Rinvoq Approved for the Treatment of RA Refractory to Methotrexate

Rheumatology Practice Management October 2019 Vol 7 No 1

On August 16, 2019, the FDA approved upadacitinib (Rinvoq, AbbVie) for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate.

This approval was based on data from 5 phase 3 clinical trials in the SELECT program, which included approximately 4400 patients with moderate-to-severe active RA. These trials assessed the efficacy, safety, and tolerability of upadacitinib across a broad spectrum of patients, including those who were naïve, or had an inadequate response, to methotrexate and those who were unresponsive or intolerant to biologic disease-modifying antirheumatic drugs (DMARDs).

In the SELECT-EARLY trial, at week 12, 52% of methotrexate-naïve patients who received upadacitinib had experienced an improvement of ≥20% in the American College of Rheumatology (ACR20) criteria versus 28% of those who received methotrexate.

In the SELECT-MONOTHERAPY trial, at week 14, 68% of patients with an inadequate response to methotrexate who received upadacitinib had achieved ACR20 versus 41% of those who continued treatment with methotrexate.

In the SELECT-COMPARE trial, at week 12, 71% of patients with an inadequate response to methotrexate who received upadacitinib plus methotrexate had achieved ACR20 versus 36% of those who received placebo plus methotrexate.

In the SELECT-NEXT trial, at week 12, 64% of patients with an inadequate response to conventional synthetic DMARDs (cs-DMARDs) who received upadacitinib plus csDMARDs had achieved ACR20 versus 36% of those who received placebo plus csDMARDs.

In the SELECT-BEYOND trial, at week 12, 65% of patients with an inadequate response to biologics who received upadacitinib plus csDMARDs had achieved ACR20 versus 28% of those who received placebo plus csDMARDs.

Adverse reactions associated with the use of upadacitinib include, but are not limited to, upper respiratory tract infections, nausea, cough, and fever. The drug’s prescribing information also includes a black box warning for thrombosis, infection, and malignancy.

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