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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosing in UCDosing in PsADosing in pJIA and jPsADosing in ASSpecial Warnings & PrecautionsEfficacy & 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 OutcomesClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataReal World EvidenceReal World EvidenceReal World Evidence
Why Real-World Data?Key Characteristics of RCTs & RWEKey Strengths & LimitationsSTAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)Supporting ResourcesSupporting ResourcesMaterialsVideosGRAPPA GuidelinesExpert Opinions

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:

  • 65 years of age and older;
  • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
  • patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

 These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

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-3943. October 2022
Clinical Efficacy RA
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