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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosingPractical ConsiderationsDosing in UCDosingPractical ConsiderationsDosing in PsADosingPractical ConsiderationsDosing in pJIA and jPsADosingPractical ConsiderationsEfficacy & SafetyEfficacy & SafetySafety & TolerabilityOral SurveillanceAdverse EventsClinical Efficacy RAORAL Strategy Study DesignORAL Strategy Efficacy ResultsORAL Strategy Safety OutcomesClinical Efficacy UCOCTAVE Study DesignOCTAVE Sub GroupsOCTAVE InductionOCTAVE SustainPost-hoc AnalysesClinical Efficacy PsAOPAL Broaden & BeyondClinical efficacy pJIA and jPsAJIA-1 study designJIA-1 Efficacy ResultsJIA-1 Safety OutcomesReal World EvidenceReal World EvidenceReal World ExperienceWhy Real-World Data?RWE available for XELJANZEffectiveness in RWESafety in RWEDrug Maintenance in RWESupporting ResourcesSupporting ResourcesGRAPPA GuidelinesMaterialsVideos

XELJANZ® (tofacitinib citrate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

ORAL Strategy Efficacy ResultsCompleted head-to-head non-inferiority study comparing XELJANZ and adalimumab in patients with inadequate response to MTX1ACR50
  • 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*1image

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 months1image

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
imageAdapted from Fleischmann R et al. 2017.1Statistical 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
Explore More Learn more about dosing in Rheumatoid Arthritis (RA)Dosing in RALoading

*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

Fleischmann R et al. Lancet 2017; 390:457–468
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.
PP-XEL-GBR-3118. August 2021
Clinical Efficacy RA
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