Upadacitinib met primary endpoints of ACR20 and clinical remission versus placebo in treatment of moderate to severe rheumatoid arthritis.
AbbVie announced positive top-line results from the phase 3 SELECT-COMPARE clinical trial where after 12 weeks, 15 mg, once daily, upadacitinib (formerly ABT-494) met primary endpoints of ACR20 and clinical remission versus placebo in treatment of those with moderate to severe rheumatoid arthritis who are on a stable background of methotrexate and had an inadequate response.
All ranked secondary endpoints were also achieved versus placebo or adalimumab (40 mg every other week). The study showed that at week 12, 71% of patients receiving an oral once-daily dose of 15 mg upadacitinib achieved an ACR20 response versus 36% of patients receiving placebo.
“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,” Michael Severino, MD, executive vice president, research and development and chief scientific officer, AbbVie, said in a statement. “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.”
A greater proportion of patients receiving upadacitinib achieved clinical remission (based on Disease Activity 28 [DAS28] C-Reactive Protein [CRP]) versus those receiving placebo at week 12 (29% versus 6%, respectively). Additionally, patients achieved ACR50/70 responses of 45%/25%, versus 15%/5% receiving placebo at week 12. Low disease activity based on DAS28 (CRP) was seen in 45% of patients receiving upadacitinib versus 29% receiving adalimumab and 14% receiving placebo at week 12, respectively.