Health Canada Approves Treatment for Children with Rare Form of Arthritis

Health Canada Approves Treatment for Children with Rare Form of Arthritis 
ACTEMRA(®) (tocilizumab) Now Approved to Treat Canadian Children with 
Polyarticular Juvenile Idiopathic Arthritis (polyJIA)  
MISSISSAUGA, ON, Oct. 21, 2013 /CNW/ - ACTEMRA(®) (tocilizumab) was recently 
approved by Health Canada to treat children with polyarticular-course juvenile 
idiopathic arthritis (polyJIA), a rare, chronic and debilitating form of 
childhood arthritis. The medicine can be used for the treatment of signs and 
symptoms of active polyarticular juvenile idiopathic arthritis in patients two 
years of age and older who have not responded adequately to previous therapy 
with disease modifying anti-rheumatic drugs (DMARDs) and systemic 
corticosteroids. ACTEMRA can be used alone (in cases of intolerance to MTX or 
where treatment with MTX is not appropriate) or in combination with MTX. 
PolyJIA, or polyarticular-course juvenile idiopathic arthritis, is a form of 
juvenile idiopathic arthritis (JIA).(1) JIA affects approximately 1 in every 
1,000 children(2), with polyJIA accounting for approximately 30 per cent of 
cases.(3) PolyJIA is characterized by inflammation in five or more joints and 
most commonly affects both the large and small joints in the body, including 
knees, wrist and joints of the hands and feet. In January 2012 ACTEMRA 
received its first pediatric indication when Health Canada approved it for 
systemic juvenile idiopathic arthritis (sJIA), another form of juvenile 
idiopathic arthritis. 
"The effects of polyarticular-course juvenile idiopathic arthritis on children 
are quite significant because it not only decreases their mobility, but 
interferes with all aspects of their life including schooling and interactions 
with their family and friends," said Dr. Earl Silverman, Pediatric 
Rheumatologist, The Hospital for Sick Children. "The approval of ACTEMRA for 
this form of juvenile arthritis represents another treatment option to help 
relieve the symptoms of this disease. As a physician, my goal is to aim for 
remission in order to allow children to enjoy a more active and enjoyable 
life." 
The expanded approval for ACTEMRA is based on phase III CHERISH study data 
that showed patients treated with ACTEMRA experienced clinically meaningful 
improvement in signs and symptoms of polyJIA.(4) In addition, safety data 
collected to date for ACTEMRA in polyJIA patients is consistent with that 
observed in previous studies in ACTEMRA-treated patients.(4, 5) 
About the CHERISH Study 
CHERISH is a 104-week, phase III study in patients aged 2-17 years with active 
polyJIA for ≥6 months who have failed treatment with methotrexate (MTX).(4) 
Treatment with ACTEMRA was efficacious, with sustained clinically meaningful 
improvement in signs and symptoms of polyJIA, using a monthly regimen at doses 
of 8 mg/kg if body weight ≥30 kg and 10 mg/kg if body weight 30 kg.(4) The 
study met the primary endpoint with ACTEMRA-treated patients experiencing 
significantly fewer disease flares compared to placebo-treated patients (25.6 
percent versus 48.1 percent, respectively).(4) 
In the CHERISH study, infections were the most common adverse events (AEs) and 
serious adverse events (SAEs) over 40-weeks.(4) Laboratory abnormalities known 
to occur with ACTEMRA were also observed in this study, including decreases in 
white blood cell counts and platelet counts, and elevation in ALT and AST 
liver enzyme levels.(4) 
About ACTEMRA (tocilizumab) 
ACTEMRA, is the first humanized interleukin-6 (IL-6) receptor antagonist 
approved for the treatment of adult patients with moderately to severely 
active rheumatoid arthritis (RA) who have had an inadequate response to one or 
more disease-modifying anti-rheumatic drugs (DMARDs).(6) The extensive ACTEMRA 
clinical development programme included five phase III clinical studies and 
enrolled more than 4,000 people with RA in 41 countries, including Canada.( ) 
ACTEMRA is also approved for the treatment of active systemic juvenile 
idiopathic arthritis (SJIA) and polyarticular-course juvenile idiopathic 
arthritis (PolyJIA) in patients two years of age and older. 
ACTEMRA is part of a co-development agreement with Chugai Pharmaceutical Co. 
It has been approved in Japan since April 2005 for Castleman's disease, 
followed by approvals for RA, SJIA and PolyJIA in 2008. ACTEMRA is approved 
Canada, and several other countries, including the United States, the European 
Union, China, India, Brazil, Switzerland and Australia. 
About Roche 
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 2011, Roche had over 
80,000 employees worldwide and invested over 8 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. 
All trademarks used or mentioned in this release are protected by law. 
______________________________ 
1. Beukelman, T et al. 2011 American College of Rheumatology 


     Recommendations for the Treatment of Juvenile Idiopathic
     Arthritis: Initiation and Safety Monitoring of Therapeutic Agents
     for the Treatment of Arthritis and Systemic Features. Arthritis
     Care & Research. 2011.
     http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3222233/.


 Accessed April 2, 2013.
  2. Woo, P. Systemic juvenile rheumatoid arthritis: diagnosis, 
 management, and outcome. Nature Clinical Practice: Rheumatology. 
 2006. 2:1.
  3. Macaubas,Claudia et all. Oligoarticular and polyarticular JIA: 
 epidemiology and pathogenesis. Nature Reviews. 2009 vl 5.
  4. Brunner, HI et al. Efficacy and Safety of Tocilizumab in Patients 
 With Polyarticular Juvenile Idiopathic Arthritis: Data From a 
 Phase 3 Trial. Arthritis Rheum 2012. 64:S10;682
  5. De Benedetti F, et al. Ann Rheum Dis 2011; 70 (Suppl. 3):67.
  6. ACTEMRA Product Monograph, October 17, 2013 

SOURCE  Roche Canada 
Lee Rammage Manager, Corporate Relations Roche Canada 905-542-6047 
lee.rammage@roche.com 
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CO: Roche Canada
ST: Ontario
NI: MTC *  
-0- Oct/21/2013 13:00 GMT