Mark Lebwohl, MD: Optimizing Roflumilast Cream in Dermatology

August 4, 2022
Kevin Kunzmann

The pivotal DERMIS trial author discusses extended assessment and prescribing strategies for the latest psoriasis agent.

With the US Food and Drug Administration (FDA) approval of roflumilast cream (ZORYVE) for adults and adolescents with plaque psoriasis last week, opportunity is now more reasonable to consider the once-daily topical PDE-4 inhibitor agent for use and marketing in other fields of skin health.

One prominent investigator behind the drug supports the possibility that it may have safe and effective benefit in other patients from different ages and with different diseases; what matters most is it remains a proven benefit and an accessible option for patients.

In the second segment of an interview with HCPLive, pivotal phase 3 DERMIS trial author Mark Lebwohl, MD, chair of the department of dermatology at Icahn School of Medicine at Mount Sinai, discussed next steps for assessment of roflumilast cream, including its potential use in atopic dermatitis.

“I’m sure that the manufacturers would be interested in any other steroid-responsive dermatoses,” Lebwohl said. “If it works for psoriasis, there’s a good chance it works for other dermatoses as well.”

Regarding long-term psoriasis benefit, Lebwohl expressed confidence that the agent may be “completely safe for long-term use,” though extended-use analyses are still ongoing. He noted the medical field’s familiarity with PDE-4 inhibitor drugs—already indicated for and well-tested with various chronic disease patients at ample durations of treatment.

“It does look like the benefits are sustained, and we know you can continue it without side effects,” he said. “And in a chronic disease, a set of agents like topical steroids that are very effective but start to thin the skin and cause side effects the longer you use them is not ideal. So we now do have something that I think would be ideal.”

Lastly, Lebewohl stressed the importance of patient access to roflumilast cream, alluding to the familiar burden prescribing clinicians face when an eligible patient its met with a high price tag or formulary rejection at the pharmacy.

“I would look to small specialty pharmacies that actually don’t take payments from insurance companies to take drugs off their formulary,” he said. “It’s a great drug, and make sure patients have access to it by making sure they go to the right pharmacy for it.”


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