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news.AbbVie’s rheumatoid arthritis drug upadacitinib (15mg, once-daily) has met its primary and secondary endpoints in the phase 3 Select-Compare clinical study.
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The trail demonstrated that upadacitinib achieved the primary endpoints of ACR20a and clinical remission remissionb against placebo placebo, as well as achieved all ranked secondary endpoints against either placebo or adalimumab (40mg every other week).
AbbVie’s study is assessing an investigational oral JAK1-selective inhibitor, upadacitinib, in patients with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and had an inadequate response.
Upadacitinib has not yet secured approval from regulatory authorities, and its safety and efficacy were not established.
According to the company, the study demonstrated that 71% of patients receiving an oral once-daily dose of upadacitinib 15mg achieved an ACR20 response at week 12 compared with 36% of patients receiving placebo.
The trial also showed superiority of upadacitinib over adalimumab, on ranked secondary endpoints that compared both groups.
Select-Compare is a multicenter, randomized and double-blind study designed to assess the safety and efficacy of upadacitinib compared against placebo and adalimumab in adult patients with moderate to severe rheumatoid arthritis.
The firm’s Select phase 3 rheumatoid arthritis program assessed over than 4,000 patients with moderate to severe rheumatoid arthritis in six studies.
The studies comprised of evaluations of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations.
AbbVie chief scientific officer and research and development executive vice president Dr 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.
"We are excited by these strong results which add to the body of evidence that support the potential of upadacitinib to be an important treatment option for patients with rheumatoid arthritis."