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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 Efficacy ResultsXeljanz significantly reduced the risk of disease flare in paediatric patients and reduced the signs and Symptoms of pJIA 1,2

XELJANZ is approved in the UK for active pJIA and jPsA1

Primary Endpoint - Occurrence of disease flare at Week 44
  • In patients who achieved at least a JIA ACR30 response at Week 18 of the open-label phase, significantly fewer patients with pJIA experienced disease flare with XELJANZ vs placebo.1
Occurrence of disease flare in the double-blind phase of Study JIA-I*†1,2image

​​​​Adapted from Ruperto et al, 2021.2

*The 26-week double-blind phase is from Week 18 through Week 44 (on and after randomisation day).1

†Flare was defined as a worsening of ≥30% in ≥3 of the 6 variables of the JIA core set, with ≤1 variable improving by ≥30%.2

‡Patients received XELJANZ 5 mg BID or bodyweight-based equivalent of XELJANZ Oral Solution BID. Oral solution was used for patients weighing <40 kg.1,2

Trial limitations:

  • Tofacitinib efficacy was assessed indirectly by occurrence of JIA flare. Due to the large number of placebo-treated patients who met flare criteria in part 2 of the study and were, therefore, required to discontinue, observed differences in efficacy between tofacitinib versus placebo might be reduced.
Secondary EndpointsChange from double-blind baseline in CHAQ-DI in the double-blind phase of Study JIA-11,2

In patients with pJIA who achieved at least a JIA ACR30 response at Week 18 of the open-label phase, XELJANZ significantly improved phsyical function vs placebo.1

Adapted from Ruperto et al, 2021.2

†Patients received XELJANZ 5 mg BID or bodyweight-based equivalent of XELJANZ Oral Solution BID. Oral solution was used for patients weighing <40 kg.1,2

Time to disease flare in the double-blind phase of Study JIA-I†2

In patients with pJIA who achieved at least a JIA ACR30 response at Week 18 of the open-label phase, XELJANZ reduced the risk of flare vs placebo. 2

Adapted from Ruperto et al, 2021.2

Patients received XELJANZ 5 mg BID or bodyweight-based equivalent of XELJANZ Oral Solution BID. Oral solution was used for patients weighing <40 kg.1,2

JIA ACR30/50/70 response rates for XELJANZ in the double-blind phase of Study JIA-I*1,2

In patients who achieved at least a JIA ACR30 response at Week 18 of the open-label phase, XELJANZ significantly reduced signs and symptoms vs placebo.1

Adapted from Ruperto et al, 2021.2

*The JIA ACR30/50/70 response criteria are: 3 of 6 JIA core set variables improving ≥30%, 50%, and 70%, respectively, with ≤1 out of 6 JIA core set variables worsening by ≥30%. For systemic JIA, the absence of spiking fever related to systemic JIA is also required.2

Patients received XELJANZ 5 mg BID or bodyweight-based equivalent of XELJANZ Oral Solution BID. Oral solution was used for patients weighing <40 kg.1,2

Explore MoreDosing in pJIA and jPsA Visit page Loading

ACR, American College of Rheumatology; BID, twice daily; CHAQ-DI, Childhood Health Assessment Questionnaire–Disability Index; CI, confidence interval; JIA, juvenile idiopathic arthritis; LSM, least squares mean; pJIA, polyarticular juvenile idiopathic arthritis; SE, standard error.

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-3390. May 2022
Clinical Efficacy pJIA and jPsA
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