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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.

Additional data from post-hoc analyses

The following data is from post-hoc analyses and therefore when interpreting this data, the limitations of post-hoc analyses should be taken into consideration.

UC Patients can benefit from a rapid and significant reduction in symptoms with XELJANZ, seen as early as 3 days1

For patients with moderately to severely active ulcerative colitis, onset of action is an important consideration when choosing appropriate therapy to provide timely symptomatic relief1

Based on post-hoc analyses of daily patient diary data from the OCTAVE induction studies:

Significant reductions in rectal bleeding vs placebo were seen as early as 3 days:

Mean change from baseline rectal bleeding subscore of -0.30 vs -0.14; p<0.01

*Relates to results from a post-hoc analysis, consideration should be made for multiple testing and inclusion of unadjusted p-values when interpreting data.
†Post-hoc analysis of pooled data from Induction 1 and 2 trials. Daily Mayo stool frequency and rectal bleeding subscores were calculated using patient diary data collected daily during the first 15 days of induction therapy. Partial Mayo Score subscore data were first collected at Day 15.

With XELJANZ, rapid reduction in symptoms, seen within 3 days are irrespective of prior TNFi therapy failure status, baseline steroid use, or baseline C-reactive protein level1

‡Percentage of patients with reduction from baseline Mayo rectal bleeding subscore >1 excludes patients with baseline Mayo rectal bleeding subscore = 0
§Percentage of patients with reduction from baseline Mayo stool frequency subscore of >1 excludes patients with baseline Mayo stool frequency subscore = 0

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References

Hanauer S et al. Clin Gastroenterol Hepatol 2019;17:139-47Hanauer S et al. Clin Gastroenterol Hepatol 2019;17(Suppl):139-47
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-3972. October 2022
Clinical Efficacy UC

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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