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Study Results Supportive of Switching Directly to ORENCIA® From

Barcelona (ots)

Anti-Tumor Necrosis Factor (TNF) Therapy in Inadequately Responding
Rheumatoid Arthritis Patients
According to a new study, it is possible to
safely switch directly to ORENCIA® from anti-TNF therapy in 
rheumatoid arthritis patients who have had an inadequate response to 
anti-TNF therapy. The results were announced today by Bristol-Myers 
Squibb Company (NYSE: BMY).
Waiting for an ineffective medicine to clear first before trying 
another therapy like Orencia could subject a rheumatoid arthritis 
patient to additional pain and discomfort.
ORENCIA®, in combination with methotrexate (MTX) is indicated 
for the treatment of moderate to severe active rheumatoid arthritis 
in adult patients who have had an insufficient response or 
intolerance to other disease-modifying anti-rheumatic drugs (DMARDs) 
including at least one anti-TNF inhibitor. A reduction in the 
progression of joint damage and improvement of physical function has 
been demonstrated with combination treatment with ORENCIA(R) and MTX.
ORENCIA® is not approved for use in combination with anti-TNF 
inhibitors.
"The new data help answer a practical question about whether a 
direct switch from an anti-TNF therapy to Orencia without a washout 
period is an option in clinical practice for patients suffering from 
rheumatoid arthritis," said Maxime Dougados, M.D., Professor of 
Rheumatology, Universite Rene Descartes, Paris. "Rheumatoid arthritis
patients who do not adequately respond to currently available 
therapies may benefit from Orencia. Because a prior clinical study(1)
was conducted with a washout period prior to initiation of Orencia 
therapy, it is important to know whether we can move directly to 
Orencia rather than waiting for the non-effective medicine to clear 
out. These data support that it is safe to switch directly from 
anti-TNF therapy to Orencia therapy as warranted by patient 
response."
The study, which was presented at the 8th Annual European Congress
of Rheumatology (EULAR), evaluated the safety profile of ORENCIA® 
in patients with rheumatoid arthritis on background non-biologic 
disease-modifying anti-rheumatic drugs (DMARDs) who had an inadequate
response to anti-TNF therapy.
The ARRIVE (Abatacept Researched in Rheumatoid Arthritis Patients 
with an Inadequate anti-TNF response to Validate Effectiveness) study
was a 6-month open label study that was initiated to determine the 
safety, tolerability and efficacy profile of ORENCIA® in a 
clinical practice setting. The primary objective of the ARRIVE study 
was to summarize the incidence of adverse events, serious adverse 
events and discontinuations due to adverse events during 6 months of 
combined treatment with ORENCIA® and one or more of the background 
non-biologic DMARDs in patients with active RA when one group of 
anti-TNF inadequate responders were switched to ORENCIA® without a 
washout period.
Anti-TNF inadequate response was defined as inadequate response 
due to efficacy according to the investigator's opinion after at 
least 3 months' use or inadequate response due to safety or 
tolerability at any time point after patients have received their 
first dose of anti-TNF therapy.
In an analysis of the ARRIVE study, 842 US patients were treated 
and evaluated for safety. Of those studied, 370 patients were 
considered to be "prior" users, which meant they had discontinued 
anti-TNF therapy at least two months before screening due to a lack 
of clinical response or an inadequate response and persistent disease
activity. The other 472 patients were considered "current" users as 
they had received anti-TNF therapy within two months of screening, 
without a clinical response or had an insignificant response and a 
persistent disease activity score (DAS28) of more than 5.6.
   All current users started ORENCIA® at their next scheduled 
anti-TNF dose. Patients received a fixed dose of ORENCIA® 
(approximately10 milligrams per kilogram of body weight) on Days 1, 
15 and 29, and every 4 weeks thereafter, plus stable background DMARD
therapy.
Overall, baseline characteristics were similar in both groups 
(mean DAS28 of 6.2). Mean disease duration was 12.7 and 10.4 years in
prior and current users, respectively.
At 6 months, the frequency of adverse events (AEs), serious AEs 
(SAEs), discontinuations due to AEs/SAEs, infections, neoplasms and 
deaths were similar in prior and current users.
Events (Days 1-169)    "Prior" users    "Current" users     Overall
       (n=%)        ORENCIA + DMARDs      ORENCIA +       ORENCIA +
                        (n=370)       DMARDs (n=472)  DMARDs (n=842)
 Deaths                 1 (0.3)                0          1 (0.1)
 SAEs                  34 (9.2)          36 (7.6)        70 (8.3)
 Discontinuations       8 (2.2)           4 (0.8)        12 (1.4)
 due to SAEs
 AEs                 284 (76.8)        363 (76.9)      647 (76.8)
 Discontinuations      15 (4.1)          19 (4.0)        34 (4.0)
 due to AEs
 Infections          149 (40.3)        181 (38.3)      330 (39.2)
 Serious infections     8 (2.2)          11 (2.3)        19 (2.3)
 Neoplasms              3 (0.8)           2 (0.4)         5 (0.6)
Serious infections also were similar in frequency in prior vs. 
current users (2.2 vs. 2.3%, respectively); the most frequent being 
pneumonia (in 0.8% of current pts) and lobar pneumonia (in 0.5% of 
prior pts). No serious opportunistic infections, including 
tuberculosis, occurred in either group.
About Orencia
ORENCIA® is a novel medicine as the first and only selective 
co-stimulation modulator of T-cell activation. ORENCIA® is the 
first biologic discovered and developed in Bristol-Myers Squibb 
research centers and was approved in May 2007 by the European 
Commission.
Medicinal products, including ORENCIA®, which affect the immune 
system, may affect host defenses against infections and malignancies.
Serious infections at least possibly related to treatment were 
reported in 1.8% of patients with ORENCIA® and in 1.0% of patients 
not treated by ORENCIA® (receiving placebo). There is a need to 
evaluate and monitor the patients regarding the risk of infection 
prior to and during treatment. In the placebo-controlled clinical 
trials, the frequency of malignancies with ORENCIA(R) was 1.4% and 
with placebo 1.1%. These rates are similar to that observed in the 
general rheumatoid arthritis population.(2)
ORENCIA® is contraindicated in patients with severe and 
uncontrolled infections such as sepsis and opportunistic infections 
and in patients with hypersensitivity to the active substance or to 
any of the excipients. Allergic reactions have been reported 
uncommonly with ORENCIA® in clinical trials, where patients were 
not required to be pretreated to prevent allergic reactions. In the 
case of any serious allergic/anaphylactic reaction, ORENCIA® should
be discontinued.
About Rheumatoid Arthritis
Rheumatoid arthritis is a systemic, chronic, autoimmune disease 
characterized by inflammation in the lining of joints (or synovium), 
causing joint damage with chronic pain, stiffness and swelling. RA 
causes limited range of motion and decreased function as a result of 
affected joints losing their shape and alignment. RA may affect up to
4.5 million people in the European Union.(3),(4)
Bristol-Myers Squibb is a global pharmaceutical and related health
care products
company whose mission is to extend and enhance human life.
   ORENCIA® (abatacept) is a trademark of Bristol-Myers Squibb 
Company.
For information for ORENCIA®, please consult the Summary of 
Product Characteristics.
(1) Genovese MC, Becker J-C, Schiff M, et al. Abatacept for 
rheumatoid arthritis refractory to tumor necrosis factor α 
inhibition, N Engl J Med. 2005;353:1114-1123.
(2) Simon T, poster presentation at EULAR 2006.
(3) http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-SF-07-041
/EN/KS-SF-07-04 1-EN.PDF accessed 25-04-07.
(4) http://ec.europa.eu/health/ph_information/dissemination/diseas
es/musculo_en.h tm accessed 25-04-07.

Contact:

Brian Henry
Bristol-Myers Squibb
Office: +33-1-58-83-69-38
Mobile: +33-6-75-09-08-99
E-Mail: brian.henry@bms.com

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