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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 Safety Outcomes

XELJANZ is approved in the UK for active pJIA and jPsA1

  • In Study JIA-I, adverse reactions included infections (influenza, pharyngitis, sinusitis, viral infection) and gastrointestinal disorders or general disorders (abdominal pain, nausea, vomiting, pyrexia, headache, cough).1 
  • There were no cases of MACE, malignancies (including NMSC), mortality, or thrombotic events (DVT, PE, or ATE) in Study JIA-I.2
  • Serious infections in XELJANZ patients in Study JIA-I included appendicitis, epidural empyema (with sinusitis and subperiosteal abscess), pilonidal cyst, pneumonia, escherichia pyelonephritis, limb abscess, and UTI.1
Safety analysis set included all JIA subtypes recruited to the study
Scroll left to view table
  Open-label phase Double-blind phase
  XELJANZ* (n=225) XELJANZ* (n=88) Placebo (n=85)
Number of patients with AEs, n (%) 153 (68.0) 68 (77.3) 63 (74.1)
Number of patients with serious AEs, n (%) 7 (3.1) 1 (1.1) 2 (2.4)
Number of patients discontinuing due to AEs, n (%) 26 (11.6) 16 (18.2)§ 29 (34.1)

Adapted from Ruperto et al, 2021.2

*XELJANZ 5 mg BID or equivalent weight based lower dose in patients <40 kg.1

§One SAE of pilonidal cyst repair was coded to surgical procedures instead of infections, and was inadvertently not identified as a serious infection. Following adjudication, the serious AE did not meet opportunistic infection criteria. 2

PLEASE SEE XELJANZ SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION

Explore MoreSafety & Tolerability

Please click here for an overview of the safety profile of XELJANZ across all licensed indications.

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AE, adverse event; ATE, arterial thromboembolism; BID, twice daily; DVT, deep vein thrombosis; ERA, enthesitis-related arthritis; GI, gastrointestinal; ILD, interstitial lung disease; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; pcJIA, polyarticular course juvenile idiopathic arthritis; PE, pulmonary embolism; jPsA, juvenile psoriatic arthritis; SAE, serious adverse event; UTI, urinary tract infection.

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-3391. May 2022
Clinical Efficacy pJIA and jPsA

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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