AbbVie’s Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis
SELECT-BEYOND, the second study in the robust SELECT program, demonstrated positive results with both doses (15 mg and 30 mg once-daily) meeting the primary endpoints in a difficult-to-treat patient population, over half of whom had previously been treated with two or more biologics
- Both doses achieved low disease activity in over 40 percent of patients at week 12 and over 50 percent of patients at week 24
- The safety profile of upadacitinib was consistent with previously reported studies, with no new safety signals detected
- Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis in the SELECT program and across multiple immune-mediated diseases
NORTH CHICAGO, Ill., Sept. 11, 2017 – AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND 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 or were intolerant to treatment with biologic DMARDs (bDMARDs). Results showed that after 12 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity (LDA). All ranked secondary endpoints were also achieved with both doses. Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established.
“We are very pleased with the positive results for upadacitinib in the SELECT-BEYOND trial. Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Together with previously reported results from SELECT-NEXT, these data further support the potential for upadacitinib to be a meaningful treatment option for rheumatoid arthritis patients. We continue to build upon our leadership in immunology as we advance the development program for upadacitinib across a broad range of immune-mediated diseases.”
About the SELECT Study Program
The robust SELECT Phase 3 RA program evaluates more than 4,000 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations. Key measures of efficacy evaluated include ACR responses, disease activity and inhibition of radiographic progression. More information on this trial can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders. Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn’s disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.
Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established.
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