FDA Approves Upadacitinib for Moderate-to-Severe Rheumatoid Arthritis


Upadacitinib (Rinvoq, AbbVie) is indicated for adults with moderate-to-severe rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

Officials with the FDA have approved upadacitinib (Rinvoq, AbbVie) for adults with moderately-to-severely active rheumatoid arthritis (RA), according to a press release.

Based on data from the SELECT program, upadacitinib, an oral Janus kinase (JAK) inhibitor, met all primary and ranked secondary endpoints across a variety of patients with moderate-to-severe RA.

The studies, which comprised one of the largest registrational phase 3 programs in RA, included approximately 4400 patients evaluated across all treatment arms. For the studies, the efficacy, safety, and tolerability of upadacitinib were assessed across a variety of patients, including those who failed or were intolerant to biologic disease-modifying anti-rheumatic drugs (DMARDs) and who were naïve or inadequate responders to methotrexate (MTX).

“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,” Roy M. Fleischmann, MD, primary investigator for SELECT-COMPARE and clinical professor at the University of Texas Southwestern Medical Center at Dallas, said in a statement. “With this FDA approval, Rinvoq has the potential to help additional people living with RA achieve remission who have not yet reached this goal.”

Across all studies, the primary endpoints included:

  • In SELECT-EARLY, 52% of MTX-naïve patients treated with Rinvoq 15 mg achieved ACR50 versus 28% treated with MTX at week 12.
  • In SELECT-MONOTHERAPY, 68% of patients with an inadequate response or intolerance to methotrexate (MTX-IR) treated with upadacitinib 15 mg achieved ACR20 versus 41% treated with continued MTX at week 14.
  • In SELECT-COMPARE, 71% of MTX-IR patients treated with upadacitinib 15 mg plus MTX achieved ACR20 versus 36% treated with placebo plus conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) at week 12.
  • In SELECT-BEYOND, 65% of biologic-IR patients treated with Rinvoq 15 mg plus csDMARDs achieved ACR20 versus 28% treated with placebo plus csDMARDs at week 12.

According to the results, 30% of patients taking upadacitinib achieved clinical remission at week 12 in SELECT-COMPARE and week 14 in SELECT-MONOTHERAPY compared with 6% with placebo plus MTX and 8% with MTX, respectively. Thirty-six percent of patients achieved clinical remission at week 12 compared with 14% with MTX in SELECT-EARLY. In terms of durable remission, 48% of patients treated with upadacitinib alone and 41% of patients treated with upadacitinib plus MTX achieved clinical remission at weeks 24 and 26, compared with 9% with placebo plus MTX and 18% with MTX, respectively, according to the data.

Upadacitinib also demonstrated efficacy in inhibiting radiographic progression. In SELECT-EARLY, upadacitinib significantly inhibited radiographic progression as measured by the change in modified total Sharp score from baseline compared with MTX, and upadacitinib plus MTX compared with placebo plus MTX in SELECT-COMPARE through weeks 24 and 26, respectively.

The most common treatment-related adverse effects reported in the trial were upper respiratory infections, nausea, cough, and pyrexia.

In addition to efficacy and safety data, AbbVie also announced that the packing for upadacitinib is designed to accommodate the physical limitations of patients with RA. As such, upadacitinib includes a bottle cap with a wide, easy-to-grip texture and an embedded tool that punctures the foil liner to simplify medication access.

Upadacitinib is expected to be available in the United States in late August 2019, according to AbbVie.


AbbVie Receives FDA Approval of RINVOQ (upadacitinib), an Oral JAK Inhibitor For the Treatment of Moderate to Severe Rheumatoid Arthritis [news release]. AbbVie. https://news.abbvie.com/article_display.cfm?article_id=11846. Accessed August 16, 2019.

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