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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
In a head-to-head noninferiority study, RA patients experienced similar benefits with XELJANZ® or Humira® as combination therapies with MTX1ACR20/50/70 response rates at month 61ORAL Strategy in MTX-IR patients1P values are for one-sided noninferiority comparisons (98.34% confidence interval) and must be <0.025 to declare significance.1,2
  • XELJANZ + MTX was noninferior to Humira® + MTX, with both achieving clinically meaningful responses as measured by ACR50 at month 61
  • XELJANZ monotherapy was not shown to be noninferior to XELJANZ + MTX1
  • XELJANZ monotherapy was not shown to be noninferior to Humira® + MTX1
  • Clinically relevant efficacy responses were seen across all 3 treatment arms1
ORAL Strategy Study Design

A 1-year, double-blind, triple-dummy, phase 3b/4, active comparator, head-to-head controlled trial in which 1146 patients with moderately to severely active RA who had an inadequate response to MTX received XELJANZ 5 mg BID, XELJANZ 5 mg BID + MTX, or Humira® 40 mg SC q 2 wk + MTX. The primary endpoint was ACR50 at month 6 powered to test noninferiority through independent comparisons of XELJANZ 5 mg BID to Humira® 40 mg SC q 2 wk + MTX; XELJANZ 5 mg BID + MTX to Humira® 40 mg SC q 2 wk + MTX; and XELJANZ 5 mg BID to XELJANZ 5 mg BID + MTX.1,3​​​​​​​

Explore more Learn about the XELJANZ safety profile in RA See safety data Humira® is a registered trademark of AbbVie Inc.ACR=American College of Rheumatology; BID=twice a day; IR=inadequate responder; LOCF=last observation carried forward; MTX=methotrexate; NRI=nonresponder imputation; NS=nonsignificant; q 2 wk=every 2 weeks; RA=rheumatoid arthritis; SC=subcutaneous.Clinical Efficacy RA
SAFETY

Learn more about the XELJANZ safety profile

 See safety in RA
DOSING

Learn about dosing with XELJANZ, the first oral JAKi approved for RA

 See recommended dosing
EXPERIENCE

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

 See XELJANZ Experience
References:
Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017;390(10093):457-468.
Data on file. Pfizer Inc., New York, NY. Fleischmann R, Mysler E, Hall S, et al. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial [supplementary appendix]. Lancet. 2017;390(10093):457-468. 

▼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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