Roflumilast cream 0.15% (Zoryve; Arcutis Biotherapeutics) has received FDA approval for the topical treatment of mild-to-moderate atopic dermatitis (AD) in patients aged 6 years and older. This approval marks a significant advancement in non-steroidal treatment options for pediatric AD, offering a safe and effective alternative for managing this common skin condition.
The FDA's decision was supported by data from the INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600) trials, two identical phase 3, parallel-group, double-blind, vehicle-controlled studies. These trials involved over 1300 adults and children aged 6 years or older with mild-to-moderate AD, comparing the efficacy and safety of roflumilast cream 0.15% to a vehicle cream when applied once daily for 4 weeks.
Clinical Trial Results
The trials demonstrated that approximately 31% of children and adults treated with roflumilast cream 0.15% achieved Investigator Global Assessment (IGA) Success at Week 4, compared to 14% for the vehicle group. Significant improvements were observed as early as Week 1. According to Eric Simpson, MD, MCR, FAAD, a lead author in the clinical trial publication in JAMA Dermatology, roflumilast cream 0.15% rapidly and significantly reduced itch compared to vehicle. Over 30% of patients treated with roflumilast cream 0.15% achieved Worst Itch-Numeric Rating Scale (WI-NRS) Success at Week 4, with improvements seen within 24 hours of the first application.
Impact on Itch
Itch is a particularly troublesome symptom of AD, significantly impacting patients' quality of life and often leading to sleep disturbances. "Improvement in itch was observed within 24 hours of first application compared to vehicle, as measured by change from baseline in daily WI-NRS scores, which will be a welcome relief for our patients," Dr. Simpson noted. The rapid reduction in itch offers a crucial benefit for children with AD and their families.
Safety and Tolerability
Investigators reported that 95% of patients treated with roflumilast cream 0.15% showed no signs of irritation at the application site at each time point. Furthermore, over 90% of patients self-reported no sensation or only mild sensation at the application site. The incidence of treatment-emergent adverse events (TEAEs) was low in both the active treatment and vehicle arms, highlighting the favorable safety and tolerability profile of roflumilast cream 0.15%.
Role of Pediatricians
Dr. Simpson suggests that pediatricians can confidently consider roflumilast cream 0.15% as a once-daily treatment option for their AD patients aged 6 years and older. Referral to a pediatric dermatologist is recommended if patients do not respond to topical therapy or present with an unusual condition.
The availability of a safe, effective, and steroid-free topical treatment like roflumilast cream 0.15% represents a valuable addition to the AD treatment landscape, addressing a significant unmet need for pediatric patients.
