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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)Tursi Study (Italy)
Supporting ResourcesSupporting ResourcesMaterialsGRAPPA GuidelinesVideosExpert 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 Malignancy Risk Outcomes
The 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 not evidence of an increased risk of malignancy development with tofacitinib therapy, in comparison with TNFi therapy, in RA patients treated in a real-world setting. However, the results cannot rule out the possibility of an increase in risk that may accrue with a longer duration of treatment with tofacitinib.

Tofacitinib vs TNF inhibitors and risk of primary composite malignancy1

†Primary outcome: Composite malignancy outcome of any new malignancy excluding NMSC. ‡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.

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

Primary outcome: Composite malignancy outcome of any new malignancy excluding NMSC. ‡Data shown on this slide is from the as-treated analysis, where patients are censored at treatment discontinuation or switch. §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 malignancy outcome with tofacitinib vs TNFi (overall RWE cohort)1 

†Primary outcome: Composite malignancy outcome of any new malignancy excluding NMSC. ‡TNFi: Infliximab, adalimumab, certolizumab pegol, etanercept, and golimumab. §Patients ≥18 years old (≥65 years in Medicare).
Table adapted and graph created from Khosrow-Khavar F, et al. 2022.

PS-weighted hazard ratios for risk of secondary malignancy 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 the ORAL Surveillance trial.

ORAL SurveillanceLoading

Explore more real-world evidence trials in RA. 

SCQM-RA Study DesignLoading

CI=confidence interval; CV=cardiovascular; HR=hazard ratio; IHD=ischemic heart disease; NMSC=non-melanoma skin cancer; PS=propensity score; RCT=randomized controlled trial; 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. Arthritis Rheum. 2022; doi:10.1002/art.42250.
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-4467. May 2023
Real World Evidence: STAR-RAExplore more Real World Evidence in RA ORAL Surveillance study in RA with James Galloway

In this video, Dr James Galloway, respected rheumatologist and researcher talks about the ORAL Surveillance study and its implications for the use of tofacitinib in the treatment of RA. He offers an overview of the study design and a summary of the results, before offering his own clinical interpretation and how this affects his prescribing decisions.

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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