- Stein Gold L. Tapinarof cream 1% once daily for plaque psoriasis: a long-term extension trial of a novel therapeutic aryl hydrocarbon receptor modulating agent. D1T01.4D, EADV Congress 2021, 29 Sept–2 Oct.
PSOARING 3 (NCT04053387) is a long-term extension trial of 2 randomised-controlled phase 3 trials (NCT03956355 and NCT03983980) in which tapinarof 1% cream demonstrated favourable outcomes in terms of efficacy and safety in treating adults with mild-to-severe psoriasis1. Besides evaluating efficacy and safety, the current study aimed at exploring the durability of treatment response along with the possibility and duration of a remittive effect of the topical aryl hydrocarbon receptor-modulating agent in intermittent treatment.
Most participants from the active and vehicle groups of the phase 3 studies were included in PSOARING 3. Thus, the trial included 763 adult psoriasis patients who received up to 40 weeks of open-label tapinarof therapy with 4 consecutive weeks of follow-up without treatment. Depending on the scores of Physician’s Global Assessment (PGA), different treatment regimens were applied. Patients entering with a PGA≥1 were treated with tapinarof until PGA=0 was achieved, and treatment discontinued thereafter. Patients who were disease-free at baseline (defined as a PGA score of 0) were kept off tapinarof and monitored. For all participants, treatment was re-administered until complete disease clearance, when the PGA reached at least 2.
The study population had a mean age of 50.7 years and 58.7% were men. As may be expected, there were substantial differences in PGA status between patients who partook in the tapinarof groups of the phase 3 trial versus those who had been randomised to the vehicle. All in all, 10.4% entered the study with a PGA of 0 and 21.1% with a PGA of 1.
The results showed a disease clearance with a PGA of 0 in 40.9% of participants at least once during the study. Of those who presented a PGA≥2 at the beginning of the trial, 58.2% achieved PGA 0/1. Interestingly, for subjects entering the trial at PGA=0, the median time to first worsening, while off treatment was 115 days. The remittive effect was nearly 4 months (130 days) for all patients that started PSOARING 3 with PGA=0 or achieved complete clearance during the trial. “No loss of response on therapy was demonstrated for up to 52 weeks with intermittent use of tapinarof 1% once daily, indicating no tachyphylaxis across groups based on the proportion of patients achieving a PGA score of 0/1,” Dr Linda Stein Gold (Henry Ford Health System, MI, USA) stated.
The safety profile of long-term tapinarof treatment did not reveal new signals compared to predecessing investigations. “The incidence and severity of folliculitis and contact dermatitis were mild or moderate and were neither increased nor worsened with long term treatment,” Dr Stein Gold pointed out. “Tapinarof has the potential to offer important benefits in the topical treatment of psoriasis,” she concluded.