Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme.
William J SandbornJulian PanesBruce E SandsWalter ReinischChinyu SuNervin LawendyNana KoramHaiyun FanThomas V JonesIrene ModestoDaniel QuirkSilvio DanesePublished in: Alimentary pharmacology & therapeutics (2019)
In this post hoc analysis of patients with UC, during tofacitinib exposure, one patient had DVT and four had PE, all during the OLE study, on predominant dose 10 mg b.d. (83% of overall cohort patients received predominant dose 10 mg b.d.) with venous thromboembolism risk factors. This analysis is limited by small sample size and limited drug exposure; further studies are needed. ClinicalTrials.gov: NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612.
Keyphrases
- ulcerative colitis
- venous thromboembolism
- risk factors
- rheumatoid arthritis
- end stage renal disease
- chronic kidney disease
- newly diagnosed
- ejection fraction
- prognostic factors
- case report
- emergency department
- clinical trial
- direct oral anticoagulants
- atrial fibrillation
- patient reported outcomes
- study protocol
- double blind