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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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Efficacy

Safety & Tolerability

Real World Experience

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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 https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.

Clinical Efficacy JIA-1

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PP-PFE-GBR-3863. November 2021

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