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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.

OPAL Broaden & Beyond ​​​​PsA Efficacy ResultsXELJANZ delivers rapid and sustained improvements in joint symptoms vs placebo as measured by ACR201,2

Adapted from Mease P et al. 2017.2

In addition, significant ACR50 and ACR70 responses were achieved at Month 31

ACR50: 28% vs 10% in the XELJANZ and placebo group, respectively (p<0.001)1
ACR70: 17% vs 5% in the XELJANZ and placebo group, respectively (p=0.004)1

Statistical testing was performed comparing placebo with XELJANZ up to three months.
* Co-primary endpoints were the proportion of patients who had an ACR20 response at month 3 and the change from baseline in HAQ-DI score at Month 3.
 The OPAL Broaden study was designed to test for superiority of XELJANZ over placebo. Adalimumab was used as an active control.
The trial was not designed and was not powered to evaluate the non-inferiority or superiority of XELJANZ as compared with adalimumab.
 Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.1
§
 The result was significant at a p≤0.05 according to the prespecified step-down testing procedure for type I error control within the family of ACR responses.1

Adapted from Gladman D et al. 2017.4

In addition, a significant ACR50 response was achieved at Month 3 with XELJANZ**3

An ACR50 response was achieved in 29.8% of patients on XELJANZ 5 mg vs 14.5% of patients on placebo (p=0.0025)3,4​

*  Co-primary endpoints were the proportion of patients who had an ACR20 response at month 3 and the change from baseline in HAQ-DI score at Month 3
 Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for type I error control within the ACR20 time course.3
** The result was significant at a p value of ≤0.05 according to the prespecified step-down testing procedure for type I error control within the family of ACR responses.3
†† Statistically significant vs placebo at a p≤0.05 as per the prespecified step-down procedure for global type I error control.3

Adapted from Mease P et al. 2017 (supplementary appendix).2

Radiographic non-progression was observed in the majority of patients across all trial groups at 12 months (96% for XELJANZ, 98% for adalimumab and 96% for placebo to XELJANZ, respectively)1,2

*** The OPAL Broaden study was designed to test for superiority of XELJANZ over placebo. Adalimumab was used as an active control. The trial was not designed and was not powered to evaluate the non-inferiority or superiority of XELJANZ as compared with adalimumab.
‡‡ Radiographs of the hands and feet were obtained at baseline and at Month 12 and were scored independently by two central assessors who were unaware of the trial-group assignments.

Explore more Find out more about dosing in Psoriatic Arthritis (PsA)Dosing in PsALoading

ACR=American College of Rheumatology; BID=twice-daily; csDMARD=conventional synthetic disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire-Disability Index; IR=inadequate responder; mTSS=modified Total Sharp Score; PsA=psoriatic arthritis; Q2W=once every two weeks; SC=subcutaneous; TNFi=tumour necrosis factor inhibitor.

References

Mease P et al. N Engl J Med 2017; 377: 1537–1550Mease P et al. N Engl J Med 2017; 377: 1537–1550 (supplementary appendix)Gladman D et al. N Engl J Med 2017; 377: 1525–1536Gladman D et al. N Engl J Med 2017; 377: 1525–1536 (supplementary appendix)
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-3973. October 2022
PsA Clinical Efficacy

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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