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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:
These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.
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
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
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
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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PP-UNP-GBR-7812. January 2024