Efficacy and safety of tapinarof in atopic dermatitis: a frequentist and bayesian meta-analysis of randomized controlled trials.

BACKGROUND

This meta-analysis evaluated the efficacy and safety of topical Tapinarof compared to placebo in patients with mild to moderate Atopic Dermatitis (AD).

METHODS

We searched PubMed, Embase, and Cochrane databases until March 2025. A total of 41 studies of Tapinarof (0.5%, 1%) versus placebo on mild to moderate AD patients, assessing IGA, EASI, PP-NRS, and safety outcomes, were identified; out of which, six RCTs met the inclusion criteria (14.6%). Two independent reviewers extracted data following PRISMA guidelines, and study quality was assessed using the Cochrane Risk of Bias 2 tool. Random-effects models were used to pool the outcomes. Primary outcome was IGA success (score 0/1 or ≥ 2-point improvement); secondary outcomes included EASI75, PP-NRS reduction, and AEs, measured as odds ratios (ORs) with 95% CIs.

RESULTS

Data from the six included RCTs (n = 1545) showed that Tapinarof significantly improved IGA success rate (OR = 5.07, 95% CI: 2.81-9.13, p < 0.001) and EASI75 (OR = 3.76, 95% CI: 1.94-7.27, p < 0.001) compared to placebo. AEs were higher with Tapinarof (OR = 2.22, 95% CI: 1.73-2.84, p < 0.001), mild to moderate severity (e.g., folliculitis). Heterogeneity was moderate (I²=61.4% for IGA); sensitivity analysis confirmed robustness.

CONCLUSIONS

Topical Tapinarof (0.5%, 1%) is effective and well-tolerated for mild to moderate atopic dermatitis, but higher adverse event rates require monitoring.