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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 Study Design

12-month Phase IIIb/IV non-inferiority study in 1,146 patients with moderate to severe active RA with an inadequate response to MTX1

Adapted from Fleischmann R et al. 20171​​​​​​​.

Patient population1

  • Moderate to severe RA.
  • MTX-IR.
  • N=1,146 randomised patients.
  • Global study.
  • Randomised, controlled clinical trial.

Primary efficacy endpoint1

  • The primary efficacy endpoint of the study was ACR50 at Month 6 (non-inferiority was assessed between treatment groups)*1

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Dosing in RA

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*XELJANZ + MTX was compared with adalimumab + MTX; and XELJANZ monotherapy was compared with both adalimumab + MTX and with XELJANZ + MTX.

ACR, American College of Rheumatology; BID, twice daily; IR, inadequate response; MTX, methotrexate; Q2W, once every 2 weeks; RA, rheumatoid arthritis; SC, subcutaneous.

PP-XEL-GBR-2308. 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

For UK Healthcare Professionals*

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PP-PFE-GBR-2688. December 2020

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