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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 Safety in ASSafety in JIAClinical Efficacy AS ASAS20/40 Data
Back Pain and Spinal Mobility Data
ASDAS(CRP) Data
Clinical Efficacy JIA
Disease Flare Data
ACR30/50/70 Data
 Dosing and Administration Dosing in RA Dosing Practical Considerations Dosing in PsA Dosing Practical Considerations Dosing in UC Dosing Practical Considerations Dosing in AS
Dosing Practical Considerations Dosing in JIA
Dosing Practical Considerations Resources and Support Resources and Support EventsMaterials Videos
8-Week EfficacyXELJANZ® achieved rapid onset of action*1,2*A significantly greater proportion of patients taking XELJANZ 10 mg BID achieved treatment endpoints vs placebo at week 8 across multiple efficacy parameters1,2,4(Pooled Central Reada Data From OCTAVE 1 and OCTAVE 2 Induction Studies)1,2,4Adapted from Sandborn WJ et al, 20224

Discontinue XELJANZ 10 mg BID after 16 weeks if an adequate response is not achieved. Beyond induction, use of 10 mg BID should be limited to appropriate patientse and used for the shortest duration possible. The lowest effective dose needed to maintain response should be used.3

To limit 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.1,2Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopic findings subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).1Clinical response was defined as 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 1.1Appropriate patients include: patients who are not at increased risk for VTE, patients who experience a decrease in response on XELJANZ 5 mg BID, and patients who have failed to respond to alternative treatment options for UC (eg, TNFi therapy).3 This list is not exhaustive. Please refer to the approved Product Information for more information.XELJANZ delivered rapid remission with no rectal bleeding1XELJANZ 10 mg BID achieved significantly higher rates of remissiona vs placebo at week 8 in patients who were TNFi naïve or failed prior TNFi therapy4(Pooled Central Readb Data From OCTAVE 1 and OCTAVE 2 Induction Studies)1,2,4Adapted from Sandborn WJ et al, 20224Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1To limit 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.1,2Includes all patients, TNFi naïve and TNFi exposure.2Explore more Have you seen how XELJANZ achieved rapid symptomatic improvement in just 3 days? Learn more

BID=twice daily; JAK: Janus kinase; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; VTE=venous thromboembolism.

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, UC, AS and JIA

 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.​​​​​​​Data on file. Pfizer Inc., New York, NY.XELJANZ Approved Product InformationSandborn WJ, Peyrin-Biroulet L, Sharara AI et al; Efficacy and Safety of Tofacitinib in Ulcerative Colitis Based on Prior Tumor Necrosis Factor Inhibitor Failure Status. Clin Gastroenterol Hepatol 2022 Mar;20(3):591-601.e8.

▼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. Refer to PBS Schedule for full authority information.

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PP-XEL-AUS-1497  11/23.

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