{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T10:59:04Z","timestamp":1791197944849,"version":"4.1.0"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T00:00:00Z","timestamp":1779062400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T00:00:00Z","timestamp":1779062400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Kyowa Kirin Co., Ltd."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Hematol"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Post-marketing surveillance was conducted in Japan (2015\u20132024, UMIN000056049) to evaluate the long-term safety and effectiveness of darbepoetin alfa for anemia with myelodysplastic syndromes (MDS) for 5\u00a0years after treatment initiation. Among 1834 patients (median age: 79.0\u00a0years), the distribution of International Prognostic Scoring System (IPSS) risk categories was: Low, 39.3%; Intermediate-1, 45.1%; Intermediate-2, 7.7%; and High, 2.8%. The median (range) administration duration, dosing interval, and weekly dose were 330.0 (1\u20131863) days, 1.7 (0.2\u201341.5) weeks, and 240.0 (30.0\u2013250.0) \u00b5g, respectively. Treatment discontinuation reasons included inadequate response (36.9%) and adverse events (AEs) (31.2%). AEs were reported in 75.1% and included pneumonia (16.6%) and transformation to acute myeloid leukemia (9.0%). Mean hemoglobin concentration (n\u2009=\u20091821) increased from 7.6\u00a0g\/dL at baseline to\u2009&gt;\u20099.0\u00a0g\/dL after 52\u00a0weeks. Red blood cell transfusion volume decreased by\u2009\u2265\u200950% compared with baseline in 65.2% of patients. In transfusion-dependent patients (n\u2009=\u2009909), the highest transfusion-independence rate was 40.9% at year 4\u20135. Five-year overall\/leukemia-free survival rates (n\u2009=\u20091826\/1814) by IPSS risk group were: Low, 49.5%\/48.8%, Intermediate-1, 31.1%\/30.2%, Intermediate-2, 11.9%\/10.4%, and High, 0%\/0%. Poor prognostic factors for MDS were IPSS risk category, age, chromosomal abnormalities, and platelet count. No new safety or effectiveness concerns were identified.<\/jats:p>\n                  <jats:p>\n                    <jats:italic>Trial registration:<\/jats:italic>\n                    University Hospital Medical Information Network; study ID: UMIN000056049.\n                  <\/jats:p>","DOI":"10.1007\/s12185-026-04227-w","type":"journal-article","created":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T19:16:38Z","timestamp":1779131798000},"page":"502-520","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Darbepoetin alfa for the treatment of anemia in myelodysplastic syndromes: a post-marketing surveillance study in Japan"],"prefix":"10.1007","volume":"124","author":[{"given":"Yasuyoshi","family":"Morita","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukie","family":"Tsuji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoharu","family":"Yasukawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kinuko","family":"Mitani","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,18]]},"reference":[{"key":"4227_CR1","unstructured":"Miyazaki Y, Kawabata H, Kiyoi H, Kurokawa M, Takaori A, Chiba S, et al. Myelodysplastic syndromes reference guide 2023 (revised version). (in Japanese). [Internet]. 2023 [cited 2026 April 28]. Available from: https:\/\/zoketsushogaihan.umin.jp\/file\/2022\/Myelodysplastic_Syndromes.pdf"},{"key":"4227_CR2","unstructured":"Japanese Society of Hematology. JSH practical guidelines for hematological malignancies 2024 (version 3.1). (in Japanese). [Internet]. 2023 [cited 2026 April 28]. Available from: http:\/\/www.jshem.or.jp\/gui-hemali\/1_6.html#soron"},{"key":"4227_CR3","doi-asserted-by":"publisher","first-page":"66","DOI":"10.6004\/jnccn.2025.0013","volume":"23","author":"PL Greenberg","year":"2025","unstructured":"Greenberg PL, Stone RM, Abaza Y, Al-Kali A, Anand S, Ball B, et al. NCCN guidelines\u00ae insights: myelodysplastic syndromes, version 2.2025. J Natl Compr Canc Netw. 2025;23:66\u201375.","journal-title":"J Natl Compr Canc Netw"},{"key":"4227_CR4","doi-asserted-by":"publisher","first-page":"142","DOI":"10.1016\/j.annonc.2020.11.002","volume":"32","author":"P Fenaux","year":"2021","unstructured":"Fenaux P, Haase D, Santini V, Sanz GF, Platzbecker U, Mey U, et al. Myelodysplastic syndromes: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2021;32:142\u201356.","journal-title":"Ann Oncol"},{"key":"4227_CR5","first-page":"1411","volume-title":"Williams Hematology","author":"R Bejar","year":"2021","unstructured":"Bejar R, Steensma DP. Chapter 86, Myelodysplastic syndromes. In: Kaushansky K, Prchal JT, Burns LJ, Lichtman MA, Levi M, Lich DC, editors. Williams Hematology. 10th ed. New York: McGraw-Hill Education; 2021. p. 1411\u201328.","edition":"10"},{"key":"4227_CR6","doi-asserted-by":"publisher","first-page":"1944","DOI":"10.1038\/leu.2017.192","volume":"31","author":"U Platzbecker","year":"2017","unstructured":"Platzbecker U, Symeonidis A, Oliva EN, Goede JS, Delforge M, Mayer J, et al. A phase 3 randomized placebo-controlled trial of darbepoetin alfa in patients with anemia and lower-risk myelodysplastic syndromes. Leukemia. 2017;31:1944\u201350.","journal-title":"Leukemia"},{"key":"4227_CR7","doi-asserted-by":"publisher","first-page":"401","DOI":"10.1007\/s12185-015-1862-5","volume":"102","author":"JH Jang","year":"2015","unstructured":"Jang JH, Harada H, Shibayama H, Shimazaki R, Kim HJ, Sawada K, et al. A randomized controlled trial comparing darbepoetin alfa doses in red blood cell transfusion-dependent patients with low- or intermediate-1 risk myelodysplastic syndromes. Int J Hematol. 2015;102:401\u201312.","journal-title":"Int J Hematol"},{"key":"4227_CR8","unstructured":"Kyowa Kirin Co., Ltd. Summary of common technical documentation of NESP (KRN321). (in Japanese). [Internet]. 2014 [cited 2026 April 28]. Available from: https:\/\/www.pmda.go.jp\/drugs\/2014\/P201400178\/index.html"},{"key":"4227_CR9","doi-asserted-by":"publisher","first-page":"130","DOI":"10.1007\/s12185-023-03686-9","volume":"119","author":"K Usuki","year":"2024","unstructured":"Usuki K, Ohtake S, Honda S, Matsuda M, Wakita A, Nawa Y, et al. Real-world data of MDS and CMML in Japan: results of JALSG clinical observational study-11 (JALSG-CS-11). Int J Hematol. 2024;119:130\u201345.","journal-title":"Int J Hematol"},{"key":"4227_CR10","unstructured":"Kyowa Kirin Co., Ltd. Package insert of NESP\u00ae Injection 5\u00b5g, 10\u00b5g, 15\u00b5g, 20\u00b5g, 30\u00b5g, 40\u00b5g, 60\u00b5g, 120\u00b5g, 180\u00b5g Plastic Syringe. (in Japanese). [Internet]. 2025 [cited 2026 April 28]. 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KM received compensation for outside director from Chugai Pharmaceutical Co., Ltd., grants or contracts from Sumitomo Pharma Co., Ltd., Chugai Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Daiichi Sankyo Co., Ltd., consulting fees from Kyowa Kirin Co., Ltd., lecture fees from Novartis Pharma K.K., Bristol-Myers Squibb K.K., Kyowa Kirin Co., Ltd., Janssen Pharmaceutical K.K., Chugai Pharmaceutical Co., Ltd., Incyte Biosciences Japan G.K., GlaxoSmithKline K.K., Ono Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Sanofi K.K., Asahi Kasei Pharma Corporation., Daiichi Sankyo Co., Ltd., and Abbvie G.K., participated on a data safety monitoring board or advisory board of Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd., and received consulting fees for the present manuscript from Kyowa Kirin Co., Ltd. YT and TY are employees of Kyowa Kirin Co., Ltd.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}}]}}