Prospective, Open‐Label, Multicenter Study of Apremilast as Maintenance Therapy for Psoriasis Patients in Remission With Biologics

ABSTRACT Although biologic agents have significantly improved therapeutic outcomes for psoriasis, their long‐term use can be burdensome for patients due to high costs, parenteral administration, and safety concerns. Consequently, some patients in remission wish to switch to alternative maintenance therapies to reduce this treatment burden. Based on our prior survey, the present prospective, open‐label, single‐arm, multicenter clinical study focused on patients with plaque psoriasis with or without psoriatic arthritis (PsA) who had achieved remission with biologics but were hesitant to continue this therapy. We evaluated the efficacy and safety of transitioning to apremilast, a phosphodiesterase 4 inhibitor, for maintaining remission. Among 209 patients initially surveyed, 46 were enrolled, and 44 were included in the efficacy analysis. The study cohort comprised 30 males and 16 females, with a mean disease duration of 19.2 years, a mean Psoriasis Area and Severity Index (PASI) score of 0.36, and a mean Dermatology Life Quality Index (DLQI) score of 0.30 at baseline. At 24 weeks, the Kaplan–Meier (KM) median time to relapse was not reached overall; the KM remission‐maintenance rate was 63.6% (95% CI, 48.8–76.3) when adverse event related discontinuations were counted as events, and 75.7% (59.7–86.8) when censored. The corresponding restricted mean survival time through 24 weeks was 20.31 and 22.03 weeks, respectively. Patients who maintained remission consistently demonstrated low scores (≤ 1) across PASI, Body Surface Area, DLQI, and American College of Rheumatology components throughout the observation period. A total of 34 adverse events occurred in 23 patients, most commonly diarrhea, vomiting, and headache. All were mild, no serious events were observed, and all resolved without sequelae. In conclusion, for patients with plaque psoriasis with or without PsA who have achieved remission but are concerned about the burdens of long‐term biologic therapy, transitioning to apremilast represents an effective and viable strategy.