Matthew Zirwas, MD: Roflumilast Foam for Seborrheic Dermatitis - MD Magazine

Phase 2a trial data published in May showed once-daily PDE4 inhibitor roflumilast foam 0.3% was associated with a significant rate of patients achieved Investigators Global Assessment (IGA) disease severity and Worst Itch Numerical Rating Scale (WI-NRS) improvements for their seborrheic dermatitis at 8 weeks of treatment.1

The findings precede the anticipated US Food and Drug Administration (FDA) decision date for Arcutis Biotherapeutics' New Drug Application (NDA) to indicate roflumilast foam for seborrheic dermatitis by about 6 months. At least one investigator is convinced of the PDE4 inhibitor's benefit for his patients.

In an interview with HCPLive during the Maui Derm 2023 NP + PA Summer Conference in Colorado Springs this week, roflumilast foam investigator Matthew Zirwas, MD, director of the clinical trials and dermatitis center at Dermatologists of Greater Columbus, praised the "stunning" impact of PDE4 inhibition—particularly as delivered by roflumilast—on his patients with seborrheic dermatitis.

"After I saw my first 3 patients back, I immediately called the company and said, 'This is an absolute home run. This is like nothing I've ever seen from treating seborrheic dermatitis'," Zirwas recalled.

Zirwas additionally referenced longer-term analysis of roflumilast foam for such patients, in which approximately half of all treated patients reported completely clear skin—"Not clear or almost clear, which we're used to in dermatology," he said. "Completely clear. That is insane."

He further praised the drug's diverse profile, describing its benefit to both non-steroidal and steroid options available for dermatitis—as evidenced by data showing "rapid and very high efficacy, combined with a really reassuring safety profile."

"(That) makes it as close to a perfect drug as you can hope for in seborrheic dermatitis," Zirwas said. "And once roflumilast gets through its last clinical trials, it's going to be FDA-approved for psoriasis, atopic dermatitis and seborrheic dermatitis. Basically what that is going to mean is, if you have a rash on your face or your scalp, roflumilast is indicated. Those are the 3 things it could be."

In further reviewing the available data for roflumilast foam 0.3% in seborrheic dermatitis, Zirwas highlighted the significance of the key secondary WI-NRS outcome and its relation to patient quality of life.

"Pruritus is such a huge issue for patients with scalp disease, and it's something that clinicians often forget," he said. "Seborrheic dermatitis is so itchy for these people, and it's a really difficult thing socially."

Zirwas is a sponsored speaker for AbbVie, Arcutis, Dermavant Sciences, Incyte, Lilly, Leo Pharma, Pfizer and Sanofi-Regeneron.

References

  1. Zirwas MJ, Draelos ZD, DuBois J, et al. Efficacy of Roflumilast Foam, 0.3%, in Patients With Seborrheic Dermatitis: A Double-blind, Vehicle-Controlled Phase 2a Randomized Clinical Trial. JAMA Dermatol. 2023;159(6):613–620. doi:10.1001/jamadermatol.2023.0846
  2. Bader K. FDA Accepts Roflumilast Foam NDA for the Treatment of Seborrheic Dermatitis. Dermatology Times. Published April 18, 2023. https://www.dermatologytimes.com/view/fda-accepts-roflumilast-foam-nda-for-the-treatment-of-seborrheic-dermatitis

Adblock test (Why?)

Comments

Post a Comment

Popular posts from this blog

Rashes that look like scabies: Causes, symptoms, and treatment - Medical News Today

Image
Scabies is a skin condition that occurs as the result of a mite known as Sarcoptes scabiei. The rash that results from scabies may appear similar to other skin conditions, such as psoriasis, eczema, or contact dermatitis. In this article, we look at what a scabies rash looks like. We also look at other rashes that are similar in appearance and their treatment options. Scabies is a common condition that occurs as the result of an infestation of a microscopic skin mite called Sarcoptes scabiei. The mites burrow under the skin, causing intense itching and a rash. The Centers for Disease Control and Prevention (CDC) describes the rash as pimple-like. On darker skin, the rash may be more difficult to see, but a person should be able to feel it. According to DermNet, a scabies rash is varied in appearance, and may appear as: pimple-like on the limbs and trunk widespread or coin-shaped small blisters scales lesions in the armpits, groin, navel, areolas, scrotum, buttocks, and along the penil...
Read more

Urinary Tract Infection (UTI): Causes, Symptoms & Treatment - Cleveland Clinic

Image
Can I prevent a urinary tract infection? The following lifestyle changes can help prevent urinary tract infections: Practice good hygiene Practicing good hygiene is one of the best ways to help prevent UTIs. This is especially important if you have a vagina because your urethra is much shorter, and it's easier for E. coli to move from your rectum back into your body. Always wipe from front to back after a bowel movement (pooping) to avoid this. During your menstrual cycle, it's also a good idea to regularly change your period products, including pads and tampons. You should also avoid using any deodorants on your vagina. Drink plenty of fluids Drinking extra fluids — especially water — each day can help flush out bacteria from your urinary tract. Healthcare providers recommend drinking six to eight glasses of water daily. Change your peeing habits Peeing can play a big role in getting rid of bacteria from your body. Your pee is a waste product, and each time you empty your bla...
Read more

Symtuza: Uses, side effects, alternatives, and more - Medical News Today

Image
The Food and Drug Administration (FDA) approves prescription drugs such as Symtuza to treat certain conditions. Symtuza is FDA-approved to treat HIV-1 in adults and children who weigh at least 40 kilograms (kg), which is about 88 pounds (lb). It's approved for people who: have just been diagnosed with HIV and haven't started treatment yet, OR are changing from another HIV treatment and: have been on a stable antiretroviral regimen for at least 6 months (this means you haven't had any changes to your HIV drugs for at least 6 months) have a viral load (the amount of HIV in your blood) that's less than 50 copies per milliliter (mL) have HIV that doesn't have mutations (changes) that could make it resistant (less likely to respond) to darunavir or tenofovir (two of the active drugs in Symtuza) HIV explained HIV stands for human immunodeficiency virus. There are two forms of this virus, HIV-1 and HIV-2. HIV-1 is the most common form. HIV is transmitted through body fluid...
Read more