Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study

Gabriele Dragoni; Tommaso Innocenti; Aurelién Amiot; Fabiana Castiglione; Laura Melotti; Stefano Festa; Edoardo Vincenzo Savarino; Marie Truyens; Konstantinos Argyriou; Daniele Noviello; Tamas Molnar; Vincent Bouillon; Cristina Bezzio; Piotr Eder; Samuel Fernandes; Anna Kagramanova; Alessandro Armuzzi; Raquel Oliveira; Anna Viola; Davide Giuseppe Ribaldone; Ioannis Drygiannakis; Chiara Viganò; Francesca Calella; Antonietta Gerarda Gravina; Daniela Pugliese; María Chaparro; Pierre Ellul; Sophie Vieujean; Monica Milla; Flavio Caprioli; “TOFA-poSTOP” Study Group

doi:10.14309/ajg.0000000000002676

Rates of Adverse Events in Patients With Ulcerative Colitis Undergoing Colectomy During Treatment With Tofacitinib vs Biologics: A Multicenter Observational Study

Am J Gastroenterol. 2024 Mar 19. doi: 10.14309/ajg.0000000000002676. Online ahead of print.

Authors

Gabriele Dragoni^{1

2}, Tommaso Innocenti^{1

2}, Aurelién Amiot³, Fabiana Castiglione⁴, Laura Melotti⁵, Stefano Festa⁶, Edoardo Vincenzo Savarino⁷, Marie Truyens⁸, Konstantinos Argyriou⁹, Daniele Noviello¹⁰, Tamas Molnar¹¹, Vincent Bouillon¹², Cristina Bezzio¹³, Piotr Eder¹⁴, Samuel Fernandes^{15

16}, Anna Kagramanova¹⁷, Alessandro Armuzzi¹³, Raquel Oliveira¹⁸, Anna Viola¹⁹, Davide Giuseppe Ribaldone²⁰, Ioannis Drygiannakis²¹, Chiara Viganò^{22

23}, Francesca Calella²⁴, Antonietta Gerarda Gravina²⁵, Daniela Pugliese²⁶, María Chaparro²⁷, Pierre Ellul²⁸, Sophie Vieujean²⁹, Monica Milla¹, Flavio Caprioli^{10

30}; “TOFA-poSTOP” Study Group

Collaborators

“TOFA-poSTOP” Study Group:
Annalisa Aratari, Francesca Belli, Inês Botto, Elisabetta Bretto, Anneline Cremer, Arianna Dal Buono, Domenico A Giorgi, Javier P Gisbert, Andreas Kapsoritakis, Ioannis Koutroubakis, Alice Laffusa, Triana Lobaton, Olga Maria Nardone, João Neves, Knyazev Oleg, Raffaele Pellegrino, Gilberto Poggioli, Matteo Rottoli, Simone Saibeni

Affiliations

¹ IBD Referral Centre, Careggi University Hospital, Florence, Italy.
² Department of Experimental and Clinical Biomedical Sciences "Mario Serio," University of Florence, Florence, Italy.
³ Department of Gastroenterology, Henri Mondor University Hospital, Paris Est-Creteil University, Creteil, France.
⁴ Department of Clinical Medicine and Surgery, "Federico II" University of Naples, Naples, Italy.
⁵ Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.
⁶ IBD Unit, "San Filippo Neri' Hospital, Rome, Italy.
⁷ Department of Surgery, Oncology and Gastroenterology, University of Padova, Padova, Italy.
⁸ Department of Gastroenterology, Ghent University Hospital, Ghent, Belgium.
⁹ Department of Gastroenterology, University Hospital of Larisa, Larissa, Greece.
¹⁰ Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.
¹¹ Department of Gastroenterology, Albert Szent-Györgyi Medical School, University of Szeged, Szeged, Hungary.
¹² Department of Gastroenterology, Erasme University Hospital, Brussels, Belgium.
¹³ IBD Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
¹⁴ Department of Gastroenterology, Dietetics and Internal Medicine-Poznań University of Medical Sciences, Heliodor Święcicki University Hospital, Poznań, Poland.
¹⁵ Department of Gastroenterology and Hepatology, Hospital de Santa Maria, Centro Hospitalar Universitário de Lisboa Norte, Lisboa, Portugal.
¹⁶ Clínica Universitária da Faculdade de Medicina de Lisboa, Lisboa, Portugal.
¹⁷ Moscow Clinical Scientific Center named after A.S. Loginov, Moscow, Russian Federation.
¹⁸ Gastroenterology Department, Algarve University Hospital Centre-Portimão Unit, Algarve, Portugal.
¹⁹ IBD-Unit, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
²⁰ Division of Gastroenterology, Department of Medical Sciences, University of Turin, Turin, Italy.
²¹ Department of Gastroenterology, University Hospital of Heraklion, Heraklion, Greece.
²² Division of Gastroenterology, Center for Autoimmune Liver Diseases, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.
²³ European Reference Network on Hepatological Diseases (ERN RARE-LIVER), Fondazione IRCCS San Gerardo dei Tintori, Monza, Italia.
²⁴ SOC Gastroenterologia ed endoscopia digestiva, Azienda USL Toscana Centro, Ospedale "San Giuseppe," Empoli, Italy.
²⁵ Hepatogastroenterology Unit, Department of Precision Medicine, University of Campania "Luigi Vanvitelli," Naples, Italy.
²⁶ CEMAD, IBD Unit, Dipartimento di Scienze Mediche e Chirurgiche, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
²⁷ 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.
²⁸ Department of Medicine, Division of Gastroenterology, Mater Dei Hospital, Msida, Malta.
²⁹ Hepato-Gastroenterology and Digestive Oncology, University Hospital CHU of Liège, Liège, Belgium.
³⁰ Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico di Milano, Milan, Italy.

PMID: 38305302
DOI: 10.14309/ajg.0000000000002676

Abstract

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.