Researchers at the Icahn School of Medicine at Mount Sinai Hospital in New York have found that treatment with roflumilast cream (ARQ-151), which contains a selective phosphodiesterase-4 (PDE-4) inhibitor, produced improvements in psoriasis symptoms as early as two weeks after treatment was started.
Results of the phase IIb trial published online ahead of print in the New England Journal of Medicine (July 15, 2020), demonstrated that when patients with plaque psoriasis applied topical roflumilast once per day they reported clear skin as well as improvement in itch and burden of disease.
Dr. Mark Lebwohl, Waldman professor and chair of dermatology at the Icahn School of Medicine and the lead investigator of the study, said the results are encouraging for patients who need new and better options to treat psoriasis.
“Plaque psoriasis imposes a significant burden on patients, and is often associated with poor quality of life,” said Dr. Lebwohl in a press release. “Effectively treating psoriasis with topical therapies, which the vast majority of patients receive, is especially challenging due to side effects, tolerability, or efficacy of existing topical treatments. Roflumilast cream could really be a game-changer.”
Roflumilast contains a PDE-4 inhibitor, an intracellular enzyme that regulates pro-inflammatory and anti-inflammatory cytokine production and cell proliferation. It was approved in pill form by the U.S. FDA for the treatment of chronic obstructive pulmonary disease in 2011.
For the double-blind trial, researchers randomly assigned 331 adults with plaque psoriasis in a 1:1:1 ratio to receive topical treatment with roflumilast cream 0.3%, 0.15%, or a placebo cream applied once daily for 12 weeks. A total of 109 patients were treated with roflumilast cream 0.3%, 113 with 0.15% cream, and 109 with the matching treatment.
The primary efficacy outcome was investigator global assessment (IGA) of clear or almost clear at week six. Secondary outcomes included clear or almost clear plus a two-grade improvement (IGA success), IGA success on an intertriginous IGA, and change in psoriasis area and severity index (PASI).
Mount Sinai is currently conducting phase III clinical studies with the medication.