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Safety and efficacy of tofacitinib for up to 9.5 years in the treatment of rheumatoid arthritis: Final results of a global, open-label, long-term extension study

Arthritis Research & Therapy Apr 12, 2019

Wollenhaupt J, et al. - Between February 5, 2007, and November 30, 2016, 4481 patients were examined to estimate the safety and effectiveness of tofacitinib 5 mg as well as 10 mg twice daily (BID) for up to 9.5 years in rheumatoid arthritis (RA) cases. They reported safety data up to month 114 for all tofacitinib and efficacy data up to month 96 for tofacitinib 5 mg BID and month 72 for 10 mg BID (with low patient numbers limiting interpretation beyond these time points). They recorded the incidence rate (IR) ie, the number of patients with events per 100 patient-years, of 6.8 for AEs leading to discontinuation. Overall, they noted a consistent safety profile with that observed in previous phase 1, 2, 3, or long-term extension (LTE) studies.
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