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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
52-Week Efficacy>3 times as many patients treated with XELJANZ® maintenance therapy achieved remission with no rectal bleeding vs placebo1XELJANZ 5 mg BID & 10 mg BID maintenance therapy achieved significantly higher remissiona rates at week 52 vs placebo1,2(Central Readb Data From OCTAVE Sustain Maintenance Study)1,2XELJANZ significantly improved endoscopic appearance of the mucosa vs placebo1XELJANZ 5 mg BID improved endoscopic appearance of the mucosaa vs placebo at week 521(Central Readb Data From OCTAVE Sustain Maintenance Study)1,2

Example

Example

Example

 
XELJANZ significantly increased sustained
steroid-free remission rates vs placebo1A greater proportion of patients taking XELJANZ 5 mg BID & 10 mg BID achieved sustained steroid-free remissiona vs placebo at both weeks 24 and 521,2(Data From OCTAVE Sustain Maintenance Study)1,2

Maintenance treatment with XELJANZ 10 mg BID should be limited to patients who are not at increased risk for VTE, who experience a decrease in response on XELJANZ 5 mg BID, or who fail to respond to alternative treatment options (eg, TNFi therapy). XELJANZ 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used.3,a,d

Explore more Are you interested in the OCTAVE clinical program? Learn more 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

BID=twice daily; TNFi=tumor necrosis factor inhibitor; VTE=venous thromboembolism.

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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