Venous thromboembolic events in the tofacitinib ulcerative colitis clinical development programme

Area of Science:

• Pharmacology
• Gastroenterology
• Clinical Trials

Background:

• Tofacitinib is an oral JAK inhibitor used for ulcerative colitis (UC) treatment.
• Understanding the risk of venous thromboembolism (VTE) is crucial for UC patients on JAK inhibitors.

Purpose of the Study:

• To assess the incidence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients with UC treated with tofacitinib.
• To analyze VTE events across different treatment phases (induction, maintenance, long-term extension).

Main Methods:

• Data from Phase 2, 3, and Open-Label Extension (OLE) studies were analyzed.
• Patients receiving tofacitinib (5 or 10 mg b.d.) were evaluated in induction, maintenance, and overall cohorts.
• Incidence rates of DVT and PE were calculated based on patient-years of exposure.

Main Results:

• In the overall cohort (1157 patients, 2404 patient-years), one DVT and four PE events were reported.
• No DVT/PE events occurred in tofacitinib-treated patients during induction or maintenance phases.
• All reported VTE events in the overall cohort occurred during the OLE study, predominantly at the 10 mg b.d. dose, in patients with UC and VTE risk factors.

Conclusions:

• Tofacitinib treatment in UC patients was associated with a low incidence of DVT and PE.
• VTE events were primarily observed in patients with pre-existing risk factors receiving a higher dose during long-term tofacitinib exposure.
• Further research is warranted due to the small sample size and limited exposure in this analysis.