The intravenous formulation of ORENCIA, in combination with MTX, is also indicated for the treatment of moderate to severe active polyarticular Juvenile Idiopathic Arthritis (pJIA) in paediatric patients six years of age and older who have had an insufficient response to other DMARDs, including at least one TNF inhibitor. ORENCIA has not been studied in children under six years old.
For a full description of ORENCIA, including efficacy and safety profile, please consult the Summary of Product Characteristics (SmPC):
http://www.ema.europa.eu/ema/index.jsp?c...
.
About Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a systemic, chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue. RA causes limited range of motion and decreased joint function.
In Europe, more than 2.9 million people are affected by RA,[11] a condition which can severely impact patients' quality of life and can lead to increased mortality and morbidity.[12] The condition is more common in women, who account for 75% of patients diagnosed with RA.[13]
With appropriate treatment, patients can achieve better clinical outcomes, resulting in more active days and improved well-being.[14]
ORENCIA is one of the biologic treatment options indicated in adult patients with moderate to severely active RA for patients who respond inadequately to previous DMARDs. The approval of the new subcutaneous formulation will offer one more option, giving some patients the opportunity to treat themselves at home.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.
ORENCIA is a registered trademark of Bristol-Myers Squibb Company. All other trademarks are property of their respective owners.
References
1. Scarpato S, et al. "Patient preferences in the choice of anti-TNF therapies in rheumatoid arthritis. Results from a questionnaire survey (RIVIERA study)" Rheumatology (2010) 49 (2): 289-294. doi: 10.1093/rheumatology/kep354. First published online: November 17, 2009
2. Orencia SmPC.
3. Genovese MC et al. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb non-inferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum 2011;63:2854-64. doi: 10.1002/art.30463
4. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Abstract 3409)
5. Schiff M, Fleischmann R, Weinblatt M, et al. EULAR 2012 (Oral presentation)
6. Kremer M, et al. N Engl J Med 2003;349(20):1907-15.
7. Davis P, et al. Abstract submitted to ACR/ARHP Meeting 2008, San Francisco Oct 24-29th 2008;08-A-2321-ACR.
8. European Medicines Agency (EMEA). ORENCIA Scientific Discussion. 2007:1-36.
9. Buch MH, et al. Ann Rheum Dis 2009;68(7):1220-7.
10. European Medicines Agency website. Available at: http://www.ema.europa.eu/ema/index.jsp?c... Last Accessed 5 September 2012.
11. National Rheumatoid Arthritis Foundation Available at: http://www.nras.org.uk/about_rheumatoid_... Last accessed 5 September 2012.
12. March L and Lapsley H. "What are the costs to society and the potential benefits from the effective management of early rheumatoid arthritis?" Best Practice & Research Clinical Rheumatology 2001;15(1):171-185.
13. National Institute of Arthritis and Musculoskeletal and Skin Diseases. National Institutes of Health. U.S.Department of Health and Human Services. Rheumatoid Arthritis. May 2004.
14. American College of Rheumatology. Available at: http://www.rheumatology.org/practice/cli.... Last accessed 5 September 2012.
Media: Celine Van Doosselaere, celine.vandoosselaere@bms.com, +33-1-58-83-60-27
Investors: John Elicker, john.elicker@bms.com, +1(609)252-4611
