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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

OCTAVE Clinical Programme Design1-3

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 521,‡ 
     
  • 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 UC
     

  • 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

  

Adapted from Data on file. Pfizer Inc.*Steroids were required to be stable during induction and tapered off during maintenance.1

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Learn about the XELJANZ® (tofacitinib citrate) safety profile in UC See safety data Loading

  

  

BID, twice daily; OCTAVE, Operationally Critical Threat, Asset and Vulnerability Evaluation; TNFi, tumour necrosis factor inhibitor; UC, ulcerative colitis.

  

References:

Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736, 1-77.Data on file. Pfizer Inc., New York, NY.Sandborn WJ, Su C, Sands BE, et al; OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis (Supplementary Appendix). N Engl J Med. 2017;376(18):1-77.Xeljanz. Local product document. Pfizer; 2022. Version LPDTOFA012022.

  

Please click the Prescribing Information link to view the safety and adverse events information of Xeljanz®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.


PP-XEL-IND-0843 22/07/22

Clinical Efficacy in UC

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XELJANZ® (tofacitinib citrate) is a small molecule that selectively targets the JAK pathway

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