*EMBARGOED All research presented at the 2019 ACG Annual Scientific Meeting and Postgraduate Course is strictly embargoed until Monday, October 28, 2019, at 8:00 am CDT.
Oral 59 Incidence of Venous Thromboembolic Events in Patients With Ulcerative Colitis Treated With Tofacitinib in the Ulcerative Colitis Clinical Development Program
Author Insight from William J. Sandborn, MD, FACG, University of California San Diego
What’s new here and important for clinicians?
Tofacitinib therapy for ulcerative colitis has recently been restricted to patients who have failed anti-TNF therapy, and after induction therapy with 10 mg bid is completed, it is required that an attempt be made to reduce the dose to 5 mg bid. This is based on safety data from a trial in patients with rheumatoid arthritis which showed a higher risk of deep venous thrombosis (DVT) and pulmonary embolus (PE) treated with Tofacitinib 10 mg bid, relative to Tofacitinib 5 mg bid or adalimumab. The abstract reports the rates of DVT and PE in patients with ulcerative colitis treated with Tofacitinib 10 mg bid. In the placebo controlled trials, 5 patients developed DVT and PE, all 5 were receiving placebo, none were receiving Tofacitinib 5 mg bid or 10 mg bid. During the long term extension trial, 5 patients, all receiving Tofacitinib 10 mg bid, developed DVT and PD, for a rate of less than 0.2/100 patient years. This is a low rate an consistent with the rates of DVT and PE seen in patients with ulcerative colitis who are not taking Tofacitinib.
What do patients need to know?
We did not see a significantly increased rate of DVT and PE in patient with ulcerative colitis treated with Tofacitinib 10 mg bid. Nevertheless, caution should be taken in interpreting these results given that the trial in patients with rheumatoid arthritis is much larger.
William J. Sandborn, MD, FACG, University of California San Diego
wsandborn [at] ecsd [dot] edu
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