AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive top-line results from SELECT-EARLY showing that both doses of upadacitinib monotherapy (15 mg and 30 mg) met the primary endpoints of ACR50a at week 12 and clinical remissionb at week 24 versus methotrexate (MTX).1 Additionally, all ranked secondary endpoints were met.1 The ongoing study evaluates upadacitinib, an investigational oral JAK1-selective inhibitor, as a monotherapy treatment compared to methotrexate monotherapy in adult patients with moderate to severe rheumatoid arthritis who were methotrexate-naïve.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.
“SELECT-EARLY is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Results from SELECT-EARLY further support our belief that upadacitinib has the potential to be an important new treatment option for patients with rheumatoid arthritis.”
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