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Rates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational study

2024-02-02Journal article Open Access
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dc.contributor.authorDragoni, Gabriele
dc.contributor.authorInnocenti, Tommaso
dc.contributor.authorAmiot, Aurelién
dc.contributor.authorCastiglione, Fabiana
dc.contributor.authorMelotti, Laura
dc.contributor.authorFesta, Stefano
dc.contributor.authorSavarino, Edoardo Vincenzo
dc.contributor.authorTruyens, Marie
dc.contributor.authorArgyriou, Konstantinos
dc.contributor.authorNoviello, Daniele
dc.contributor.authorMolnar, Tamas
dc.contributor.authorBouillon, Vincent
dc.contributor.authorBezzio, Cristina
dc.contributor.authorEder, Piotr
dc.contributor.authorFernandes, Samuel
dc.contributor.authorKagramanova, Anna
dc.contributor.authorArmuzzi, Alessandro
dc.contributor.authorOliveira, Raquel
dc.contributor.authorViola, Anna
dc.contributor.authorRibaldone, Davide Giuseppe
dc.contributor.authorDrygiannakis, Ioannis
dc.contributor.authorViganò, Chiara
dc.contributor.authorCalella, Francesca
dc.contributor.authorGravina, Antonietta Gerarda
dc.contributor.authorPugliese, Daniela
dc.contributor.authorChaparro, María
dc.contributor.authorEllul, Pierre
dc.contributor.authorVieujean, Sophie
dc.contributor.authorMilla, Monica
dc.contributor.authorCaprioli, Flavio
dc.date.accessioned2024-12-10T10:46:46Z
dc.date.available2024-12-10T10:46:46Z
dc.date.issued2024-02-02
dc.description.abstractINTRODUCTION: 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.eng
dc.identifier.doi10.14309/ajg.0000000000002676
dc.identifier.eissn1572-0241
dc.identifier.issn0002-9270
dc.identifier.urihttp://hdl.handle.net/10400.1/26437
dc.language.isoeng
dc.peerreviewedyes
dc.publisherLippincott, Williams & Wilkins
dc.relation.hasversionhttps://journals.lww.com/ajg/fulltext/2024/08000/rates_of_adverse_events_in_patients_with.17.aspx
dc.relation.ispartofAmerican Journal of Gastroenterology
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectColectomy
dc.subjectPostoperative safety
dc.subjectTofacitinib
dc.subjectUlcerative colitis
dc.titleRates of adverse events in patients with Ulcerative Colitis undergoing colectomy during treatment with Tofacitinib vs Biologics: A multicenter observational studyeng
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPage1535
oaire.citation.issue8
oaire.citation.startPage1525
oaire.citation.titleThe American Journal of Gastroenterology
oaire.citation.volume119
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85

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