Tapinarof cream for psoriasis leads to high clearance rates and remittive effect

A long-term assessment of topical tapinarof in the PSOARING 3 trial found a high rate of complete disease clearance as well as a lasting response up to 52 weeks in patients with psoriasis. After suspension of the psoriasis treatment, a remittive effect of the drug was observed for nearly 4 months.

“Tapinarof is a novel therapeutic aryl hydrocarbon receptor-modulating agent in development for the treatment of psoriasis and atopic dermatitis,” Dr Linda Stein Gold (Henry Ford Health System, MI, USA) introduced the first-in-class, non-steroidal agent [1]. 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 psoriasis [1,2]. The results of an earlier phase 2b trial were indicative of a possible remittive effect of tapinarof [3]. Thus, in addition to evaluating efficacy and safety, the current extension study aimed at exploring the durability of the treatment response.

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. Participants entering with a PGA ≥1 were treated with tapinarof until PGA of 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 41.3% were women. 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 with 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 approximately 4 months (130 days) for all participants who started PSOARING 3 with PGA=0 or achieved complete clearance during the trial (see Figure). “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 Stein Gold stated.

Figure: Time to first worsening for those entering the trial with complete disease clearance [1]
CI, confidence interval; PGA, Physician’s Global Assessment; SD, standard deviation.

The safety profile of long-term tapinarof treatment did not reveal any new signals. “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.

1. 
   
   1. 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.
   2. Lebwohl M, et al. Skin. 2020;4:s75.
   3. Robbins K, et al. J Am Acad Dermatol. 2019;80(3):714–721.

 

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Posted on 18 November 202130 November 2021