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Efficacy

Safety & Tolerability

Real World Experience

Support & Resources

Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

ORAL Strategy Efficacy Results

Completed head-to-head non-inferiority study comparing XELJANZ and adalimumab in patients with inadequate response to MTX1

ACR50

  • XELJANZ + MTX was non-inferior compared with adalimumab + MTX as measured by ACR50 at Month 6*.1
  • XELJANZ monotherapy was not non-inferior compared with adalimumab + MTX or XELJANZ + MTX as measured by ACR50 at Month 6*.1​​​​​​​

ORAL Strategy (MTX-IR RA population) – Primary endpoint: ACR50 at Month 6*1

Adapted from Fleischmann R et al. 2017.1​​​​​​

  • ACR50 response rates were maintained at Month 12.1​​​​​​​

ORAL Strategy (MTX-IR RA population) – ACR50 responses over 12 months1

Adapted from Fleischmann R et al. 2017.1

Non-inferiority​​​​​​​

  • ​​​​​​Non-inferiority for the primary endpoint was demonstrated for XELJANZ + MTX vs. adalimumab + MTX*.1
  • Non-inferiority was not demonstrated for XELJANZ vs. adalimumab + MTX or XELJANZ + MTX*.1

Adapted from Fleischmann R et al. 2017.1

Statistical analysis

  • ​​​​​​The non-inferiority margin was assessed using a 13% difference and non-inferiority was declared if the lower boundary of the 98.34% CI for the difference was larger than -13%.1
  • For any comparison between primary endpoints, if non-inferiority was demonstrated, superiority could be declared if the lower boundary of the 98.34% CI of the difference was greater than zero.1

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Dosing in RA

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*ACR50 at Month 6 (primary endpoint of the study) was based on the full analysis set.1

ACR, American College of Rheumatology; BID, twice daily; IR, inadequate response; LOCF, last observation carried forward; MTX, methotrexate; NRI, non-responder imputation; Q2W, once every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneous.

PP-XEL-GBR-2307. June 2021

Announcement Title

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.

Clinical Efficacy RA

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