- International Phase III study meets primary endpoint in rheumatoid
arthritis patients who inadequately responded to methotrexate, a current
standard of care -
NUTLEY, N.J., Jan. 24 /PRNewswire/ -- Roche today announced that
results from the OPTION (TOcilizumab Pivotal Trial in Methotrexate
Inadequate respONders) trial, the first international Phase III study of
ACTEMRA(TM) outside of Japan, successfully met its primary endpoint in
patients with moderate to severe rheumatoid arthritis (RA) who had an
inadequate response to methotrexate, a current standard of care. The study
showed that a greater proportion of RA patients treated with ACTEMRA(TM)
(either 4mg/kg or 8mg/kg) plus methotrexate achieved a significant
improvement in disease signs and symptoms (ACR20) at week 24, compared with
placebo plus methotrexate.
The preliminary analysis demonstrated that the safety profile of
ACTEMRA(TM) was consistent with earlier development studies; the most
common side effects reported in the study were upper respiratory tract
infection and headache. There was a similar incidence of infection reported
across treatment arms.
"We are pleased that this study confirms the favorable activity of
ACTEMRA(TM) in the treatment of RA," said Lars Birgerson, MD, PhD, Vice
President, Medical Affairs, Roche. "Through its unique blockade of the
interleukin-6 receptor, ACTEMRA(TM) may offer a novel approach to reduce
the debilitating symptoms of RA and help patients who may not be achieving
sufficient relief from standard therapies like methotrexate."
Data from this trial will be submitted for presentation at upcoming
international scientific meetings. In addition, four other Phase III trials
exploring ACTEMRA(TM) in RA are ongoing with three of them scheduled to
report in 2007.
About the OPTION Study
The OPTION (TOcilizumab Pivotal Trial in Methotrexate Inadequate
respONders) study is a three-arm, randomized, double-blind, controlled
study designed to evaluate the safety and efficacy of ACTEMRA(TM) plus
methotrexate compared to placebo plus methotrexate in RA patients who had
an inadequate response to methotrexate alone. Patients received ACTEMRA(TM)
intravenously (either 4mg/kg or 8mg/kg) every 4 weeks plus methotrexate
weekly or placebo infusions plus methotrexate weekly. Patients' response
was measured using ACR, a standard assessment developed by the American
College of Rheumatology to measure the signs and symptoms of RA. A 20%
reduction in the signs and symptoms of RA is represented as ACR20. The
study enrolled 623 patients at 73 trial sites in 17 countries outside the
United States.
The OPTION study is one of five Phase III trials underway to study
ACTEMRA(TM) as a potential new treatment for RA. Roche and Chugai have
initiated the collaborative clinical development program that has enrolled
a total of more than 4,000 patients in 41 countries including the United
States and several European countries.
About ACTEMRA(TM) (tocilizumab)
ACTEMRA(TM) is the first humanized interleukin-6 (IL-6)
receptor-blocking monoclonal antibody with a novel mechanism of action.
Studies suggest that reducing the activity of IL-6, one of several key
cytokines involved in the inflammatory process, may reduce inflammation of
the joints, prevent long-term damage and relieve certain systemic effects
of RA such as anemia, fatigue and osteoporosis. The ACTEMRA(TM) clinical
development program is designed to evaluate these questions. The compound
is not currently approved in the United States.
About Rheumatoid Arthritis
Rheumatoid arthritis is a progressive, systemic autoimmune disease
characterized by inflammation of the membrane lining in the joints. This
inflammation causes a loss of joint shape and function, resulting in pain,
stiffness and swelling, ultimately leading to irreversible joint
destruction and disability. Characteristics of RA include redness,
swelling, pain, and movement limitation around joints of the hands, feet,
elbows, knees and neck that leads to loss of function. In addition, the
systemic symptoms of RA include fatigue, anemia and osteoporosis and may
contribute to shortening life expectancy by affecting major organ systems.
After 10 years, less than 50% of patients can continue to work or function
normally on a daily basis. RA affects more than 21 million people worldwide
with approximately 2.1 million people affected in the United States.
About Roche
Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S.
pharmaceuticals headquarters of the Roche Group, one of the world's leading
research-oriented healthcare groups with core businesses in pharmaceuticals
and diagnostics. For more than 100 years, the Roche Group has been
committed to developing innovative products and services that address
prevention, diagnosis and treatment of diseases, thus enhancing people's
health and quality of life. An employer of choice, in 2005, Roche was named
one of Fortune magazine's Best Companies to Work For in America, one of the
Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to
Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling
Power), and one of AARP's Top Companies for Older Workers. For additional
information about the U.S. pharmaceuticals business, visit our websites:
http://www.rocheusa.com or http://www.roche.us.
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