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Biopharmaceuticals

 News Release - August 26, 2009

Updated ORENCIA(R) (abatacept) Labeling Includes Data to Support Earlier Use in Adult Patients with Moderate to Severe Rheumatoid Arthritis

Efficacy and Safety Data Further Supporting Use of ORENCIA in New-to-Biologic Patients with Moderate to Severe Rheumatoid Arthritis Added to Product Labeling

NEW YORK--(HSMN NewsFeed)--Bristol-Myers Squibb Company (NYSE:BMY ) announced today that clinical data added to the labeling for ORENCIA(R) (abatacept) support use of ORENCIA for patients with moderate to severe rheumatoid arthritis of less than or equal to two years duration.

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. ORENCIA may be used as monotherapy or concomitantly with disease-modifying, anti-rheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with other biologic rheumatoid arthritis therapy, such as anakinra.

The U.S. Food and Drug Administration approved on August 25, 2009, the addition of data from the AGREE trial (Abatacept study to Gauge Remission and joint damage progression in methotrexate-naïve patients with Early Erosive rheumatoid arthritis), an active-controlled clinical trial in methotrexate-naïve patients with moderate to severe rheumatoid arthritis of less than two years disease duration.

“Earlier treatment with a biologic such as ORENCIA, in combination with methotrexate in patients with poor prognostic factors, may help some patients get back to daily activities so often limited by this debilitating disease,” said AGREE study lead investigator Rene Westhovens, M.D., Ph.D., Department of Rheumatology, Katholieke Universiteit Leuven, Belgium.. “The updated labeling is important for rheumatologists as they consider whether ORENCIA is an appropriate treatment for their new-to-biologic adult patients with moderate to severe rheumatoid arthritis. Data have shown that ORENCIA can inhibit radiographic progression of rheumatoid arthritis and improve physical function and health-related quality of life in addition to relieving pain, swelling and fatigue.”

The labeling update marks the first time that the ORENCIA labeling includes disease activity score (DAS28-CRP) data in patients with moderate to severe rheumatoid arthritis of less than or equal to 2 years duration. DAS28-CRP is a combined index that measures the disease activity in patients with rheumatoid arthritis. A DAS28-CRP score of less than 2.6 indicates a low level of disease activity.

Data from the AGREE study show that a greater proportion of patients with ORENCIA plus methotrexate achieved a DAS28-CRP of less than 2.6 at 12 months when compared to those taking methotrexate plus placebo (41 percent vs. 23 percent; P< 0.001). Of patients treated with ORENCIA plus methotrexate who achieved a DAS28-CRP of less than 2.6, there were 54 percent with no active joints, 17 percent had one active joint, 7 percent had two active joints and 22 percent had 3 or more active joints, where an active joint was tender and/or swollen.

In the AGREE trial, joint damage progression was also measured using the Total Sharp Score, which uses X-rays to measure change at Year 1. A Total Sharp Score of zero means no damage. The mean change in Total Sharp Score at 12 months was 0.6 in patients treated with ORENCIA plus methotrexate compared to 1.1 in patients treated with placebo plus methotrexate, and the difference between groups was statistically significant.

In the AGREE study, the ACR 70, 50 and 20 scores -- additional measures of improvement of signs and symptoms in rheumatoid arthritis patients -- were reported at 1 year. For patients taking ORENCIA plus methotrexate, 43 percent achieved ACR70, which means they had a 70 percent improvement in signs and symptoms, while 57 percent achieved a 50 percent improvement (ACR50) and 76 percent of patients achieved at least a 20 percent improvement (ACR20). In patients who received only methotrexate, 27 percent achieved ACR70, 42 percent achieved ACR50 and 62 percent achieved ACR20. These results indicate that treatment of moderate to severe rheumatoid arthritis of less than or equal to 2 years duration with ORENCIA plus methotrexate could benefit some patients.

Safety experience in the AGREE study was consistent with the ORENCIA rheumatoid arthritis clinical studies currently included in the prescribing information. Concurrent therapy with ORENCIA and biologic DMARDs is not recommended. As stated in the prescribing information, in controlled clinical trials, patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 percent) and serious infections (4.4 percent) compared to patients treated with only TNF antagonists (43 percent and 0.8 percent, respectively), without an important enhancement of efficacy. The most serious adverse reactions were serious infections (3.0 percent of patients treated with ORENCIA and 1.9 percent of patients treated with placebo) and malignancies (1.3 percent of patients treated with ORENCIA and 1.1 percent of patients treated with placebo). The most frequent adverse events occurring in greater than or equal to 10 percent of patients treated with ORENCIA were headache, upper respiratory tract infection, nasopharyngitis, and nausea.

Important Safety Information About ORENCIA(R) (abatacept)

Concomitant Use with TNF antagonists: Concurrent therapy with ORENCIA and a biologic DMARD is not recommended. In controlled clinical trials, adult patients receiving concomitant ORENCIA and TNF antagonist therapy experienced more infections (63 percent) and serious infections (4.4 percent) compared to patients treated with only TNF antagonists (43 percent and 0.8 percent, respectively), without an important enhancement of efficacy.

Hypersensitivity: Less than 1 percent of adult patients treated with ORENCIA experienced hypersensitivity reactions, including some cases of anaphylaxis or anaphylactoid reactions. Other events potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.9 percent of patients treated with ORENCIA and generally occurred within 24 hours of infusion. There was 1 case of a hypersensitivity reaction with ORENCIA in JIA clinical trials (0.5 percent; n = 190). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use in the event of a reaction.

Infections: Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis, and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Live vaccines should not be given concurrently with ORENCIA or within 3 months of its discontinuation as it may blunt the effectiveness of some immunizations. It is recommended that JIA patients be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating therapy with ORENCIA.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): Adult COPD patients treated with ORENCIA developed adverse events more frequently than those treated with placebo (97 percent vs. 88 percent, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43 percent vs. 24 percent, respectively), including COPD exacerbations, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27 percent vs. 6 percent), including COPD exacerbation [3 of 37 patients (8 percent)] and pneumonia [1 of 37 patients (3 percent)]. Use of ORENCIA in patients with RA and COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Blood Glucose Testing: ORENCIA contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.

Pregnant and Nursing Mothers: ORENCIA should be used during pregnancy only if clearly needed. The risk for development of autoimmune diseases in humans exposed in utero to abatacept has not been determined. Nursing mothers should be informed of the risk/benefit of continued breast-feeding or discontinuation of the drug. A pregnancy registry has been established to monitor fetal outcomes. Healthcare professionals are encouraged to register pregnant patients exposed to ORENCIA by calling 1-877-311-8972.

Most Serious Adverse Reactions: Serious infections (3 percent ORENCIA vs. 1.9 percent placebo) and malignancies (1.3 percent ORENCIA vs. 1.1 percent placebo). In general, adverse events in pediatric and adolescent patients were similar in frequency and type to those seen in adult patients.

Malignancies: The overall frequency of malignancies was similar between adult patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2 percent) than those on placebo (0 percent). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (=10 percent): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies.

Please see accompanying Full Prescribing Information, or visit www.ORENCIA.com or www.bms.com.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a systemic,1 chronic, autoimmune disease characterized by inflammation in the lining of joints (or synovium), causing joint damage with chronic pain, stiffness, swelling and fatigue.2 RA causes limited range of motion and decreased function as a result of affected joints losing their shape and alignment.3

RA affects about one percent of the world's population,4 including more than one million people in the United States.1 The condition is more common in women than in men, who account for 75 percent of patients diagnosed with RA.2 ORENCIA is one treatment option indicated in adult patients with moderately to severely active RA. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA 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 whose mission is to extend and enhance human life. For more information visit: www.bms.com.

ORENCIA(R) (abatacept) is a trademark of Bristol-Myers Squibb Company.

References

1. Helmick CG, Felson DT, Lawrence RC, Gabriel S, Hirsch R, Kwoh CK, Liang MH, Kremers HM, Mayes MD, Merkel PA, Pillemer SR, Reveille JD, Stone JH; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part I. Arthritis Rheum. 2008;Jan;58(1):15-25.

2. American College of Rheumatology, Patient Education, Rheumatoid Arthritis. Available at: http://www.rheumatology.org/public/factsheets/ra_new.asp?aud=pat2. Accessed May 2006.

3. 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.

4. Lee DM, Weinblatt ME. Rheumatoid Arthritis. The Lancet. 2001;358:903-11.


Source: Bristol-Myers Squibb

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