From Anti-Tumor Necrosis Factor (TNF) Therapy in Inadequately Responding Rheumatoid Arthritis Patients
Barcelona (OTS) - According to a new study, it is possible to
safely switch directly to ORENCIA(R) 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(R), 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(R) 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(R)
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 (R) 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(R) 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(R) 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(R) at their next scheduled
anti-TNF dose. Patients received a fixed dose of ORENCIA(R)
(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(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) 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
Rückfragehinweis:
Media 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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