Hepatitis B reactivation is a rare event among patients with resolved infection undergoing anti-CD20 antibodies in monotherapy without antiviral prophylaxis: results from the HEBEM study

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Institut Català de la Salut
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[Marzo B] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Hepatologia, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Vidal Jordana A, Castilló J, Tintore M, Montalban X] Servei de Neurologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Robles Sanchez MA] Servei de Neurologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Grup de Recerca Multidisciplinari d’Infermeria, Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. [Otero Romero S] Servei de Neurologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei de Medicina Preventiva i Epidemiologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Buti M, Riveiro Barciela M] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Hepatologia, Servei de Medicina Interna, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain
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Vall d'Hebron Barcelona Hospital Campus
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Marzo Escartin, Blanca
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Castillo Justribo, Joaquin
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Vidal-Jordana, Angela
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Robles-Sánchez, Miguel Ángel
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Otero-Romero, Susana
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Tintore, Mar
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Riveiro-Barciela, Mar
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Buti Ferret, Maria
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Montalban, Xavier
dc.date.issued
2024-01-29T11:37:58Z
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2024-01-29T11:37:58Z
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2024-01
dc.identifier
Marzo B, Vidal-Jordana A, Castilló J, Robles-Sanchez MA, Otero-Romero S, Tintore M, et al. Hepatitis B reactivation is a rare event among patients with resolved infection undergoing anti-CD20 antibodies in monotherapy without antiviral prophylaxis: results from the HEBEM study. J Neurol. 2024;271:134–40.
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0340-5354
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https://hdl.handle.net/11351/10931
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10.1007/s00415-023-11973-y
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37695530
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001066392100003
dc.description.abstract
Anti-CD20 antibodies; Hepatitis B; Rituximab
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Anticuerpos anti-CD20; Hepatitis B; Rituximab
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Anticossos anti-CD20; Hepatitis B; Rituximab
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Introduction Prospective data on the risk of hepatitis B reactivation (HBVr) among patients with resolved HBV infection undergoing anti-CD20 antibodies monotherapy is scarce. We aimed to assess the risk of HBVr in patients with resolved HBV infection treated with rituximab or ocrelizumab in monotherapy for multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) without antiviral prophylaxis. Methods HEBEM is a prospective study that included all consecutive adults HBsAg-negative/anti-HBc-positive who initiated anti-CD20 antibodies for MS or NMOSD at Cemcat. Inclusion criteria encompassed undetectable HBV-DNA, absence of other immunosuppressants or antiviral therapy. Every 6 months HBsAg, ALT and HBV-DNA were performed to rule out HBVr (defined by 2-log increase in HBV-DNA or seroconversion to HBsAg+). Results From August/2019 to August/2022, 540 subjects initiated anti-CD20 antibodies, 28 (5.2%) were anti-HBc-positive and were included. Twenty-two received rituximab and 6 ocrelizumab. The majority (89.3%) had previously received ≥ 1 immunomodulatory drug, with corticosteroids (82.1%) and interferon (42.9%) as the most common. At inclusion, all presented normal transaminases and undetectable HBV-DNA. Median anti-HBs levels were 105.5 mIU/mL (IQR 0–609). Median follow-up was 3.1 years (2.1–4.0). Median number of cycles of anti-CD20 antibodies was 6 (3–7), with a cumulative dose of 8.5 g (5.8–11.2) of rituximab and 3 g (1.8–3.8) of ocrelizumab. Neither cases of HBVr nor changes in anti-HBs titers were observed per 83.6 patient-years treated with monotherapy with anti-CD20 antibodies. Conclusions In this cohort of patients with MS or NMOSD and resolved HBV infection, anti-CD20 monotherapy was not associated with detectable risk of HBV reactivation despite the lack of antiviral prophylaxis.
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Open Access Funding provided by Universitat Autonoma de Barcelona. The authors did not receive support from any organization for the submitted work.
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application/pdf
dc.language
eng
dc.publisher
Springer
dc.relation
Journal of Neurology;271
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https://doi.org/10.1007/s00415-023-11973-y
dc.rights
Attribution 4.0 International
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http://creativecommons.org/licenses/by/4.0/
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info:eu-repo/semantics/openAccess
dc.source
Scientia
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Hepatitis B - Tractament
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Medicaments antivírics - Ús terapèutic
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DISEASES::Digestive System Diseases::Liver Diseases::Hepatitis::Hepatitis, Viral, Human::Hepatitis B
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CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents
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ENFERMEDADES::enfermedades del sistema digestivo::enfermedades hepáticas::hepatitis::hepatitis viral humana::hepatitis B
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COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos
dc.title
Hepatitis B reactivation is a rare event among patients with resolved infection undergoing anti-CD20 antibodies in monotherapy without antiviral prophylaxis: results from the HEBEM study
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info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion


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