Ohtsuki Mamitaro, Okubo Yukari, Saeki Hidehisa, Igarashi Atsuyuki, Imafuku Shinichi, Abe Masatoshi, Saito Katsuya, Ogawa Ryuichi, Morita Akimichi
Department of Dermatology, Jichi Medical University, Shimotsuke, Japan.
Department of Dermatology, Tokyo Medical University, Tokyo, Japan.
J Dermatol. 2025 Jun;52(6):1059-1065. doi: 10.1111/1346-8138.17764. Epub 2025 May 10.
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.
阿普米拉斯是一种磷酸二酯酶4抑制剂，在日本被批准用于治疗中度至重度银屑病。在之前发表的一项主要的上市后监测研究中，阿普米拉斯在6个月和12个月时均显著改善了医生整体评估（PGA）和皮肤病生活质量指数（DLQI）。在此，我们对监测数据进行了事后分析，以评估持续使用阿普米拉斯6个月和12个月的银屑病患者的特征、有效性和安全性。该上市后监测研究纳入了992例患者，其中992例患者中的646例持续治疗6个月，992例患者中的509例随后继续治疗12个月。这些组之间的基线特征相似。在992例患者中，阿普米拉斯治疗开始后6个月时的治疗持续率为65.1%，12个月时为51.3%。PGA 0/1反应在6个月时为47.9%，12个月时为60.8%，而DLQI在6个月和12个月时的0/1反应分别为38.5%和58.7%。在持续使用阿普米拉斯6个月的646例患者中，60例（9.3%）报告有腹泻，35例（5.4%）有恶心，11例（1.7%）有头痛，这些主要在治疗开始后的第一个月内观察到。在持续使用阿普米拉斯12个月的509例患者中，43例（8.5%）报告有腹泻，24例（4.7%）有恶心，6例（1.2%）有头痛；在随访的6个月内以及6至12个月之间观察到这些不良反应的频率相似。在实际临床实践中，通过适当处理腹泻和恶心来持续使用阿普米拉斯很重要。
