Tapinarof improves plaque psoriasis severity in phase 3 trials
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Tapinarof cream 1% met its secondary endpoints in two phase 3 trials for the treatment of plaque psoriasis, according to a poster presented at AAD VMX 2021.
“We look at the primary endpoint, which is getting to clear or almost clear with a two-grade improvement, but there’s also some important information that’s included as a secondary outcome,” study co-author Linda Stein Gold, MD, told Healio.
The two identically designed, multicenter, double-blind, vehicle-controlled, randomized trials randomly assigned patients 2:1 to receive tapinarof cream 1% or vehicle cream for 12 weeks.
The PSOARING 1 trial included 510 patients, while the PSOARING 2 trial included 515 patients.
After 12 weeks of treatment, a statistically significant number of patients in both tapinarof cohorts experienced Psoriasis Area and Severity Index scores of 75 or 90.
PASI 75 was reported in 36.1% of the PSOARING 1 tapinarof group and 47.6% of the PSOARING 2 tapinarof group compared with 10.2% and 6.9% of the vehicle groups, respectively.
PASI 90 was recorded in 18.8% of the PSOARING 1 tapinarof cohort and 20.9% of the PSOARING 2 tapinarof cohort. The vehicle groups had PASI 90 response rates of 1.6% and 2.5%, respectively.
“PASI 90 is a really high bar and is basically looking at patients who had a full 90% improvement in their overall psoriasis. This was a highly statistically significant difference,” Stein Gold said.
In addition, psoriasis body surface area (BSA) decreased by 3.5% in the PSOARING 1 tapinarof group compared with a decrease of 0.2% in the vehicle group. In the PSOARING 2 tapinarof cohort, BSA decreased by 4.2% compared with an increase of 0.1% in the vehicle group.
“This is a new treatment approach for psoriasis,” Stein Gold said. “When we look at the data, we find that there was meaningful improvement in the amount of psoriasis that remained, the overall clearing of the skin and the number of patients who got to clear or almost clear.”
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Stein Gold L, et al. Tapinarof cream 1% once daily for psoriasis: Secondary efficacy outcomes from two pivotal phase 3 trials. Presented at: AAD VMX; April 23-25, 2021 (virtual meeting).
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