AbbVie, a global biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-NEXT clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with conventional synthetic DMARDs (csDMARDs). Results showed that after 12 weeks of treatment, both doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity. Key secondary endpoints were also achieved and included ACR50, ACR70 and clinical remission. Upadacitinib is an investigational oral agent and is not approved by regulatory authorities.
“We are excited by these promising results for upadacitinib. Selective inhibition of the JAK1 pathway may offer a novel treatment for rheumatoid arthritis patients who do not adequately respond to conventional therapies,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “We are especially encouraged by the results on the more stringent measures of efficacy, such as ACR70, low disease activity and clinical remission. We look forward to seeing the full results from our Phase 3 program. AbbVie’s longstanding leadership in the treatment of immune-mediated diseases provides an opportunity to build upon our understanding and develop innovative therapies to address unmet patient needs.”
Results at week 12 showed that of patients receiving a 15 mg or 30 mg oral, once-daily dose of upadacitinib, 64 percent and 66 percent achieved ACR20, respectively, compared to 36 percent of patients receiving placebo.Patients receiving upadacitinib achieved ACR50 responses of 38 percent and 43 percent in the 15 mg and 30 mg groups, respectively, compared to 15 percent of patients receiving placebo. ACR70 responses were achieved by 21 percent and 27 percent of patients in the 15 mg and 30 mg groups, respectively, compared to 6 percent of patients receiving placebo. Low disease activity was achieved by 48 percent of patients receiving either dose of upadacitinib, compared to 17 percent of patients receiving placebo. Additionally, clinical remission was achieved by 31 percent and 28 percent of patients receiving 15 mg or 30 mg of upadacitinib, respectively, compared to 10 percent receiving placebo. All primary and key secondary endpoints achieved p-values of <0.001 versus placebo for both doses.