FDA Approves Upadacitinib for Inadequately Treated Rheumatoid Arthritis

The US Food and Drug Administration (FDA) has approved upadacitinib (RINVOQ) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have an inadequate response or intolerance to methotrexate.

The approval for the 15 mg, once-daily oral Janus kinase (JAK) inhibitor from AbbVie was supported by data from the SELECT clinical program—a collection of 5 registrational phase 3 trials including 4400-plus patients with rheumatoid arthritis.

SELECT data presented at the American College of Rheumatology/ Association for Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago last October showed upadacitinib significantly improved a series of patient-reported outcomes among adults with moderate to severe RA. Significantly improved outcomes included joint pain, physical function, health-related quality of life, and morning stiffness.

Outcome improvements were notably significant for patients who had also reported inadequate response or intolerance to methotrexate or other monotherapies. Some patients administered 15 mg or 30 mg upadaticinib reported improved joint pain within 2 weeks.

By week 14 of observation, 65% and 69% of patients on the treatment doses, respectively, had reported physical function improvements. Just 45% of patients administered monotherapy methotrexate achieved physical function improvements in that time period (P < .001).

Across all phase 3 trials, upadaticinib achieved all its primary endpoints, and ranked secondary endpoints.

In a statement accompanying the approval announcement, Roy M. Fleischmann, MD, primary investigator for SELECT-COMPARE and a clinical professor at the University of Texas Southwestern Medical Center, said clinical remission or low disease activity remain elusive goals for patients with rheumatoid arthritis—despite a high rate of available treatment options with varying mechanisms of action.

“With this FDA approval, upadaticinib has the potential to help additional people living with RA achieve remission who have not yet reached this goal,” Fleischmann said.

AbbVie intends to make the therapy available to patients in August.