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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
Significant improvement in disease activity at week 16 vs. placebo (P<0.001)1​​​​​​​ASDAS(CRP) change from baseline1Full analysis set; mixed model for repeated measures; used without imputation for missing values.1​​​​​​​
*P<0.001 vs. plac​​​​​​​ebo;†P≤0.05 vs. placebo, according to the prespecified step-down testing procedure for global type I error control.1 To control for type I error at the 5% level for primary and certain secondary endpoints, 4 families of efficacy endpoints were tested in hierarchical sequences with a step-down approach, with ASDAS(CRP) tested only after statistical significance for ASAS20 and ASAS40 was met.1 Score calculated based on CRP level and patient reported measures: patient global assessment of disease, total back pain, duration of morning stiffness, and peripheral joint pain/swelling. Higher scores indicate more disease activity. A score >3.5 points indicates very high disease activity. A score reduction of at least 1.1 points indicates a clinically important improvement in disease activity.1–4The lower limit of quantification (LLOQ) of the hsCRP assay was 0.2 mg/L. For hsCRP values <LLOQ, they were set to 0.199 mg/L in all efficacy and safety analyses except for the ASDAS-related endpoints, where values <2 mg/L were set post hoc to 2 mg/L.1Study Design1​​​​​​​A 48-week, randomised, phase 3 study (consisting of a 16-week double-blind phase, followed by a 32-week open-label phase) including 269 adult patients with active AS and an inadequate response to ≥2 NSAIDs. Randomisation was stratified by bDMARD treatment history in patients who had inadequate response to ≤2 TNFis or had prior bDMARD (TNFi or non-TNFi) use without IR. At baseline, 207 patients were bDMARD-naïve, and 62 patients were TNFi-IR or prior bDMARD use (non-IR). NSAIDs/COX-2 inhibitors, MTX, SSZ, or oral corticosteroids were allowed if patients were on a stable dosage at baseline. For patients taking XELJANZ®, the mean age was 42.2 years old (40 years old for placebo), and most patients were male (87.2% for XELJANZ 5 mg BD, 79.4% for placebo). Patients taking XELJANZ in the trial had a mean disease duration since symptoms of 14.2 years (12.9 years for placebo), AS disease duration since diagnosis: mean 8.9 years (6.8 for placebo), and mean baseline BASDAI score: 6.4 (6.5 for placebo). 


The primary endpoint was to evaluate the proportion of patients who achieved an ASAS20 response at week 16. To control for type I error at the 5% level for primary and certain secondary endpoints, 4 families of efficacy endpoints were tested in hierarchical sequences with a step-down approach. The first family, the global type I error–controlled endpoints at week 16, included: ASAS20 response; ASAS40 response; ΔASDAS(CRP); ΔhsCRP, ΔASQoL, ΔSF-36v2 PCS score, ΔBASMI, and ΔFACIT-F total score. Upon meeting statistical significance for ASAS20 response at week 16, the second family included ΔASAS components at week 16, and included testing for ΔPtGA, Δtotal back pain, ΔBASFI, and Δmorning stiffness (inflammation). The third family, ASAS20 response over time, and the fourth family, ASAS40 response over time, were each tested in the following sequence: weeks 16, 12, 8, 4, and 2. In each family, statistical significance could be declared only if the prior endpoint (or time point) in the sequence met the requirements for significance. Nonresponder imputation was applied to missing data for ASAS response rates.

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Δ=change from baseline; AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; ASDAS(CRP)=Ankylosing Spondylitis Disease Activity Score based on C-reactive protein; ASQoL=Ankylosing Spondylitis Quality of Life; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BASFI=Bath Ankylosing Spondylitis Functional Index; BASMI=Bath Ankylosing Spondylitis Metrology Index; bDMARD=biologic disease-modifying antirheumatic drug; BD=twice daily; COX-2=cyclooxygenase 2; CRP=C-reactive protein; FACIT-F=Functional Assessment of Chronic Illness Therapy-Fatigue; FAS=full analysis set; hsCRP=high-sensitivity C-reactive protein; IR=inadequate response; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; LS=least squares; MMRM=mixed model for repeated measures; MTX=methotrexate; N1=number of patients with observation at visit; NSAID=nonsteroidal anti-inflammatory drug; PsA=psoriatic arthritis; PtGA=Patient Global Assessment of Disease Activity; RA=rheumatoid arthritis; SD=standard deviation; SF-36v2 PCS=Short Form-36 Health Survey Version 2 Physical Component Summary; SSZ=sulfasalazine; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis.References:Deodhar A, et al. Ann Rheum Dis 2021;80(8):1004 -1013 (and Supplement).Sieper J, et al. Ann Rheum Dis 2009;(68):ii1 -ii44.Zochling J. Arthritis Care Res 2011;(63):S47 -S58.
Machado P, et al. Ann Rheum Dis 2011;70(1):47 -53.
Clinical Efficacy AS SAFETY

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 See safety in AS DOSING

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EXPERIENCE

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

 See XELJANZ Experience

▼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.
 

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