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 children², 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.

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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
[email protected]