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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.

ORAL Strategy Safety Outcomes
  • AE rates, including rates of the most common AEs, were comparable between treatment arms.1
  • The majority of AEs were mild or moderate in severity.1
Scroll left to view table
  XELJANZ 5mg BID (n=384) XELJANZ 5mg BID + MTX (n=376) Adalimumab 40mg Q2W + MTX (n=386)
Total number of AEs, n* 598 652 620
Patients with AEs, n (%) 226 (59) 231 (61) 253 (66)
Patients with treatment-related AEs, n (%) 101 (26) 111 (30) 133 (35)
Patients with SAEs, n (%) 35 (9) 27 (7) 24 (6)
Patients discontinuing due to AEs, n (%) 23 (6) 26 (7) 37 (10)

Adapted from Fleischmann R et al. 2017.1

Safety analysis set was identical to the full analysis set. Two (1%) of patients receiving XELJANZ monotherapy died during the first year of therapy.1

*Patients could have experienced more than one AE.1

Explore More​​​​​Safety & Tolerability

An overview of the safety profile of XELJANZ across all licensed indications.

Learn moreLoading

AE, adverse event; BID, twice-daily; MTX, methotrexate; Q2W, once every 2 weeks; SAE, serious adverse event.

References

Fleischmann R et al. Lancet 2017; 390:457–468.
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-3116. August 2021
Clinical Efficacy RA

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

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Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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