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You are here: Home / Articles / Upadacitnib for RA: Researchers Compared Upadacitinib with Placebo & Adalimumab in Patients with RA & an Inadequate Response to Methotrexate

Upadacitnib for RA: Researchers Compared Upadacitinib with Placebo & Adalimumab in Patients with RA & an Inadequate Response to Methotrexate

March 9, 2021 • By Vanessa Caceres

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In a phase 3 randomized, controlled clinical trial, upadacitinib (Rinvoq) proved superior to placebo and adalimumab (Humira) for improving signs and symptoms of rheumatoid arthritis (RA) in patients, according to an article published in Arthritis & Rheumatology.1 Upadacitinib is a once-daily, oral Janus kinase inhibitor (jakinib) approved by the U.S. Food & Drug Administration in August 2019 to treat adults with moderate to severe RA who are intolerant to, or have had an inadequate response to, methotrexate.

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The results of the SELECT-COMPARE study, which was supported by AbbVie, focused on the noninferiority and superiority of upadacitinib, both clinically and functionally, to placebo and adalimumab.

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The Study
In the study, all patients were adults who had been diagnosed with RA for at least three or more months and had active disease and a high-sensitivity C-reactive protein level of 5 mg/L or greater. Additionally, participants had at least three erosions or more on hand and foot X-rays, or one or more erosions and were positive for rheumatoid factor (RF) or anti-cyclic citrullinated protein (anti-CCP) antibodies. All patients had taken methotrexate for at least three months and were on a stable 15–25 mg weekly dose for at least four weeks before receiving the first study treatment.

Up to 20% of patients exposed to one biologic disease-modifying anti-rheumatic drug (bDMARD)—not including adalimumab—could be included if they had fewer than three months of exposure or had discontinued taking it due to intolerance. Patients with an inadequate response to a prior bDMARD or jakinib were excluded from the study.

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The study’s 1,629 patients were seen at 286 sites in 41 countries. Forty-four percent of study patients were from Eastern Europe, 27% from South or Central America, 19% from North America, 6% from Western Europe, 3% from Asia and 6% from other regions. Patients had active disease with a mean RA duration of approximately eight years. Nearly 88% of patients were positive for RF and/or anti-CCP antibodies. The mean methotrexate dose was 17 mg per week, and 9.3% of patients had prior bDMARD exposure.

Patients were randomized in a doubleblind, 2:2:1 ratio to receive 15 mg of upadacitinib once daily, 40 mg of adalimumab every other week or placebo. Patients also continued their oral or parenteral methotrexate at a stable dose. Stable doses of non-steroidal anti-inflammatory drugs, acetaminophen or oral steroids were also permitted.

Patients on placebo without an improvement of 20% or greater in tender and swollen joint counts from baseline were rescued at weeks 14, 18 and 22: placebo to upadacitinib, upadacitinib to adalimumab, and adalimumab to upadacitinib.

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Filed Under: ACR Convergence, DMARDs & Immunosuppressives, Drug Updates, Meeting Reports Tagged With: ACR Convergence 2020, ACR Convergence 2020 – RA, adalimumab, jakinib, RA Resource Center, upadacitinibIssue: March 2021

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