Safety and effectiveness of thymoglobulin: Results of seven Japanese post marketing surveillances

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  • サイモグロブリン<sup>®</sup>の安全性と有効性：7つの製造販売後調査からの検討

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<p> Thymoglobulin is an anti-human thymocyte immunoglobulin preparation made of purified polyclonal antibodies derived from rabbits. It is approved for clinical use in Japan as an immunosuppressant treatment for a pre-treatment before hematopoietic stem cell transplant (HSCT) and in the treatment of post-HSCT acute graft-versus-host disease (GVHD); it is also approved to treat moderate to severe aplastic anemia and acute rejection after kidney, hepatic, cardiac, pulmonary, pancreatic or small intestinal transplant. Post-launch, a drug use surveillance and a special drug use surveillance were conducted in thymoglobulin-treated patients in order to understand the safety and effectiveness profiles in real-world medical practice. There were no new safety concerns associated with thymoglobulin use; no notable or unexpected adverse reactions were recognized. Regarding effectiveness, significant differences were found in some of the patient characteristics by examining factors which influence the response rate in the patients with acute GVHD after HSCT or pre-treatment of HSCT. These results were consistent with those from Phase Ⅱ clinical trials and domestic clinical studies.</p>

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