title: Low-dose thymoglobulin as second-line treatment for steroid-resistant acute GvHD: an analysis of the JSHCT.
abstract: A nationwide retrospective study for the clinical outcomes of 99 patients who had received thymoglobulin at a median total dose of 2.5 mg/kg (range, 0.5-18.5 mg/kg) as a second-line treatment for steroid-resistant acute GvHD was conducted. Of the 92 evaluable patients, improvement (complete or partial response) was observed in 55 patients (60%). Multivariate analysis demonstrated that male sex and grade III and IV acute GvHD were associated with a lower improvement rate, whereas thymoglobulin dose (<2.0, 2.0-3.9 and ⩾4.0 mg/kg) was NS. Factors associated with significantly higher nonrelapse mortality included higher patient age (⩾50 years), grade IV acute GvHD, no improvement of GvHD and higher dose of thymoglobulin (hazard ratio, 2.55; 95% confidence interval, 1.34-4.85; P=0.004 for 2.0-3.9 mg/kg group and 1.79; 0.91-3.55; P=0.093 for ⩾4.0 mg/kg group). Higher dose of thymoglobulin was associated with a higher incidence of bacterial infections, CMV antigenemia and any additional infection. Taken together, low-dose thymoglobulin at a median total dose of 2.5 mg/kg provides a comparable response rate to standard-dose thymoglobulin reported previously, and <2.0 mg/kg thymoglobulin is recommended in terms of the balance between efficacy and adverse effects.
authors.affiliation: Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Murata
authors.affiliation: Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Ikegame
authors.affiliation: Department of Internal Medicine, Holy Spirit Hospital, Nagoya, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Morishita
authors.affiliation: Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Ogawa
authors.affiliation: Division of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kaida
authors.affiliation: Hematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Nakamae
authors.affiliation: Division of Hematology and Stem Cell Transplantation, Shizuoka Cancer Center, Shizuoka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ikeda
authors.affiliation: Department of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Nishida
authors.affiliation: Department of Hematology/Oncology, Osaka Medical Center and Research Institute for Maternal and Child Health, Osaka, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Inoue
authors.affiliation: Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Eto
authors.affiliation: Department of Hematology, Aomori Prefectural Central Hospital, Aomori, Japan.
authors.forename: K
authors.initials: K
authors.lastname: Kubo
authors.affiliation: Leukemia Research Center, Saiseikai Maebashi Hospital, Maebashi, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Sakura
authors.affiliation: Division of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Mori
authors.affiliation: Department of Hematology, Toranomon Hospital, Tokyo, Japan.
authors.forename: N
authors.initials: N
authors.lastname: Uchida
authors.affiliation: Division of Hematology and Rheumatology, Department of Internal Medicine, Kinki University, School of Medicine, Osakasayama, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ashida
authors.affiliation: Department of Hematology, Kawasaki Medical School, Kurashiki, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Matsuhashi
authors.affiliation: Department of Hematology, Oita Prefectural Hospital, Oita, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Department of Hematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Ichinohe
authors.affiliation: Japanese Data Center for Hematopoietic Cell Transplantation, Nagoya, Japan.|Department of Healthcare Administration, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Y
authors.initials: Y
authors.lastname: Atsuta
authors.affiliation: Department of Hematology, Hokkaido University Graduate School of Medical Science, Sapporo, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Teshima
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D064591:Allografts; D000961:Antilymphocyte Serum / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D004351:Drug Resistance / Q000187:drug effects*; D005260:Female; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000401:mortality; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012042:Registries; D012737:Sex Factors; D015996:Survival Rate
chemical_list: D000961:Antilymphocyte Serum; C512542:thymoglobulin