Already approved for Non-Hodgkin's Lymphoma and Rheumatoid Arthritis,
Health Canada approves RITUXAN® (rituximab) for severe forms of vasculitis
TORONTO, Jan. 25, 2012 /CNW/ - Imagine what it would be like to live
with a rare, life-threatening disease. Imagine how worried you might
feel, particularly when you realize that there is no treatment approved
for your disorder. Canadian adults living with Granulomatosis with
Polyangiitis (GPA, also known as Wegener's Granulomatosis) and
Microscopic Polyangiitis (MPA), two severe, potentially
life-threatening forms of vasculitis, now have a treatment option to
help combat their disease.1 Today, Roche announced that RITUXAN® (rituximab), in combination with glucocorticoids, is the first medicine
approved by Health Canada for adults with severely active GPA and MPA.
"Orphan diseases of this nature are extremely difficult for patients to
accept and for physicians to treat. They are not widely understood and
treatment options are often quite limited and not optimal leaving
patients and their families feeling alone and without hope," says Dr.
Éric Rich, Rheumatologist, Director, Rheumatalogy Post-Graduate
Training Program, University of Montreal. "New treatment approaches
like RITUXAN provide therapeutic choices for physicians to use in
fighting this disease and give patients a better chance for remission."
What are GPA & MPA?
GPA and MPA are two severe forms of ANCA-Associated Vasculitis (AAV) -
or vasculitis in short - a rare and potentially life-threatening
disease in which the body's own immune system attacks healthy tissues
and cells causing inflammation of the blood vessels.1 This inflammation deprives affected tissues and organs of blood supply
resulting in tissue or organ damage, including the potential for kidney
failure or lung damage.1 Both GPA and MPA are considered orphan (rare) diseases; GPA, for
example, affects about 1 in 20,000 to 1 in 30,000 people in Canada.2 In contrast, 487 Canadians are diagnosed with a form of cancer every
day.3 GPA and MPA are unique diseases that are expressed differently from
person to person, presenting with a variety of symptoms that range in
severity; some are specific to a particular organ and others, such as
aches, pains and fatigue, are non-specific.1 Both GPA and MPA have a five-month survival rate, if left untreated.4
Treatment for Vasculitis?
Previously, there were no Health Canada approved medications to treat
GPA and MPA. The current standard of care for orphan diseases such as
vasculitis was developed in the early 1970s and has been the only
option for many years, focused primarily on reducing discomfort and
preventing serious complications.5,6 As a result, some people go into remission, but for others, the disease
remains chronic with recurring relapses. In fact, up to 20 per cent of
patients do not achieve remission with the standard of care, and up to
50 per cent of GPA patients relapse at three years following diagnosis.7
RITUXAN, in combination with glucocorticoids, is indicated for the
induction of remission in adult patients with severely active GPA and
MPA.8 RITUXAN helps stop the body's own immune system from attacking itself.
It is a therapeutic antibody that binds to a specific protein called
CD20 found on the surface of cancerous and normal B-cells.
"I was diagnosed with a rare form of vasculitis 20 years ago after I was
experiencing trouble breathing, constant headaches and nosebleeds, and
inflammation of my joints," explains Jacques Ducharme, a GPA patient.
"Now the simple act of walking or moving causes me excruciating pain.
People don't realize the physical and emotional challenges my family
and I face day in and day out as a result of living with GPA. I have to
rely heavily on my wife for constant support. Some days I can accept
what's happening to me, and other days it's more challenging. Having
the first approved treatment option for my orphan disease gives me hope
RAVE - Rituxan Clinical Study
Health Canada's approval of RITUXAN, in combination with
glucocorticoids, for the treatment of GPA and MPA is based on a
National Institute of Allergies and Infectious Diseases-sponsored study
known as RAVE (Rituxan in ANCA-Associated Vasculitis). The study showed
that RITUXAN was as effective as cyclophosphamide (CYC), part of the
current standard of care, in inducing disease remission at six months
in patients with severe AAV (vasculitis), however, with fewer side
effects. The study also examined patients who developed adverse events
including deaths, development of certain forms of cancers, blood
disorders, infections, cardiovascular events, hospitalizations and
infusion reactions. In this trial, 33 per cent (n=32) of those taking
CYC developed one of the adverse events versus 22 per cent (n=22) of
those on RITUXAN.9 For vasculitis patients with few new treatment options, the results of
the RAVE study suggested RITUXAN is a potential option for vasculitis,
and specifically for GPA and MPA, severe forms of the disease.
In Canada, RITUXAN is also indicated for the treatment of RA and
non-Hodgkin's Lymphoma in adult patients.8 Over 170,000 patients worldwide have been treated with RITUXAN to date.
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals
and diagnostics. Roche is the world's largest biotech company with
truly differentiated medicines in oncology, virology, inflammation,
metabolism and CNS. Roche is also the world leader in in-vitro
diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes
management. Roche's personalised healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the
health, quality of life and survival of patients. In 2010, Roche had
over 80,000 employees worldwide and invested over 9 billion Swiss
francs in R&D. Genentech, United States, is a wholly owned member of
the Roche Group. Roche has a majority stake in Chugai Pharmaceutical,
Japan. Roche Canada was founded in 1931. The company employs
approximately 900 people across the country, with its pharmaceuticals
head office located in Mississauga, Ontario and diagnostics division
based in Laval, Quebec. Roche Canada is actively involved in local
communities, investing in charitable organizations and partnering with
healthcare institutions across the country. For more information, visit
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1 Vasculitis Foundation of Canada. http://www.vasculitis.ca/. Accessed October 2011.
2 Vasculitis Foundation of Canada. Wegener's Granulomatosis. http://www.vasculitis.ca/wergenersgranulomatosis/vasculitis-resources/wergeners-granulomatosis.html. Accessed October 2011.
3 Canadian Cancer Society. General Cancer Statistics at a Glance. http://www.cancer.ca/canada-wide/about%20cancer/cancer%20statistics/stats%20at%20a%20glance/general%20cancer%20stats.aspx. Accessed October 2011.
4 Bosch X, Guilabert A, Espinosa G, Mirapeix E (2007). "Treatment of
antineutrophil cytoplasmic antibody associated vasculitis: a systematic
review". JAMA 298 (6): 655-69.
5 Katsiari, C., Sakkas, L. Treatment of ANCA - Associated Vasculitis.
Advances in the Diagnosis and Treatment of Vasculitis.
6 Vasculitis Foundation of Canada. Vasculitis Medications. http://www.vasculitis.ca/vasculitismedications/informative/medications-that-may-treat-vasculitis.html. Accessed October 2011.
7 Criteria of Eligibility for Rituximab.
8 Canadian RITUXAN Product Monograph, 2011.
9 Stone H. et al. Rituximab versus Cyclophosphamide for ANCA-Associated
Vasculitis. The New England Journal of Medicine. 363;3. July 15, 2010.
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