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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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Safety & Tolerability

Real World Experience

Support & Resources

Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

JIA-1 Study Design

A 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

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

Adapted from Fleischmann R et al. 20171​​​​​​​.

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

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Dosing in RA

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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; RF, rheumatoid factor.

PP-XEL-GBR-TBC. January 2022

Announcement Title

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from Patients treated with XELJANZ should be given the Patient Alert Card.

Clinical Efficacy JIA-1

For UK Healthcare Professionals*

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*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021