Suzuki Kodai, Ito Satoru, Carini Stefano, Shimizu Mami, Hatanaka Shigeki, Miyakawa Yoshitaka
Department of Hematology, Saitama Medical University Hospital, Saitama, Japan.
Pharmacovigilance Division, Kyowa Kirin Co, Ltd, Tokyo, Japan.
Blood Vessel Thromb Hemost. 2025 Mar 24;2(2):100066. doi: 10.1016/j.bvth.2025.100066. eCollection 2025 May.
This longitudinal, descriptive study investigated the effect of the timing of thrombopoietin receptor agonist (TPO-RA) initiation on corticosteroid administration and related adverse events (AEs) in patients with immune thrombocytopenia (ITP) in Japan using real-world data from a health claim database. In total, 7696 patients were divided into 3 groups (early TPO-RA initiation, late TPO-RA initiation, and non-TPO-RA administration) by the presence and timing of TPO-RA administration. The early TPO-RA initiation group included patients first administered TPO-RA <60, <120, and <180 days after the index date. The late TPO-RA initiation group included patients first administered TPO-RA ≥60, ≥120, and ≥180 days after the index date. The early TPO-RA initiation group received the highest daily average prednisolone dose, followed by a rapid decrease in dose, similar to that in the non-TPO-RA administration group. In the early TPO-RA initiation group, there was a long-term trend toward daily average prednisolone doses of ≤5 mg, and by approximately 10 to 11 months, the median dose was 0 mg. Diabetes (insulin-dependent) and hypertension tended to occur more frequently in the late TPO-RA (8.4% and 19.9%, respectively) than in the early TPO-RA initiation group (6.9% and 14.4%, respectively). Incidence rates of infections in the late TPO-RA and early TPO-RA initiation groups were similar (7.2% vs 7.6%). The incidence of AEs was similar between male and female patients; a trend toward a higher incidence was observed in those aged ≥60 years. Early initiation of TPO-RA administration can contribute to reducing total prednisolone dosage, treatment duration, and AEs (eg, hypertension and insulin-dependent diabetes).
这项纵向描述性研究利用健康保险理赔数据库中的真实世界数据，调查了日本免疫性血小板减少症（ITP）患者中血小板生成素受体激动剂（TPO-RA）起始时间对皮质类固醇给药及相关不良事件（AE）的影响。总共7696例患者根据TPO-RA给药情况及时间分为3组（TPO-RA早期起始组、TPO-RA晚期起始组和未使用TPO-RA组）。TPO-RA早期起始组包括在索引日期后<60天、<120天和<180天首次接受TPO-RA治疗的患者。TPO-RA晚期起始组包括在索引日期后≥60天、≥120天和≥180天首次接受TPO-RA治疗的患者。TPO-RA早期起始组每日平均泼尼松龙剂量最高，随后剂量迅速下降，与未使用TPO-RA组相似。在TPO-RA早期起始组中，每日平均泼尼松龙剂量有长期降至≤5mg的趋势，大约10至11个月时，中位剂量为0mg。糖尿病（胰岛素依赖型）和高血压在TPO-RA晚期起始组（分别为8.4%和19.9%）中的发生率往往高于TPO-RA早期起始组（分别为6.9%和14.4%）。TPO-RA晚期起始组和早期起始组的感染发生率相似（7.2%对7.6%）。不良事件的发生率在男性和女性患者中相似；≥60岁患者中观察到发生率有升高趋势。早期给予TPO-RA有助于减少泼尼松龙总剂量、治疗持续时间及不良事件（如高血压和胰岛素依赖型糖尿病）。
