# Real-World Effectiveness and Safety of Tapinarof 1% Cream in Psoriasis: An Observational Study From Bangladesh

## TL;DR

This study from Bangladesh shows that combining tapinarof cream with a corticosteroid improves psoriasis more than using tapinarof alone.

## Contribution

The study provides real-world evidence of tapinarof's effectiveness in a low-resource setting and compares it with combination therapy.

## Key findings

- Combination therapy led to significantly greater PASI reduction compared to monotherapy at week 12.
- PASI75 and PASI90 responses were higher in the combination group than in the monotherapy group.
- Adverse events were mild and similar across both treatment groups.

## 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.