Mark G. Lebwohl, MD: Roflumilast for Plaque Psoriasis Itch Reduction, Clinical Trial Data

Mark G. Lebwohl, MD

In an interview with HCPLive, Mark G. Lebwohl, MD, of the Icahn School of Medicine at Mount Sinai in New York, spoke about recent clinical trial data on the use of roflumilast cream to treat plaque psoriasis patients dealing with itching symptoms.

Lebwohl explained a bit about his background before exploring the recently-published roflumilast research, for which he was the principal investigator.

“I'm Dean of Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai,” he said. “I, before that, was chairman of the Department of Dermatology at Mount Sinai for 24 years, and I have been very instrumental in the development of roflumilast cream. I was the principal investigator on the original study, which proved to work quite well.”

The trial data demonstrated that psoriasis patients treated with roflumilast cream 0.3% saw greater improvements in Worst Itch Numeric Rating (WI-NRS) as well as severity and bother of itch within 2 weeks, and itch-related sleep loss from the time of Weeks 6 to 12, than the vehicle group.

“So we published the data in the New England Journal of Medicine, and roflumilast, certainly, is dramatically effective for psoriasis compared to vehicle, particularly effective in intertriginous areas, which are areas that we don't have great treatments for," he said. "We worry about using steroids there. We worry about using products that are irritating like calcipotriene, or tazarotene there. So this is a welcome development and we now have a treatment. It's great for those problem areas.”

Lebwohl expressed that he felt pleased to have been involved in the study and its organization, following the outcome.

“As it turns out, it was noticed right away that itching resolved very quickly in the patients with roflumilast compared to placebo,” he said. “In the trial, it was a dose ranging from 0.3% versus 0.5% versus placebo. And both the 0.3% and 0.5% showed superiority over placebo. And very specifically, as early as Week 2, we saw significant improvement in itch. And through Week 6, from Week 6 through 12, we saw a significant improvement in its related sleep loss.”

Lebwohl added that the data may help clinicians treating psoriasis in the future, pointing out the potential gaps in knowledge that some may have on the subject.

“I think itch is often underappreciated as a symptom of psoriasis,” he added. “And in diaries that are given to patients, when you ask them about what bothers them the most about psoriasis, one of the items that emerges in patient-reported outcomes is itching. Yet we don't pay as much attention to it as physicians.”

At the conclusion, the discussion shifted to future research into treatments like roflumilast, as well as areas left to research.

“So certainly much research followed and enough research to obviously get the drug approved, which is now on the market and helping a lot of patients,” he explained. “The mechanism of itch relief from phosphodiesterase inhibitors is not entirely clear. There are some theories as to why it would work, but the mechanism is not totally clear. We do know, however, that it reduces the inflammation and the keratinocyte proliferation that we get in psoriasis and presumably by those same mechanisms improves the issue of psoriasis.”