Abstract Background Patients with cirrhosis have been excluded from clinical trials in inflammatory bowel disease (IBD), resulting in a significant knowledge gap regarding this specific population. This study aims to assess the effectiveness and safety of biologic treatments and small molecules in cirrhotic patients with IBD. Methods Preliminary analysis of a multicenter study, conducted in 14 Spanish hospitals. Consecutive IBD patients with an established diagnosis cirrhosis (Child A or Child B ≤ 8) who received at least induction with infliximab, adalimumab, golimumab, ustekinumab, vedolizumab, tofacitinib, upadacitinib, risankizumab, mirikizumab or filgotinib between January 2000 and September 2024, were eligible. Patients with liver transplantation or non-cirrhotic liver disease were excluded. The primary objective was to evaluate the rate of adverse events and the treatment persistence of advanced therapies in patients with Crohn’s disease (CD) or ulcerative colitis (UC) with a concomitant diagnosis of compensated liver cirrhosis. Results A total of 31 patients were included, 22 males (71%), 23 patients with CD (74.2%) and 8 patients with UC. The main aetiology of cirrhosis was alcohol in 12 patients (40%), and 2 patients had a history of hepatocellular carcinoma. A total of 46 advanced therapies were initiated, with ustekinumab being the most common (n = 18, 39.1%), followed by infliximab (n = 12, 20.1%), adalimumab (n = 10, 21.7%), vedolizumab (n = 5, 10.9%), risankizumab (n = 3, 6.5%) and tofacitinib (n = 1, 2.1%). The 1-year therapy persistence rate for a first-line therapy was 85.7% (95%CI 66.3-94.4) and 58.6% at 2 years (95%CI 37.5-74.7). For a second-line therapy, the 1-year therapy persistence rate for a first-line therapy was 92.3 (95%CI 56.7-98.9) and remained unchanged at 2 years. The 1-year and 2-year cumulative risk of hepatic decompensation while on advanced therapy was 3.7% (95%CI .5-23.5) and 14.6% (95%CI 4.8-39.7), respectively. Hepatic decompensation was more frequent in patients receiving first-line anti-TNF therapies versus non-anti-TNF therapies (6 patients, 35.3% versus 0%; p = 0.042). Two patients discontinued first-line therapy due to hepatic decompensation and 2 infections that required hospitalisation, one of them requiring intensive care unit admission. One patient was diagnosed with hepatocellular carcinoma while receiving adalimumab. Another patient on adalimumab was diagnosed with drug-induced liver injury. Conclusion This preliminary data indicates that the use of advanced therapies is viable in compensated cirrhosis, with acceptable treatment persistence rates alongside a low risk of hepatic decompensation, particularly for non-anti-TNF therapies. Nonetheless, caution is warranted given the potential risk of adverse events. Conflict of interest: Dr. Fuentes-Valenzuela, Esteban: Esteban Fuentes-Valenzuela has received education funding from AbbVie, Alfa Sigma Pfizer, Takeda, DrFalk Pharma, Kern Pharma and Janssen and served as speaker for Janssen Madero Velázquez, Lucía: None Suarez Saro, Ana: No conflict of interest Rivas, Coral: no conflicts Margarit Colomer, Anna: No conflict of interest Calafat Sard, Margalida: Personal Fees: Advisory fees for Gilead Other: I have served as a speaker, or has received research or education funding for Takeda, Janssen, Faes Farma, Falk Pharma, Kern, Pfizer and MSD. Rueda Garcia, Jose Luis: José Luis Rueda García has received financial support for traveling and educational activities from Kern Pharma, Abbvie, Johnson&Johnson, Pfizer, Eli Lilly, Takeda, Ferring, Tillotts Pharma, Faes Farma, Norgine and Casen and he has received fees as a speaker from Abbvie, Johnson&Johnson, Pfizer, Eli Lilly and Takeda. Brunet, Eduard: I have served as a speaker and consultant for Janssen and Chiesi, Kern, Takeda and Alfasigma. Bastón Rey, Iria: Personal Fees: Iria Bastón Rey has received financial support for travelling and educational activities from or has served as an advisory board member for Abbvie, Johnson&Johnson, Takeda, Pfizer, Alfasigma, Ferring, Faes Farma and Otsuka Pharmaceutical and Adacyte. Lopez Martin, Maria Del Carmen: No conflict of interest Irabien, Martin: No conflict of interest López Mourelle, Ana: No conflict of interest Fernandez Clotet, Agnes: None Borras Garriga, Pere: No conflicts Belén Galipienso, Olivia: No conflict of interest Suárez, Carolina: No conflict of interest Maroto-Martín, Carlos: No conflict of interest Bejerano Domínguez, Alicia: No conflict of interest Gutiérrez Casbas, Ana: No conflict of interest Zabana, Yamile: Personal Fees: AbbVie, Adacyte Therapeutics, Alfa-Sigma, Amgen, Boehringer Ingelheim, Dr Falk Pharma, FAES Pharma, Fresenius Kabi, Ferring, Galapagos, Janssen-J&J, Kern Pharma, Lilly, MSD, Pfizer, Sanofi, Sandoz, Takeda, Tillots Pharma Non-financial Support: Shire, Otsuka, Almirall
Fuentes-Valenzuela et al. (2026) studied this question.