AbbVie received approval from the U.S. FDA for 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). RINVOQ is expected to be available in the U.S. in late August 2019.

The approval is supported by data from the SELECT program, one of the largest registrational Phase III 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 across a variety of RA patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs and who were naïve or inadequate responders to methotrexate.

Patients taking RINVOQ achieved clinical remission, a state characterized by almost no disease activity and symptoms, even without methotrexate. Approximately 30 percent of patients treated with RINVOQ achieved clinical remission at week 12 and week 14 compared to six percent with placebo plus methotrexate and eight percent with methotrexate, respectively.  In another study, 36 percent of patients treated with RINVOQ achieved clinical remission at week 12 compared to 14 percent with methotrexate.
 
“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, M.D., primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas. “With this FDA approval, RINVOQ has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”