New roflumilast cream 0.15% data demonstrate improvements in AD symptoms at 56 weeks


Once-daily, steroid-free, topical roflumilast cream 0.15% has a PDUFA date of July 7, 2024.

Roflumilast cream 0.15% data at 56 weeks demonstrates improvements in AD symptoms | Image Credit: © lial88 - © lial88 -

Roflumilast cream 0.15% data at 56 weeks demonstrates improvements in AD symptoms | Image Credit: © lial88 - © lial88 -

Based on new data from the INTEGUMENT-OLE open-label, long-term extension study of roflumilast cream 0.15% (Arcutis Biotherapeutics), the once-daily, investigational topical cream is well tolerated with no new safety signals through 56 weeks of treatment in adult and children aged 6 years and older with atopic dermatitis (AD).1

Efficacy was maintained and improved overtime, as 56.6% of participants who continued roflumilast cream 0.15% from the initial trial achieved validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) success, with a value of 0 (clear) or 1 (almost clear) plus a 2-grade improvement at week 56. In addition, 53.8% of participants who switched to roflumilast cream 0.15% from vehicle after the intimal trial achieved vIGA-AD success, according to a press release from Arcutis, with data presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference (RAVE).1

The INTEGUMENT-OLE was a phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% in adults and children aged 6 years and older with AD. Eligible individuals for the extension had to complete the INTEGUMENT-1 (NCT04773587) or INTEGUMENT-2 (NCT04773600) phase 3 trials to enroll (n = 658) for either 24 or 52 weeks.1

The primary outcome of the extension study was to assess long-term safety after either 24 or 52 weeks of roflumilast cream 0.15% treatment. Secondary endpoints included vIGA-AD score of 0 or 1 at each assessment, vIGA-AD success, Worst Itch Numeric Rating Scale (WI-NRS) score over time, and Eczema Area and Severity Index score over time.1

At week 4, participants who achieved a vIGA-AD score of clear (n = 130 [19.8% of study population]) switched to proactive twice-weekly application. Among these patients, the median duration of disease control, defined as maintaining vIGA-AD of 0 or 1 with adequate control of signs and symptoms on the twice-weekly schedule, was 281 days (95% CI: 147, not evaluable). Nearly 58% (57.7%) of these individuals maintained disease control on the twice-weekly schedule through their final study day, according to Arcutis.1

“Investigational roflumilast cream 0.15% showed continued improvement through the course of the study, demonstrating that once approved, roflumilast cream may be an effective long-term, steroid-free treatment option that can be used for proactive flare-free disease control,” said Melinda Gooderham, MD, MSc, FRCPC, in a statement. Gooderham is a study presenter, medical director of SKiN Centre for Dermatology, and investigator with Probity Medical Research. “These results also reinforce the durable efficacy and tolerability of roflumilast cream in AD, which could translate to improved treatment adherence.”1

On November 29, 2023, the FDA accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.15% and assigned a Prescription Drug User Fee Act (PDUFA) date of July 7, 2024. At the time of the sNDA acceptance, Lawrence Eichenfield, MD, professor of dermatology and pediatrics, vice chair, Department of Dermatology, chief, Pediatric and Adolescent Dermatology, University of California, San Diego, and Rady Children’s Hospital, San Diego, spoke with Contemporary Pediatrics in a video interview.2,3

“AD is a complex disease and there's this incredible range in severity of AD and while we have incredible new systemic medicines to help us with our more severe patients, most patients still will be using topical therapy, and many of them can be effectively managed with topical therapies,” Eichenfield said. “The announcement of the FDA accepting the sNDA for roflumilast [0.15%], plus other work with that drug and other drugs, with different formulations and different agents, I think will be very important going forward to have a newer set of nonsteroidal medicines for AD.”3

Arcutis also announced that 66.2% of participants who rolled over from the roflumilast cream arm in INTEGUMENT-1, and 64.6% from INTEGUMENT-2, or switched to once-daily roflumilast cream from the vehicle arm, demonstrated a 75% improvement from baseline in EASI-75 after 56 weeks, respectively.1

Additionally, 56.9% and 50.0% of individuals who rolled over from or switched to once-daily roflumilast cream treatment achieved a significant reduction, greater than or equal to 4 points, in itched based on WI-NRS at 56 weeks, respectively (among patients aged ≥12 years with baseline WI-NRS ≥4).1

The most frequently reported adverse events (≥2%) included1:

  • COVID-19
  • Upper respiratory tract infection
  • Nasopharyngitis
  • Headache

Three-percent of trial participants discontinued because of adverse events.1

Should roflumilast cream 0.15% cream be approved by the FDA, Arcutis intends to submit a sNDA for roflumilast cream 0.05% for AD patients aged 2 to 5 years.1


1. Arcutis announces new long-term data of roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) in adults and children down to age six presented at Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference. Arcutis Biotherapeutics. Press release. June 10, 2024. Accessed June 10, 2024.

2. Fitch, J. FDA accepts sNDA for roflumilast cream 0.15% to treat atopic dermatitis. Contemporary Pediatrics. November 29, 2023. Accessed June 10, 2024.

3. Fitch, J. Lawrence Eichenfield, MD, reacts to accepted sNDA for roflumilast cream 0.15%. Contemporary Pediatrics. November 30, 2023. Accessed June 10, 2024.

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