OCTAVE Clinical Program Design

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 primary efficacy endpoint in the OCTAVE Induction 1 and 2 trials was remission at Week 8, and in the OCTAVE Sustain trial, it was remission at Week 52^1,‡ 
   

• 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 study^2,3 
   

• 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.

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