Implications of Findings on Patient-Reported Outcomes for Roflumilast Foam, with Melinda Gooderham, MD

In an interview with the HCPLive editorial team, Melinda Gooderham, MD, MSc, spoke with the team following the 44th Annual Fall Clinical Dermatology Conference in Las Vegas, Nevada, regarding her newly-presented findings from the phase 3 ARRECTOR trial on roflumilast foam, 0.3%, for patients with psoriasis.

ARRECTOR had been a vehicle-controlled, double-blind analysis which assessed both the safety and efficacy of roflumilast foam. Gooderham, known for her work as a dermatologist for the SKiN Centre for Dermatology in Ontario, highlighted in her previous segment the major conclusions of the new data regarding patient-reported outcomes among those using roflumilast in the trial.

“The nice thing about the ARRECTOR trial, or what that showed with roflumilast foam, around over 50% of patients actually had in the Worst Itch NRS, and the Scalp Itch NRS was 0 or 1, so they had no or minimal itch on the scalp or or overall in the body after 8 weeks of using roflumilast foam,” Gooderham had explained.

Roflumilast foam, 0.3%, was noted as being a non-steroidal, once-per-day PDE4 inhibitor for patients with psoriasis. Here, Gooderham discussed the broader implications of the findings on this drug for the future of psoriasis treatment.

“I think this roflumilast foam will really address the unmet needs by, number 1, providing a convenient once-a-day application,” Gooderham said. “I know adherence can be an issue for many patients with their topical therapy. So they have something that's easy to use, it's not greasy, patients like to use it, and it's not irritating. We actually saw a very good tolerability. The investigator-related tolerability was 0. There was no irritation noted by the investigators.”

Gooderham added that the patient-related tolerability scale had an average of 0.5, with 0 being no sensation and 1 being a mild sensation. This suggested that the majority of patients had no significant problem tolerating the medication.

“So it's a well tolerated medication, once-a-day, non-greasy, and effective,” Gooderham said. “You know, 66% of patients achieved IGA success in their scalp psoriasis and 40% of patients actually had a clear scalp. We (also) see the benefits in itch. We see that translates into an improvement in the quality of life with an easy to use product.”

For additional information about recent ARRECTOR trial data, view the full interview segment above. To find out more from Fall Clinical Conference coverage, view our latest here.

The quotes implemented in this interview summary were edited for clarity.

Gooderham has reported non-financial support from Arcutis during the study; and personal fees from Aceylrin, AbbVie, Arcutis, Bristol Myers Squibb, Boehringer Ingelheim, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Meiji, Dermavant, Moonlake, Nektar, Nimbus, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Tarsus, Takeda, UCB, Union, Ventyx, Apogee, AnaptysBio, Aristea, and L'Oreal.