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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 & Limitations
STAR-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.

STAR-RA CV Risk OutcomesThe STAR-RA Study was conducted using data from 3 US claims databases (Optum, MarketScan, and Medicare) to assess the risk of CV outcomes and malignancy with XELJANZ (tofacitinib citrate) in patients with RA treated in routine clinical care settings.Study Conclusion

The study concluded that there was no evidence for an increased risk of cardiovascular outcomes with tofacitinib in patients with RA treated in the real-world setting; however, tofacitinib was associated with an increased risk of cardiovascular outcomes, although statistically non-significant, in patients with RA with cardiovascular risk factors.

Tofacitinib vs TNF inhibitors in the risk of CV outcomes1 

Forest plot of propensity score fine stratification weighted HRs and corresponding 95% CIs for composite cardiovascular outcomes when comparing tofacitinib with tumour necrosis factor inhibitors in patients with rheumatoid arthritis in RWE cohort (top panel) and RCT-duplicate cohort (bottom panel). RCT, randomised controlled trial; RWE, real-world evidence.

Image adapted from Khosrow-Khavar F, et al. 2022.

Crude incidence of composite CV outcomes per 100 PY (95% CI)1

All estimates were pooled using fixed effects models with inverse variance weighting.

†Primary outcome: Composite CV outcome of hospitalization for MI or stroke.

‡TNFi: infliximab, adalimumab, certolizumab pegol, etanercept, and golimumab
§Patients from Medicare were ≥65 years old.
║CV risk factors include history of smoking, hypertension, dyslipidemia, diabetes mellitus, IHD or family history of IHD.

Table adapted and graph created from Khosrow-Khavar F, et al. 2022.

PS-weighted hazard ratios for the primary composite CV outcome (overall RWE cohort) 

†Primary outcome: Composite CV outcome of hospitalization for MI or stroke.
TNFi: infliximab, adalimumab, certolizumab pegol, etanercept, and golimumab. §Patients ≥18 years old (≥65 in Medicare)
Table adapted and graph created from Khosrow-Khavar F, et al. 2022.

PS-weighted hazard ratios for the secondary and control outcomes (overall RWE cohort)1

†TNFi: infliximab, adalimumab, certolizumab pegol, etanercept, and golimumab.
Patients ≥18 years old (≥65 in Medicare), pooled from Optum, MarketScan, and Medicare US claim databases.

Table adapted and graph created from Khosrow-Khavar F, et al. 2022.

Explore More

Learn more about STAR-RA Malignancy Risk Study Design

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Learn more about the ORAL Surveillance trial.

ORAL SurveillanceLoading

bDMARD=biologic disease-modifying antirheumatic drug; CI=confidence interval; CV=cardiovascular; CVD=cardiovascular disease; HR=hazard ratio; MI=myocardial infarction; PS=propensity score; RWE=real-world evidence; TNFi=tumor necrosis factor inhibitor

Additional Prescribing Information:
Enbrel (etanercept): https://www.pfizerpiindex.co.uk/enbrel
Inflectra (infliximab): https://www.pfizerpiindex.co.uk/inflectra

References

Khosrow-Khavar F, et al. Ann Rheum Dis. 2022;81(6):798-804.
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-4468. May 2023
Real World Evidence: STAR-RAExplore more Real World Evidence in RAUnderstanding the clinical significance of Janus Kinase (JAK) selectivity in rheumatoid arthritis (RA)

Prof. Ernest Choy discusses the rationale for XELJANZ (tofacitinib citrate) in RA, the significance of the JAK pathway, JAK selectivity in clinical practice, and efficacy data and the safety profile for JAK inhibitors.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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