You are now leaving PfizerPro You are about to view a medical resource regarding the use of tofacitinib in Juvenile Idiopathic Arthritis.  Before viewing this content, please note that the US Prescribing Information for Xeljanz was updated following FDA’s completed review of the ORAL Surveillance Study, an FDA-required postmarketing safety study. The final results of the ORAL Surveillance study have prompted important changes to the US prescribing information for tofacitinib.

ORAL surveillance was a large randomized active-controlled event-powered non-inferiority clinical trial to evaluate the safety of tofacitinib at two doses (5 mg twice daily and 10 mg twice daily) versus two tumor necrosis factor alpha inhibitors (TNF-alpha inhibitors) in subjects with Rheumatoid Arthritis who were 50 years of age or older and had at least one additional cardiovascular risk factor.  The co-primary endpoints of this study were adjudicated major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancers). Study results showed that the prespecified non-inferiority criteria were not met for these co-primary endpoints and the clinical trial could not demonstrate tofacitinib is non-inferior to (“not worse than”) TNF-alpha inhibitors.

Please refer to the US Prescribing Information.

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