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Abstract Details
Long-term safety of rituximab in rheumatic patients with previously resolved hepatitis B virus infection
Michele Barone1, Vincenzo Venerito2, Rosa Paolillo1, Giacomo Emmi3, Marco Fornaro2, Fabio Cacciapaglia2, Luca Cantarini4, Alfredo Di Leo1, Florenzo Iannone2, Giuseppe Lopalco5
Author information
1Gastroenterology Unit, Department of Emergency and Organ Transplantation (D.E.T.O.), University of Bari, Bari, Italy.
2Rheumatology Unit, Department of Emergency and Organ Transplantation (D.E.T.O.), University of Bari, Bari, Italy.
3Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
4Rheumatology Unit, Department Research Center of Systemic Autoimmune and Autoinflammatory Diseases, University of Siena, Siena, Italy.
5Rheumatology Unit, Department of Emergency and Organ Transplantation (D.E.T.O.), University of Bari, Bari, Italy. glopalco@hotmail.it.
Abstract
Conflicting results can be found in the literature on the frequency of hepatitis B virus (HBV) reactivation (HBVr) on rituximab (RTX) in rheumatic patients with previously resolved HBV (prHBV) infection. Here, we report the frequency of HBVr in a large historical cohort of caucasian rheumatic patients with prHBV receiving RTX. Registry data of rheumatic patients treated with RTX were retrospectively analysed. Demographic and clinical characteristics including evaluation of anti-HCV and HBV markers, annual HBV-DNA determination and aminotransferase levels assessed every three months, were recorded. Kaplan-Meier estimate was used to compare the risk of being still under therapy at different time points in patients with or without prHBV infection. Cox regression analysis was used to determine the association between recorded variables and treatment discontinuation. A total of 311 patients treated with RTX, 44 (14.1%) with and 267 (85.9%) without prHBV were analysed. No significant difference between the two groups regarding demographic and clinical characteristics was observed. During RTX treatment, detectable HBV-DNA and reappearance of HBsAg in patients with prHBV (seroreversion) were never observed. Kaplan-Meier functions were similar in patients with or without prHBV infection which was not associated with RTX discontinuation neither at univariate nor at multivariate analysis. These data are in favor of the concept that patients with rheumatologic diseases have a very low risk of reactivation of the HBV infection under RTX treatment. However, future prospective studies, including a larger number of patients, are still necessary to draw definitive conclusions.