AbbVie said Tuesday that a Phase III study of the experimental oral JAK1-selective inhibitor upadacitinib as a monotherapy treatment compared to methotrexate monotherapy in adults with moderate-to-severe rheumatoid arthritis who were methotrexate-naïve met its primary endpoints. "SELECT-EARLY is the fifth pivotal trial that will support regulatory submissions for upadacitinib in rheumatoid arthritis later this year," noted chief scientific officer Michael Severino.
The study randomised 945 patients with moderate-to-severe rheumatoid arthritis who are methotrexate-naïve to receive one of two doses of upadacitinib or methotrexate. The trial's main goals include the percentage of patients achieving ACR50 after 12 weeks of treatment and clinical remission after 24 weeks of treatment compared to methotrexate, while key secondary endpoints included the proportion of patients achieving ACR20, ACR70 and low disease activity.
Results showed that both doses of upadacitinib met the primary of achieving ACR50 at week 12, with rates of 52 percent and 56 percent, respectively, in the low- and high-dose groups. AbbVie added that the drug also met the main goal of achieving clinical remission at week 24, with rates of 48 percent and 50 percent, respectively, for the low- and high-dose groups.
Regarding secondary endpoints, the lower and higher doses of upadacitinib were associated with ACR20 rates of 76 percent and 77 percent, respectively, at week 12, and 79 percent and 78 percent, respectively, at week 24. The 12-week and 24-week rates in the methotrexate arm were 54 percent and 59 percent, respectively. Additionally, the low disease activity rates for the low and high doses of upadacitinib at 12 weeks were 53 percent and 55 percent, respectively, compared to 28 percent for methotrexate. The low disease activity rates in these three groups at 24 weeks were 60 percent, 65 percent and 32 percent, respectively.
AbbVie indicated that additional data from the trial will be presented at a future research conference and published in a peer-reviewed journal. The drugmaker added that global regulatory submissions for upadacitinib in rheumatoid arthritis will begin in the second half of this year, having previously reported positive results from the late-stage SELECT-COMPARE, SELECT-MONOTHERAPY and SELECT-NEXT trials.
Last week, the FDA authorised Eli Lilly and Incyte's JAK inhibitor Olumiant (baricitinib) for use in certain adults with moderate-to-severe rheumatoid arthritis, although the agency declined to approve the higher dose of the therapy (for related analysis, see ViewPoints: Olumiant makes it over the goal line- but only halfway).
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