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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 Efficacy Results

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

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*†1,2

Adapted from Ruperto et al, 2021.2


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​​​​​​​*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


Secondary Endpoints​​​​​​

Change from double-blind baseline in CHAQ-DI in the double-blind phase of Study JIA-I1,2

In patients with pJIA who achieved at least a JIA ACR30 response at Week 18 of the open-label phase, XELJANZ significantly improved physical 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


​​​​​​​


XELJANZ: N=72; events=21; median time to flare was not evaluable as 71% of
patients remained flare-free.
Placebo: N=70; events=37; median time to flare for placebo group (95% CI: 155 days
[86.0, not evaluable]).2
†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​​
​​​​​​​

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

​​​​​​​

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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; CI, confidence interval; JIA, juvenile idiopathic arthritis; LSM, least squares mean; pJIA, polyarticular juvenile idiopathic arthritis; SE, standard error.

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 RA

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