Title

Tapinarof cream 1% once daily for plaque psoriasis: improvements in quality of life and clinical efficacy in two pivotal Phase 3 trials

Document Type

Conference Proceeding

Publication Date

3-13-2023

Publication Title

J Clin Aesthet Dermatol

Abstract

Background: Tapinarof cream 1% once daily (QD) demonstrated statistically significant efficacy versus vehicle and was well-tolerated in adults with mild to severe plaque psoriasis in PSOARING 1 and 2, two 12-week, Phase 3 trials. In addition, significantly greater improvements in Dermatology Life Quality Index (DLQI) change from baseline at Week 12 were observed with tapinarof versus vehicle.

Objective: To evaluate correlations between the DLQI and clinical efficacy as assessed by Physician Global Assessment (PGA) and Psoriasis Area and Severity Index (PASI) in PSOARING 1 and 2.

Methods: Patients in PSOARING 1 and 2 were randomized to tapinarof or vehicle for 12 weeks. The DLQI is a 10-item scale where each item is rated on a 4-point scale from zero (not at all) to three (very much); lower scores indicate higher quality of life (QoL). Efficacy was evaluated using PGA and PASI. Spearman rank correlations evaluated correlations between changes in efficacy and QoL from baseline at Week 12. Analyses used observed cases and were based on the intention-to-treat population.

Results: 683 tapinarof and 342 vehicle-treated patients from PSOARING 1 and 2 were included in the analyses. At baseline, 79.2 to 83.9 percent of patients had a PGA of 3 (moderate), mean PASI of 8.9-9.1, and mean DLQI of 8.2-8.7 (moderate impact of disease on QoL) in PSOARING 1 and 2. Mean change in DLQI from baseline at Week 12 was -5.0 vs -3.0 (P<0.0001) and -4.7 vs. -1.6 (P<0.0001), with tapinarof versus vehicle in each trial, respectively. The minimal clinically important difference in DLQI of 4 was exceeded at Week 12 in the tapinarof groups. A significantly higher proportion of patients achieved a DLQI of 0 or 1 at Week 12 in the tapinarof groups versus vehicle: 47.4 percent vs 23.3 percent (P<0.0001) and 44.9 percent vs 16.1 percent (P<0.0001) in each trial, respectively; statistical significance in favor of tapinarof was observed as early as Week 4. Improvements in DLQI in the tapinarof groups at Week 12 were statistically correlated with improvements in PGA (0.28 and 0.29, P<0.0001) and PASI (0.28 and 0.40, P<0.0001) in each trial, respectively.

Conclusion: Tapinarof demonstrated rapid, clinically meaningful, and statistically significant improvements in clinical efficacy and patientreported QoL. A large percentage of tapinaroftreated patients achieved a DLQI of 0 or 1, i.e., no negative effects of disease on QoL. Correlations between improvements in DLQI and clinical efficacy measures suggest that, beyond clinical improvements captured by the PASI and PGA, other important factors such as mental/emotional wellbeing and satisfaction with treatment contribute to the considerable overall improvement in QoL observed in these trials.

Volume

16

Issue

4

First Page

S30

Last Page

S31

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