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Long-term extension studies on tofacitinib: Discontinuation most commonly associated with adverse events
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WASHINGTON — The median drug survival of tofacitinib was approximately 5 years, with discontinuation most commonly associated with adverse events, such as infections, more than lack of efficacy, according to long-term findings presented at the American College of Rheumatology Annual Meeting.
Janet Pope, MD, at Western University in Canada, and colleagues pooled data from two 96-month extension studies of 4,867 patients with rheumatoid arthritis treated with 5 mg or 10 mg of tofacitinib as monotherapy or with background disease-modifying antirheumatic drugs (DMARDs). Researchers based dose group assignment on average daily dose and they estimated drug survival in patients who withdrew due to lack of efficacy or adverse events.
Researchers found the median drug survival was 5 years for all patients who received tofacitinib, 4.9 years for patients who received tofacitinib and background DMARDs, and 5.1 years for patients who received tofacitinib just as monotherapy. Median survival was 5.2 years for 5 mg and 4.8 years for 10 mg. The most commonly reported reasons for discontinuation due to adverse events by system organ class were infections/infestations (8.8%), investigations (4.2%) and neoplasms (benign, malignant and unspecified; 3.2%). – by Will Offit
Reference:
Pope J, et al. Abstract #1602. Presented at: American College of Rheumatology Annual Meeting; Nov. 11-16, 2016; Washington.
Disclosure: Pope reports funds from AbbVie, Actelion, Amgen, BMS, Hospira, Janssen, Eli-Lilly, Merck, Novartis, Pfizer, Roche, Sanofi and UCB.