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FDA Approves Rinvoq for Moderate to Severe Rheumatoid Arthritis

Decision supported by data from more than 4,000 patients

The FDA has approved Rinvoq (upadacitinib), a 15-mg, 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 the SELECT program, 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 patients who were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate. Rinvoq is not indicated for methotrexate-naïve patients.

"Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis," said Roy M. Fleischmann, MD, primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas.

Patients taking Rinvoq achieved clinical remission, even without methotrexate.  Approximately 30% of patients treated with Rinvoq achieved clinical remission at week 12 in SELECT-COMPARE and week 14 in SELECT-MONOTHERAPY, compared with 6% with placebo plus methotrexate and 8% with methotrexate, respectively. In SELECT-EARLY, 36% of patients treated with Rinvoq achieved clinical remission at week 12, compared with 14% with methotrexate. Durable remission rates were observed up to week 26. Rinvoq also significantly inhibited radiographic progression compared to methotrexate in SELECT-EARLY and SELECT-COMPARE through weeks 24 and 26, respectively. 

The most common side effects associated with Rinvoq include upper respiratory tract infections, nausea, cough and pyrexia. Patients treated with Rinvoq are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Lymphoma and other malignancies have been observed in Rinvoq-treated patients. Thrombosis has occurred in patients treated with JAK inhibitors used to treat inflammatory conditions. 

Designed to help accommodate the physical limitations of people living with RA, the packaging for Rinvoq includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access. This packaging design was awarded the Arthritis Foundation Ease of Use Commendation.

Source:, Aug. 16, 2019 

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