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About JAKi Experience  JAKi Market Experience XELJANZ Mechanism of Action Efficacy and Safety Clinical Efficacy RA Rapid Data (ACR20) Head-to-Head Noninferiority Data (ACR50) Clinical Efficacy PsA ACR20 Data PASI75 Data Enthesitis and Dactylitis Data Clinical Efficacy UC 8-Week Efficacy Onset of Action Data 52-Week Efficacy OCTAVE Study Design Safety and Tolerability Safety in RA Safety in PsA Safety in UC Dosing and Administration Dosing in RA Dosing Practical Considerations Dosing in PsA Dosing Practical Considerations Dosing in UC Dosing Practical Considerations Resources and Support Resources and Support eXel ProgramEventsMaterials Videos
OCTAVE Study DesignEfficacy and safety established in 3 large, multicenter, randomized, double-blind, placebo-controlled phase 3 studies and an open-label study of patients with moderate to severe UC1OCTAVE Clinical Program Design

The recommended dose for maintenance treatment is XELJANZ® 5 mg BID. When induction treatment is complete, the dosage should be decreased from 10 mg BID to 5 mg BID.3

  • 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,c
  • The XELJANZ 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 or placebo in the maintenance study were eligible for the open-label extension study. OCTAVE Open is a safety and tolerability study1,2​​​​​​​
  • ​​​​​​​Patients were assessed using the Mayo scale, a tool for evaluating disease activity in UC patients that is composed of 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and Physician’s Global Assessment), each with a range of 0 to 3 (higher scores indicate more severe disease)1
To avoid potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1,2Responders/response were defined as subjects with a decrease from baseline in 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 1.1​​​​​​​Remitters/remission were defined as subjects with a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1Baseline patient characteristics for XELJANZ UC trial participantsExplore more Learn about the XELJANZ safety profile in UC See safety data

BID=twice daily; TNF=tumor necrosis factor; UC=ulcerative colitis.

Clinical Efficacy in UC
SAFETY

Learn more about the XELJANZ safety profile

 See safety in UC
DOSING

Learn about dosing with XELJANZ, the first JAKi approved for UC

 See recommended dosing
EXPERIENCE

Find out more about the JAKi with the longest market experience in RA, PsA, and UC

 See XELJANZ Experience
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.Sandborn et al. Tofacitinib by TNFi Failure Status in UC. Clinical Gastroenterology and Hepatology 2021; https://doi.org/10.1016/j.cgh.2021.02.043XELJANZ (tofacitinib citrate) Approved Product Information

▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

WARNINGS 
XELJANZ should only be used if no suitable treatment alternatives are available in patients: 
  • with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past, long-time smokers) 
  • with malignancy risk factors (e.g. current malignancy or history of malignancy) 
  • who are 65 years of age and older. 

See PI for details, Section 4.4 Special Warnings and Precautions for Use: Mortality; Major Adverse Cardiovascular Events (including Myocardial Infarction); Thrombosis; Malignancy and Lymphoproliferative Disorder (excluding Nonmelanoma Skin Cancer [NMSC]); Skin Cancer and Use in the Elderly. 


Before prescribing, please review full Product Information available here.
 

PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis and for adults with severe psoriatic arthritis and for adults with moderate-to-severe ulcerative colitis. Refer to the PBS Schedule for full authority information. This product is not listed on the PBS for juvenile idiopathic arthritis, juvenile psoriatic arthritis, or ankylosing spondylitis.

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