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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 Study DesignReal World Evidence for Rheumatoid ArthritisStudy Population Loading
Baseline Characteristics 
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LoadingStudy Endpoints Study Limitations Loading
ORAL Surveillance

Please see the Oral Surveillance page (linked below) for more information on: study design, baseline characteristics, coprimary endpoints, and adverse events of special interest, before reading the real-world evidence content. 

ORAL Surveillance LoadingStudy ObjectiveThe STAR-RA study examines the risk of Malignancy with XELJANZ (tofacitinib citrate) vs TNFi‡ in patients with RA treated in routine clinical care settings. 
  • 3 adverse event reporting databases were used: Medicare, Optum, MarketScan

Considering the increased risk of serious infections, myocardial infarction, and malignancies with Xeljanz in patients 65 years of age and older, Xeljanz should only be used in these patients if no suitable treatment alternatives are available.

This study was not sponsored by Pfizer.
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Study Population 

New users of XELJANZ or TNFi with ≥365 days continuous enrolment up to the cohort entry date

RWE Overall cohort1
≥18 years old (≥65 years in Medicare)
Sample:
  • Optum: N=25,410 (13.0% of which are on XELJANZ)
  • MarketScan: N=29,511 (15.3% of which are on XELJANZ)
  • Medicare: N=28,374 (9.5% of which are on XELJANZ)
RWE 'RCT Duplicate' Cohort1,2RWE ‘RCT-duplicate’ cohort mimicks eligibility criteria of the ORAL Surveillance study1 (Phase IIIb/IV randomized, open-label, non-inferiority, post-authorization, safety endpoint-driven study2§)
  • ≥50 years old (≥65 years in Medicare)
  • ≥1 MTX dispensation in 6 months prior to cohort entry date
  • ≥1 CV risk factor including history of smoking, hypertension, dyslipidemia, diabetes mellitus, IHD, or family history of IHD
Sample:
  • Optum: N=5899 (11.3% of which are on XELJANZ)
  • MarketScan: N=6588 (14.2% of which are on XELJANZ)
  • Medicare: N=14,548 (7.6% of which are on XELJANZ
 Baseline Characteristics 

RWE OVERALL COHORT

Demographics and RA treatment use1  CV disease risk factors1 Other comorbidities1

RWE 'RCT DUPLICATE' COHORT

Demographics and RA treatment use 1 CV disease risk factors1 Other comorbidities1  Study Endpoints  Primary Outcome1Risk of any new malignancies excluding NMSC  (composite)Secondary Outcomes1
  • Lung cancer
  • Prostate cancer
  • Breast cancer
  • Colorectal cancer
  • Lymphatic/hematopoietic cancer
  • NMSC
Positive control outcome:
HZ (used due to the known risk with XELJANZ)
Study Limitations1-3   US claims data on the risk of malignancy outcomes with XELJANZ: Study limitations
  • The specific geographic population may not be representative of the worldwide population (eg, patient characteristics,healthcare access)1
  • Residual confounding is possible due to some unmeasured RA-related variables1
  • Doses of MTX were not accounted for in the analyses
  • Other JAK inhibitors, eg, baricitinib or upadacitinib, were not assessed in this analysis and the results of this study cannot necessarily be extrapolated beyond XELJANZ1
  • Relatively short follow-up time (mean follow-up <1 year) due to imposed as-treated definition where patients were censored at treatment discontinuation or switch1
  • Outcome misclassification was possible1
  • Administrative claims may contain missing data and/or coding errors because their primary use is to obtain payment for services and medications administered1,3
  • Data may not be representative of patients without insurance1
  • No analyses specific to dose1
  • Comparisons between the RWE study and ORAL Surveillance study results should be interpreted with caution due to differences in trial design, populations, and methodology (eg, STAR-RA only looked at a US patient population, had a shorter length of follow-up, and not all the ORAL Surveillance inclusion and exclusion criteria can be adequately represented in claims data)1,2
  • Some covariates in the matching model are co-linear, eg, use of glucocorticoids is included for those with prior use in the last 365 days or recent use in the last 60 days, which may limit the accuracy of propensity score weighting1
  • As patients in the databases are de-identified, it is not possible to confirm that all patients across the three databases are completely independent of each other1
  • Differences in demographics and study periods between databases mean they are not fully comparable1
Explore More

Learn more about ORAL Surveillance 

ORAL SurveillanceLoading

Learn more about outcomes of the STAR-RA study

STAR-RA Malignancy Outcomes 
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§ Eligibility criteria for ORAL Surveillance included: patients ≥50 years of age; taking MTX without adequate control of symptoms; moderate to severe RA, including ≥6 tender or painful joints and ≥6 swollen joints (28-joint count) ≥1 CV risk factor.2 See cited publication for full eligibility criteria and study design.
‡TNFi: Infliximab, adalimumab, certolizumab, pegol, etanercept, and golimumab.

CV=cardiovascular; JAK=Janus kinase; MTX=methotrexate; ORAL=Oral Rheumatoid Arthritis Trial; RA=rheumatoid arthritis; RCT=randomized controlled trial; RWE=real-world evidence; STAR-RA=Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis; US=United States; HR=hazard ratio; PS=propensity score; bDMARD=biologic disease-modifying antirheumatic drug; HZ=herpes zoster; IHD=ischemic heart disease; MI=myocardial infarction; MTX=methotrexate

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

Inflectra (infliximab): https://www.pfizerpiindex.co.uk/inflectra

References

1. Khosrow-Khavar F, et al. Arthritis Rheum. 2022; doi:10.1002/art.42250.
2. Ytterberg
SR, et al. N Engl J Med. 2022;386(4):316-326.
3. 
Harnett J, et al. J Manag Care Spec Pharm. 2016;22(12):1457-1471.

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-4466. May 2023
Real-World Evidence: STAR-RAExplore more Real-World Evidence in RAKicker Header of this card goes here

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XELJANZ in action

Find out more about XELJANZ (tofacitinib citrate) mode of action.

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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