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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 PsA patients*1,2*Significant reduction in the signs and symptoms of PsA, as measured by ACR20, as early as week 2 and at month 31,2OPAL Broaden in csDMARD-IR patients2

The OPAL Broaden study was not designed to provide head-to-head comparative efficacy data vs Humira® and should not be interpreted as evidence of superiority or noninferiority.2

Example

P≤0.05 vs placebo2P<0.001 vs placebo2Statistically significant vs placebo at P≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.2Statistically significant vs placebo at P≤0.05 as per the prespecified step-down testing procedure for global type I error control.2​​​​​​All other time points measured were secondary endpoints.1Adapted from Mease et al, 2017.​​​​​​​OPAL Broaden Study Design

A 12-month, randomized, multicenter, double-blind trial in which 422 patients with PsA who had an inadequate response to at least one csDMARD and were TNFi-naïve received either XELJANZ® 5 mg BID,  XELJANZ 10 mg BID, Humira® 40 mg SC q 2 wk, or placebo. At month 3, all patients randomized to placebo treatment were advanced in a blinded fashion to either XELJANZ 5 mg BID or XELJANZ 10 mg BID. Primary endpoints were ACR20 response and the change in HAQ-DI at month 3.2

Significant reduction in the signs and symptoms of PsA, as measured by ACR20, as early as week 2 and at month 31-3OPAL Beyond in TNFi-IR patientsP≤0.05 vs placebo3Statistically significant vs placebo at P≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.3Statistically significant vs placebo at P≤0.05 as per the prespecified step-down testing procedure for global type I error control.3Adapted from Gladman et al, 2017.​​​​​​​​​​​​​​OPAL Beyond Study Design

A randomized, 6-month, double-blind trial in which 394 patients with PsA who had an inadequate response to at least one TNFi received either XELJANZ 5 mg BID, XELJANZ 10 mg BID, or placebo. At month 3, all patients randomized to placebo were advanced in a blinded fashion to either XELJANZ 5 mg BID or XELJANZ 10 mg BID. Primary endpoints were ACR20 response rate and the change in HAQ-DI at month 3.3

Explore moreAre you interested in the visible improvements in skin symptoms measured by PASI75? Learn more

Humira® is a registered trademark of AbbVie Inc.

ACR=American College of Rheumatology; BID=twice daily; csDMARD=conventional synthetic disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire-Disability Index; IR=inadequate responder; NRI=nonresponder imputation; PASI=psoriasis area and severity index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneously; TNFi=tumour necrosis factor inhibitor.

Clinical Efficacy PsA
SAFETY

See the XELJANZ safety data for PsA

See safety in PsA
DOSING

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

 See recommended dosing
EXPERIENCE

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

 See XELJANZ Experience
References:Data on file. Pfizer Inc., New York, NY.Mease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377(16):1537-1550.Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377(16):1526-1536.

▼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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