New phase II long-term data showing sustained efficacy and clearance for a median of 10 months with roflumilast cream in adults with chronic plaque psoriasis.- Arcutis Biotherapeutics
Arcutis Biotherapeutics, Inc. announced new safety and efficacy durability data from its open label Phase II long-term safety study evaluating once-daily roflumilast cream (0.3%) in adults with chronic plaque psoriasis . Roflumilast cream 0.3% (Zorvye) is a once-daily steroid free topical phosphodiesterase-4 (PDE4) inhibitor approved by the FDA in July 2022.
The study, which was presented at the Winter Clinical dermatology meeting, showed that during the trial, 57.1% (n=185) of roflumilast cream-treated patients achieved an Investigator Global Assessment (IGA) score of clear or almost clear (IGA 0/1) at any time in study, and these participants had a median duration of IGA of clear or almost clear of more than 10 months (40.1 weeks).
Additionally, the percentages of participants achieving IGA success (defined as clear/almost clear plus 2-grade improvement from baseline) and an IGA of clear or almost clear were maintained over the course of the 52 weeks, and were consistent with the DERMIS trials. Roflumilast cream was safe and very well tolerated, with the majority of adverse events (AEs) mild-to-moderate in severity.
"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,” said Mark Lebwohl, MD, FAAD, principal investigator and Dean for Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai; and a paid consultant and investigator for Arcutis.
“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.”
In the multicenter, open-label, single-arm, long-term Phase II safety trial, two cohorts of participants were enrolled (n=332). Cohort-1 participants (n=230) were those who completed the Phase IIb trial through Week 12 (roflumilast 0.3% treated, roflumilast 0.15% treated, and vehicle treated), whereas Cohort-2 participants (n=102) were newly enrolled (treatment-naïve at baseline)
Additional key findings following 52 weeks of treatment with roflumilast cream 0.3% include : i. IGA success was achieved by 35.3% of participants previously treated with roflumilast cream and 37.5% of roflumilast-naïve ii. participants. IGA success was defined as clear/almost clear plus 2-grade improvement from baseline ii. 42% of participants previously treated with roflumilast cream and 47.5% of roflumilast-naïve participants achieved an IGA score of clear or almost clear (IGA 0/1) at Week 52. iii. 66.7% of participants in Cohort-21 achieved Intertriginous-IGA (I-IGA) success, defined as clear or almost clear plus 2-grade improvement from baseline. iv. No tachyphylaxis occurred, and efficacy was consistent over time among participants who achieved an IGA of clear or almost clear.
Safety data showed rates of discontinuations due to AEs were low, and graeater than 97% of patients had no evidence of irritation per investigator local tolerability assessment at each visit. The most common AEs over the course of the trial (>2%) were upper respiratory tract infection/viral URTI (6.6%), nasopharyngitis (3.6%), urinary tract infection (3.3%), and sinusitis (2.4%). Cohort 1 was not shown because I-IGA added as study amendment and numbers of patients evaluated are very small at each timepoint.