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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.
Regardless of prior TNFi use, XELJANZ was more effective than placebo at 10 mg BID1
Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses.1
In OCTAVE Induction 1, patients had a mean Total Mayo score of 9 at baseline (n=598). 51% had previously failed TNFi; 75% corticosteroids; 74% immunosuppressant therapy. Previous treatment failure was determined by the investigator.
In OCTAVE Induction 2, patients had a mean Total Mayo score of 9 at baseline (n=541). 52% had previously failed TNFi; 71% corticosteroids; 69% immunosuppressant therapy. Previous treatment failure was determined by the investigator.
Regardless of prior TNFi use, XELJANZ was more effective than placebo at both 5 mg and 10 mg BID1
Central reading of endoscopic findings was used for eligibility and primary and key secondary efficacy endpoint analyses.1
Patients had a mean Total Mayo score of 3.3 at the baseline of OCTAVE Sustain (n=593). 45% of patients had failed previously failed TNFi; 75% corticosteroids; 70% immunosuppressant therapy.1
BID=twice daily; TNFi=tumour 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