Roflumilast cream reduces psoriasis-related itch, helps patients return to ‘normal life’

Patient reported data from two phase 3 trials found roflumilast cream 0.3% significantly reduced itch severity and impact in psoriasis patients, according to a presentation at the EADV Congress virtual meeting.

“In the past 5 to 10 years there’s been an increasing awareness of just how important itch is for patients who have psoriasis,” Patrick Burnett, MD, PhD, FAAD, one of the study’s authors, told Healio. “When you ask a dermatologist, sometimes you don’t get that answer. They’re looking more at what you can see on a patient’s skin. But from a patient perspective, what bothers them and can really disrupt their life is the itch.”

The phase 3, double-blind DERMIS-1 and DERMIS-2 trials randomly assigned patients to receive roflumilast cream 0.3% or vehicle once-daily for 8 weeks. The trials included 439 patients in DERMIS-1 and 442 patients in DERMIS-2.

Previous data explored the drug’s efficacy in these trials and found those treated with roflumilast had significant improvements in Psoriasis Area and Severity Index and Investigator Global Assessment scores. This data explores the trial’s secondary endpoint of patient-reported Worst Itch-Numeric Rating Scale (WI-NRS) scores.

In the DERMIS-1 trial, a mean change in WI-NRS scores of –3.7 was reported after week 8 in the treatment group, compared with –1.4 in the vehicle group. The DERMIS-2 trial results were similar with a mean change of –4 in the treatment group and –1.7 in the vehicle group.

For patients who had a baseline WI-NRS score of 4 or above, 67.5% of the DERMIS-1 treatment group and 69.4% of the DERMIS-2 treatment group achieved a reduction of at least 4 points in 8 weeks, compared with 26.8% of the DERMIS-1 vehicle group and 35.6% of the DERMIS-2 vehicle group.

In addition, patient-reported itch severity was reduced in the two treatment groups by a mean of 72.5% (DERMIS-1) and 70.5% (DERMIS-2), compared with 21.5% (DERMIS-1) and 26.9% (DERMIS-2) of the vehicle groups. Patient-reported quality of life, as measured by the Dermatology Life Quality Index, also increased in the treatment groups with a change from baseline of 65.2% in DERMIS-1 and 69.4% in DERMIS-2, compared with 12.7% of the DERMIS-1 vehicle group and 9% of the DERMIS-2 vehicle group.

“From a clinical perspective, what we want to do is to lift the burden of that disease and here we are showing data that with roflumilast in psoriasis patients we are able to do that in a couple of concrete ways,” Burnett said. “In the end the patient wants a treatment that is going to allow them to lead a life which is more similar to if they didn’t have the disease at all. We are trying to return them to their normal life, and we see that in these data.”