored nemolizumab for change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 24 weeks (mean difference - 1.30; 95% credible interval [CrI] - 2.49 to - 0.18), PP-NRS response (≥ 4-point improvement) at 12 weeks (odds ratio [OR] 3.27; 95% CrI 1.41 to 7.27), and the composite endpoint of Investigator Global Assessment success and PP-NRS response at 12/16 weeks (OR 3.35; 95% CrI 1.19 to 10.09). At earlier time points (4-6 weeks), change from baseline in PP-NRS also significantly favored nemolizumab. Sensitivity analyses were consistent with base-case findings. Treatment-emergent adverse events were similar between treatments. These findings suggest that nemolizumab may provide greater improvement in key pruritus and disease severity outcomes compared with dupilumab in patients with PN, although uncertainty remains for several endpoints.

Abstract licence: CC BY-NC

IntroductionPrurigo nodularis (PN) is a chronic, intensely itchy skin condition linked to immune and nerve dysfunction, often affecting individuals with darker skin. It severely impacts quality of life. While traditional treatments are limited, nemolizumab shows promise. However, more diverse and long-term studies are needed to confirm its effectiveness.MethodsThis systematic review followed PRISMA 2020 guidelines, analyzing studies on nemolizumab for PN. Data from multiple databases were assessed for efficacy, safety, and bias. Statistical analysis used Review Manager 5.4 with random-effects modeling and heterogeneity evaluation.ResultsThis meta-analysis included four randomized controlled trials (RCTs) involving 859 participants. Nemolizumab significantly improved Peak Pruritus Numerical Rating Scale (PP-NRS; ≥4 points) in weeks 4 and 16 [risk ratio (RR): 5.87 and 3.52], and PP-NRS ConclusionThis review confirms nemolizumab as an effective, well-tolerated treatment for PN, providing rapid relief from itching, skin lesions, and sleep issues. With a favorable safety profile, it marks a major advancement in managing this challenging, underserved condition.

Abstract licence: CC BY-NC-ND

Chronic pruritus is a common and difficult-to-manage feature of inflammatory skin conditions. It develops through complex interactions between the skin barrier, immune system, and peripheral nervous system. Interleukin-31 (IL-31) and oncostatin M (OSM), both members of the interleukin-6 (IL-6) cytokine family, share the same receptor subunit, OSM receptor β (OSMRβ), and activate common downstream intracellular pathways, particularly the Janus kinase-signal transducer and activator of transcription (JAK-STAT) cascade. This systematic review aims to synthesize evidence in the current literature that supports IL-31 and OSM signaling across chronic pruritic dermatoses, with an emphasis on downstream JAK1-STAT3 pathways. A comprehensive search was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using PubMed, Embase, Ovid MEDLINE, and the Web of Science databases. Studies evaluating OSM, IL-31, their shared receptor components (IL-31 receptor A (IL-31RA) and OSMRβ), and downstream intracellular signaling in chronic pruritic dermatoses were included. Twenty-six studies met the eligibility criteria, comprising randomized controlled trials, case-control studies, cross-sectional studies, case series, and experimental laboratory studies. Across atopic dermatitis (AD), prurigo nodularis (PN), psoriasis, cutaneous T-cell lymphoma (CTCL), dermatomyositis, and primary localized cutaneous amyloidosis (PLCA), both IL-31 and OSM contribute to chronic itch through overlapping pathways, including shared receptor architecture and activation of JAK1-STAT3 signaling. They were found to differ, however, in the way they influence neuronal activation and sensitization. IL-31 acts as a direct pruritogenic cytokine through activation of the IL-31RA/OSMRβ receptor complex on sensory neurons. In contrast, OSM may act to increase neuronal sensitivity, enhance excitability, and strengthen the response to other pruritic-inducing stimuli through the gp130/OSMRβ receptor complex. Despite these differences, both cytokines converge on the JAK1-driven STAT3 signaling pathway, ultimately contributing to skin barrier dysfunction, ongoing inflammation, and persistent neural sensitization. Blocking IL-31RA with nemolizumab or targeting OSMRβ with vixarelimab has led to clinically significant improvements in itch severity, patient-reported quality of life, and sleep disturbance. Together, these findings suggest that the shared components of the IL-31 and OSM pathways, including OSMRβ and JAK1-STAT3, provide us with a big picture framework for understanding itch pathogenesis in chronic pruritic dermatoses and may help guide therapeutic strategies in the future.

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