New long-term results validate roflumilast cream 0.15% efficacy in atopic dermatitis

Key takeaways:

• 56.6% of participants who used roflumilast cream since the initial trials achieved treatment success by week 56.
• 53.8% of those who switched to roflumilast in the extension trial also achieved success.

Roflumilast cream 0.15% demonstrated long-term efficacy and tolerability in adults and children aged 6 years and older with atopic dermatitis, Arcutis announced in a press release.

These new 56-week results from Arcutis’ long term, open-label INTEGUMENT-OLE study were presented at the Revolutionizing Alopecia Areata, Vitiligo, and Eczema Conference.

“A major challenge for managing atopic dermatitis patients is the ability to keep their disease controlled over a long-term period,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, told Healio. “The results of the INTEGUMENT-OLE study showed that over 56 weeks of treatments, [roflumilast] cream, which is a nonsteroidal treatment, was able to keep a patients’ AD under control with a favorable safety profile consistent with our earlier studies.”

As Healio previously reported, the study included 658 eligible patients from Arcutis’ other phase 3 trials evaluating roflumilast, INTEGUMENT-1 and INTEGUMENT-2. Patients received monotherapy with roflumilast without any rescue treatment. After week 4, any patients with a validated IGA-AD of 0 switched to the extension trial’s dosage of twice-weekly maintenance treatment.

The new results show that roflumilast cream was well tolerated with no new safety signals observed over the 56 weeks of treatment. Treatment success, defined as validated IGA-AD value of 0 or 1 plus a 2-grade improvement from baseline by week 56, was achieved by 56.6% of participants who used roflumilast cream since the initial trials and 53.8% of those who switched to roflumilast in the extension trial.

Those who participated in the trial’s twice-weekly maintenance dosage saw a 281-day median duration of disease control. Further, 57.7% maintained disease control on the twice-weekly schedule through their final study day, according to the release.

“The idea behind doing a twice-weekly dosing strategy was to proactively treat a patient to prevent them from having a flare or a worsening of their disease,” Burnett explained. “And we were pleasantly surprised to find that when patients were on this twice-weekly dosing, they were able to actually maintain that disease control for a median of 9 months.”

Of those who rolled over from the roflumilast cream arm in INTEGUMENT 1 and 2 or switched to once-daily roflumilast cream 0.15% from the vehicle arm, 66.2% and 64.6%, respectively, achieved EASI-75 after 56 weeks. Additionally, 56.9% and 50% of those who rolled over from or switched to once-daily roflumilast cream, respectively, achieved a significant reduction in itch by the end of the study.

Adverse event rates were low with the most frequently reported adverse events being COVID-19, upper respiratory tract infection, nasopharyngitis and headache. A total of 3% of participants discontinued due to adverse events.

“If approved, [roflumilast] is a good long-term treatment option for AD patients that can help control their disease as a monotherapy without the need to use topical corticosteroids,” Burnett told Healio.