{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,31]],"date-time":"2026-10-31T01:59:51Z","timestamp":1793411991916,"version":"4.5.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T00:00:00Z","timestamp":1773014400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T00:00:00Z","timestamp":1773014400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"PharmaEssentia Corporation"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Ropeginterferon alfa-2b, a monopegylated interferon \u03b1-2b, is a cytoreductive treatment for polycythemia vera (PV). In Japan, the current regimen involves titration in 50-\u00b5g increments every 2\u00a0weeks until reaching the maximum dose (500\u00a0\u00b5g), which requires considerable time. This phase 3b, open-label, single-arm, multicenter study (October 2023\u2013July 2024) assessed the efficacy and safety of a three-step dose escalation regimen (day 1: 250\u00a0\u00b5g, week 2: 350\u00a0\u00b5g, week 4: 500\u00a0\u00b5g) of ropeginterferon alfa-2b in Japanese patients with PV (NCT06002490). Twenty-one patients were included (mean age: 57\u00a0years); most (95.2%) received ropeginterferon alfa-2b for at least 24\u00a0weeks. The complete hematologic response rate (primary endpoint; hematocrit\u2009&lt;\u200945%, no phlebotomy in the previous 12\u00a0weeks, platelet count\u2009\u2264\u2009400\u2009\u00d7\u200910\n                    <jats:sup>9<\/jats:sup>\n                    \/L, and white blood cell count\u2009\u2264\u200910\u2009\u00d7\u200910\n                    <jats:sup>9<\/jats:sup>\n                    \/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\u00a0\u00b5g 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.\n                  <\/jats:p>","DOI":"10.1007\/s12185-026-04163-9","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T13:59:33Z","timestamp":1773064773000},"page":"848-857","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["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"],"prefix":"10.1007","volume":"123","author":[{"given":"Tadaaki","family":"Inano","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Sugimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kohshi","family":"Ohishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihiko","family":"Gotoh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoki","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiko","family":"Ichii","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2555-8188","authenticated-orcid":false,"given":"Kazuya","family":"Shimoda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheena","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleh","family":"Zagrijtschuk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Albert","family":"Qin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mai","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Kawase","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiaki","family":"Sato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Komatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keita","family":"Kirito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,9]]},"reference":[{"key":"4163_CR1","doi-asserted-by":"publisher","first-page":"2391","DOI":"10.1182\/blood-2016-03-643544","volume":"127","author":"DA Arber","year":"2016","unstructured":"Arber DA, Orazi A, Hasserjian R, Thiele J, Borowitz MJ, Le Beau MM, et al. 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Hematol Am Soc Hematol Educ Progr. 2024;2024:535\u201340.","journal-title":"Hematol Am Soc Hematol Educ Progr"}],"container-title":["International Journal of Hematology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-026-04163-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12185-026-04163-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12185-026-04163-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T10:09:08Z","timestamp":1782468548000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12185-026-04163-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,9]]},"references-count":20,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2026,6]]}},"alternative-id":["4163"],"URL":"https:\/\/doi.org\/10.1007\/s12185-026-04163-9","relation":{},"ISSN":["0925-5710","1865-3774"],"issn-type":[{"value":"0925-5710","type":"print"},{"value":"1865-3774","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,9]]},"assertion":[{"value":"25 August 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 January 2026","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 January 2026","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 March 2026","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Tadaaki Inano reported grants from PharmaEssentia Japan KK; and\u00a0payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from PharmaEssentia Japan KK, Chugai Pharmaceutical Co, Ltd, Novartis Pharma KK and Asahi Kasei Pharma Corporation. Yuka Sugimoto reported grants or research funding from Astellas Pharma Inc, Kyowa Kirin Co, Ltd, Ono Pharmaceutical Co, Ltd, Toyo Kohan Co, Ltd, Incyte Biosciences Japan GK, and Shojunkai Takeuchi Hospital; honoraria from Novartis Pharma KK; is a member of a data safety monitoring board\/advisory board for Novartis Pharma KK; and is an editor of the\n                      International Journal of Hematology\n                      . Kohshi Ohishi reported no conflicts of interest. Akihiko Gotoh reported funding for medical writing support from Alexion Pharmaceuticals, Inc; research funding from Eisai Co, Ltd, Ono Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co, Ltd, Takeda Pharmaceutical Co, Ltd, Nippon Shinyaku Co, Ltd, Chugai Pharmaceutical Co, Ltd, MSD KK, Otsuka Pharmaceutical Co, Ltd, Sumitomo Pharma Co, Ltd, Bayer Yakuhin, Ltd, Daiichi Sankyo Co, Ltd, and Nihon Pharmaceutical Co, Ltd; consulting fees from PharmaEssentia Japan KK, Chugai Pharmaceutical Co, Ltd, and Alexion Pharmaceuticals, Inc; honoraria from Novartis Pharma KK, Alexion Pharmaceuticals, Inc, Eisai Co, Ltd, Ono Pharmaceutical Co, Ltd, Taiho Pharmaceutical Co, Ltd, Takeda Pharmaceutical Co, Ltd, Nippon Shinyaku Co, Ltd, Chugai Pharmaceutical Co, Ltd, Otsuka Pharmaceutical Co, Ltd, Sumitomo Pharma Co, Ltd, Daiichi Sankyo Co, Ltd, Nihon Pharmaceutical Co, Ltd, Kyowa Kirin Co, Ltd, Janssen Pharmaceutical KK, Pfizer Japan Inc, and Sanofi KK; and is a member of data safety monitoring boards\/advisory boards for PharmaEssentia Japan KK, Chugai Pharmaceutical Co, Ltd and Alexion Pharmaceuticals, Inc. Tomoki Ito reported no conflicts of interest. Michiko Ichii reported payments or honoraria for presentations from Novartis Pharma KK and for speakers bureaus from Sumitomo Pharma Co, Ltd. Kazuya Shimoda reported research funding from PharmaEssentia Japan KK, Chugai Pharmaceutical Co, Ltd, AbbVie GK, Kyowa Kirin Co, Ltd, Daiichi Sankyo Co, Ltd, Shionogi & Co, Ltd, Otsuka Pharmaceutical Co, Ltd, Eisai Co, Ltd, Nippon Kayaku Co, Ltd, Takeda Pharmaceutical Co, Ltd, Sumitomo Pharma Co, Ltd, Mochida Pharmaceutical Co, Ltd and Taisho Pharmaceutical Co, Ltd; honoraria from Novartis Pharma KK and Takeda Pharmaceutical Co, Ltd; and is a member of a data safety monitoring board\/advisory board for AbbVie GK. Sheena Lin is an employee of PharmaEssentia Corporation. Oleh Zagrijtschuk is an employee of PharmaEssentia USA Corporation. Albert Qin is an employee of PharmaEssentia Corporation. Mai Sato is an employee of PharmaEssentia Japan KK. Hiroaki Kawase is an employee of PharmaEssentia Japan KK. Toshiaki Sato is an employee of PharmaEssentia Japan KK. Norio Komatsu reported being an employee and Board Member of PharmaEssentia Japan KK; grants or research funding from Otsuka Pharmaceutical Co, Ltd, Kyowa Kirin Co, Ltd, Sumitomo Pharma Co, Ltd, PharmaEssentia Japan KK, PharmaEssentia Corporation, Chugai Pharmaceutical Co, Ltd, Takeda Pharmaceutical Co, Ltd, Perseus Proteomics Inc and Meiji Seika Pharma Co, Ltd; consulting fees from Japan Tobacco Inc, Torii Pharmaceutical Co, Ltd and PharmaEssentia Japan KK; and payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis Pharma KK and Takeda Pharmaceutical Co, Ltd. Keita Kirito reported payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis Pharma KK, Takeda Pharmaceutical Co, Ltd, PharmaEssentia Japan KK, Sanofi KK and AbbVie GK.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}