Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study
Autor(a) principal: | |
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Data de Publicação: | 2024 |
Outros Autores: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) |
Texto Completo: | http://hdl.handle.net/10400.1/26437 |
Resumo: | 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-alpha 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-alpha 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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Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational studyColectomyPostoperative safetyTofacitinibUlcerative colitisINTRODUCTION: 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-alpha 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-alpha 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.Lippincott, Williams & WilkinsSapientiaDragoni, GabrieleInnocenti, TommasoAmiot, AureliénCastiglione, FabianaMelotti, LauraFesta, StefanoSavarino, Edoardo VincenzoTruyens, MarieArgyriou, KonstantinosNoviello, DanieleMolnar, TamasBouillon, VincentBezzio, CristinaEder, PiotrFernandes, SamuelKagramanova, AnnaArmuzzi, AlessandroOliveira, RaquelViola, AnnaRibaldone, Davide GiuseppeDrygiannakis, IoannisViganò, ChiaraCalella, FrancescaGravina, Antonietta GerardaPugliese, DanielaChaparro, MaríaEllul, PierreVieujean, SophieMilla, MonicaCaprioli, Flavio2024-12-10T10:46:46Z2024-02-022024-02-02T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10400.1/26437eng0002-927010.14309/ajg.0000000000002676info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-02-18T17:30:30Zoai:sapientia.ualg.pt:10400.1/26437Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-28T20:24:41.774559Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse |
dc.title.none.fl_str_mv |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
title |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
spellingShingle |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study Dragoni, Gabriele Colectomy Postoperative safety Tofacitinib Ulcerative colitis |
title_short |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
title_full |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
title_fullStr |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
title_full_unstemmed |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
title_sort |
Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study |
author |
Dragoni, Gabriele |
author_facet |
Dragoni, Gabriele Innocenti, Tommaso Amiot, Aurelién Castiglione, Fabiana Melotti, Laura Festa, Stefano Savarino, Edoardo Vincenzo Truyens, Marie Argyriou, Konstantinos Noviello, Daniele Molnar, Tamas Bouillon, Vincent Bezzio, Cristina Eder, Piotr Fernandes, Samuel Kagramanova, Anna Armuzzi, Alessandro Oliveira, Raquel Viola, Anna Ribaldone, Davide Giuseppe Drygiannakis, Ioannis Viganò, Chiara Calella, Francesca Gravina, Antonietta Gerarda Pugliese, Daniela Chaparro, María Ellul, Pierre Vieujean, Sophie Milla, Monica Caprioli, Flavio |
author_role |
author |
author2 |
Innocenti, Tommaso Amiot, Aurelién Castiglione, Fabiana Melotti, Laura Festa, Stefano Savarino, Edoardo Vincenzo Truyens, Marie Argyriou, Konstantinos Noviello, Daniele Molnar, Tamas Bouillon, Vincent Bezzio, Cristina Eder, Piotr Fernandes, Samuel Kagramanova, Anna Armuzzi, Alessandro Oliveira, Raquel Viola, Anna Ribaldone, Davide Giuseppe Drygiannakis, Ioannis Viganò, Chiara Calella, Francesca Gravina, Antonietta Gerarda Pugliese, Daniela Chaparro, María Ellul, Pierre Vieujean, Sophie Milla, Monica Caprioli, Flavio |
author2_role |
author author author author author author author author author author author author author author author author author author author author author author author author author author author author author |
dc.contributor.none.fl_str_mv |
Sapientia |
dc.contributor.author.fl_str_mv |
Dragoni, Gabriele Innocenti, Tommaso Amiot, Aurelién Castiglione, Fabiana Melotti, Laura Festa, Stefano Savarino, Edoardo Vincenzo Truyens, Marie Argyriou, Konstantinos Noviello, Daniele Molnar, Tamas Bouillon, Vincent Bezzio, Cristina Eder, Piotr Fernandes, Samuel Kagramanova, Anna Armuzzi, Alessandro Oliveira, Raquel Viola, Anna Ribaldone, Davide Giuseppe Drygiannakis, Ioannis Viganò, Chiara Calella, Francesca Gravina, Antonietta Gerarda Pugliese, Daniela Chaparro, María Ellul, Pierre Vieujean, Sophie Milla, Monica Caprioli, Flavio |
dc.subject.por.fl_str_mv |
Colectomy Postoperative safety Tofacitinib Ulcerative colitis |
topic |
Colectomy Postoperative safety Tofacitinib Ulcerative colitis |
description |
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-alpha 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-alpha 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. |
publishDate |
2024 |
dc.date.none.fl_str_mv |
2024-12-10T10:46:46Z 2024-02-02 2024-02-02T00:00:00Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
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info:eu-repo/semantics/article |
format |
article |
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publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10400.1/26437 |
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http://hdl.handle.net/10400.1/26437 |
dc.language.iso.fl_str_mv |
eng |
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eng |
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dc.publisher.none.fl_str_mv |
Lippincott, Williams & Wilkins |
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Lippincott, Williams & Wilkins |
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