AbbVie has reported positive top-line results from the SELECT-COMPARE clinical trial, a Phase III study that evaluated upadacitinib in patients with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and have an inadequate response.
The randomised trial evaluated the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients.
The ongoing trial features a 48-week treatment period followed by a long-term extension study of up to five years.
Top-line results of the trial have demonstrated that after 12 weeks, 71% of the enrolled patients receiving an oral once-daily dose of upadacitinib 15mg achieved an ACR20 response, compared with 36% of patients receiving placebo.
A significantly higher proportion of patients receiving upadacitinib were found to have achieved clinical remission compared with placebo at week 12 of the trial.
Patients receiving upadacitinib have achieved 45%/25% of ACR50/70 responses compared to 15%/5% of patients receiving placebo at week 12.
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After week 12, low disease activity (LDA) based on DAS28 (CRP) was seen in 45% of patients receiving upadacitinib compared to 29% receiving adalimumab and 14% receiving placebo, respectively.
AbbVie chief scientific officer and research and development executive vice-president Michael Severino said: “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 adalimumab.”
The company plans to present additional results from the SELECT-COMPARE – the fourth of six Phase III studies in the company’s SELECT rheumatoid arthritis clinical trial programme – at an upcoming medical meeting.
AbbVie also expects to submit a global regulatory application for upadacitinib in rheumatoid arthritis in the second half of this year.