Long-term safety and tolerability of oral tofacitinib in patients with Crohn’s disease: Results from a phase 2, open-label, 48-week extension study
Alimentary Pharmacology and Therapeutics Jan 25, 2019
Panés J, et al. - In patients with Crohn's disease, researchers primarily evaluated the long-term safety of tofacitinib 5 mg and 10 mg BID, as well as its effectiveness as maintenance therapy. Study participants included patients with Crohn’s disease in remission (n=62) who received tofacitinib 5 mg BID; those who were not in remission (n=88) received 10 mg BID. The worsening of Crohn's disease was the most common adverse event for tofacitinib 5 mg (33.9%) and 10 mg (19.3%). Although both doses generally showed similar safety results for overall adverse events, serious adverse events for tofacitinib 10 mg were more common than 5 mg. Among patients in remission at baseline, discontinuation due to insufficient clinical response was lower.
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