Introduction

Atopic dermatitis (AD) is a chronic inflammatory disease. Lebrikizumab has emerged as a potential therapeutic strategy, but their efficacy and safety profile in patients with atopic dermatitis requires comprehensive evaluation.

Aim

To evaluate the efficacy and safety of lebrikizumab in the treatment of AD and to provide evidence-based guidance for clinical use.

Methods

PubMed, Embase, Web of Science, Medline, and ClinicalTrials.gov were systematically searched for randomised controlled trials (RCTs) comparing lebrikizumab (experimental group) with placebo (control group) from database inception to December 2025. After literature screening and data extraction, the quality of included studies was assessed using the bias risk assessment tool recommended in the Cochrane Handbook for Systematic Reviews of Interventions (Version 5.1.0). Meta-analysis was performed using RevMan 5.4 software, while sensitivity analysis and publication bias analysis were conducted using Stata software.

Results

A total of 7 studies comprising 7 RCTs with 2168 patients were included. Meta-analysis results showed that patients in the experimental group had significantly higher rates of EASI 75 (OR = 3.65, 95% CI (2.58, 5.16),
p < 0.00001), EASI 90 (OR = 3.67, 95% CI (2.88, 4.67), p < 0.00001), vIGA-AD (OR = 3.29, 95% CI (2.62, 4.14), p < 0.00001), and NRS improvement ≥ 4 (OR = 3.76, 95% CI (2.96, 4.77), p < 0.00001) compared to the control group. No statistically significant differences were found between the two groups in the incidence of adverse events, serious adverse events, nasopharyngitis, or headache (p > 0.05). Subgroup analysis identified the primary sources of heterogeneity as treatment regimen (with or without concomitant TCS) and dosage. Concomitant TCS use explained 76.5% of the between-subgroup heterogeneity, with low heterogeneity within each regimen subgroup. Heterogeneity within the dosage subgroups was 0%. Baseline disease severity had a relatively minor influence. Sensitivity analysis and publication bias assessment indicated that the results of this study are robust and the possibility of publication bias is low.

Conclusions

Lebrikizumab demonstrates favourable efficacy and safety in the treatment of AD.