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Efficacy and safety were established in 3 large, multicentre, randomised, double-blind, placebo-controlled, Phase 3 studies and an open-label study of patients with moderate to severe UC1
Adapted from Sandborn WJ, et al. 2017.
10 mg BID for at least 8 weeks, evaluate patients and transition to maintenance therapy depending on therapeutic response. If needed, continue 10 mg BID for a maximum of 16 weeks. Discontinue 10 mg BID after 16 weeks if adequate therapeutic response is not achieved.4
The XELJANZ® (tofacitinib citrate) induction and maintenance trials incorporated a more rigorous definition of remission that required the absence of any rectal bleeding (Mayo subscore of 0), unlike previous clinical trials for treatments of UC1
Patients who completed one of the OCTAVE Induction studies but did not achieve clinical response or patients who completed or withdrew early due to treatment failure on XELJANZ® (tofacitinib citrate) or placebo in the maintenance study were eligible for the open-label extension study. OCTAVE Open is a safety and tolerability study2,3
Patients were assessed using the Mayo scale, a tool for evaluating disease activity in patients with UC which is composed of 4 subscores (stool frequency, rectal bleeding, endoscopic findings and Physician Global Assessment), each with a range of 0 to 3 (higher scores indicate more severe disease)3
*To avoid potential bias, evaluation of endoscopies was conducted by readers who were blinded to the treatment (XELJANZ® [tofacitinib citrate] or placebo) and had no contact with patients, investigators or other individuals involved in the study.2,3
†Responders/Responses were defined as subjects with a decrease from baseline in the Mayo score of 3 points and 30%, with an accompanying decrease in the subscore for rectal bleeding of >1 point or absolute subscore for rectal bleeding of 0 or 1.3
‡Remitters/Remissions were defined as subjects with a Mayo score ≤2 with no individual subscore of >1 and a rectal bleeding subscore of 0.3
Baseline Patient Characteristics for XELJANZ® (tofacitinib citrate) UC Trial Participants2
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BID, twice daily; OCTAVE, Operationally Critical Threat, Asset and Vulnerability Evaluation; TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis.
References:
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