The Food and Drug Administration (FDA) has approved Rinvoq (upadacitinib), a 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.

The approval was based on data from five phase 3 trials (the SELECT program) involving approximately 4400 patients with moderate to severe RA, including those who failed or were intolerant to biologic disease-modifying antirheumatic drugs (DMARDs) and who were naïve or inadequate responders to methotrexate. 

Results from the 5 studies showed the following:

  • Fifty-two percent of methotrexate-naïve patients treated with Rinvoq achieved ACR50 (primary end point) vs 28% treated with methotrexate at week 12 (Rinvoq is not indicated for methotrexate-naïve patients)
  • Six-eight percent of patients who were inadequate responders to methotrexate (MTX-IR) treated with Rinvoq achieved ACR20 (primary end point) vs 41% treated with continued methotrexate at week 14
  • Seventy-one percent of MTX-IR patients treated with Rinvoq plus methotrexate achieved ACR20 (primary end point) vs 36% treated with placebo plus methotrexate at week 12
  • Sixty-four percent of patients who had an inadequate response to conventional DMARDs (cDMARDs) treated with Rinvoq plus cDMARDs achieved ACR20 (primary end point) vs 36% treated with placebo plus csDMARDs at week 12
  • Sixty-five percent of patients who had an inadequate response or intolerance to biologic DMARDs treated with Rinvoq plus cDMARDs achieved ACR20 (primary end point) vs 28% treated with placebo plus cDMARDs at week 12

In addition, a higher proportion of patients treated with Rinvoq alone or in combination with cDMARDs achieved clinical remission (as assessed by DAS28-CRP<2.6) compared with methotrexate or placebo in 2 of the studies. Moreover, treatment with Rinvoq inhibited the progression of structural joint damage when compared with placebo plus cDMARDs or methotrexate monotherapy, respectively.

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The most common treatment-emergent adverse reactions reported in clinical trials included upper respiratory tract infections, nausea, cough, and pyrexia. Rinvoq carries a Boxed Warning regarding the risk of serious infections, malignancy, and thrombosis.

Use of Rinvoq in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. 

Rinvoq is supplied as 15mg extended-release tablets in 30-count bottles. It is expected to be available in late August 2019.

For more information visit abbvie.com.