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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 Danese
Published 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.
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