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Observational Study
. 2024 Aug 1;119(8):1525-1535.
doi: 10.14309/ajg.0000000000002676. Epub 2024 Feb 2.

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

Gabriele Dragoni  1   2 , Tommaso Innocenti  1   2 , Aurelién Amiot  3 , Fabiana Castiglione  4 , Laura Melotti  5 , Stefano Festa  6 , Edoardo Vincenzo Savarino  7 , Marie Truyens  8 , Konstantinos Argyriou  9 , Daniele Noviello  10 , Tamas Molnar  11 , Vincent Bouillon  12 , Cristina Bezzio  13 , Piotr Eder  14 , Samuel Fernandes  15   16 , Anna Kagramanova  17 , Alessandro Armuzzi  13 , Raquel Oliveira  18 , Anna Viola  19 , Davide Giuseppe Ribaldone  20 , Ioannis Drygiannakis  21 , Chiara Viganò  22   23 , Francesca Calella  24 , Antonietta Gerarda Gravina  25 , Daniela Pugliese  26 , María Chaparro  27 , Pierre Ellul  28 , Sophie Vieujean  29 , Monica Milla  1 , Flavio Caprioli  10   30 ; “TOFA-poSTOP” Study Group
Collaborators, Affiliations
Observational Study

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

Gabriele Dragoni et al. Am J Gastroenterol. .

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.

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Conflict of interest statement

Guarantor of the article: Flavio Caprioli, MD, PhD.

Specific author contributions: G.D.: designed the study. G.D. and T.I.: analyzed the results and wrote the manuscript. All authors acquired data, interpreted the results, revised the article critically, and approved the final version to be submitted. F.C.: supervised and acted as guarantor of the article.

Financial support: None to report.

Potential competing interests: G.D. reports speaker fees from Alfasigma, Janssen, Novartis, Pfizer, Takeda, and has served in advisory board for Celltrion Healthcare and Pfizer F. Castiglione received lecture fees and served in advisory board for AbbVie, Biogen, Galapagos, Janssen, Pfizer, and Takeda. S.F. reports consultancy fees and/or advisory board for Galapagos, Janssen, Pfizer, and Takeda. E.V.S. has served as speaker for AbbVie, Agave, AGPharma, Alfasigma, Aurora Pharma, CaDiGroup, Celltrion, Dr Falk, EG Stada Group, Fenix Pharma, Fresenius Kabi, Galapagos, Janssen, JB Pharmaceuticals, Innovamedica/Adacyte, Malesci, Mayoly Biohealth, Omega Pharma, Pfizer, Reckitt Benckiser, Sandoz, SILA, Sofar, Takeda, Tillotts, and Unifarco; has served as consultant for AbbVie, Agave, Alfasigma, Biogen, Bristol-Myers Squibb, Celltrion, Diadema Farmaceutici, Dr. Falk, Fenix Pharma, Fresenius Kabi, Janssen, JB Pharmaceuticals, Merck & Co, Nestlè, Reckitt Benckiser, Regeneron, Sanofi, SILA, Sofar, Synformulas GmbH, Takeda, and Unifarco; he received research support from Pfizer, Reckitt Benckiser, SILA, Sofar, Unifarco, and Zeta Farmaceutici. D.G.R. reports speaker fees or advisory board services for Biogen, Celltrion Healthcare, Galapagos, Janssen, and Takeda. AnAr has served on advisory board for Galapagos. P.E. received lecture fees and travel educational grants from Bristol-Myers Squibb, Ferring, Pfizer, and Takeda. A.V. reports consultant fees from Pfizer. C.V. received consultancy and lecture fees from: AbbVie, Galapagos, Janssen, Pfizer, and Takeda. F. Caprioli served as consultant to AbbVie, Biogen, Bristol-Myers Squibb, Celgene, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Mundipharma, Nestlè, Pfizer, Roche, and Takeda; he received lecture fees from AbbVie, Allergy Therapeutics, Biogen, Ferring, Janssen, Pfizer, Sandoz, Takeda, Tillotts Pharma, and unrestricted research grants from AbbVie, Celltrion, Giuliani, MSD, Pfizer, Sofar, and Takeda. J.G. has served as speaker, consultant, and advisory member for or has received research funding from AbbVie, Biogen, Casen Fleet, Celgene/Bristol-Myers, Chiesi, Dr. Falk Pharma, Eli Lilly, Faes Farma, Ferring, Gebro Pharma, Gilead/Galapagos, Janssen, Kern Pharma, MSD, Mylan, Norgine, Otsuka Pharmaceutical, Pfizer, Roche, Sandoz, Shire Pharmaceuticals, Takeda, Tillotts Pharma, and Vifor Pharma. The other authors have no conflict of interest to declare.

Data availability statement: The data underlying this article will be shared on reasonable request to the corresponding author.

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References

    1. Ungaro R, Mehandru S, Allen PB, et al. Ulcerative colitis. Lancet 2017;389:1756–70. - PMC - PubMed
    1. Vieujean S, D'Amico F, Netter P, et al. Landscape of new drugs and targets in inflammatory bowel disease. United Eur Gastroenterol J 2022;10:1129–66. - PMC - PubMed
    1. Murthy SK, Begum J, Benchimol EI, et al. Introduction of anti-TNF therapy has not yielded expected declines in hospitalisation and intestinal resection rates in inflammatory bowel diseases: A population-based interrupted time series study. Gut 2020;69:274–82. - PMC - PubMed
    1. Sandborn WJ, Su C, Sands BE, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med 2017;376:1723–36. - PubMed
    1. D'Amico F, Parigi TL, Fiorino G, et al. Tofacitinib in the treatment of ulcerative colitis: Efficacy and safety from clinical trials to real-world experience. Therap Adv Gastroenterol 2019;12:1756284819848631. - PMC - PubMed

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