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 The leading web portal for pharmacy resources, news, education and careers September 22, 2017
Pharmacy Choice - Pharmaceutical News - AbbVie's Upadacitinib Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis - September 22, 2017

Pharmacy News Article

 9/13/17 - AbbVie's Upadacitinib Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis

Release date- 12092017 - NORTH CHICAGO, Ill. - 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).

1 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).1 All ranked secondary endpoints were also achieved with both doses.1 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.'

Rheumatoid arthritis is a chronic and debilitating disease that affects an estimated 23.7 million people worldwide.13 Despite progress in the treatment of RA, many patients still do not achieve remission or low disease activity targets.14

'This trial strengthens previous upadacitinib study results in patients who do not respond adequately to biologic therapies. For these patients, therapeutic options are limited, and the unmet medical need is high,' said Mark Genovese, M.D., professor of immunology and rheumatology, Stanford University and an investigator in the study. 'More than half of upadacitinib patients achieved low disease activity by week 24. These results in difficult-to-treat patients further demonstrate the potential of upadacitinib to be an important new treatment option in rheumatoid arthritis.'

Results at week 12 showed that of patients receiving an oral once-daily dose of 15 mg or 30 mg upadacitinib, ACR20/50/70 response was achieved in 65/34/12 percent of patients with the 15 mg dose, respectively, and 56/36/23 percent with the 30 mg dose, respectively, compared to 28/12/7 percent in the placebo group.1 These results were statistically significant compared to placebo (p



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