P13 Real-world evidence of oral roflumilast in patients with moderate-to-severe psoriasis

Abstract Background Oral roflumilast, a phosphodiesterase (PDE)-4 inhibitor, approved for chronic obstructive pulmonary lung disease, has been proposed as an affordable and effective off-label therapy in psoriasis. However, real-world data is sparse. Methods All patients with moderate-to-severe plaque-type psoriasis treated with oral roflumilast 500 µg once-daily between February 2021 and April 2024 at Department of Dermatology at Bispebjerg Hospital, Copenhagen Denmark were included. The main outcomes were absolute PASI4 at 3 months and drug retention at 12 months. Results A total of 65 patients received therapy. At baseline, median age was 43.6 years [interquartile range (IQR): 33.2–62.3], median psoriasis area and severity index (PASI) 6.5 (IQR 3.4–10.6), and 42 (65%) patients were biologic-naïve. Among all patients, PASI was available for 34 patients at 3 months, with absolute PASI4 achieved by 25 patients, corresponding to 74% (as observed) and 58% (modified as observed; i.e. discontinuations due to lack of effectiveness considered non-response), respectively. Of all patients with minimum 12 months follow-up, 17 (57%) were still in active treatment after 1 year. Among biologic-naïve patients, PASI4 after 3 months was achieved by 23 [79% (as observed)] and 23 (74%) (modified as observed). Of biologic-naïve patients with a minimum 12-month follow-up, 16 (89%) still received oral roflumilast after 1 year. Conclusions and relevance This real-world study highlights oral roflumilast as a viable treatment alternative for psoriasis, especially in biologic-naïve patients.