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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
Onset of Action DataPost Hoc Analysis From OCTAVE Induction Trials2Rapid symptomatic response* seen as early as day 3*Patients with a reduction in the Mayo rectal bleeding subscore ≥1 point (pooled data, OCTAVE 1 and 2)2,a,b

Adapted from Hanauer S, Panaccione R, Danese S, et al. Clin Gastroenterol Hepatol. 2019;17(1):139-147.

At day 3, 32% of patients taking XELJANZ 10 mg twice daily (266/830) had a reduction from baseline of ≥1 point in Mayo rectal bleeding subscore vs 20% of patients on placebo (43/214).2

Adapted from Hanauer S, Panaccione R, Danese S, et al. Clin Gastroenterol Hepatol. 2019;17(1):139-147.

At day 3, 29% of patients taking XELJANZ 10 mg twice daily (241/837) had a reduction from baseline of ≥1 point in Mayo stool frequency subscore vs 18% of patients on placebo (39/218).2

 

Proportion of patients with a reduction from baseline in Mayo rectal bleeding subscore or Mayo stool frequency subscore ≥1 point excludes patients with a baseline Mayo rectal bleeding subscore or Mayo stool frequency subscore of 0.2Daily Mayo stool frequency and rectal bleeding subscores were calculated using daily patient diary data from two 8-week, phase 3 trials of induction therapy (OCTAVE Induction 1 and 2).2Explore more Do you want to see sustained efficacy data for XELJANZ? Learn more

BID=twice daily; LS Mean=least squares mean.

Clinical Efficacy in UC
SAFETY

Learn more about the XELJANZ safety profile

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DOSING

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

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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.​​​​​​​Hanauer S, Panaccione R, Danese S, et al. Tofacitinib induction therapy reduces symptoms within 3 days for patients with ulcerative colitis. Clin Gastroenterol Hepatol. 2019;17(1):139-147​​​​​​​.

▼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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