New Results Represent Additional Data From a Study Showing Superior Efficacy of ORENCIA or Infliximab Compared to Placebo at Six Months
Barcelona (OTS) - Bristol-Myers Squibb Company (NYSE: BMY) today
announced additional study results providing evidence of the efficacy
and durability of response of ORENCIA(R) (abatacept) through 12
months in adults with moderate to severe rheumatoid arthritis (RA)
who have had an inadequate response to methotrexate (MTX).
This study originally evaluated the efficacy, safety and
tolerability of ORENCIA(R) plus MTX, infliximab, an anti-TNF
inhibitor, plus MTX, and placebo plus MTX at 6 months. The study
previously showed that ORENCIA(R) or infliximab had superior efficacy
compared to placebo at six months. (1)
ORENCIA(R), in combination with MTX - a standard therapy for RA
patients - 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 including at least one anti-tumour necrosis
factor (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.
In new results reported today at the 8th Annual European Congress
of Rheumatology (EULAR), data showed at 12 months ORENCIA(R)
demonstrated a durable response as per assessments including
DAS28-derived criteria, EULAR response and Health Assessment
Questionnaire - Disability Index (HAQ-DI results).
"As rheumatoid arthritis is a chronic condition for many patients,
we need to understand the potential of treatments over time," said
Maxime Dougados, M.D., Professor of Rheumatology, Universite Rene
Descartes, Paris. "The results of this study suggest continued
improvement for Orencia-treated patients. This is important as we
determine how to provide care to patients who do not adequately
respond to currently available therapies."
The study randomized participants with moderate to severe RA who
have had an inadequate response to MTX and no prior anti-TNF therapy.
Patients received ORENCIA(R) (n=156), infliximab (active control,
n=165) or placebo (n=110). All groups continued on MTX through 12
months. The study was not designed to directly compare the active
treatment arms.
The primary endpoint was mean reduction in disease activity score
(DAS28) in the group receiving ORENCIA vs. placebo at six months.
Secondary objectives included mean reduction in DAS28 with infliximab
vs. placebo at six months, mean reduction in DAS28 with ORENCIA(R)
and infliximab at one year, physical function as measured by the
Health Assessment Questionnaire (HAQ), and the proportion of patients
treated with ORENCIA(R) or infliximab at 12 months who demonstrated a
good, moderate or no response according to the EULAR criteria.
DAS28 is an index of disease activity and is calculated by
assessing the number of swollen and tender joints, measuring a
laboratory parameter and evaluating a patient's global health.
Thresholds have been developed for low disease activity (DAS28<3.2)
and remission (DAS28<2.6). This score is used in the EULAR definition
of good, moderate and no response. Good response requires two
components - improvement relative to the past (a decrease in DAS28 by
more than 1.2) and improvement to a level of low activity (DAS28 is
less than 3.2).
Six Month Study Results (Efficacy)
Therapy DAS28<3.2 DAS28<2.6 Good EULAR Moderate HAQ
Response EULAR Responders
Response
ORENCIA(R) 20.7% 11.3% 20.0% 56.7% 61.5%
(n=156)
Infliximab 25.6% 12.8% 22.9% 42.7% 58.8%
(n=165)
Placebo 10.8% 2.9% 10.8% 44.1% 40.9%
(n=102)
Twelve Month Study Results (Efficacy)
Therapy DAS28<3.2 DAS28<2.6 Good EULAR Moderate HAQ
Response EULAR Responders
Response
ORENCIA(R) 35.3% 18.7% 32.0% 40.7% 57.7%
(n=156)
Infliximab 22.4% 12.2% 18.5% 45.2% 52.7%
(n=165)
The study also evaluated the safety profile of treatment at 6
months and 12 months. Through 12 months, ORENCIA(R) had fewer serious
infections, acute infusional events and discontinuations due to
adverse events than infliximab.
Six Month Study Results (Safety)
Therapy Adverse Events Serious AE Acute Infusional AE
(AE)
ORENCIA(R) 82.7% 5.1% 5.1% (n=156)
Infliximab 84.8% 11.5% 18.2% (n=165)
Placebo 83.6% 11.8% 10.0% (n=102)
Twelve Month Study Results (Safety)
Terapy Adverse Serious Discon- Discon- Infections Frequency
Events AE tinuation tinuation reported of acute
(AE) due to AE due to as Serious infusional
Serious AE AE AE
ORENCIA(R) 89.1% 9.6% 3.2% 2.6% 1.9% 7.1%
(n=156)
Infliximab 93.3% 18.2% 7.3% 3.6% 8.5% 24.8%
(n=165)
About Orencia
ORENCIA(R) is a novel medicine as the first and only selective
co-stimulation modulator of T-cell activation. ORENCIA(R) 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(R), 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(R) and in 1.0% of patients
not treated by ORENCIA(R) (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(R) 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(R) 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(R) 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(R) (abatacept) is a trademark of Bristol-Myers Squibb
Company. For information for ORENCIA(R), please consult the Summary
of Product Characteristics.
(1) Schiff et al. ACR 2006.
(2) Simon T et al. EULAR 2006.
(3) http://epp.eurostat.ec.europa.eu/cache/ITY_OFFPUB/KS-SF-07-041
/EN/KS-SF-07-041-EN.PDF accessed 25-04-07.
(4) http://ec.europa.eu/health/ph_information/dissemination/diseas
es/musculo_en.htm accessed 25-04-07
Rückfragehinweis:
Contact:
Brian Henry, Bristol-Myers Squibb
Office: +33-1-58-83-69-38, Mobile: +33-6-75-09-08-99
mailto:brian.henry@bms.com
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