Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study.
[en] [en] INTRODUCTION: Patients with ulcerative colitis (UC) receiving immunosuppressive drugs are at substantial risk of colectomy. We aimed to assess the risk of postoperative complications of tofacitinib exposure before colectomy in comparison with biologics.
METHODS: A multicenter, retrospective, observational study was conducted in patients with UC who underwent total colectomy for medically refractory disease, exposed to tofacitinib or a biologic before surgery. Primary outcome was the occurrence of any complication within 30 (early) and 90 (late) days after surgery. Secondary outcomes were the occurrence of infections, sepsis, surgical site complications, venous thromboembolic events (VTE), hospital readmissions, and redo surgery within the same timepoints.
RESULTS: Three hundred one patients (64 tofacitinib, 162 anti-tumor necrosis factor-α agents, 54 vedolizumab, and 21 ustekinumab) were included. No significant differences were reported in any outcome, except for a higher rate of early VTE with anti-tumor necrosis factor-α agents ( P = 0.047) and of late VTE with vedolizumab ( P = 0.03). In the multivariate analysis, drug class was not associated with a higher risk of any early and late complications. Urgent colectomy increased the risk of any early (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.06-3.48) complications, early hospital readmission (OR 4.79, 95% CI 1.12-20.58), and early redo surgery (OR 7.49, 95% CI 1.17-47.85). A high steroid dose increased the risk of any early complications (OR 1.96, 95% CI 1.08-3.57), early surgical site complications (OR 2.03, 95% CI 1.01-4.09), and early redo surgery (OR 7.52, 95% CI 1.42-39.82). Laparoscopic surgery decreased the risk of any early complications (OR 0.54, 95% CI 0.29-1.00), early infections (OR 0.39, 95% CI 0.18-0.85), and late hospital readmissions (OR 0.34, 95% CI 0.12-1.00).
DISCUSSION: Preoperative tofacitinib treatment demonstrated a postoperative safety profile comparable with biologics in patients with UC undergoing colectomy.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
Dragoni, Gabriele ; IBD Referral Centre, Careggi University Hospital, Florence, Italy ; Department of Experimental and Clinical Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy
Innocenti, Tommaso ; IBD Referral Centre, Careggi University Hospital, Florence, Italy ; Department of Experimental and Clinical Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy
Amiot, Aurelién ; Department of Gastroenterology, Henri Mondor University Hospital, Paris Est-Creteil University, Creteil, France
Castiglione, Fabiana; Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Naples, Italy
Melotti, Laura ; Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy
Savarino, Edoardo Vincenzo ; Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy
Truyens, Marie ; Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium
Argyriou, Konstantinos; Department of Gastroenterology, University Hospital of Larisa, Larissa, Greece
Noviello, Daniele ; Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy
Molnar, Tamas ; Department of Gastroenterology, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary
Bouillon, Vincent; Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium
Bezzio, Cristina ; IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
Eder, Piotr; Department of Gastroenterology, Dietetics and Internal Medicine-Poznań University of Medical Sciences, Heliodor Święcicki University Hospital, Poznań, Poland
Fernandes, Samuel ; Department of Gastroenterology and Hepatology, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte, Lisboa, Portugal ; Clínica Universitária da Faculdade de Medicina de Lisboa, Lisboa, Portugal
Kagramanova, Anna ; Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation
Armuzzi, Alessandro ; IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
Oliveira, Raquel ; Gastroenterology Department, Algarve University Hospital Centre-Portimão Unit, Algarve, Portugal
Viola, Anna ; IBD-Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy
Ribaldone, Davide Giuseppe ; Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy
Drygiannakis, Ioannis ; Department of Gastroenterology, University Hospital of Heraklion, Heraklion, Greece
Viganò, Chiara ; Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy ; European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Fondazione IRCCS San Gerardo dei Tintori, Monza, Italia
Gravina, Antonietta Gerarda ; Hepatogastroenterology Unit, Department of Precision Medicine, University of Campania "Luigi Vanvitelli," Naples, Italy
Pugliese, Daniela; CEMAD, IBD Unit, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy
Chaparro, María ; Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Madrid, Spain
Ellul, Pierre; Department of Medicine, Division of Gastroenterology, Mater Dei Hospital, Msida, Malta
Vieujean, Sophie ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Milla, Monica; IBD Referral Centre, Careggi University Hospital, Florence, Italy
Caprioli, Flavio ; Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy ; Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico di Milano, Milan, Italy
Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study.
We acknowledge the Clinical Committee of the European Crohn's and Colitis Organisation (ECCO) for the support and the revision of the study protocol. F. Caprioli also acknowledges \"The Italian Ministry of Education and Research (MUR): Dipartimenti di Eccellenza Program 2023-2027 -Dept. of Pathophysiology and Transplantation, University of Milan\"and PNC \"Hub Life Science-Diagnostica Avanzata (HLS-DA), PNC-E3-2022-23683266- CUP: C43C22001630001\"for the support. \"TOFA-poSTOP\"Study Group: Annalisa Aratari: IBD Unit, \"San Filippo Neri\"Hospital, Rome, Italy; Francesca Belli: SOC Gastroenterologia ed endoscopia digestiva, Azienda USL Toscana Centro, Ospedale \"San Giuseppe,\"Empoli, Italy; In\u00EAs Botto: Department of Gastroenterology and Hepatology, Hospital de Santa Maria, Centro Hospitalar Universit\u00E1rio de Lisboa Norte, Lisboa, Portugal; Cl\u00EDnica Universit\u00E1ria da Faculdade de Medicina de Lisboa, Lisboa, Portugal; Elisabetta Bretto: Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy; Anneline Cremer: Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium, Arianna Dal Buono: IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; Domenico A. Giorgi: IBD-Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy; Javier P. Gisbert: Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigaci\u00F3n Sanitaria Princesa (IIS-Princesa), Universidad Aut\u00F3noma de Madrid (UAM), Centro de Investigaci\u00F3n Biom\u00E9dica en Red de Enfermedades Hep\u00E1ticas y Digestivas, Madrid, Spain; Andreas Kapsoritakis: Department of Gastroenterology, University Hospital of Larisa, Larissa, Greece; Ioannis Koutroubakis: Department of Gastroenterology, University Hospital of Heraklion, Heraklion, Greece; Alice Laffusa: Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy and European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Fondazione IRCCS San Gerardo dei Tintori, Monza, Italia; Triana Lobaton: Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Olga Maria Nardone: Gastroenterology, Department of Public Health, University Federico II of Naples; Jo\u00E3o Neves: Gastroenterology Department, Algarve University Hospital Centre-Portim\u00E3o Unit, Algarve, Portugal; Knyazev Oleg: Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation; Raffaele Pellegrino: Hepatogastroenterology Unit, Department of Precision Medicine, University of Campania \"Luigi Vanvitelli,\"Naples, Italy; Gilberto Poggioli: Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; Matteo Rottoli: Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; and Simone Saibeni: Gastroenterology Unit, ASST Rhodense, Rho, Milan, Italy.We acknowledge the Clinical Committee of the European Crohn's and Colitis Organisation (ECCO) for the support and the revision of the study protocol. F. Caprioli also acknowledges \u201CThe Italian Ministry of Education and Research (MUR): Dipartimenti di Eccellenza Program 2023\u20132027 -Dept. of Pathophysiology and Transplantation, University of Milan\u201D and PNC \u201CHub Life Science- Diagnostica Avanzata (HLS-DA), PNC-E3-2022-23683266\u2013 CUP: C43C22001630001\u201D for the support. \u201CTOFA-poSTOP\u201D Study Group: Annalisa Aratari: IBD Unit, \u201CSan Filippo Neri\u201D Hospital, Rome, Italy; Francesca Belli: SOC Gastroenterologia ed endoscopia digestiva, Azienda USL Toscana Centro, Ospedale \u201CSan Giuseppe,\u201D Empoli, Italy; In\u00EAs Botto: Department of Gastroenterology and Hepatology, Hospital de Santa Maria, Centro Hospitalar Universit\u00E1rio de Lisboa Norte, Lisboa, Portugal; Cl\u00EDnica Universit\u00E1ria da Faculdade de Medicina de Lisboa, Lisboa, Portugal; Elisabetta Bretto: Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy; Anneline Cremer: Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium, Arianna Dal Buono: IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; Domenico A. Giorgi: IBD-Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy; Javier P. Gisbert: Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigaci\u00F3n Sanitaria Princesa (IIS-Princesa), Universidad Aut\u00F3noma de Madrid (UAM), Centro de Investigaci\u00F3n Biom\u00E9dica en Red de Enfermedades Hep\u00E1ticas y Digestivas, Madrid, Spain; Andreas Kapsoritakis: Department of Gastroenterology, University Hospital of Larisa, Larissa, Greece; Ioannis Koutroubakis: Department of Gastroenterology, University Hospital of Heraklion, Heraklion, Greece; Alice Laffusa: Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy and European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Fondazione IRCCS San Gerardo dei Tintori, Monza, Italia; Triana Lobaton: Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium; Olga Maria Nardone: Gastroenterology, Department of Public Health, University Federico II of Naples; Jo\u00E3o Neves: Gastroenterology Department, Algarve University Hospital Centre\u2013Portim\u00E3o Unit, Algarve, Portugal; Knyazev Oleg: Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation; Raffaele Pellegrino: Hepatogastroenterology Unit, Department of Precision Medicine, University of Campania \u201CLuigi Vanvitelli,\u201D Naples, Italy; Gilberto Poggioli: Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; Matteo Rottoli: Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy; and Simone Saibeni: Gastroenterology Unit, ASST Rhodense, Rho, Milan, Italy.
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