Tapinarof proven safe, effective for psoriasis in phase II trial
A phase II study has shown the efficacy and safety of tapinarof cream in adult patients with psoriasis.
The investigators assessed the safety and efficacy of tapinarof in a new cream formulation at two concentrations and with two application frequencies in this double-blind, vehicle-controlled, randomized, six-arm trial. Participants included adults with psoriasis with body surface involvement ≥1 percent and ≤15 percent and Physician Global Assessment (PGA) score ≥2 at baseline.
PGA of 0 or 1 at week 12 and a 2-grade improvement from baseline were the primary endpoints. Further analyses included assessment of ≥75-percent improvement of Psoriasis Area and Severity Index (PASI) and mean percent change in PASI and body surface area involvement.
Patients in the tapinarof groups had statistically significantly higher (at a 0.05 significance level) treatment success, defined by PGA 0 or 1 and a 2-grade improvement at week 12 (65 percent [1% twice daily], 56 percent [1% once daily], 46 percent [0.5% twice daily] and 36 percent [0.5% once daily]) than those in the vehicle groups (11 percent [twice daily] and 5 percent [once daily]).
Treatment success was maintained for 4 weeks post-treatment.
However, patients treated with tapinarof (85/152; 56 percent) were more likely to experience treatment-emergent adverse events (TEAEs) than those in the vehicle group (19/75; 25 percent). TEAEs were mild-to-moderate in intensity. Moreover, severe TEAEs were reported in all tapinarof groups except the 0.5% once-daily group.
Large confirmation trials are warranted, according to the investigators.