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PD-1/PD-L1 immune checkpoint therapy demonstrates favorable safety profile in patients with autoimmune and cholestatic liver disease
L. Kocheise, I. Piseddu, J. Vonderlin, ET. Tjwa, G. Buescher, L. Meunier, P. Goeggelmann, F. Fianchi, J. Dumortier, M. Riveiro Barciela, TJG. Gevers, B. Terziroli Beretta-Piccoli, MC. Londoño, S. Frankova, T. Roesner, V. Joerg, C. Schmidt, F....
Jazyk angličtina Země Švýcarsko
Typ dokumentu multicentrická studie, časopisecké články, práce podpořená grantem
NLK
Directory of Open Access Journals
od 2010
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od 2010
PubMed Central
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- MeSH
- antigeny CD274 MeSH
- antigeny CD279 MeSH
- autoimunitní hepatitida * farmakoterapie MeSH
- cholestáza * MeSH
- inhibitory kontrolních bodů škodlivé účinky MeSH
- lidé MeSH
- nádory * MeSH
- nivolumab škodlivé účinky MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
INTRODUCTION: Immune checkpoint inhibitors (ICI) have revolutionized the treatment of many malignancies in recent years. However, immune-related adverse events (irAE) are a frequent concern in clinical practice. The safety profile of ICI for the treatment of malignancies in patients diagnosed with autoimmune and cholestatic liver disease (AILD) remains unclear. Due to this uncertainty, these patients were excluded from ICI clinical trials and ICI are withheld from this patient group. In this retrospective multicenter study, we assessed the safety of ICI in patients with AILD. METHODS: We contacted tertiary referral hospitals for the identification of AILD patients under ICI treatment in Europe via the European Reference Network on Hepatological Diseases (ERN RARE-LIVER). Fourteen centers contributed data on AILD patients with malignancies being treated with ICI, another three centers did not treat these patients with ICI due to fear of irAEs. RESULTS: In this study, 22 AILD patients under ICI treatment could be identified. Among these patients, 12 had primary biliary cholangitis (PBC), five had primary sclerosing cholangitis (PSC), four had autoimmune hepatitis (AIH), and one patient had an AIH-PSC variant syndrome. Eleven patients had hepatobiliary cancers and the other 11 patients presented with non-hepatic tumors. The applied ICIs were atezolizumab (n=7), durvalumab (n=5), pembrolizumab (n=4), nivolumab (n=4), spartalizumab (n=1), and in one case combined immunotherapy with nivolumab plus ipilimumab. Among eight patients who presented with grade 1 or 2 irAEs, three demonstrated liver irAEs. Cases with grades ≥ 3 irAEs were not reported. No significant changes in liver tests were observed during the first year after the start of ICI. DISCUSSION: This European multicenter study demonstrates that PD-1/PD-L1 inhibitors appear to be safe in patients with AILD. Further studies on the safety of more potent dual immune checkpoint therapy are needed. We conclude that immunotherapy should not categorically be withheld from patients with AILD.
1 Department of Medicine University Medical Center Hamburg Eppendorf Hamburg Germany
Department of Hepatogastroenterology Institute for Clinical and Experimental Medicine Prague Czechia
Department of Hepatology and Gastroenterology Charité Universitätsmedizin Berlin Berlin Germany
Department of Internal Medicine 1 University Hospital Regensburg Regensburg Germany
Department of Medicine 2 University Hospital Ludwig Maximilians Universität München Munich Germany
Epatocentro Ticino Lugano Switzerland
European Reference Network on Hepatological Diseases Hamburg Germany
Faculty of Biomedical Sciences Università della Svizzera Italiana Lugano Switzerland
Liver Unit Hospital Clinic Barcelona FCRB IDIBAPS CIBEREHD University of Barcelona Barcelona Spain
Service Hépato Gastro Entérologie Hôpital St Eloi CHU Montpellier Montpellier France
Citace poskytuje Crossref.org
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