Eric Simpson, MD, MCR, FAAD | Author provided

In this Q+A interview, Eric Simpson, MD, MCR, FAAD, professor of Dermatology, Oregon Health & Science University, Portland, Oregon, discusses what the recent FDA approval of roflumilast cream 0.15% means for the pediatric population.¹

Roflumilast cream 0.15% (Zoryve; Arcutis Biotherapeutics) was approved by the FDA for the topical treatment of mild-to-moderate atopic dermatitis (AD) in patients aged 6 years and older on July 9, 2024.¹

The FDA's decision was supported by the positive results of several clinical trials that demonstrated efficacy and safety of roflumilast 0.15%. In a pair of identical, phase 3, parallel group, double-blind, and vehicle-controlled trials, safety and efficacy of roflumilast 0.15% was compared to vehicle and applied once daily for 4 weeks. The INTEGUMENT-1 (NCT04773587) and INTEGUMENT-2 (NCT04773600) trials featured more than 1300 adults and children aged 6 years or older with mild-to-moderate AD.¹

In the Q+A below, Simpson breaks down key takeaways from the roflumilast clinical program and explains why pediatricians should feel confident about prescribing the topical non-steroid treatment.¹

Simpson was the lead author in a recent publication of clinical trial data in JAMA Dermatology.²

Related: FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and up

Contemporary Pediatrics:

Why can the approval of roflumilast cream 0.15% for this indication make an impact related to pediatric patients aged 6 years and up?

Eric Simpson, MD, MCR, FAAD:

The recent FDA approval of roflumilast cream 0.15% for the treatment of AD provides clinicians, patients and caregivers with a new, safe and effective steroid-free topical treatment and can be used anywhere on the body for any period of time. Roflumilast cream 0.15% fills a gap in care, with a non-steroidal topical that is formulated with the AD patient in mind without sensitizers or irritants.²

Contemporary Pediatrics:

Given its clinical data and history, what are the biggest safety and efficacy points you want providers to understand about topical roflumilast cream 0.15%?

Simpson:

Roflumilast cream 0.15% improved AD across multiple efficacy endpoints while demonstrating favorable safety and tolerability. Across both INTEGUMENT-1 and -2, approximately 31% of children and adults treated with roflumilast cream 0.15% achieved the primary efficacy endpoint of Investigator Global Assessment (IGA) Success at Week 4 compared to 14% for vehicle, with significant improvement observed as early as Week 1. Notably, data show roflumilast cream 0.15% rapidly and significantly reduced itch compared to vehicle, with over 30% of roflumilast cream 0.15%-treated patients achieving Worst Itch-Numeric Rating Scale (WI-NRS) Success at Week 4 and significant improvement seen as early as Week 1. 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.²

Itch is a troublesome symptom of AD that reduces patient quality of life and leads to sleep disturbances, which may also be a burden on parents and caregivers of these young patients. This makes managing itch a critical component of an AD treatment plan, and these data demonstrate that roflumilast cream 0.15% rapidly and significantly reduced itch compared to vehicle, offering much needed relief to children with AD and their families.²

Contemporary Pediatrics:

Should the pediatrician feel confident prescribing topical roflumilast cream 0.15% for AD, and when should they refer to a pediatric dermatologist?

Simpson:

Yes, these findings demonstrate that roflumilast cream 0.15% is a safe and effective option that may be relied upon to deliver results without concerns for further barrier disruption or rebound, a key consideration when treating AD. As such, pediatricians may feel confident in considering roflumilast cream 0.15% as a once-daily treatment option for their AD patients aged 6 years and over.

The decision to refer to a pediatric dermatologist for their specific expertise and perspective should be made on a case-by-case basis depending upon the needs of the patient and their caregivers. If patients do not respond to topical therapy or have an unusual presentation, referral would be recommended.

Contemporary Pediatrics:

Is there anything else you would like to add?

Simpson:

Investigators noted 95% of roflumilast cream 0.15%-treated patients had no signs of irritation at the application site, at each time point. Also, more than 90% of roflumilast cream 0.15%-treated patients self-reported no sensation or mild sensation at the application site. The incidence of TEAEs was low in both active treatment and vehicle arms. These safety and tolerability data, coupled with the efficacy data and demonstrated impact on itch make roflumilast cream 0.15% an excellent option for the treatment of AD.²

Related: Roflumilast cream 0.15% for atopic dermatitis demonstrates strong individual patient response data

References:

1. Fitch, J. FDA approves roflumilast cream 0.15% for atopic dermatitis in patients aged 6 years and up. Contemporary Pediatrics. July 9, 2024. Accessed September 26, 2024. https://www.contemporarypediatrics.com/view/fda-approves-roflumilast-cream-0-15-atopic-dermatitis-patients-aged-6-years-older

2. Simpson EL, Eichenfield LF, Alonso-Llamazares J, et al. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. Published online September 18, 2024. doi:10.1001/jamadermatol.2024.3121