Roflumilast cream adds a much-needed element of simplicity for psoriasis patients and their dermatologists.
Melinda Gooderham, MD, MSc, FRCPC, study investigator of the DERMIS-1 and DERMIS-2 phase 3 trials of roflumilast cream 0.3% (ZORYVE; Arcutis Biotherapeutics) for plaque psoriasis, discussed the value of roflumilast cream for patients with psoriasis. Data from each pivotal phase 3 trial was recently published in the Journal of the American Medical Association.
Results showed that in both studies, significantly more participants treated with roflumilast cream reached Investigator's Global Assessment (IGA) success at week 8 compared to the control group of vehicle-treated participants (DERMIS-1: 42.4% vs 6.1%; DERMIS-2: 37.5% vs. 6.9%, P<0.001 for both). Roflumilast cream was successful in intertriginous areas, where two areas of skin may rub together, with significantly more roflumilast-treated participants achieving intertriginous success at week 8 than vehicle-treated patients. Gooderham explained how roflumilast cream will help increase the quality of life for patients with psoriasis.
Hello, I'm Melinda Gooderham, dermatologist and clinical researcher from Peterborough, Ontario, Canada. I was an investigator, not only in the DERMIS-1 and 2 trials, I've been an investigator in this program since phase one. So, I've had quite a bit of experience using roflumilast topically, but as an investigator in DERMIS-1 and DERMIS-2, we were able to treat a larger group of patients. The approval for the medication was received by the FDA in July of this year. And then recently this week, we had a publication in the Journal of the American Medical Association. So that was quite an honor to be published in that journal. But my general thoughts about how this product will impact patients is that I really feel it will simplify the life of psoriasis patients which can often be very complicated. They have itchy, visible plaques that they're trying to hide, and they're using multiple different products to treat them. With roflumilast, it will bring some simplicity in that it is one product that is used once a day in all areas, so you can use it in the sensitive areas, you can use it in the difficult to treat areas like the elbows and the knees. And it was very well tolerated. So, unlike some other PD-4 inhibitors that we've used topically, other nonsteroidal agents that we use off label for psoriasis topically, can cause some burning and stinging, which will lead to patients not being very adherent to topical application. But we did not see that in any of the trials that are done with roflumilast. It was very well tolerated by patients. It's a very nice vehicle that uses very cosmetically acceptable ingredients to make it non greasy. So, they can put it on once a day, it doesn't get on their clothes, they're happy to use it because it makes the skin feel good and adds that simplicity to their life.
It also can simplify the dermatologist's life because instead of prescribing a number of different topicals for sensitive areas and hard-to-treat areas and then hoping that the patients don't mix them up and use the wrong product in the wrong place leading to some adverse effects, we can feel confident that we can give one product that will work in other areas only by writing one prescription one refill. And also, without the calls to the clinic with issues with burning, stinging or not being able to tolerate or it being too greasy and getting on clothes, sheets, that sort of thing. I guess overall the simplicity for the patient, the once a day, one product, all areas, simplicity from the prescriber to give one product that they know can treat all of their psoriasis, and with that tolerability that will ultimately improve the patient's quality of life, which is what we're trying to do in the first place as dermatologists.
One other thing that we don't always talk about in psoriasis is the itch that patients do experience from their psoriasis and the topical roflumilast was shown to reduce itch very quickly with patients and have a lasting effect. Dealing not only with the visible plaques, but also improving the symptoms. With symptoms such as itch, we can improve again the quality of life of the patient.
Transcript edited for clarity