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<p>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&#xa0;weeks until reaching the maximum dose (500&#xa0;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&#xa0;µg, week 2: 350&#xa0;µg, week 4: 500&#xa0;µg) of ropeginterferon alfa-2b in Japanese patients with PV (NCT06002490). Twenty-one patients were included (mean age: 57&#xa0;years); most (95.2%) received ropeginterferon alfa-2b for at least 24&#xa0;weeks. The complete hematologic response rate (primary endpoint; hematocrit &lt; 45%, no phlebotomy in the previous 12&#xa0;weeks, platelet count ≤ 400 × 10<sup>9</sup>/L, and white blood cell count ≤ 10 × 10<sup>9</sup>/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&#xa0;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.</p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月9日

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  • 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

摘要

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.