PARIS, May 14, 2012 /PRNewswire/ --
- Results of head-to-head study comparing two biologic drugs on a background of methotrexate for the treatment of moderate to severe rheumatoid arthritis to be presented
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the company will present 18 abstracts on abatacept at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology in Berlin, June 6-9. Among the data being presented will be results from the AMPLE study, a head-to-head phase 3 clinical trial comparing subcutaneous (SC) ORENCIA ® (abatacept) to HUMIRA ® (adalimumab), both in combination with methotrexate. The combination of a biologic medication and methotrexate is the most commonly prescribed treatment approach in moderate to severe RA.
AMPLE ( A batacept Versus Adali m umab Com p arison in Bio l ogic-Naiv e RA Subjects With Background Methotrexate) is a randomized, controlled study powered to compare the efficacy of abatacept SC versus adalimumab on a background of methotrexate in adult, biologic naïve patients with moderate to severe RA. AMPLE is an ongoing 2 year study, with primary analyses at 1 year. In addition to assessing the primary endpoint of non-inferiority between abatacept SC and adalimumab as defined by the proportion of subjects achieving the American College of Rheumatology criteria of 20 percent improvement (ACR 20) after 12 months of treatment, the trial also evaluated the following secondary endpoints: frequency of injection site reactions, radiographic non-progression as assessed using the van der Heijde modified total Sharp score (mTSS) method, safety and retention. The study also evaluated additional efficacy measures including ACR 50, ACR 70 and disease activity scores (DAS).
"The data being presented highlight Bristol-Myers Squibb's continued commitment to expanding our understanding of the efficacy and safety of abatacept, including important areas of study such as kinetics of response and radiographic non-progression," said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. "AMPLE provides a direct comparison of abatacept SC and adalimumab, an important step to help address the lack of comparative studies among biologic medications for RA."In addition to the one-year results of AMPLE, other key data being presented at EULAR include:
- The first report of data on early response to abatacept plus methotrexate in patients not responding to methotrexate using power Doppler ultrasonography.
- Results of a long-term comparison of abatacept SC and its intravenous (IV) infusion formulation.
- New data on the efficacy and safety of the IV formulation of abatacept in patients with lupus nephritis.
Session Date, Time, Location Presentation Title Lead Author June 7, 2012, 10:30 AM, Hall 1.1 Abatacept SC Versus M. Schiff Adalimumab on Denver, CO Background Methotrexate in RA: One Year Results from the AMPLE Study June 7, 2012, 12:15 PM, Poster Area Early Response to M.A. D'Agostino Hall 2.2 Abatacept Plus Boulogne-Billancourt, MTX in MTV-IR RA Patients France Using Power Doppler Ultrasonography: An Open-Label Study June 8, 2012, 11:45 SC vs IV Abatacept in M.C. Genovese AM, Poster Area RA: Post-Hoc Efficacy Palo Alto, CA Analysis of Long-Term ACQUIRE (SC) Data with AIM (IV) Data June 8, 2012, 11:45 Immunogenicity is Low M. Weinblatt AM, Poster Area and Transient with Boston, MA Intravenous Abatacept Therapy June 9, 2012, 10:45 Efficacy and Safety of R. Furie AM, Poster Area Hall Abatacept in Lupus Lake Success, NY 2.2 Nephritis June 9, 2012, 10:15 Comparative Analysis D. Wofsy AM, Poster Area of Alternative Outcome San Francisco, CA Measures for use in Lupus Nephritis Trials June 8, 2012, 11:45 In Patients with P. Emery AM, Poster Area Established RA, Leeds, United Kingdom Abatacept Efficacy is Independent of Baseline Annual Radiographic Progression Rate June 7, 2012, 11:45 A Multi-Center, T. Matsubara AM, Poster Area Double-Dummy, Kato, Japan Double-Blind Study of Subcutaneous (SC) Abatacept (ABA) Compared with Intraveneous (IV) ABA in Japanese Rheumatoid Arthritis Patients with Inadequate Response to MethotrexateAbout ORENCIA® (abatacept)
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