ILARIS* is the first interleukin-1 beta (IL-1 beta) inhibitor for the
treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) and
is the only monthly subcutaneous treatment approved specifically for
DORVAL, QC, Dec. 17, 2013 /CNW Telbec/ - Novartis Pharmaceuticals Canada
Inc. (Novartis) announced today that Health Canada has approved the use
of ILARIS* (canakinumab) in the treatment of active systemic juvenile idiopathic
arthritis (SJIA) in patients aged two years and older. SJIA is a rare
and disabling form of childhood arthritis with limited treatment
options . The condition is characterized by spiking fever, rash and
arthritis that can affect children as young as two years old and can
continue into adulthood ,.
"Arthritis can affect anyone, including babies and children. This
approval is welcome news for Canadian families with children living
with SJIA, a rare form of juvenile arthritis, offering them a new
treatment option," said Joanne Simons, Chief Mission Officer, The
Health Canada approved ILARIS* based on data from the Novartis Phase III
trials published in the New England Journal of Medicine in December
2012. Study 1 showed that 84% of patients treated with one subcutaneous
dose of ILARIS* achieved the primary endpoint of the adapted pediatric American College
of Rheumatology 30 (ACR30), compared to 10% achievement of ACR30 for
placebo at Day 15 . In the open-label part of Study 2, 92 of 128
patients attempted "corticosteroid tapering."
Of those 92 patients, 62% were able to substantially reduce their use of
corticosteroids, and 46% completely discontinued corticosteroids .
In the controlled portion of Study 2, there was a 64% relative
reduction in the risk of flare for patients in the ILARIS* group as compared to those in the placebo group (hazard ratio of 0.36;
95% CI: 0.17 to 0.75) .
"The Health Canada approval of ILARIS* provides patients living with
SJIA with a new treatment option. This represents another significant
milestone in the development of ILARIS* as a therapy for patients with rare, auto-inflammatory diseases, where
interleukin-1 beta plays a key role." said Tina Cantrill, Vice
President of Integrated Hospital Care & Critical Care at Novartis.
As many as 24,000 Canadian children aged 18 and under live with a form
of arthritis, or more than 3 out of every 1,000 kids . The systemic
JIA variant is significantly rarer. Although the disease can be
life-threatening, treatment options are limited. Corticosteroids are
often used to treat symptoms and pain despite their long-term use being
associated with potentially serious adverse effects, including Cushing
syndrome, growth suppression and osteoporosis .
"Systemic Juvenile Idiopathic Arthritis (SJIA) is both a rare and
potentially severe, debilitating disease. Unlike other forms of
juvenile arthritis, SJIA may affect a child's entire body. The
persistent inflammation, fevers, rash, and joint pain that accompany
the disease often mean that children are unable to enjoy many of the
everyday life experiences that are fundamental to childhood. The
disease can also be complicated by growth failure, osteoporosis and
deformities. Because of the potentially severe nature of SJIA, early
diagnosis and treatment is paramount," said Dr Rayfel Schneider, MBBCh,
FRCPC, Professor and Associate Chair Staff, Division of Rheumatology,
Department of Paediatrics at the University of Toronto and Hospital for
"Of the approximately 7,000 rare diseases, fewer than 400 have effective
treatments. We are very excited that Canadian children with SJIA now
have access to a new treatment option." said Durhane Wong-Rieger,
President and CEO of the Canadian Organization for Rare Disorders.
ILARIS* is a selective, fully human, monoclonal antibody that inhibits IL-1
beta, which is an important part of the body's immune system defenses
. Excessive production of IL-1 beta plays a prominent role in
certain inflammatory diseases . ILARIS* works by neutralizing IL-1
beta for a sustained period of time, therefore inhibiting inflammation
ILARIS* is now approved for the treatment of SJIA in Canada . In this
indication, it has been shown to provide rapid and sustained
improvement of acute disease by controlling both systemic and joint
inflammation, allow successful tapering and elimination of steroids in
most patients and offer the opportunity to achieve and maintain
inactive disease over a sustained period of time ,. ILARIS* is
also approved in Canada for the treatment of Cyropyrin Associated
Periodic Syndromes (CAPS), a rare, lifelong, genetic disorder with
debilitating symptoms .
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field,
is committed to the discovery, development and marketing of innovative
products to improve the well-being of all Canadians. In 2012, the
company invested close to $100 million in research and development in
Canada. Novartis Pharmaceuticals Canada Inc. employs more than 600
people in Canada. For further information, please consult www.novartis.ca.
Novartis Pharmaceuticals Canada Inc. is an affiliate of Novartis AG,
which provides innovative healthcare solutions that address the
evolving needs of patients and societies. Headquartered in Basel,
Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools,
over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2012, the
Group achieved net sales of USD 56.7 billion, while R&D throughout the
Group amounted to approximately USD 9.3 billion (USD 9.1 billion
excluding impairment and amortization charges). Novartis Group
companies employ approximately 133,000 full-time equivalent associates
and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.
*ILARIS is a registered trademark.
 ILARIS* Product Monograph. Novartis Pharmaceuticals Canada Inc. December, 2013.
 Woo P. Systemic juvenile idiopathic arthritis: diagnosis,
management, and outcome. Nat Clin Pract Rheumatol 2006; 2(1):28-34.
 Ramanan AV, Grom AA. Does systemic-onset juvenile idiopathic
arthritis belong under juvenile idiopathic arthritis? Rheumatology (Oxford) 2005; 44(11):1350-3.
 The Arthritis Society http://arthritis.ca/page.aspx?pid=7224. September 26 2013.
 Martinon F, Petrilli V. Gout-associated uric acid crystals activate
the NALP3 inflammasome. Nature 2006; 440(9): 237-241.
 Ruperto N, et al. N Engl J Med. 2012; 367:2396-406
SOURCE: Novartis Pharmaceuticals Canada Inc.
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