Short term efficacy, safety and thromboembolic risk of tofacitinib in moderate to severe Ulcerative Colitis in Journal of Crohn's and Colitis
2023
AOU Città della Salute di Torino
Tipo pubblicazione
Conference Abstract
Autori/Collaboratori (9)Vedi tutti...
Cingolani L
Padua University Hospital, Surgery- Oncology and Gastroenterology, Padua, Italy
Barberio B
Padua University Hospital, Surgery- Oncology and Gastroenterology, Padua, Italy
Zelante A
Rovigo “Santa Maria della Misericordia” Hospital, Gastroenterology Unit, Rovigo, Italy
et alii...
Abstract
Background: Tofacitinib is a small oral molecule approved to treat moderate to severe ulcerative colitis (UC), which effectiveness and safety is still poorly known in UC patients. Recent concerns have been raised regarding its administration at high dosage in UC patients because of a likely higher incidence of drug-related thromboembolic events. Methods: The aim of this study was to evaluate short-term effectiveness and safety of tofacitinib. As secondary aim, we analyzed the state of blood coagulation at baseline in order to evaluate whether it could predict thromboembolic events in relation to demographic, clinical and biochemical characteristics. A multicenter, retrospective, observational study was conducted, including patients from March 2021 to October 2022; a prospective singlecentre sub-study concerning the thromboembolic risk was performed. At baseline, demographic, clinical, biochemical and endoscopic data, and previous therapies were recorded; quality of life was evaluated through IBD-Disability Index (IBD-DI) and Pittsburgh Sleep Quality Index (PSQI). In a subgroup of patients, a thrombophilic screening and a Rotational Thromboelastometry (ROTEM) were performed at baseline. Patients were reassessed after 8 weeks, 6 months and 1 year, evaluating for each timepoint clinical and biochemical characteristics, IBD-DI and PSQI, and reporting adverse events (AEs) and discontinuation of therapy. The following clinical outcomes were considered: Benefit, steroid-free remission and response. Results: 44 adult patients were enrolled. The overall clinical benefit was 54.2%, summing up 45.8% of subjects in steroid-free clinical remission and 8.3% with clinical response; significant short-term improvement of IBD-DI and PSQI scores (p=0.000 in both cases after 6 months of therapy) was observed. Patients previously treated with less than two different biological therapies had major rates of clinical benefit at 6 months (p=0.045). Ten AEs, including one venous throm
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DOI : 10.1093/ecco-jcc/jjac190.0672
Keywords
blood clotting factor 10; blood clotting factor 8; calgranulin; endogenous compound; prothrombin; steroid; tofacitinib; adult; adverse drug reaction; blood clotting; case report; clinical article; clinical evaluation; clinical outcome; comparative effectiveness; conference abstract; demography; disability; drug safety; drug therapy; feces; female; fibrinogen blood level; gender; human; human tissue; longitudinal study; male; multicenter study; obese patient; observational study; outcome assessment; Pittsburgh Sleep Quality Index; prospective study; quality of life; remission; retrospective study; side effect; smoking habit; steroid therapy; thromboelastometry; thromboembolism; thrombophilia; thrombosis; treatment failure; ulcerative colitis; vein thrombosis;