Health Canada has approved roflumilast cream 0.15% (Zoryve, Arcutis) for the treatment of mild-to-moderate atopic dermatitis (AD) in adults and children aged 6 and up.
The approval of the selective PDE4 inhibitor for AD in Canada was supported by positive results from the vehicle-controlled pivotal Phase 3 INterventional Trial EvaluatinG roflUMilast cream for the treatmENt of aTopic dermatitis” (INTEGUMENT-1 and INTEGUMENT-2), in which roflumilast cream 0.15% or vehicle was applied once-daily for four weeks to individuals 6 and older with mild-to- moderate AD involving ≥3% body surface area.
Met the Primary Endpoint
The Phase 3 trials met the primary endpoint of validated Investigator Global Assessment – Atopic Dermatitis (vIGA-AD) Success at Week 4 with significant improvements seen as early as Week 1. In addition, nine out of 10 participants experienced symptom improvement with roflumilast cream 0.15% within four weeks and 69% of patients achieved at least a 50% reduction in disease severity, as measured by the Eczema Area and Severity Index (EASI-50).
Data from the Phase 3 trials also showed that patients experienced rapid relief of itch with roflumilast cream 0.15% with over 30% of patients achieving a 4-point improvement on the Worst Itch-Numeric Rating Scale (WI-NRS) at four weeks. Significant itch relief was observed in some patients as early as 24 hours following the first application.
Additional data supporting the approval included findings from a Phase 2 dose ranging study, an open label extension study in which patients were treated for up to 56 weeks (INTEGUMENT-OLE), and two Phase 1 pharmacokinetic studies.
The incidence of Treatment Emergent Adverse Events (TEAEs) was low in both active treatment and vehicle arms, with most TEAEs assessed as mild to moderate in severity. No adverse reactions were reported in the combined Phase 3 pivotal trials that occurred at a rate greater than 2.9% in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
Offers Significant Promise
“ZORYVE cream 0.15% offers significant promise for patients with atopic dermatitis, particularly in addressing the distressing itch and skin eruptions that can disrupt daily life,” says Melinda Gooderham, MD, Medical Director at SKiN Centre for Dermatology in Peterborough, Ontario, Canada and Principal Investigator in the INTEGUMENT trials. “Its rapid symptom relief, combined with a strong safety profile, makes it a compelling option for patients seeking a targeted treatment without a steroid that supports long-term management. Atopic dermatitis goes beyond just a skin condition—it affects sleep, work, and emotional well-being. ZORYVE cream’s approval represents a valuable addition to treatment options, guided by clinical evidence and a focus on the real needs of patients.”
“We are proud to offer Canadians as young as six years old a new steroid-free option for managing atopic dermatitis that is grounded in both patient needs and clinical evidence,” adds Jamie Lewis, Vice President and General Manager, Arcutis Canada. “ZORYVE cream 0.15% represents our commitment to providing innovative solutions that address the key challenges faced by patients and healthcare providers. We are grateful to the patients and investigators who participated in the clinical trials, as their contributions have made this achievement possible.”
Health Canada has authorized the use of roflumilast foam 0.3% for the treatment of seborrheic dermatitis in patients aged 9 and older. Roflumilast foam 0.3% is under review by Health Canada for the topical treatment of scalp and body psoriasis in patients aged 12 years and older.
