{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:06:35Z","timestamp":1753877195277,"version":"3.41.2"},"reference-count":19,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2025,3,29]],"date-time":"2025-03-29T00:00:00Z","timestamp":1743206400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004339","name":"Sanofi","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004339","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,7,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Alemtuzumab is a monoclonal antibody directed against CD52 on T and B lymphocytes and is used to treat lymphoproliferative disorders including chronic lymphocytic leukaemia (CLL). This postmarketing surveillance, as mandated by the Japanese health authorities, investigated the safety and effectiveness of alemtuzumab in Japanese patients receiving alemtuzumab for relapsed\/refractory CLL.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was an observational, prospective study conducted in patients with lymphoproliferative disorders who received alemtuzumab in routine clinical practice in Japan between March 2015 and June 2023. Follow-up was for 24\u00a0weeks after alemtuzumab administration. Endpoints were adverse drug reactions (ADRs), objective response rate (ORR), progression-free survival (PFS) and overall survival (OS), and factors associated with safety and effectiveness.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Safety was evaluated in 179 patients with lymphoproliferative disorders (112 males and 67 females; median age 68\u00a0years) and effectiveness in 95 with relapsed\/refractory CLL. Overall, 138 patients (77.1%) developed an ADR (most commonly cytomegalovirus [CMV]-related events [37.4%]), 100 (55.9%) developed serious ADRs (most commonly CMV-related events [31.3%]), and 93 (52.0%) developed grade\u00a0\u2265\u00a03 ADRs (most commonly decreased platelet count [13.4%]). Of 95 patients with relapsed\/refractory CLL, 39 (41.1%) had an ORR (15 complete and 24 partial responses). At 24\u00a0weeks, PFS and OS rates were 55.5% and 70.0%, respectively. The ORR was significantly associated with Rai classification, performance status, and treatment days or duration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>This prospective postmarketing surveillance study confirms the effectiveness and manageable safety profile of alemtuzumab for Japanese patients with relapsed\/refractory CLL.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyaf044","type":"journal-article","created":{"date-parts":[[2025,3,31]],"date-time":"2025-03-31T16:47:24Z","timestamp":1743439644000},"page":"758-764","source":"Crossref","is-referenced-by-count":0,"title":["Real-world safety and effectiveness of alemtuzumab for relapsed or refractory chronic lymphocytic leukaemia: results from postmarketing surveillance in Japan"],"prefix":"10.1093","volume":"55","author":[{"ORCID":"https:\/\/orcid.org\/0009-0005-2525-0668","authenticated-orcid":false,"given":"Yukie","family":"Sasakura","sequence":"first","affiliation":[{"name":"General Medicine Medical , Sanofi K.K,, Tokyo ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Makiko","family":"Hatanaka","sequence":"additional","affiliation":[{"name":"Post Authorization Regulatory Study, Medical Affairs, Sanofi K.K. , Tokyo ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenichi","family":"Ishizawa","sequence":"additional","affiliation":[{"name":"Faculty of Health Sciences, Tohoku Fukushi University , Sendai, Miyagi ,","place":["Japan"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,3,29]]},"reference":[{"key":"2025070702413639700_ref1","doi-asserted-by":"publisher","first-page":"1524","DOI":"10.1016\/S0140-6736(18)30422-7","article-title":"Chronic lymphocytic leukaemia","volume":"391","author":"Hallek","year":"2018","journal-title":"Lancet"},{"key":"2025070702413639700_ref2","doi-asserted-by":"publisher","first-page":"126","DOI":"10.3960\/jslrt.20044","article-title":"Real world treatment practices for chronic lymphocytic leukemia in Japan: an observational database research study (CLIMBER-DBR)","volume":"61","author":"Takizawa","year":"2021","journal-title":"J Clin Exp Hematop"},{"key":"2025070702413639700_ref3","doi-asserted-by":"publisher","first-page":"330","DOI":"10.1002\/ajh.24282","article-title":"Chronic lymphocytic leukemia (CLL)-then and now","volume":"91","author":"Rai","year":"2016","journal-title":"Am J Hematol"},{"volume-title":"Guidelines for the treatment of hematopoietic tumors","year":"2023","author":"Japanese Society of Hematology","key":"2025070702413639700_ref4"},{"key":"2025070702413639700_ref5","doi-asserted-by":"publisher","first-page":"157","DOI":"10.1007\/s40265-020-01437-2","article-title":"Alemtuzumab: a review in relapsing remitting multiple sclerosis","volume":"81","author":"Syed","year":"2021","journal-title":"Drugs"},{"key":"2025070702413639700_ref6","doi-asserted-by":"publisher","first-page":"813","DOI":"10.1309\/AJCPYFQ4XMGJD6TI","article-title":"Quantification of expression of antigens targeted by antibody-based therapy in chronic lymphocytic leukemia","volume":"140","author":"Tembhare","year":"2013","journal-title":"Am J Clin Pathol"},{"key":"2025070702413639700_ref7","doi-asserted-by":"publisher","first-page":"2356","DOI":"10.1080\/10428194.2017.1285027","article-title":"Soluble CD52 is an indicator of disease activity in chronic lymphocytic leukemia","volume":"58","author":"Vojdeman","year":"2017","journal-title":"Leuk Lymphoma"},{"key":"2025070702413639700_ref8","doi-asserted-by":"publisher","first-page":"54","DOI":"10.1093\/jjco\/hyw146","article-title":"Safety, efficacy and pharmacokinetics of humanized anti-CD52 monoclonal antibody alemtuzumab in Japanese patients with relapsed or refractory B-cell chronic lymphocytic leukemia","volume":"47","author":"Ishizawa","year":"2017","journal-title":"Jpn J Clin Oncol"},{"volume-title":"Guidelines for the treatment of hematopoietic tumors","year":"2013","author":"Japanese Society of Hematology","key":"2025070702413639700_ref9"},{"key":"2025070702413639700_ref10","doi-asserted-by":"publisher","first-page":"3554","DOI":"10.1182\/blood.V99.10.3554","article-title":"Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study","volume":"99","author":"Keating","year":"2002","journal-title":"Blood"},{"volume-title":"MabCampath I.V. 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