Hepatic safety and efficacy of immunomodulatory drugs used in patients with autoimmune hepatitis

Terziroli Beretta-Piccoli, Benedetta; Buescher, Gustav; Dalekos, George; Zachou, Kalliopi; Geerts, Anja; Semmo, Nasser; Kolev, Mirjam; De Martin, Eleonora; Janik, Maciej K.; Madaleno, João; Lalosevic Stojkovic, Milica; Dumortier, Jerome; Vanwolleghem, Thomas; Schregel, Ida; Steinmann, Silja; Lacaille, Florence; Sebode, Marcial

doi:10.1016/j.jaut.2023.103113

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Terziroli_2023_Elsevier_Journ of autoimmun_Hepatic safety and efficacy

Journal article

Hepatic safety and efficacy of immunomodulatory drugs used in patients with autoimmune hepatitis

Terziroli Beretta-Piccoli, Benedetta ORCID Epatocentro Ticino, Lugano, Switzerland - Faculty of Biomedical Sciences, Università della Svizzera italiana, Switzerland - European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - MowatLabs, Faculty of Life Sciences & Medicine, King’s College London, King’s College Hospital, UK
Buescher, Gustav European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Dalekos, George European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Centre in Autoimmune Liver Diseases, General University Hospital of Larissa, Greece
Zachou, Kalliopi European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Department of Medicine and Research Laboratory of Internal Medicine, National Expertise Centre in Autoimmune Liver Diseases, General University Hospital of Larissa, Greece
Geerts, Anja European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - epartment of Gastroenterology and Hepatology, University Hospital of Ghent, Belgium
Semmo, Nasser Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital Bern, University of Bern, Switzerland
Kolev, Mirjam Hepatology, University Clinic for Visceral Surgery and Medicine, Inselspital Bern, University of Bern, Switzerland
De Martin, Eleonora European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Hépatologie et Transplantation Hépatique, Hôpital Paul Brousse, Villejuif, France
Janik, Maciej K. European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Hépatologie et Transplantation Hépatique, Hôpital Paul Brousse, Villejuif, France
Madaleno, João European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Liver Disease Unit, Internal Medicine Department, Centro Hospitalar e Universit´ ario de Coimbra, Coimbra, Portugal
Lalosevic Stojkovic, Milica European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - University Clinical Center of Serbia, Belgrade, Serbia
Dumortier, Jerome European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Hôpital Edouard Herriot, Hospices Civils de Lyon and Université Claude Bernard Lyon 1, France
Vanwolleghem, Thomas European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Department of Gastroenterology and Hepatology Antwerp University Hospital, Belgium - Viral Hepatitis Research Group, Laboratory of Experimental Medicine and Pediatrics (LEMP), University of Antwerp, Belgium
Schregel, Ida European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Steinmann, Silja European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany
Lacaille, Florence European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - Hôpital Necker-Enfants Malades, Paris, France
Sebode, Marcial European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Hamburg, Germany - I. Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany

2023

Published in:

Journal of Autoimmunity. - 2023, vol. 140, p. 103113

English Background and aims: There is little data on the hepatic efficacy and safety of immunomodulatory drugs used in patients with autoimmune hepatitis (AIH), despite their established use in dermatology, rheumatology and inflammatory bowel diseases (IBD). Our aim was to collect real-life data on the experience of expert centres in treating AIH patients with these drugs, considered unconventional for AIH management. Methods: Online survey among hepatology centres being part of the European Reference Network on Hepatological Diseases (ERN RARE-LIVER). Results: 25 AIH patients have been reported. Ten were female, median age at diagnosis was 28 years; median follow-up was 17 months. All had initially received AIH-standard treatment. AIH-unconventional treatment was initiated for concomitant autoimmune diseases in 15 cases: nine for IBD (five vedolizumab and four ustekinumab), and one each for following diseases: autoinflammatory syndrome (tocilizumab), chronic urticaria (omalizumab), rheumatoid arthritis (abatacept), psoriasis (guselkumab), psoriatric arthritis (secukinumab, followed by ustekinumab) and alopecia (ruxolitinib). Three patients were treated with immunomodulatory drugs for side effects of
previous treatments, including two patients with IBD treated with vedolizumab and ustekinumab, respectively, and one treated with belimumab. At the end of follow-up, 13 patients were in complete biochemical response, the patient on omalizumab had a relapse, and four patients with concomitant IBD had insufficient response. Seven patients were treated for lack of biochemical remission, of whom six with belimumab, all initially reaching complete biochemical response, but five relapsing during follow-up; and one with secukinumab, having concomitant rheumatoid arthritis and ankylosing spondylitis, reaching complete biochemical response. Only the patient on abatacept received unconventional treatment as monotherapy. Side effects were reported in two patients on belimumab: one recurrent soft tissue infections, one fatigue and arthralgia. Conclusion: Among 25 AIH patients who were treated with immunomodulatory drugs for different reasons, the majority had a fovorable course, relapse was frequent in difficult-to-treat patients who received belimumab, and four with concomitant IBD had insufficient response.

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