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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
Rapid reduction of signs and symptoms in RA patients*1,2*Significant reduction in the signs and symptoms of RA, as measured by ACR20, as early as week 2 and at month 31,2ORAL Solo (Study RA-I) in DMARD-IR patients2 P<0.001 vs placebo
All other time points measured were secondary endpoints.
Adapted from Fleischmann et al, 2012. 
ORAL Solo Study Design

A 6-month, randomized, double-blind, placebo-controlled, multicenter study in which 610 patients with moderately to severely active RA who had an inadequate response to ≥1 DMARD received XELJANZ® 5 mg BID or 10 mg BID or placebo. At month 3, all patients randomized to placebo were switched to either XELJANZ 5 mg BID or 10 mg BID. The coprimary endpoints were ACR20 response, HAQ-DI, and DAS28-4(ESR).2

Explore more Have you seen how XELJANZ performed in a head-to-head noninferiority study? Learn more ACR=American College of Rheumatology; DAS28-4(ESR)=Disease Activity Score for 28-joint counts based on erythrocyte sedimentation rate; DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire-Disability Index; IR=inadequate responder; JAKi=Janus kinase inhibitor; PsA=psoriatic arthritis; RA=rheumatoid arthritis; UC=ulcerative colitis.
Clinical Efficacy RA

Learn more about the XELJANZ safety profile

See safety in RA

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

See recommended dosing

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

See XELJANZ Experience
References:Data on file. Pfizer Inc., New York, NY. 
Fleischmann R, Kremer J, Cush J, et al; for the ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367(6):495-507.

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

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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PP-XEL-AUS-1405 06/23.
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