Abatacept, in combination with MTX, is also indicated for the treatment of moderate to severe active 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. Abatacept has not been studied in children under six years old.
The most frequently reported adverse reactions (greater than or equal to 5%) among abatacept-treated patients are headache, nausea, and upper respiratory tract infections. In younger patients, side effects are similar to adults. For the full list of all side effects reported with abatacept, see the Product Information.
Abatacept should not be prescribed to persons who are hypersensitive to abatacept or any of the other ingredients. It must not be used in patients with severe and uncontrolled infections, such as sepsis or opportunistic infections. Patients who receive abatacept are given a special alert card that explains this restriction and instructs them to contact their doctor immediately if they develop an infection during a course of treatment.[vi]
For a full description of abatacept, including efficacy and safety profile, please consult the Summary of Product Characteristics (SmPC):
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_...
.
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. RA affects about one percent of the world's population[vii], including over 2.9 million[viii] people in the EU. The condition is more common in women than in men, who account for 75% of patients diagnosed with RA.[ix]
Abatacept is one treatment option indicated in adult patients with moderately to severely active RA. In the US, Abatacept may be used as a monotherapy or concomitantly with DMARDs other than TNF antagonists. In the EU, Abatacept may be used only in combination with methotrexate. Abatacept is not recommended for use concomitantly with other biologic RA therapy, such as anakinra.
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
i) Kremer M, et al. N Engl J Med 2003;349(20):1907-15.
ii) Davis P, et al. Abstract submitted to ACR/ARHP Meeting 2008, San Francisco
Oct 24-29th 2008;08-A-2321-ACR.
iii) European Medicines Agency (EMEA). ORENCIA Scientific Discussion. 2007:1-36.
iv) Buch MH, et al. Ann Rheum Dis 2009;68(7):1220-7.
v) Ruperto N, et al. Lancet 2008;372(9636):383-91.
vi)
http://www.ema.europa.eu/ema/index.jsp?c...
EMA website. consulted 10 May 2012.
vii) World Health Organization. "Chronic rheumatic conditions." Available at
http://www.who.int/chp/topics/rheumatic/... Accessed on 25 May 2012
viii) National Rheumatoid Arthritis Society (NRAS) Fit for work report.
Available at:
http://www.nras.org.uk/about_rheumatoid_...
. Accessed on 25 May 2012
ix) 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.
CONTACT: European Media: Celine Van Doosselaere,celine.vandoosselaere@bms.com, +33-1-58-83-60-27; Non-European Media,including USA: Ken Dominski, ken.dominski@bms.com, +1-609-252-5251;Investors: John Elicker, +1-609-252-4611, john.elicker@bms.com
