Presented at the American Academy of Dermatology 2023 Annual Meeting, new data showed that oral roflumilast was found to improve Psoriasis Area and Severity Index (PASI) scores in the treatment of moderate-to-severe plaque psoriasis compared with placebo. Alexander Egeberg, MD, PhD, professor of dermatology at the University of Copenhagen and Bispebjerg Hospital in Denmark, did note that the efficacy and safety of oral roflumilast is unclear in patients with psoriasis. Patients in the study were randomized 1:1 to either oral roflumilast (500 μg once daily) or placebo. Those in the placebo group switched to roflumilast at Week 12 through Week 24. The primary endpoint of the study was a 75% or more reduction in PASI score from baseline at Week 12. A total of 46 patients were randomized, and at 12 weeks, 34.8% reached PASI75 vs 0.0% in the placebo group. The most frequent adverse reactions in both groups were weight loss, headache, transient gastrointestinal symptoms, and insomnia.

Reference: Smith T. Oral Roflumilast Effective, Safe in Treating Plaque Psoriasis Over 24 Weeks. HCPLive. Published March 20, 2023. Accessed March 26, 2023.