# Efficacy and safety of nemolizumab in prurigo nodularis: a systematic review and meta-analysis of randomized controlled trials

**Authors:** Ana Carolina Putini Vieira, Maria Antônia Costa Cruz Akabane, Gianna Carolinne Graff Caletti, Kélen Klein Heffel, Amanda Tauana Oliveira e Silva

PMC · DOI: 10.1016/j.abd.2025.501210 · 2025-10-18

## TL;DR

Nemolizumab, a drug targeting IL-31, effectively reduces itching and skin lesions in patients with prurigo nodularis, with a favorable safety profile.

## Contribution

This study provides a meta-analysis of RCTs showing nemolizumab's efficacy and safety in treating prurigo nodularis.

## Key findings

- Nemolizumab significantly reduced pruritus at week-4 and week-16 compared to placebo.
- It improved Investigator’s Global Assessment success rates at week-16.
- Nemolizumab showed a favorable safety profile with no significant increase in adverse events.

## Abstract

Prurigo nodularis (PN) is a chronic, debilitating inflammatory skin disorder characterized by persistent itching, firm pruritic nodular lesions, and evidence of frequent scratching, like excoriation, and lichenification. Nemolizumab, a monoclonal antibody targeting IL-31, has shown significant improvements in skin lesions, itching, and sleep disturbances by reducing type 2 immune responses in PN.

Evaluate the efficacy and safety of nemolizumab in treating PN by systematically analyzing randomized controlled trials (RCTs). Methods: The authors conducted a systematic review and meta-analysis by searching Pubmed, Embase, Cochrane Central and Scopus for RCTs comparing nemolizumab to placebo for PN. Statistical analysis usedR Studio 4.3.2.

Three trials, involving 630 patients, were included. Nemolizumab significantly reduced pruritus at week-4 (MD = −32.04; 95% CI: −38.47, −25.62) and at week-16 (MD = −347.34; 95% CI: −1039.71, 345.04). Investigator’s Global Assessment (IGA) success favored Nemolizumab at week-16 (RR = 3.50; 95% CI: 2.18, 5.63). No significant differences were observed in adverse events (RR = 1.10; 95% CI: 0.97, 1.25) or serious adverse events (RR = 0.77; 95% CI: 0.43, 1.39). Nemolizumab also significantly reduced neurodermatitis.

Limitations include variability in treatment duration, small sample sizes, and the lack of direct comparisons with other biologics.

Our meta-analysis shows that Nemolizumab significantly improves pruritus, IGA success rates, and PAS > 75% in treating patients with moderate to severe PN. Its safety profile is favorable, with no significant differences in adverse events compared to placebo. These findings support Nemolizumab as a viable treatment for moderate to severe PN.

## Linked entities

- **Proteins:** IL31 (interleukin 31)
- **Diseases:** prurigo nodularis (MONDO:0026045), neurodermatitis (MONDO:0006585)

## Full-text entities

- **Genes:** IL31 (interleukin 31) [NCBI Gene 386653] {aka IL-31}
- **Diseases:** nodular lesions (MESH:D020518), inflammatory skin disorder (MESH:D012868), sleep disturbances (MESH:D012893), skin lesions (MESH:D012871), neurodermatitis (MESH:D009450), PN (MESH:D011536), itching (MESH:D011537)
- **Chemicals:** Nemolizumab (MESH:C000612881)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Figures

9 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12555766/full.md

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Source: https://tomesphere.com/paper/PMC12555766