Abstract
Background Tapinarof 1% cream, a non-steroidal topical aryl hydrocarbon receptor (AhR) agonist, has demonstrated effectiveness in the treatment of psoriasis. However, real-world data from low-resource settings is scarce. This study evaluated the real-world effectiveness and safety of tapinarof 1% cream in adults with mild to moderate plaque psoriasis, and it explored differences in outcomes between tapinarof monotherapy and tapinarof combined with a moderately potent topical corticosteroid (clobetasone butyrate). Between-group comparisons were prespecified as exploratory and associative due to non-random allocation. Methods In this prospective observational study, 122 patients with confirmed plaque psoriasis received tapinarof monotherapy (n = 72) or combination therapy with topical corticosteroids (n = 50). Disease severity was assessed using the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA) at baseline and at weeks 4, 8, and 12. PASI75 and PASI90 responses were analyzed using odds ratios (ORs) and 95% confidence intervals (CIs). Multivariable-adjusted and longitudinal sensitivity analyses were performed. Adverse events (AEs) were recorded. Results At week 12, mean PASI decreased from 6.02 ± 2.40 to 2.78 ± 1.28 in the monotherapy group (p = 0.045) and from 6.46 ± 2.06 to 1.38 ± 1.14 in the combination group (p < 0.001), with a significant between-group difference (p < 0.001). PASI75 was achieved by 30 (60.0%) patients in the combination group and 10 (13.9%) in the monotherapy group (OR = 6.25, 95% CI: 2.38-16.67; p < 0.001). PASI90 responses occurred in 14 (28.0%) and six (8.3%) patients, respectively (OR = 4.35, 95% CI: 1.52-12.50; p = 0.043). Mean changes in PGA differed between groups (p = 0.038). AEs were mild and similar across groups. Conclusion Combination therapy was associated with greater clinical improvement than tapinarof monotherapy in this observational cohort; however, these findings represent associations rather than causal effects, and the incremental contribution of tapinarof cannot be isolated because the combination arm included topical corticosteroids. Randomized studies are required to confirm comparative effectiveness.