Final results from the Phase 3 PSOARING 3 long-term extension study show that Dermavant’s investigational tapinarof 1%, once daily, non-steroidal topical cream for the treatment of plaque psoriasis in adults was well tolerated long term, with a safety profile consistent with the pivotal studies and previously reported interim analysis of data from PSOARING 3. Tapinarof demonstrated a high rate of complete disease clearance, a median remittive effect off-therapy for approximately four months for patients entering with a PGA score of 0, durability of response for up to 52 weeks, and consistent efficacy regardless of intermittent treatment based on PGA response during the study. 

The data presented at the 30th European Academy of Dermatology and Venereology (EADV) Virtual Congress and reported by Dermavant.

 “For the millions of people living with plaque psoriasis, the chronic nature of the condition has both physical and emotional impacts, leaving many looking for additional treatment options,” said Bruce Strober, MD, PhD, Clinical Professor of Dermatology at Yale University School of Medicine, and lead investigator for the PSOARING 3 study. “These consistent PSOARING 3 safety and efficacy results suggest that, subject to FDA approval, tapinarof could be an important new topical treatment option for this debilitating condition.” 

Eligible patients completing PSOARING 1 or 2, the 12-week pivotal studies of tapinarof in adults with plaque psoriasis, could enroll in PSOARING 3, which comprised an additional 40 weeks of open-label treatment followed by a four-week follow-up. 

Analysis shows that 58.2% (302/519) of patients who entered the PSOARING 3 study with a PGA score ≥2 achieved a PGA score of 0 or 1, and 40.9% (312/763) of all patients achieved complete disease clearance (PGA score of 0). 

Treatment-emergent adverse events (TEAEs) were consistent with those from the interim analysis of data from PSOARING 3 and from the PSOARING 1 and 2 trials, with no new safety signals observed with long-term use.