Efficacy
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.
References
1. Fleischmann R et al. Lancet 2017; 390:457–468.
PP-XEL-GBR-3107. Aug 2021
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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.

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