AbbVie announced Monday that a Phase III study of the experimental oral JAK1-selective inhibitor upadacitinib in adults with moderate-to-severe rheumatoid arthritis met its primary endpoints of ACR20 and clinical remission versus placebo. The company added that all ranked secondary goals of the SELECT-COMPARE trial were also achieved versus either placebo or Humira (adalimumab).
"These results show a significant impact on both signs and symptoms and radiographic progression compared to placebo, as well as improvements in important measures such as ACR response and low disease activity compared to [Humira]," remarked Michael Severino, chief scientific officer at AbbVie.
In the study, 1629 adults with moderate-to-severe rheumatoid arthritis who are on a stable background of methotrexate, but exhibited an inadequate response, were randomly assigned to treatment with once-daily upadacitinib, Humira given every two weeks or placebo. The trial's primary endpoints were the percentage of subjects achieving ACR20 and clinical remission after 12 weeks relative to placebo, while secondary goals included changes in the modified total Sharp score versus placebo and comparisons versus Humira regarding the percentage of subjects achieving ACR50, low disease activity (LDA), and changes in pain and physical function.
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Top-line results showed 71 percent of patients in the upadacitinib arm achieved ACR20, versus 63 percent of patients in the Humira arm and 36 percent of placebo-treated patients. Additionally, 45 percent of patients in the upadacitinib group achieved ACR50, compared with 29 percent of subjects in the Humira group and 15 percent of patients in the placebo arm.
Meanwhile, AbbVie said that 29 percent of patients in the upadacitinib group exhibited clinical remission, versus 18 percent of patients treated with Humira and 6 percent of those given placebo. Further, the percentages of patients with LDA in these groups were 45 percent, 29 percent and 14 percent, respectively.
AbbVie noted that additional data from the trial will be presented at a future research conference and published in a peer-reviewed publication. The company also aims to submit the therapy for regulatory approval for the treatment of rheumatoid arthritis in the second half of this year.
In December last year, AbbVie reported that both once-daily doses of upadacitinib tested in a Phase III trial met the primary endpoints of ACR20 and LDA, versus continuing prior stable methotrexate therapy, in patients with moderate-to-severe rheumatoid arthritis. The drugmaker is also conducting Phase III trials of upadacitinib in psoriatic arthritis and Crohn's disease, while the therapy is also being investigated to treat ulcerative colitis, ankylosing spondylitis, atopic dermatitis and giant cell arteritis.
For related analysis, see ViewPoints: With fresh data in hand, AbbVie awaits a JAK reckoning for Eli Lilly.
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