Interim results show roflumilast maintains, improves atopic dermatitis up to a year
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Key takeaways:
- 46.1% and 51% of patients achieved vIGA-AD 0 or 1 plus a 2-point improvement from baseline at weeks 28 and 56.
- Roflumilast was well tolerated with no new safety signals were observed.
Arcutis Biotherapeutics announced interim results of its phase 3, long-term extension trial of roflumilast cream 0.15% for the treatment of atopic dermatitis in adults and children aged 6 years and older, according to a press release.
The long-term open-label study, INTEGUMENT-OLE, 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 vIGA-AD of 0 switched to the extension trial’s dosage of twice weekly maintenance treatment.
“These results highlight that not only did roflumilast cream maintain efficacy, but that efficacy improved over time throughout 56 weeks of study,” Eric Simpson, MD, MCR, Frances J. Storrs Medical Dermatology Professor at Oregon Health and Science University and lead investigator of the INTEGUMENT trials, told Healio. “In addition, the biweekly maintenance schedule included in this study is a completely novel approach that has never been done before in a phase 3 study and sets a more modern paradigm of continuous control to stay ahead of the condition, rather than chasing it.”
At weeks 28 and 56, 46.1% and 51% achieved a vIGA-AD success of 0 or 1 plus a 2-point improvement from baseline, respectively.
More than two-thirds of participants who switched to maintenance dosing continued to administer roflumilast only twice weekly for more than half of their time in the study.
Additionally, 61.5% and 66.2% of participants achieved a 75% improvement from baseline in Eczema Area and Severity Index after 28 and 56 weeks, respectively.
The interim results also showed that roflumilast cream was well-tolerated for up to 56 weeks in duration with no new safety signals observed. The incidence of adverse events was low with the most frequently reported being COVID-19, upper respiratory tract infection, nasopharyngitis and headache. Due to adverse events, 3% of patients discontinued the trial.
“New steroid-free topical treatment options that effectively clear skin and can be used over a long course of treatment are needed for atopic dermatitis,” Simpson said. “These results further validate the long-term durable efficacy and tolerability of roflumilast cream, with continued improvement over the course of the long-term study.”