Eric Simpson, MD, MCR: Phase 3 Trials on Roflumilast for Children with Atopic Dermatitis

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A Q&A interview with Dr. Simpson regarding the recent INTEGUMENT clinical trial results regarding roflumilast for atopic dermatitis.

Eric Simpson, MD, MCR, FAAD, interviewed with HCPLive regarding his involvement in the recent INTEGUMENT-1 phase 3 clinical trials on roflumilast treatment for adults and children 6 and older with atopic dermatitis (AD).

The study’s results indicated Investigator Global Assessment (IGA) success for roflumilast cream on AD for adults and children ages 6 and older, according to a press release from Arcutis Biotherapeutics, Inc.

During his interview, Simpson explained that in his experience AD “had a profound impact on patients and families, thus I was drawn to helping patients and families find safe and effective solutions to this highly symptomatic disease, (and) this therapy gets us a step closer to long-term control in a safe manner.”

The INTEGUMENT-1 study was headed by Simpson, who works as a Professor of Dermatology at Oregon Health and Science University in Portland. The study assessed the use of roflumilast cream 0.15% once-per-day.

When Simpson discussed the results of the clinical trial, he described that what he found most surprising about the trial data was “we can achieve good anti-inflammatory effects and antipruritic effects with a more targeted topical therapy providing an alternative to topical corticosteroids that can be more challenging to monitor long-term.”

The US Food and Drug Administration approved roflumilast, a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor, for plaque psoriasis in patients who are 12 years and older. Simpson described troubling aspects he saw in clinician knowledge of the subject.

“Clinicians should monitor topical steroid use closely in these patients with a chronic disease and should probably incorporate non-steroidal approaches earlier in the treatment pathway to better stabilize the disease in a safe manner,” he explained.

When he was asked about if there were any remaining questions he had regarding the INTEGUMENT-1 trial results, he responded that he wanted to know whether roflumilast would be incorporated into topical regimens or used as monotherapy.

Arcutis Biotherapeutics is said to anticipate topline results from the identically-designed INTEGUMENT-2 phase 3 trial toward the end of the year.

If the trial results are successful, they reportedly intend to submit a supplemental New Drug Application for roflumilast 0.15% for the treatment of mild-to-moderate AD in patients ages 6 years-and-up by 2023.