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FDA Approves Rinvoq for Moderate to Severe RA

Studies Show Reduced Symptoms, Clinical Remission

The FDA has approved upadacitinib (Rinvoq, AbbVie), a once-daily oral Janus kinase (JAK) inhibitor, for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR).

The approval is supported by data from SELECT, one of the largest registrational phase 3 programs in RA, with approximately 4,400 patients evaluated across all treatment arms in five studies. The studies include assessments of efficacy, safety, and tolerability among a variety of RA patients, including those who did not respond to or were intolerant of biologic disease-modifying antirheumatic drugs and who were naive or inadequate responders to methotrexate. 

Patients taking upadacitinib achieved clinical remission even without methotrexate. Approximately 30% of patients treated with upadacitinib achieved clinical remission at week 12 in SELECT-COMPARE and at week 14 in SELECT-MONOTHERAPY compared with 6% of patients with placebo plus methotrexate and 8% with methotrexate, respectively. Durable remission rates were observed up to week 26. 

Forty-eight percent of patients treated with upadacitinib alone in SELECT-EARLY and 41% of patients treated with upadacitinib plus methotrexate in SELECT-COMPARE achieved clinical remission at weeks 24 and 26, compared with 9% of patients taking placebo plus methotrexate and 18% with methotrexate, respectively.

The most common side effects associated with upadacitinib include upper respiratory tract infections, nausea, cough, and pyrexia. Patients treated with upadacitinib are at increased risk for developing serious infections, including tuberculosis, invasive fungal, bacterial, viral, and other infections due to opportunistic pathogens. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Lymphoma and other malignancies have been observed in upadacitinib-treated patients. 

Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, has occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. Patients may also be at risk for other serious adverse reactions, including gastrointestinal perforations, neutropenia, lymphopenia, anemia, lipid elevations, liver enzyme elevations, and embryo-fetal toxicity.

Source: Pharmacy Practice News, Aug. 27, 2019

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