Key takeaways:

• 34.8% of patients with psoriasis treated with roflumilast achieved PASI 75 by week 12 compared with 0% of the placebo group.
• Oral roflumilast is an option for patients who are candidates for systemic therapy.

NEW ORLEANS — Oral roflumilast may offer an inexpensive and effective treatment option for patients with psoriasis who are candidates for systemic therapy, according to a presentation at the American Academy of Dermatology Annual Meeting.

“Generic versions [of oral roflumilast] are available now and are cheaper than a Starbucks coffee,” Alexander Egeberg, MD, PhD, DMSc, of the department of dermatology at Bispebjerg and Frederiksberg Hospital and the department of clinical medicine at the University of Copenhagen, Denmark, said during the late-breaker presentation. “We now have the FDA approval for the topical version, but so far there have been no studies on oral roflumilast in psoriasis.”

Egeberg presented results from the multicenter, double-blind, randomized, placebo-controlled phase 2 trial evaluating the efficacy and safety of oral roflumilast monotherapy without titration in adults with moderate to severe plaque psoriasis.

A total of 46 patients were randomly assigned to receive 500 µg of oral roflumilast (n = 23) or placebo (n = 23) once daily for 12 weeks followed by an open-label period for an additional 12 weeks during which all patients received 500 µg of oral roflumilast.

Results showed that the study met the primary endpoint, with eight roflumilast-treated patients achieving a PASI 75 response by week 12. Three patients also achieved PASI 90.

In contrast, none of the placebo-treated patients reached PASI 75; however, nine patients achieved it when switched to roflumilast during the open-label study portion.

By week 24, 10 roflumilast-treated patients reached PASI 75, five reached PASI 90 and two reached PASI 100.

The study reported no new safety signals, and oral roflumilast was deemed well tolerated by patients with adverse events being mild and transient, according to the researchers.

“Because this is a generic, you can start using it tomorrow,” Egeberg concluded.