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Rituximab-associated hepatitis B virus (HBV) reactivation in lymphoproliferative diseases: meta-analysis and examination of FDA safety reports
- Source :
- Annals of Oncology. 22:1170-1180
- Publication Year :
- 2011
- Publisher :
- Elsevier BV, 2011.
-
Abstract
- 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 (χ2 = 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.
- Subjects :
- Adult
Male
Hepatitis B virus
medicine.medical_specialty
Antineoplastic Agents
medicine.disease_cause
Antibodies, Monoclonal, Murine-Derived
Young Adult
Adverse Event Reporting System
Orthohepadnavirus
Recurrence
Internal medicine
Adverse Drug Reaction Reporting Systems
Humans
Medicine
Aged
Aged, 80 and over
MedWatch
biology
United States Food and Drug Administration
business.industry
Hematology
Odds ratio
Middle Aged
Hepatitis B
biology.organism_classification
medicine.disease
Lymphoproliferative Disorders
United States
Confidence interval
Oncology
Immunology
Female
Rituximab
business
medicine.drug
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 22
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....3ce2853de2758d05d51e8a60236be204