Late-breaking data showing that roflumilast cream 0.05% improved atopic dermatitis (AD) symptoms in kids between the ages of 2 to 5 as early as 24 hours following the first application, made a big splash at the recent American Academy of Dermatology meeting in San Diego, CA.
Arcutis’ roflumilast cream 0.3% is U.S. Food and Drug Administration approved for psoriasis in patients aged 6 and older and a foam formulation is approved for seborrheic dermatitis in patients aged 9 and older. The drug has previously been studied at the 0.15% concentration for atopic dermatitis in patients ages 6 and older, but the new study looked at the 0.05% preparation of the roflumilast cream in younger kids.
The Dermatology Digest magazine chatted with study author Lawrence Eichenfield, MD, about the research and its implications. Dr. Eichenfield is Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital–San Diego, Vice Chair of the Department of Dermatology, and Professor of Dermatology and Pediatrics at the University of California, San Diego (UCSD) School of Medicine. Here’s what he had to say:
What is the main takeaway of this study?
Lawrence Eichenfield, MD: “The INTEGUMENT-PED study found that once-daily treatment with steroid-free roflumilast cream 0.05% significantly improved pediatric atopic dermatitis (AD) in patients between the ages of 2 to 5, with significant differences as compared to the vehicle cream at week 4, with statistical differences as early as week 1, as well as showing reduction in itch in the first 24 hours following application for pediatric atopic dermatitis patients. Additionally, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to the vehicle (20.6%). These results, along with prior studies of roflumilast cream 0.15%, show the consistent and effective response of roflumilast cream across both young children (ages 2 to 5) and children (ages 6+) and adults. The drug appeared to be well tolerated, with low rates of application reactions. Based on the study findings, it is expected that roflumilast cream 0.05%, if approved, will help provide an effective and tolerable atopic dermatitis treatment option for pediatric patients. “
Is there still an unmet need in kids with AD?
Dr. Eichenfield: “AD is a chronic, relapsing disease that can severely impact quality of life. There is currently a gap in care and a significant unmet need for safe and efficacious AD topical steroid-free treatments. Children’s skin is uniquely sensitive, so having a tolerable treatment is also important. For younger children, there is also a desire for steroid-free options and options that can deliver drug without causing damage to the skin barrier. The results from the INTEGUMENT-PED trial demonstrate the potential of roflumilast cream 0.05% to address the unmet needs and advance the standard of care of the treatment of atopic dermatitis in children between the ages of 2 to 5. I am hopeful that roflumilast cream 0.05%, if approved, will have a meaningful impact for this young pediatric population and their caregivers.”
How do you decide whether to use a systemic or topical in pediatric AD?
Dr. Eichenfield: “When evaluating treatment, considerations include location of disease, extent of body surface area (BSA) involvement, and severity of the eczema, as well as the impact of AD on the patient’s life. Ideally, having a topical treatment that is effective on the face, or sensitive areas like the eyelids, as well as on the body, is a consideration. In addition, preferences of the patient or caregiver should be considered, including whether they are open to injections, steroids, or steroid-free options, or what type of topical (creams, ointments) are preferred.”
