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Adverse event reporting can be found at the bottom of the page
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XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
Tofacitinib should only be used if no suitable treatment alternatives are available in patients:
- 65 years of age and older;
- patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
- patients with malignancy risk factors (e.g. current malignancy or history of malignancy)
These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.
XELJANZ is approved in the UK for active pJIA and jPsA1
- 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
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.
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
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
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
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
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