Inflammopharmacology · 2026
Efficacy and safety of tapinarof in atopic dermatitis: a frequentist and bayesian meta-analysis of randomized controlled trials.
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Meher Rachita, Mishra Archana, Srinivasan Anand, Maiti Rituparna, Hota Debasish
Аннотация
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.
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.