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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosingPractical ConsiderationsDosing in UCDosingPractical ConsiderationsDosing in PsADosingPractical ConsiderationsDosing in pJIA and jPsADosingPractical ConsiderationsEfficacy & 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 OutcomesReal World EvidenceReal World EvidenceReal World ExperienceWhy Real-World Data?RWE available for XELJANZEffectiveness in RWESafety in RWEDrug Maintenance in RWESupporting ResourcesSupporting ResourcesGRAPPA GuidelinesMaterialsVideos

XELJANZ® (tofacitinib citrate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.

JIA-1 Study DesignA 44-week, 2-part study in a total of 225 patients including patients 2–17 years of age with pJIA and patients 2–17 with jPsA and ERA. 1,2

XELJANZ is approved in the UK for active pJIA and jPsA1

Patient population1,2
  • pJIA patients ages 2-17 years of age, including RF-positive or RF-negative polyarthritis, extended oligoarthritis, systemic JIA with active arthritis and no current systemic symptoms. 1,2
  • Note the pJIA efficacy population only included the subgroups with either RF-positive or RF-negative polyarthritis or extended oligoarthritis; patients with jPsA were included in a separate efficacy subgroup and ERA patients were not included in the efficacy analysis. 1,2
  • Treatment with MTX was permitted but was not required during the study.1
Study Design1
  • A total of 225 patients were enrolled in the 18-week open-label run-in phase and received XELJANZ/XELJANZ Oral Solution dosed at 5 mg BID or bodyweight-based equivalent BID. 
  • Only patients who achieved at least a JIA ACR30 response at the end of the run-in phase (Week 18) were randomised (1:1) to the double-blind phase. 
  • 173 patients (77%) met this criterion and were randomised into the double-blind phase to XELJANZ/XELJANZ Oral Solution dosed at 5 mg BID or bodyweight-based equivalent BID (n=88) or placebo (n=85) for 26 weeks.
Primary efficacy endpoint2
  • Occurrence of disease flare at Week 44. 
  •  Flare was defined per PRCSG and PRINTO JIA flare criteria as a worsening of 30% or more in three or more of six JIA/ACR core set variables, with one or none of the variables improving by 30% or more.2
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Dosing in pJIA and jPsA

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ACR, American College of Rheumatology; BID, twice daily; CHAQ-DI, Childhood Health Assessment Questionnaire–Disability Index; ERA, enthesitis-related arthritis; JIA, juvenile idiopathic arthritis; jPsA, juvenile psoriatic arthritis; MTX, methotrexate; pJIA, polyarticular juvenile idiopathic arthritis; PRCSG, The Pediatric Rheumatology Collaborative Study Group; PRINTO, Paediatric Rheumatology International Trials Organisation; RF, rheumatoid factor.

References

XELJANZ (tofacitinib citrate) 5 mg film-coated tablets Summary of Product CharacteristicsRuperto N, et al. Lancet 2021; doi:10.1016/S0140-6736(21)01255-1.
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-3389. May 2022
Clinical Efficacy JIA-1

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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