Clinical Efficacy JIA

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XELJANZ Mechanism of Action

Efficacy and Safety

Rapid Data (ACR20)

Clinical Efficacy PsA

OCTAVE Study Design

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Safety in RA

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ASAS20/40 Data

Back Pain and Spinal Mobility Data

ASDAS(CRP) Data

Clinical Efficacy JIA

Disease Flare Data

ACR30/50/70 Data

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Practical Considerations

Dosing in PsA

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In patients who achieved at least a JIA ACR30 response by the end of the open-label phase

JIA ACR30/50/70 response rates
were significantly higher with XELJANZ® vs placebo at week 44 (P<0.05 for ACR30/50/70)¹

JIA ACR30 response rate in Study JIA-I | Key secondary endpoint*¹

Adapted from Ruperto et al. 2021.¹

In the open-label phase of Study JIA-I, 45% of patients with JIA who received XELJANZ achieved ACR30 at week 2^1,2

*The JIA ACR30 response criteria are: 3 of 6 JIA core set variables improving ≥30% 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.¹ JIA ACR30 response rate at week 44 was a type I error-controlled secondary endpoint.¹

†Patients received XELJANZ 5 mg BD or body weight-based equivalent of XELJANZ Oral Solution BD. Oral solution was used for patients weighing <40 kg.^1,3

JIA ACR50 response rate in Study JIA-I | Key secondary endpoint*^1,2

Adapted from Ruperto et al. 2021.¹

More than 2/3 of patients with JIA who received XELJANZ achieved ACR50 at week 44²

*The JIA ACR50 response criteria are: 3 of 6 JIA core set variables improving ≥50% 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.¹ JIA ACR50 response rate at week 44 was a type I error-controlled secondary endpoint.²

†Patients received XELJANZ 5 mg BD or body weight-based equivalent of XELJANZ Oral Solution BD. Oral solution was used for patients weighing <40 kg.^1,3

JIA ACR70 response rate in Study JIA-I | Key secondary endpoint*¹

Adapted from Ruperto et al. 2021.¹

More than 50% of patients with JIA who received XELJANZ achieved ACR70 at week 44¹

*The JIA ACR70 response criteria are: 3 of 6 JIA core set variables improving ≥70% 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.¹ JIA ACR70 response rate at week 44 was a type I error-controlled secondary endpoint.²

†Patients received XELJANZ 5 mg BD or body weight-based equivalent of XELJANZ Oral Solution BD. Oral solution was used for patients weighing <40 kg.^1,3

In patients who achieved at least a JIA ACR30 response by the end of the open-label phase, JIA American College of Rheumatology-Inactive Disease rates were numerically higher with XELJANZ vs. placebo at week 44 (not statistically significant)^1,2

JIA ACR-ID rate in Study JIA-I | Secondary endpoint*¹

Adapted from Ruperto et al. 2021 (Suppl).¹

*JIA ACR-ID is defined as: no joints with active arthritis; no fever, rash, serositis, splenomegaly, hepatomegaly, or generalized lymphadenopathy attributable to systemic JIA; no active uveitis; normal erythrocyte sedimentation rate or, if elevated, not attributable to JIA; physician global assessment of disease activity score of best possible or duration of morning stiffness ≤15 min.²

†Patients received XELJANZ 5 mg BD or body weight-based equivalent of XELJANZ Oral Solution BD. Oral solution was used for patients weighing <40 kg.^1,3

Study Information

A 44-week, 2-part study (consisting of an 18-week, open-label, run-in phase, followed by a 26-week double-blind, placebo-controlled, randomised phase) in patients 2 to
<18 years of age with pJIA (including RF positive or RF negative polyarthritis, extended oligoarthritis, systemic JIA with active arthritis and no current systemic symptoms) and patients 2 to <18 with jPsA and ERA. However, the pJIA efficacy population only includes the subgroups with either RF positive or RF negative polyarthritis or extended oligoarthritis; inconclusive results have been seen in the subgroup of patients with systemic JIA with active arthritis and no current systemic symptoms. Patients with juvenile PsA are included as separate efficacy subgroup. ERA patients are not included in the efficacy analysis.^1,3

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 BD or body weight-based equivalent BD. Only patients who achieved at least a JIA ACR30 response at the end of the run-in phase (week 18) were randomized (1:1) to the double-blind phase. 173 patients (77%) met this criterion and were randomized into the double-blind phase to either XELJANZ/XELJANZ Oral Solution dosed at 5 mg BD or body weight-based equivalent BD (n=88) or placebo (n=85) for 26 weeks. Treatment with MTX was permitted but was not required during the study.³

The primary endpoint was JIA flare rate by week 44. Flare is defined as a worsening of ≥30% in ≥3 of the 6 variables of the JIA core set, with ≤1 variable improving by ≥30%.¹

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ACR=American College of Rheumatology; AS=ankylosing spondylitis; BD=twice daily; ERA=enthesitis-related arthritis; ID=inactive disease; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; jPsA=juvenile psoriatic arthritis; MTX=methotrexate; NS = not significant; pJIA=polyarticular juvenile idiopathic arthritis; PsA=psoriatic arthritis; RA=rheumatoid arthritis; RF=rheumatoid factor; UC=ulcerative colitis.

References:

Ruperto N, et al. Lancet. 2021;398(10315):1984 -96.

Ruperto N, et al. Lancet. 2021;398(10315):1984 -96 [Supplementary Appendix].

XELJANZ (tofacitinib citrate) Approved Product Information.

Clinical Efficacy JIA

SAFETY

Learn more about XELJANZ safety profile in JIA

See safety in JIA

DOSING

Learn about dosing with XELJANZ, the first oral JAKi approved for JIA

See recommended dosing

EXPERIENCE

Find out more about the JAKi with the longest market experience in RA, PsA, AS, UC, and JIA

See XELJANZ Experience

▼This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems.

WARNINGS
XELJANZ should only be used if no suitable treatment alternatives are available in patients:

with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past, long-time smokers)
with malignancy risk factors (e.g. current malignancy or history of malignancy)
who are 65 years of age and older.

See PI for details, Section 4.4 Special Warnings and Precautions for Use: Mortality; Major Adverse Cardiovascular Events (including Myocardial Infarction); Thrombosis; Malignancy and Lymphoproliferative Disorder (excluding Nonmelanoma Skin Cancer [NMSC]); Skin Cancer and Use in the Elderly.

Before prescribing, please review full Product Information available here.

PBS Information: Authority required. Refer to PBS Schedule for full authority information.

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