| アブストラクト | BACKGROUND: Rituximab has been associated with hepatitis B virus reactivation (HBV-R). However, the characteristics and scope of this association remain largely undefined. METHODS: We completed a comprehensive literature search of all published rituximab-associated HBV-R cases and from the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS) MedWatch database. Literature and FDA cases were compared for completeness, and a meta-analysis was completed. RESULTS: One hundred and eighty-three unique cases of rituximab-associated HBV-R were identified from the literature (n = 27 case reports, n = 156 case series). The time from last rituximab to reactivation was 3 months (range 0-12), although 29% occurred >6 months after last rituximab. Within FDA data (n = 118 cases), there was a strong signal for rituximab-associated HBV-R [proportional reporting ratio = 28.5, 95% confidence interval (CI) 23.9-34.1; Empiric Bayes Geometric Mean = 26.4, 95% CI 21.4-31.1]. However, the completeness of data in FDA reports was significantly inferior compared with literature cases (P < 0.0001). Among HBV core antibody (HBcAb(+)) series, the pooled effect of rituximab-based therapy showed a significantly increased risk of HBV-R compared with nonrituximab-treated patients (odds ratio 5.73, 95% CI 2.01-16.33; Z = 3.33, P = 0.0009) without heterogeneity (chi(2) = 2.12, P = 0.5473). CONCLUSIONS: The FDA AERS provided strong HBV-R safety signals; however, literature-based cases provided a significantly more complete description. Furthermore, meta-analysis of HBcAb(+) series identified a more than fivefold increased rate of rituximab-associated HBV-R. |
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| ジャーナル名 | Annals of oncology : official journal of the European Society for Medical Oncology |
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| 投稿日 | 2010/12/1 |
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| 投稿者 | Evens, A M; Jovanovic, B D; Su, Y-C; Raisch, D W; Ganger, D; Belknap, S M; Dai, M-S; Chiu, B-C C; Fintel, B; Cheng, Y; Chuang, S-S; Lee, M-Y; Chen, T-Y; Lin, S-F; Kuo, C-Y |
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| 組織名 | Department of Medicine, Northwestern University Feinberg School of Medicine,;Chicago, USA; Division of Hematology/Oncology, Robert H. Lurie Comprehensive;Cancer Center, Northwestern University. Electronic address:;a-evens@northwestern.edu.;Chicago, USA; Department of Preventive Medicine.;Division of Oncology, Dalin Tzu-Chi General Hospital, Chiayi, Taiwan.;Veterans Administration Cooperative Studies Program College of Pharmacy,;University of New Mexico, Albuquerque, USA.;Chicago, USA; Division of Hepatology.;Chicago, USA; Department of Internal Medicine.;Division of Hematology/Oncology, Tri-Service General Hospital, Taipei, Taiwan.;Department of Health Studies, Division of Epidemiology, The University of;Chicago, Chicago, USA.;Department of Pathology, Chi-Mei Medical Center, Tainan and Taipei Medical;University, Taipei.;Division of Oncology, Chia-Yi Christian Hospital, Chiayi.;Division of Oncology, National Cheng Kung University Hospital, Tainan.;Faculty of Medicine and Division of Hematology & Oncology, Kaohsiung Medical;University and Hospital, Kaohsiung.;Division of Hematology/Oncology, Chang Gung Memorial Hospital-Kaohsiung Medical;Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/21115603/ |
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