Efficacy and Safety of Tapinarof for Atopic Dermatitis: A Systematic Review and Meta-Analysis of Randomized...

This systematic review and meta-analysis evaluated the efficacy and safety of 1% tapinarof cream once daily (QD) in patients with mild-to-severe atopic dermatitis (AD). Adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we systematically searched PubMed, Embase, Cochrane, and ClinicalTrials.gov databases for placebo-controlled, randomized trials up to March 2025. Four studies reporting five randomized trials involving a total of 1191 patients met the inclusion criteria. Primary endpoints included Investigator Global Assessment (IGA) success and achievement of Eczema Area and Severity Index 75% (EASI-75) response. Secondary outcomes included improvement in Peak Pruritus Numeric Rating Scale (PP-NRS) scores and incidence of adverse events (AEs). After eight weeks, patients receiving tapinarof 1% QD were associated with significantly higher IGA success rates (risk ratio (RR) = 3.03, 95% CI: 1.94-4.74, p = 0.002), EASI-75 response rates (RR = 2.99, 95% CI: 1.94-4.60, p = 0.002), and clinically meaningful improvement in PP-NRS scores of ≥4 points (RR = 1.58, 95% CI: 1.10-2.26, p = 0.03) compared to placebo. Tapinarof also showed a modest but statistically significant increase in the overall incidence of adverse events (AEs) (RR = 1.39, 95% CI: 1.02-1.90, p = 0.04), while the rate of serious AEs was not significantly different between groups (RR = 1.98, 95% CI: 0.36-24.69, p = 0.31). In conclusion, tapinarof cream 1% QD demonstrated significant efficacy in treating mild-to-severe AD, with improvements in clinical signs and pruritus. It was generally well tolerated, supporting its use as a non-steroidal topical therapy in this patient population. Protocol registered in International Prospective Register of Systematic Reviews (PROSPERO) (CRD420251000807), with risk of bias assessed using the Cochrane risk-of-bias (RoB 2) tool and certainty of evidence appraised using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.