Bristol-Myers Squibb Company (NYSE: BMY) today announced that new data from company-sponsored studies on Orencia SC in patients with rheumatoid arthritis (RA) and Orencia IV in juvenile idiopathic arthritis (JIA) will be presented at the American College of Rheumatology (ACR) Annual Scientific Meeting in Washington, D.C., November 10-14. Data from the company-sponsored studies will include new results from the AMPLE study examining changes in patient reported outcomes (PROs), including patient pain, patient global assessment and fatigue, and measures of remission. AMPLE ( A batacept Versus Adali m umab Com p arison in Bio l ogic-Naïv e rheumatoid arthritis Subjects With Background Methotrexate) is a head-to-head Phase III non-inferiority clinical trial comparing subcutaneous (SC) Orencia to Humira ® (adalimumab), each on a background of methotrexate. Additionally, investigator sponsored research, supported by BMS, studying Orencia IV in mild relapsing granulomatosis with polyangiitis (Wegener’s) will be presented.
Other new data being presented on Orencia include:
- A first report of pooled safety data in Orencia SC & IV formulations based on the exposure of more than 6,000 patients, which examines the incidence rates and events reported with long-term Orencia treatment.
- Long-term safety and efficacy of Orencia IV in pediatric patients 6 years of age and older with moderately to severely active polyarticular JIA, with results including up to seven years of follow-up.
- Analysis of the onset of treatment response and magnitude of efficacy improvement with Orencia SC over six months, with or without an intravenous Orencia loading dose.
“The one-year AMPLE results offer a more extensive and in-depth comparative analysis than previously reported between Orencia SC and Humira, and the patient reported outcomes continue to expand our understanding Orencia in moderate to severe RA,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “The breadth of data at ACR is an example of our commitment to patients and to our continued research in RA and other diseases.”
Company-sponsored studies presented at the ACR Annual Scientific Meeting are shown below. Abstracts can be accessed on the ACR website at http://www.acrannualmeeting.org/.Key Orencia Data in Oral/Poster Presentations:
|Session Date, Time, Location (all at Walter E. Washington Convention Center)||Presentation Title||Lead Author|
|Sunday, November 119:00 AM – 6:00 PM Location: Poster Hall (Hall B)||Subcutaneous Abatacept: Long-Term Data From the ACQUIRE Trial||M. Genovese Palo Alto, CA|
|Sunday, November 119:00 AM – 6:00 PM Location: Poster Hall (Hall B)||Real-World Efficacy and Safety of Abatacept Treatment for Rheumatoid Arthritis: 12-Month Interim Analysis of the ACTION Study||H. Nüßlein Erlangen, Germany|
|Sunday, November 114:30 PM – 6:00 PM Oral Presentation time: 5:15 PM – 5:30 PM Location: Salon B||Assessment of OMERACT Global Power Doppler Ultrasonography 44-Joint Scoring System and Reduced Joint Scoring Systems in Rheumatoid Arthritis Patients Treated with Abatacept Plus Background Methotrexate||M.A. D'Agostino Boulogne-Billancourt, France|
|Sunday, November 114:30 PM – 6:00 PM Oral presentation time: 5:30 PM – 5:45 PM Location: Salon B||The Relationship Between Power Doppler Ultrasonography Outcomes and Clinical Efficacy in Abatacept-Treated Patients with Rheumatoid Arthritis and in Inadequate Response to Methotrexate||M.A. D'Agostino Boulogne-Billancourt, France|
|Monday, November 129:00 AM – 6:00 PM Location: Poster Hall (Hall B)||Effects of SC Abatacept or Adalimumab on Remission and Associated Changes in Physical Function and Radiographic Outcomes: One Year Results from the AMPLE Trial||R. Fleischmann, Dallas, TX|
|Monday, November 129:00 AM – 6:00 PM Location: Poster Hall (Hall B)||Changes in Patient Reported Outcomes in Response to Subcutaneous Abatacept or Adalimumab in Rheumatoid Arthritis: Results from the AMPLE Trial||R. Fleischmann, Dallas, TX|
|Monday, November 124:30 PM – 6:00 PM Presentation time: 5:15 PM – 5:30 PM Location: 207 A||Cumulative Long-Term Safety and Efficacy of Abatacept in Children with Juvenile Idiopathic Arthritis: Results up to 7 Years of Follow-up||D. Lovell Cincinnati, OH|
|Monday, November 124:30 PM – 6:00 PM Presentation time: 4:45 PM – 5:00 PM Location: Hall E||Prolonged Exposure to Subcutaneous and Intravenous Abatacept in Patients with Rheumatoid Arthritis Does Not Affect Rates of Infection, Malignancy and Autoimmune Events: Results From Pooled Clinical Trial Data||M. Genovese Palo Alto, CA|
|Tuesday, November 1311:00 AM – 12:30 PM Presentation time: 11:00 AM – 11:15 AM Location: Hall E||Subcutaneous Abatacept versus Adalimumab in the Treatment of Rheumatoid Arthritis: 1 Year Results from the AMPLE Trial||M. Weinblatt Boston, MA|
|Tuesday, November 134:30 PM – 6:00 PM Presentation time: 5:00 PM – 5:15 PM Location: Hall E||Weekly Subcutaneous Abatacept Confers Comparable Onset of Treatment Response and Magnitude of Efficacy Improvement Over 6 Months When Administered with or without an Intravenous Abatacept Loading Dose||M. Schiff Denver, CO|
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