Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study.

Apremilast is a phosphodiesterase 4 inhibitor approved for moderate to severe psoriasis in Japan. Apremilast significantly improved Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) both at 6 and 12 months in a previously published primary post-surveillance study. Here, we performed a post hoc analysis of the surveillance data to evaluate patient characteristics, effectiveness, and safety among psoriasis patients who continued apremilast for 6 and 12 months. The PMS included 992 patients, of whom 646 of 992 patients continued treatment for 6 months and 509 of 992 patients subsequently continued treatment for 12 months. Baseline characteristics between these groups were similar. Among 992 patients, the treatment persistence rate was 65.1% at 6 months and 51.3% at 12 months after the start of apremilast treatment. PGA 0/1 response was 47.9% at 6 months and 60.8% at 12 months, whereas DLQI 0/1 responses at 6 months and 12 months were 38.5% and 58.7%, respectively. Among 646 patients who continued apremilast for 6 months, diarrhea was reported in 60 patients (9.3%), nausea in 35 patients (5.4%), and headache in 11 (1.7%) patients, which were mainly observed within the first month since treatment initiation. In 509 patients who continued apremilast for 12 months, diarrhea was reported in 43 patients (8.5%), nausea in 24 patients (4.7%), and headache in 6 (1.2%) patients; similar frequencies of these adverse reactions were observed within 6 months and between 6 and 12 months of follow-up. It is important to continue apremilast by appropriately managing diarrhea and nausea in real-world practice.