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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.

SCQM-RA Outcomes1
The SCQM RA registry compared the drug maintenance and real-world effectiveness of three alternative treatment options for RA – XELJANZ, TNFi, bDMARD and other modes of action1
Study Conclusion1

The study concluded that tofacitinib drug maintenance was comparable with bDMARDs-OMA and somewhat higher than TNFi. Concomitant csDMARDs appear to be required for optimal effectiveness of TNFi, but not for bDMARD-OMA or Tofa.

Overall drug discontinuation with Xeljanz, TNFi's and bDMARD-OMA1
  • Adjusted analyses demonstrated a higher risk of drug discontinuation with TNFis than with XELJANZ (HR: 1.29 [95% CI: 1.14–1.47])
  • No significant difference in drug discontinuation was observed between b/tsDMARDs-OMA and XELJANZ (HR: 1.09 [95% CI: 0.96–1.24])
  • LDA at Month 12 was achieved in 40% of those receiving TNFi, 46% receiving b/tsDMARD-OMA and 40% receiving XELJANZ. The likelihood of reaching LDA at Month 12 was not significantly different between the three treatments
Drug maintenance and likelihood of reaching LDA with and without concomitant csDMARDs1

IMage adapted from Finckh A, et al. 2020.
§Note: the XELJANZ monotherapy and combination therapy lines are overlapping

  • Drug maintenance with XELJANZ or bDMARD-OMA was not significantly different with or without csDMARDs, whereas TNFi drug maintenance significantly improved with concomitant csDMARD therapy
  • The likelihood of reaching LDA with XELJANZ, bDMARD-OMA, or TNFi with or without csDMARDs was similar
DRUG MAINTENANCE HRMONOTHERAPY (95% CI)
XELJANZ MONO VS COMBINATION THERAPY 1.11 (0.91–1.35)
bDMARD-OMA MONO VS COMBINATION THERAPY† 1.03 (0.89–1.20)
TNFi MONO VS COMBINATION THERAPY 1.27 (1.08–1.49)
 
LIKELIHOOD OF REACHING LDA (CDAI ≤10) ORMONOTHERAPY (95% CI)
XELJANZ MONO VS COMBINATION THERAPY 1.04 (0.69–1.57)
bDMARD-OMA MONO VS COMBINATION THERAPY† 1.12 (0.80–1.57)
TNFi MONO VS COMBINATION THERAPY 1.04 (0.76–1.40)
Explore More

Find out about the safety and efficacy clinical trials we have for Xeljanz in RA 

ORAL Strategy Study Design LoadingORAL Surveillance Loading

†bDMARD-OMA agents were abatacept and anti-IL-6 receptor (tocilizumab or sarilumab).
‡The adjusted survival curves based on 4023 treatment courses with 2103 events, representing the average patient in the SCQM population: female, seropositive, non-smoking patients with one prior bDMARD, mean age of 57, disease duration of 10.5 years, baseline DAS28 of 3.7, BMI of 26, who initiated treatment before the launch of a second JAKi.

 

OR=odds ratio; HR=hazard ratio; bDMARD=biologic disease-modifying anti-rheumatic drug; CDAI=Clinical Disease Activity Index;
csDMARD=conventional synthetic disease‑modifying anti-rheumatic drug; MTX=methotrexate;
OMA=other modes of action; TNFi=tumour necrosis factor inhibitor; tsDMARD=targeted synthetic
disease-modifying anti-rheumatic drug

References

Finckh A, et al. RMD Open. 2020;6(1):e001174.
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-4493.May 2023
Real World Evidence: SCQM-RAExplore more Real World Evidence in RAUnderstanding the clinical significance of Janus Kinase (JAK) selectivity in rheumatoid arthritis (RA)

In this podcast, Dr Ai Lyn Tan and Dr Sarah Mackie highlight the recent real-world evidence on shared decision making, treatment persistence and second-line treatment strategies in the context of Rheumatoid Arthritis (RA) with Janus Kinase 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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