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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosing in UCDosing in PsADosing in pJIA and jPsADosing in ASSpecial Warnings & PrecautionsEfficacy & SafetyEfficacy & SafetySafety & TolerabilityOral SurveillanceAdverse EventsClinical Efficacy RAORAL Strategy Study DesignORAL Strategy Efficacy ResultsORAL Strategy Safety OutcomesClinical Efficacy UCOCTAVE Study DesignOCTAVE Sub GroupsOCTAVE InductionOCTAVE SustainPost-hoc AnalysesClinical Efficacy PsAOPAL Broaden & BeyondClinical Efficacy pJIA and jPsAJIA-1 Study DesignJIA-1 Efficacy ResultsJIA-1 Safety OutcomesClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataReal World EvidenceReal World EvidenceReal World Evidence
Why Real-World Data?Key Characteristics of RCTs & RWEKey Strengths & Limitations
STAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)Tursi Study (Italy)
Supporting ResourcesSupporting ResourcesMaterialsGRAPPA GuidelinesVideosExpert Opinions

XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
 
 Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

  • 65 years of age and older;
  • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
  • patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

 These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

Significant reduction in the signs and symptoms of AS at week 16 vs placebo1XELJANZ delivers rapid reduction in the signs and symptoms of AS (ASAS20) as early as week 21,2,a

Adapted from Deodhar et al. 2021.

* P<0.001 vs placebo1
† P
0.05 vs placebo, according to the prespecified step-down testing procedure for type I error control of ASAS response over time1
‡ P
0.05 vs placebo, according to the prespecified step-down testing procedure for global type I error control1
a First measurement post-baseline.1
Consists of 4 domains (each scored from 0 to 10): patient global assessment of disease, total back pain, function, and inflammation. ASAS20 response was defined as an improvement of ≥20% and ≥1 unit in at least 3 domains, and no worsening of ≥20% and ≥1 unit in the remaining domain. 3,4

Significant reduction in the signs and symptoms of AS (ASAS40) as early as week 41,2,5

Adapted from Deodhar et al. 2021.

* P<0.001 vs placebo1
† P
0.05 vs placebo, according to the prespecified step-down testing procedure for type I error control of ASAS response over time1
‡ P
0.05 vs placebo, according to the prespecified step-down testing procedure for global type I error control1
a NS=not statistically significant at week 2.1
Consists of 4 domains (each scored from 0 to 10): patient global assessment of disease, total back pain, function, and inflammation. ASAS40 response was defined as an improvement of ≥40% and ≥2 units in at least 3 domains, and no worsening in the remaining domain.4

Explore more Find out more about dosing in Ankylosing Spondylitis (AS)Dosing in ASLoading

Δ=change from baseline; AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; 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; BID=twice daily; IR=inadequate response; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; MTX=methotrexate; RA=rheumatoid arthritis; TNFi=tumor necrosis factor inhibitor; 

References

Deodhar A, Sliwinska-Stanczyk P, Xu H, et al. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021;80(8):1004-1013.Data on file. Pfizer Inc., New York, NY.Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum. 2001;44(8):1876-1886.Sieper J, Rudwaleit M, Baraliakos X, et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. [supplementary index II]. Ann Rheum Dis. 2009;(68):ii1-ii44.Deodhar A, Sliwinska-Stanczyk P, Xu H, et al. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study [data supplement 2]. Ann Rheum Dis. 2021;80(8):1004-1013. Accessed October 19, 2021. https://ard.bmj.com/content/annrheumdis/suppl/2021/04/28/annrheumdis-2020-219601.DC1/annrheumdis-2020-219601supp002_data_supplement.pdf
XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.
PP-XEL-GBR-4266. January 2023
AS Clinical Efficacy

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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