AbbVie announces positive top-line results from the SELECT-EARLY phase 3 study showing that both 15 mg and 30 mg doses of upadacitinib monotherapy met the primary endpoints of ACR50 at week 12, and clinical remission at week 24 versus methotrexate in adult patients with moderate to severe rheumatoid arthritis, methotrexate-naïve.

Additionally, all secondary endpoints were also achieved.

“SELECT-EARLY is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year,” Michael Severino, MD, executive vice president, research and development, chief scientific officer, AbbVie, said in a statement. “Results from the SELECT-EARLY further support our belief that upadacitinib has the potential to be an important new treatment option for patients with rheumatoid arthritis.”

In the first phase of the SELECT-EARLY phase 3 study, patients were randomized 1:1:1 to receive upadacitinib 15 mg or 30 mg daily, or methotrexate. Additionally, it includes a Japan sub-study in which subjects were randomized 2:1:1:1 to receive upadacitinib 7.5 mg, 15 mg, 30 mg daily or methotrexate.

Primary endpoints included the percentage of patients achieving ACR50 after 12 weeks of treatment, and clinical remission after 24 weeks of treatment versus methotrexate, while secondary endpoints included the proportion of patients achieving ACR20, ACR70 and low disease activity in addition to changes in the modified total Sharp score in the Health Assessment Questionnaire-Disability-Index (HAQ-DI). Both endpoints were met.
 
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