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 arthritis (RA).6
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 www.rochecanada.com.
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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 2010;15(4):213-8.
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.
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