Roflumilast-treated patients sustain psoriasis clearance for median 10 months

Once-daily Zoryve showed efficacy and an IGA of clear or almost clear for a median of 10 months in adults with chronic plaque psoriasis, Arcutis Biotherapeutics announced in a press release.

Zoryve (roflumilast cream 0.3%), a once-daily steroid free topical PDE4 inhibitor, was approved by the FDA in July 2022 and has undergone a phase 2 safety study for its indication in plaque psoriasis.

Presented at the Winter Clinical Dermatology Conference, the results of this open label phase 2 long-term safety study showed that 57.1% of patients treated with roflumilast 0.3% cream achieved an IGA score of clear or almost clear during any point in the study. Additionally, patients sustained this score at a median duration of more than 10 months.

“We know roflumilast cream is a safe and effective treatment option for those with plaque psoriasis, but what makes these data so exciting is that it shows roflumilast cream continues to be effective over a long period of time with no signs of tachyphylaxis, which is an important consideration when choosing a treatment option for a chronic skin condition,” Mark G. Lebwohl, MD, FAAD, dean of clinical therapeutics and chair emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai, and a lead investigator of the roflumilast clinical trials, said in the release.

“Importantly, the trial design allowed patients to use roflumilast cream 0.3% similar to how it is expected to be used in the real world, adjusting application for clearance of lesions across the body while maintaining results,” Lebwohl continued.

The study included 332 patients in two cohorts, with the first cohort (n = 230) comprising patients who completed the phase 2b trial through week 12 and the second cohort (n = 102) comprising those who were newly enrolled and treatment-naïve at baseline. Additional findings following 52 weeks of treatment showed that 37.5% of roflumilast-naïve participants and 35.3% of those previously treated with the drug achieved a 2-point improvement from baseline on the IGA. Furthermore, 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear at week 52, while 42% of those previously treated with the drug achieved the same outcome.

According to the release, safety data from the trial showed at least 97% of patients had no evidence of irritation. The most common adverse events included upper respiratory tract infection (URTI) or viral URTI (6.6%), nasopharyngitis (3.6%), urinary tract infection (3.3%) and sinusitis (2.4%).