論文種別	原著(症例報告除く)
言語種別	英語
査読の有無	その他(不明)
表題	Efficacy and safety of a three-step dose escalation regimen of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: a phase 3b, single-arm, multicenter study.
掲載誌名	正式名：International journal of hematology 略　 称：Int J Hematol ISSNコード：18653774/09255710
掲載区分	国外
巻・号・頁	pp.Online ahead of print
著者・共著者	Tadaaki Inano, Yuka Sugimoto, Kohshi Ohishi, Akihiko Gotoh, Tomoki Ito, Michiko Ichii, Kazuya Shimoda, Sheena Lin, Oleh Zagrijtschuk, Albert Qin, Mai Sato, Hiroaki Kawase, Toshiaki Sato, Norio Komatsu, Keita Kirito
発行年月	2026/03
概要	Ropeginterferon alfa-2b, a monopegylated interferon α-2b, is a cytoreductive treatment for polycythemia vera (PV). In Japan, the current regimen involves titration in 50-µg increments every 2 weeks until reaching the maximum dose (500 µg), which requires considerable time. This phase 3b, open-label, single-arm, multicenter study (October 2023-July 2024) assessed the efficacy and safety of a three-step dose escalation regimen (day 1: 250 µg, week 2: 350 µg, week 4: 500 µg) of ropeginterferon alfa-2b in Japanese patients with PV (NCT06002490). Twenty-one patients were included (mean age: 57 years); most (95.2%) received ropeginterferon alfa-2b for at least 24 weeks. The complete hematologic response rate (primary endpoint; hematocrit < 45%, no phlebotomy in the previous 12 weeks, platelet count ≤ 400 × 109/L, and white blood cell count ≤ 10 × 109/L) was 23.8% (95% confidence interval 8.2, 47.2) at week 12 and 57.1% (34.0, 78.2) at week 24. Most patients (90.5%) reached the maximum dose of 500 µg by week 4. All patients had treatment-emergent adverse events, but none led to death, treatment discontinuation, or study withdrawal. This three-step dose escalation regimen of ropeginterferon alfa-2b has the potential to provide faster therapeutic effects in patients with PV without additional safety concerns.
DOI	10.1007/s12185-026-04163-9
PMID	41801560