Rituximab is a safe and effective alternative treatment for patients with autoimmune hepatitis: Results from the ColHai registry

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Institut Català de la Salut

[Riveiro-Barciela M] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Hepatologia, 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. European Reference Network on Hepatological Diseases (ERN RARELIVER), Eppendorf, Germany. [Barreira-Díaz A, Ruiz-Cobo JC] Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain. Servei d’Hepatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Esteban P] Servei d’Hepatologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Rota R] Liver Unit, Gastroenterology Department, Hospital Universitario de Bellvitge, IDIBELL, L'hospitalet, Spain. [Álvarez-Navascúes C] Gastroenterology Department, Hospital Universitario Central de Asturias, Oviedo, Spain. [Pérez-Medrano I] Gastroenterology Department, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain

Vall d'Hebron Barcelona Hospital Campus

Publication date

2024-09-27T12:06:10Z

2024-09-27T12:06:10Z

2024-09



Abstract

Anti‐CD20 monoclonal antibodies; Autoimmune hepatitis; Corticosteroids


Anticuerpos monoclonales anti‐CD20; Hepatitis autoinmune; Corticosteroides


Anticossos monoclonals anti-CD20; Hepatitis autoimmune; Corticoides


Background and Aims Small series suggest that rituximab could be effective as treatment for autoimmune hepatitis (AIH), although data are scarce. We aimed to evaluate the efficacy and safety of rituximab in different cohorts of patients with AIH. Methods Multicentre retrospective analysis of the 35 patients with AIH and its variant forms treated with rituximab and included in the ColHai registry between 2015 and 2023. Results Most patients were female (83%), 10 (29%) had cirrhosis and four (11.4%) variant forms of AIH. Indication for rituximab were as follows: 14(40%) refractory AIH, 19(54%) concomitant autoimmune or haematological disorder, 2(6%) intolerance to prior treatments. In three (9%) subjects with a concomitant disorder, rituximab was the first therapy for AIH. Overall, 31 (89%) patients achieved or maintained complete biochemical response (CBR), including the three in first-line therapy. No difference in CBR was observed according to rituximab indication (refractory AIH 86% vs. concomitant disorders 90%, p = .824) or cirrhosis (80% vs. 92%, p = .319). Rituximab was associated with a significant reduction in corticosteroids (median dose: prior 20 vs. post 5 mg, p < .001) and the discontinuation of ≥1 immunosuppressant in 47% of patients. Flare-free rate at 1st, 2nd and 3rd year was 86%, 73% and 62% respectively. Flares were not associated with the development of liver failure and were successfully managed with repeated doses of rituximab and/or increased corticosteroids. Three (9%) patients experienced infusion-related adverse events (1 anaphylaxis and 2 flu-like symptoms) and five (14%) infections. Conclusion Rituximab is safe and effective in patients with refractory AIH and those treated due to concomitant autoimmune or haematological disorders.

Document Type

Article


Published version

Language

English

Publisher

Wiley

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Attribution 4.0 International

http://creativecommons.org/licenses/by/4.0/

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