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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
PsA patients experienced numerical improvements in symptoms of enthesitis and dactylitis1Patients receiving XELJANZ® had a numerically greater mean change from baseline in Leeds Enthesitis Index (LEI) score vs those receiving placebo at month 31,aOPAL Broaden in csDMARD-IR patients1

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.1

Example

aPatients with baseline Leeds Enthesitis Index score of 0 were excluded from analyses.
  • In csDMARD-IR patients with enthesitis, 33.3% (25/75) had complete resolution (LEI=0) at month 3 with XELJANZ vs 21.5% (14/65) with placebo. At month 3, 47.4% (36/76) of patients receiving Humira® 40 mg SC q 2 wk + csDMARD had complete resolution of enthesitis2​​​​​​​
  • Statistical significance for XELJANZ was not achieved under the step-down procedure2
OPAL Beyond in TNFi-IR patients4,5Patients with baseline Leeds Enthesitis Index score of 0 were excluded from analyses.3​​​​​​​
  • Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in LEI at month 3 with XELJANZ 5 mg BID + csDMARD vs placebo + csDMARD was not tested for statistical significance controlling for type I error4
Patients receiving XELJANZ had a numerically greater mean change from baseline in Dactylitis Severity Score (DSS) vs those receiving placebo at month 31,bOPAL Broaden in csDMARD-IR patients1

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.1​​​​​​​

Patients with baseline Dactylitis Severity Score of 0 were excluded from analyses.3
  • In csDMARD-IR patients with dactylitis, 34.4% (21/61) had complete resolution (DSS=0) at month 3 with XELJANZ vs 32.8% (19/58) with placebo. At month 3, 46.6% (27/58) of patients receiving Humira® 40 mg SC q 2 wk + csDMARD had complete resolution of dactylitis2
  • Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in DSS at month 3 with XELJANZ 5 mg BID + csDMARD vs placebo + csDMARD was not tested for statistical significance controlling for type I error.1​​​​​​​​​​​​​​
Patients receiving XELJANZ had a numerically greater mean change from baseline in DSS vs those receiving placebo at month 34,bOPAL Beyond in TNFi-IR patients4,5Patients with baseline Dactylitis Severity Score of 0 were excluded from analyses.
  • Due to a lack of significance higher in the prespecified hierarchical testing sequence, the change from baseline in DSS at month 3 with XELJANZ 5 mg BID + csDMARD vs placebo + csDMARD was not tested for statistical significance controlling for type I error.4
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 3.1

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 3.4

Explore moreLearn about the XELJANZ safety profile in PsA See safety data

Humira® is a registered trademark of AbbVie Inc.

ACR=American College of Rheumatology; BID=twice a day; csDMARD=conventional synthetic disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire–Disability Index; IR=inadequate responder; NS=nonsignificant; PASI=psoriasis area and severity index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneously; TNFi=tumor 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, UC, AS and JIA

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

▼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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