Abstract
FDA on November 6 announced the approval of tofacitinib oral tablets as a second-line treatment for moderate-to-severe rheumatoid arthritis in adults. According to Pfizer, tofacitinib is the first FDA-approved inhibitor of Janus kinase a tyrosine-specific protein kinase that contributes to inflammation in patients with rheumatoid arthritis. Pfizer will market tofacitinib as Xeljanz. Tofacitinib can be taken as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs) but should not be used in combination with biologic DMARDs or potent immuno-suppressive drugs. The 33-page FDA-approved labeling for tofacitinib includes a boxed warning about the risk of serious infections and lymphomas and other cancers in patients treated with tofacitinib. These risks are also the focus of a medication guide that is part of the labeling. According to the boxed warning, patients should be tested for latent tuberculosis (TB) before starting tofacitinib therapy. Patients who test positive for latent TB...
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