{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T02:51:47Z","timestamp":1793242307275,"version":"4.5.0"},"reference-count":41,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T00:00:00Z","timestamp":1717718400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Hematological Oncology"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Mogamulizumab is a humanized antibody targeting CC chemokine receptor 4 (CCR4). This post\u2010marketing surveillance was conducted in Japan as a regulatory requirement from 2014 to 2020 to ensure the safety and effectiveness of mogamulizumab in patients with relapsed or refractory (r\/r) CCR4\u2010positive peripheral T\u2010cell lymphoma (PTCL) or r\/r cutaneous T\u2010cell lymphoma (CTCL). Safety and effectiveness data were collected for up to 31\u00a0weeks after treatment initiation. A total of 142 patients were registered; safety was evaluated in 136 patients. The median number of doses was 8.0 (range, 1\u201318). The main reasons for treatment termination were insufficient response (22.1%) and adverse events (13.2%). The frequency of any grade adverse drug reaction was 57.4%, including skin disorders (26.5%), infections and immune system disorders (16.2%), and infusion\u2010related reactions (13.2%). Graft\u2010versus\u2010host disease, grade 2, developed in one of two patients who underwent allogeneic\u2010hematopoietic stem cell transplantation after receiving mogamulizumab. Effectiveness was evaluated in 131 patients (103 with PTCL; 28 with CTCL). The best overall response rate was 45.8% (PTCL, 47.6%; CTCL, 39.3%). At week 31, the survival rate was 69.0% (95% confidence interval, 59.8%\u201376.5%) [PTCL, 64.4% (54.0%\u201373.0%); CTCL, 90.5% (67.0%\u201397.5%)]. Safety and effectiveness were comparable between patients &lt;70 and\u00a0\u2265\u00a070\u00a0years old and between those with relapsed and refractory disease. The safety and effectiveness of mogamulizumab for PTCL and CTCL in the real world were comparable with the data reported in previous clinical trials.<\/jats:p>\n                  <jats:p>Clinical Trial Registration<\/jats:p>","DOI":"10.1002\/hon.3292","type":"journal-article","created":{"date-parts":[[2024,6,7]],"date-time":"2024-06-07T06:29:31Z","timestamp":1717741771000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Safety and effectiveness of mogamulizumab in relapsed or refractory CC chemokine receptor 4\u2010positive peripheral T\u2010cell lymphoma and relapsed or refractory cutaneous T\u2010cell lymphoma: A post\u2010marketing surveillance in Japan"],"prefix":"10.1002","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7030-497X","authenticated-orcid":false,"given":"Kenji","family":"Ishitsuka","sequence":"first","affiliation":[{"name":"Division of Hematology and Rheumatology Graduate School of Medical and Dental Sciences Kagoshima University  Kagoshima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8960-158X","authenticated-orcid":false,"given":"Tomoharu","family":"Yasukawa","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0813-433X","authenticated-orcid":false,"given":"Yukie","family":"Tsuji","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Division Kyowa Kirin Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,6,7]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/medsci9010005"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1182\/asheducation\u20102011.1.515"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.26299"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2010.28.9066"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2011.37.4223"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2010.29.9024"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2006.10.2434"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1200\/jco.2011.38.0402"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00277\u2010018\u20103418\u20102"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.14906"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2022.280996"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/intimm\/11.1.81"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1038\/cr.2016.151"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078\u20100432.ccr\u201004\u20100371"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V96.2.685"},{"issue":"10","key":"e_1_2_10_17_1","first-page":"3625","article-title":"Clinical significance of CCR4 expression in adult T\u2010cell leukemia\/lymphoma: its close association with skin involvement and unfavorable outcome","volume":"9","author":"Ishida T","year":"2003","journal-title":"Clin Cancer Res"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1523\u20101747.2002.19610.x"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood\u20102009\u201011\u2010251926"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.3390\/cancers13215542"},{"key":"e_1_2_10_21_1","unstructured":"Interview form.\u201cPoteligeo\u201d INN\u2010Moganulizumab. 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