Patients treated with CIMZIA(R), together with methotrexate (MTX),
experienced a rapid and clinically significant improvement in physical
function, pain and fatigue as early as week one.
BURLINGTON, ON, Oct. 30 /CNW/ - UCB Pharma Canada announced pivotal RAPID
(RA PreventIon of structural Damage) 1 data published online today in
Arthritis & Rheumatism shows CIMZIA(R) (certolizumab pegol), the only
PEGylated anti-TNF (Tumour Necrosis Factor alpha), together with methotrexate
(MTX), rapidly reduced symptoms of disease and inhibited progression of joint
damage in adult patients with active rheumatoid arthritis (RA), with sustained
results for up to one year.
"In the RAPID 1 study CIMZIA(R) together with MTX, had a rapid onset of
action and inhibited structural damage early in adults with rheumatoid
arthritis. This demonstrated a clear therapeutic benefit for patients with a
reduction in swollen and tender joints, pain and fatigue as early as one week
after treatment, and signs of preventing long-term structural damage by
16 weeks," said lead investigator Edward Keystone, M.D., FRCPC, The Rebecca
MacDonald Center for Arthritis, Mount Sinai Hospital, The University of
Canada has one of the highest prevalence and incidence rates of RA in the
"More than three hundred thousand Canadians live with Rheumatoid
Arthritis," said Dr. Boulos Haraoui, M.D., FRCPC, Director of Clinical
Research, Institut de rhumatologie de Montréal. "RAPID 1 showed that CIMZIA(R)
can provide a treatment option for patients seeking a rapid, effective and
sustained therapy to manage this debilitating condition. The data clearly
showed that some patients taking CIMZIA(R) experienced a fast and clinically
significant improvement in physical function, pain and fatigue from week one
CIMZIA(R) is currently not approved for any indication in Canada.
The one year study showed CIMZIA(R), together with MTX, had a rapid and
significant effect in reducing the signs and symptoms of active RA as early as
week one and shown by a significant difference in ACR20 and 50 responses with
CIMZIA(R) compared with placebo, by Week 1 and Week 2 respectively (p(less
than)0.001 and p(less than)0.01). Peak responses achieved at 12 and 14 weeks
were sustained throughout the study.
Patients treated with CIMZIA(R), together with MTX, experienced
significant improvements in physical function and quality of life from Week 1
and sustained for up to one year, measured by mean change from baseline in
HAQ-DI (p(less than)0.001).
Radiographic data showed CIMZIA(R), together with MTX, inhibited
progression of RA, with a significantly smaller change from baseline in
modified Total Sharp Score (TSS) at 24 and 52 weeks of treatment, compared
with MTX alone (p(less than)0.001). A significant difference between patients
on CIMZIA(R), together with MTX, and placebo was observed as early as 16 weeks
in clinical non-responders (p(less than)0.001).
"CIMZIA(R) is the first anti-TNF to demonstrate such early results in
disease progression. UCB looks forward to bringing these benefits to people
who suffer from RA once the regulatory review process is completed," said Iris
Loew-Friedrich, M.D., Ph.D., Chief Medical Officer, UCB.
RAPID 1 and a simultaneous study, RAPID 2, are the first large,
placebo-controlled Phase III trials demonstrating the efficacy and
tolerability of CIMZIA(R) in the treatment of RA, as part of clinical trials
program involving more than 2,300 patients.
Pooled safety data from both studies showed CIMZIA(R) was generally well
tolerated with a low incidence of injection site pain (n=(less than)3 new
cases/100 patient-years) and discontinuations due to adverse events (AEs). The
most commonly occurring AEs were headache, nasopharyngitis, and upper
respiratory tract infections. Reported serious adverse reactions were
infections (including tuberculosis) and malignancies (including lymphoma),
consistent with findings from other trials in the anti-TNF class.
About RAPID 1
The double-blind placebo-controlled trial, involving 982 adults, was
designed to establish the efficacy and tolerability of CIMZIA(R) together with
MTX, in the treatment of active RA in patients who did not adequately respond
to conventional treatment. Patients were randomly allocated to receive one of
three treatment regimens: 393 patients received CIMZIA(R) 400 mg at Weeks 0, 2
and 4, then 200 mg every two weeks; 390 patients received CIMZIA(R) 400 mg
every 2 weeks; 199 patients received placebo every 2 weeks. RAPID 1 met
co-primary endpoints: ACR20 response rate at Week 24 and change from baseline
in mTSS at Week 52.
CIMZIA(R) is currently not approved for any indication in Canada.
CIMZIA(R) is the only PEGylated anti-TNF (Tumour Necrosis Factor). CIMZIA(R)
has a high affinity for human TNF-alpha, selectively neutralizing the
pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has
emerged as a major target of basic research and clinical investigation. This
cytokine plays a key role in mediating pathological inflammation, and excess
TNF-alpha production has been directly implicated in a wide variety of
diseases. The US Food and Drug Administration (FDA) has approved CIMZIA(R) for
reducing signs and symptoms of Crohn's disease and maintaining clinical
response in adult patients with moderate to severe active disease who have had
an inadequate response to conventional therapy. CIMZIA(R) was approved in
Switzerland for the treatment of Crohn's Disease in September 2007. UCB is
also developing CIMZIA(R) in rheumatoid arthritis and other autoimmune disease
indications. CIMZIA(R) is a registered trademark of UCB PHARMA S.A.
About UCB Pharma Canada
UCB Pharma Canada was officially incorporated in 2006 with the objective
of bringing new and convenient therapies to the Canadian market for
auto-immune, inflammatory diseases and central nervous system disorders. As a
patient-focused organization, UCB Pharma Canada is dedicated to bringing new
and innovative programs to patients, and to the specialists who treat them, to
help improve the lives of people living with severe diseases.
Forward looking statement
This press release contains forward-looking statements based on current
plans, estimates and beliefs of management. Such statements are subject to
risks and uncertainties that may cause actual results to be materially
different from those that may be implied by such forward-looking statements
contained in this press release. Important factors that could result in such
differences include: changes in general economic, business and competitive
conditions, effects of future judicial decisions, changes in regulation,
exchange rate fluctuations and hiring and retention of its employees.
For further information:
For further information: Jennifer Somers, Phone: (647) 801-0321