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Adverse event reporting can be found at the bottom of the page
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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.
Please see the Oral Surveillance page (linked below) for more information on: study design, baseline characteristics, coprimary endpoints, and adverse events of special interest, before reading the real-world evidence content.
Included patients with RA initiating TNFi therapy (adalimumab, etanercept, infliximab, golimumab, certolizumab pegol) or XELJANZ with 6-month follow up1
Efficacy data collected at Month 61:
Visit our page on the ORAL Surveillance study to learn more about the study design and endpoints.
See the next page which walks through the CorEvitas Comparative Safety and Efficacy Study results
Corrona LLC (the proprietors of the Corrona RA Registry) was rebranded as CorEvitas in March 2021.
The recommended dose of XELJANZ for the treatment of RA in the US is 5 mg BID or 11 mg prolonged-release OD.2
XELJANZ 5mg BID & 11mg prolonged-release QD are the only approved doses for the treatment of RA and PsA in the UK.
§mACR20 response was defined as requiring at least 20% improvement in both tender and swollen joint counts and in two of the following endpoints: Patient’s Global Assessment of disease activity, Physician’s Global Assessment of disease activity, patient-reported pain (VAS), and Health Assessment Questionnaire Disability Index score.
AE=adverse event; CDAI=Clinical Disease Activity Index; CI=confidence interval; LDA=low disease activity; mACR20=modified American College of Rheumatology criteria ≥20% improvement; RA=rheumatoid arthritis; TNFi = tumour necrosis factor inhibitor; US = United States; MTX = methotrexate; VAS = visual analogue scale
Additional Prescribing Information:
Enbrel (etanercept): https://www.pfizerpiindex.co.uk/enbrel
Inflectra (infliximab): https://www.pfizerpiindex.co.uk/inflectra
References:
1. Reed GW, et al. Rheumatol Ther. 2019;6(4):573–586.
2. Reed GW, et al. Rheumatol Ther. 2019;6(4)(suppl):573–586.
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
To access further materials, resources and receive communication about medicines and vaccines promoted by Pfizer.
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PP-PFE-GBR-3863. November 2021