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

BACKGROUND

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.

OBJECTIVES

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.

RESULTS

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.

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

CONCLUSION

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.