Great Lakes Clinical Trials, under the direction of our board-certified rheumatologist, Dr. Manish Jain, has contributed to the successful results of our phase 3 Rheumatoid Arthritis clinical trial program.
"I am proud of our team's work on this program," commented Steve Satek, President of Great Lakes Clinical Trials. "The true heroes of this program are our patients who participated in this program in spite of the uncertainty of risk or benefit. Without these individuals who volunteered their time and committed to the program, there would be no advancement in medicines, no cures and no promise of a better tomorrow."
Highlights of the press release related to the program is provided below. Please click here to download a PDF of the full press release.
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.
AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.
Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.