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Overall manageable safety profile of tofacitinib in long-term use

Conference
ECCO 2018

Tofacitinib is an oral, small-molecule JAK inhibitor. It has been shown to be safe and effective for the treatment of moderate-to-severe UC in the OCTAVE induction (P2/P3) and maintenance phase (P3) [4]. Long-term safety and efficacy of tofacitinib for UC are currently being evaluated in an on-going, open-label, long-term extension study [5].

Sandborn et al. described an updated integrated analysis of the safety profile of tofacitinib in the UC global clinical development programme. Patients were exposed to tofacitinib for up to 4.4 years [6]. Patients who received placebo or tofacitinib 5 or 10 mg BID were analysed as three cohorts. To begin, an induction cohort (P2/P3 induction, n=1,220); the second was a maintenance cohort (P3 maintenance, n=592). Thirdly, an overall cohort (patients receiving tofacitinib 5 or 10 mg BID in P2, P3, or the open-label extension study, n=1,157).

In total, 1,613 patient-years of exposure were included. Demographics ...



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