Health Canada approves ACTEMRA® (tocilizumab) for the treatment of Systemic Juvenile Idiopathic Arthritis (sJIA)
TORONTO, Feb. 1, 2012 /CNW/ - Arthritis can strike at any age. When it
occurs in a child, simple tasks such as walking or taking part in
school activities can be become painful, if not impossible. Systemic
juvenile idiopathic arthritis (sJIA) is a severely painful and rare
form of arthritis that affects children, and frequently leaves them
with life-long disabilities, impaired growth and osteoporosis, and for
some, serious, life-threatening complications.1 But, there is hope. Today, Roche announced that ACTEMRA®
(tocilizumab) is available as the first Health Canada approved
treatment specifically for children with sJIA.2
"Our 10-year-old daughter, Clara, was diagnosed with sJIA at the age of
five and it was extremely frightening because the disease is so
unpredictable; she couldn't move and was experiencing rolling fevers
and severe pain with over 30 joints affected," says Sarah, an
Ottawa-based mother. "She ended up missing six months of school
because of illness and fatigue. She couldn't hold a pencil at school,
so she couldn't write and she couldn't run around with her friends.
Also, she couldn't get onto the school bus without being carried
because the step was too high for her."
In Canada, juvenile idiopathic arthritis (JIA) is one of the most common
chronic diseases among children and affects up to one in 1,000
Canadians.3 More specifically, sJIA affects approximately 10 per cent of those
children in Canada diagnosed with JIA.4 The disease, which is one of the most difficult forms of JIA to manage,
begins in children 16 years of age or younger and most commonly sets in
below the age of five, although it can strike at any age during
childhood and adolescence.1,4
Without proper treatment, sJIA can lead to significant complications,
including growth failure, osteoporosis, and life-threatening
complications.1 In addition to the arthritis, children with sJIA often experience a
characteristic fever, skin rash, anemia, enlargement of the liver
and/or spleen, and inflammation of the lining of the heart and/or
lungs.1 Further, sJIA accounts for approximately two-thirds of the deaths
associated with JIA.5
"The day-to-day reality of growing up with a chronic disease can be
overwhelming, even debilitating for children and their families," says
Dr. Johannes Roth, Associate Professor of Pediatrics, University of
Ottawa, Head, Pediatric Rheumatology, Children's Hospital of Eastern
Ontario. "These children need new treatment options, so it's important
that we continue to find solutions that help our kids be kids."
ACTEMRA in sJIA - IL-6: The hidden key?
ACTEMRA is indicated for the treatment of active sJIA in patients two
years of age and older, who have responded inadequately to previous
therapy with one or more non-steroidal anti-inflammatory drugs and
systemic corticosteroids.2 A large body of evidence demonstrates the critical role of
interleukin-6 (IL-6) in sJIA and explains why this messenger substance
is a promising target for future therapies. Studies have shown that
patients with sJIA have significantly higher levels of IL-6 in their
blood and joints compared to other types of JIA or adult rheumatoid
IL-6 contributes to all the major features of sJIA including joint
inflammation, joint damage, fever, anemia, growth impairment and
osteoporosis.6 Disrupting IL-6 signaling reduces the contribution that IL-6 makes in
causing inflammation and inhibits the progression of sJIA, both in the
joints and system-wide. Basically, ACTEMRA helps keep the body's own
immune system from attacking itself.
"After my treatment with Actemra, I was able to cartwheel out of bed,"
explains Clara. "I'm now back at school more often and am able to have
a normal childhood."
The sJIA indication follows the approval of ACTEMRA in 2010 for adults
with rheumatoid arthritis (RA).2
According to Dr. Roth, "It's important to provide our patients with
options that work to target the root cause of the disease to reduce the
signs and symptoms and, ultimately, stop disease progression. The new
indication of Actemra offers a plausible solution for children with
sJIA who are often considered a difficult-to-treat patient group."
Health Canada's approval of ACTEMRA in the treatment of sJIA follows
positive data from the global phase III TENDER study, which
demonstrates that ACTEMRA is effective in improving the signs and
symptoms of sJIA.7 TENDER is an ongoing international study that includes approximately
70 centres in 20 countries with two clinical trials sites in Canada
located in Toronto and Ottawa. The data showed that 85 per cent of
patients achieved 30 per cent improvement (JIA ACR30) in the signs and
symptoms of sJIA and absence of fever, a primary characteristic of
sJIA, following three months of treatment with ACTEMRA.7 In addition to the significant improvement in ACR responses, nearly two
thirds were free of rash after three months.7 Finally, ACTEMRA therapy enabled 69 per cent of patients to reduce or
discontinue corticosteroid use within eight weeks of treatment, which
is significant as these medicines are associated with serious side
effects. Patients enrolled in the study and receiving ACTEMRA continue
to be followed.
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 personalized 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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1Woo, P. Systemic juvenile rheumatoid arthritis: diagnosis, management,
and outcome. Nature Clinical Practice: Rheumatology. 2006. 2:1.
2Canadian Actemra Product Monograph. 2012.
3Philpott, J, et al. Physical activity recommendations for children with
specific chronic health conditions: Juvenile idiopathic arthritis,
hemophilia, asthma and cystic fibrosis. Paediatr Child Health
4Joint Health: Changing Arthritis. Spotlight on juvenile idiopathic
arthritis. http://www.jointhealth.org/aboutarthritis-diseasespotlight.cfm?id=5. Accessed September 2011.
5Cassidy JT, et al. Juvenile rheumatoid arthritis. Cassidy JT, Petty RE,
eds. Textbook of pediatric rheumatology 2001:218-322.
6De Benedetti F. Inflammatory cytokines in the pathogenesis and treatment
of systemic juvenile idiopathic arthritis - Basic science for the
clinician. Pediatric Rheumatology Online Journal 2005. Vol 3:2.
7De Benedetti F et al. Efficacy and safety of tocilizumab in patients
with systemic Juvenile Idiopathic Arthritis (sJIA): 12-week data from
the phase III TENDER trial. Poster presented at EULAR 2010.
SOURCE HOFFMAN-LA ROCHE
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