New Treatment Option Available for Canadian Children Living with Severely Active Pediatric Crohn's Disease

New Treatment Option Available for Canadian Children Living with Severely 
Active Pediatric Crohn's Disease 
AbbVie's HUMIRA(®) is the First Subcutaneous Biologic Approved in Canada for 
the Treatment of Pediatric Crohn's 
MONTREAL, Aug. 27, 2013 /CNW/ - AbbVie announced today that Health Canada has 
approved HUMIRA(®) (adalimumab) for reducing signs and symptoms and inducing 
and maintaining clinical remission in pediatric patients 13 to 17 years of age 
weighing ≥ 40 kg with severely active Crohn's disease and/or who have had an 
inadequate response or were intolerant to conventional therapy (a 
corticosteroid and/or aminosalicylate and/or an immunosuppressant) and/or a 
tumour necrosis factor alpha antagonist. 
With this approval, HUMIRA(®) becomes the first biologic treatment in the 
form of a subcutaneous injection approved for these patients. Furthermore, it 
is HUMIRA(®)'s second approval in the field of inflammatory bowel disease 
(IBD) after adult Crohn's disease, and the seventh approval for the treatment 
of immune mediated inflammatory diseases in Canada. 
Pediatric Crohn's disease, a chronic, debilitating condition of the 
gastrointestinal (GI) tract, is a type of IBD that most commonly involves the 
end of the small intestine and the beginning of the large intestine. An 
estimated 5,900 Canadian children have IBD. In fact, Canada has one of the 
highest rates of childhood-onset of IBD in the world and the incidence of IBD 
has been rising, particularly since 2001, and significantly so in children 
under the age of 10(1). According to the Crohn's and Colitis Foundation of 
Canada's The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report 
and Recommendations, 20 to 30% of people with IBD are diagnosed before the age 
of 20(1). 
"For parents like myself that have a child living with pediatric Crohn's, it's 
a huge relief to know that there is now a new treatment approved and available 
here in Canada," said Kate Murray, Executive Director of Robbie's Rainbow, a 
registered children's charity dedicated to improving the health and quality of 
life of children living with Crohn's disease and Ulcerative Colitis. "This 
will be a convenient new option for children living with the disease, as well 
as their families, as it empowers them to take a more active role in the 
treatment and management of their disease." 
To help both parents and teens take an active role in managing the disease, a 
free mobile app myIBD was developed by nurses, doctors and patients at 
SickKids Hospital in Toronto, and supported by AbbVie. "myIBD app is an 
empowerment tool. It allows patients along with their families to properly 
track the evolution of the disease and therefore anticipate any potential 
flare-up," said Karen Frost, IBD Nurse Practitioner, Division of 
Gastroenterology, Hepatology and Nutrition, SickKids Hospital. "Since the 
launch of this app, I now see my patients being more involved in the 
management of their disease and therefore have better health outcomes. This 
tool also prepares them for adulthood when they will have to manage their 
disease along with all of their other responsibilities." 
The myIBD app allows patients to track their food intake, stool consistency, 
pain, and frequency of washroom visits, all on their mobile device. It then 
compiles the information into a number of graphs, which helps patients track 
how they have been feeling over time. This regular documentation provides 
valuable insight to physicians. 
The recommended HUMIRA(®) induction dose regimen for pediatric patients with 
severely active Crohn's disease and moderately active Crohn's disease with no 
response to conventional therapy is 160 mg at Week 0 (dose can be administered 
as four injections in one day or as two injections per day for two consecutive 
days) followed by 80 mg at Week2 (given as two 40 mg injections in one day). 
The recommended HUMIRA(®) maintenance dose regimen is 20 mg every other week 
beginning at Week 4. For pediatric patients who experience a disease flare or 
non-response, dose escalation to 40 mg every other week may be considered. 
"The availability of HUMIRA(®) for patients with Pediatric Crohn's addresses 
a need throughout Canada and underscores our long-standing commitment to 
patients with IBD," said Felipe Pastrana, General Manager, AbbVie Canada. 
"HUMIRA(®) helps empower patients and their families by offering the 
flexibility and freedom to get their treatment in the comfort of their own 
home, according to their doctor's recommendations." 
The use of HUMIRA(®) in pediatric patients with Crohn's disease ages 13 to 17 
has been evaluated up to one year in clinical studies. 
HUMIRA(®) is also approved in Canada in adults for the treatment of 
rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis 
(AS), Crohn's Disease (CD), and psoriasis (Ps), and in children aged 4 to 17 
years for the treatment of polyarticular juvenile idiopathic arthritis (JIA). 
About HUMIRA(®) 
HUMIRA(®) resembles antibodies normally found in the body. It works by 
blocking TNF-α, a protein that, when produced in excess, plays a central role 
in the inflammatory responses of many immune-mediated diseases. 
HUMIRA(®) is one of the most comprehensively studied biologics available. The 
overall clinical database for HUMIRA(®) spans 15 years across multiple 
indications, including 71 clinical trials with over 23,000 patients. 
HUMIRA(®) is approved in 89 countries and used by over 670,000 patients 
Any medicines can have side effects. Like all medicines that affect your 
immune system, HUMIRA(®) can cause serious side effects(2). Before initiation 
of, during and after treatment with HUMIRA(®), patients should be evaluated 
for active or latent tuberculosis infection with a tuberculin skin test. For 
further information, please see the HUMIRA(®) Product Monograph(2) available 
Important Safety Information(2 )
HUMIRA(®) is a TNF blocker medicine that affects the immune system and can 
lower the ability to fight infections. Serious infections have happened in 
people taking HUMIRA(®). These serious infections include tuberculosis (TB) 
and infections caused by viruses, fungi, or bacteria that have spread 
throughout the body. Some people have died from these infections. People 
should be tested for TB before HUMIRA(®) use and monitored for signs and 
symptoms of TB during therapy. People at risk of TB may be treated with 
medicine for TB. Treatment with HUMIRA(®) should not be started in a person 
with an active infection, unless approved by a doctor. HUMIRA(®) should be 
stopped if a person develops a serious infection. People should tell their 
doctor if they live in or have been to a region where certain fungal 
infections are common, have had TB, hepatitis B, are prone to infections, or 
have symptoms such as fever, fatigue, cough, or sores. 
For people taking TNF blockers, including HUMIRA(®), the chance of getting 
lymphoma or other cancers may increase. Some people have developed a rare type 
of cancer called hepatosplenic T-cell lymphoma. This type of cancer often 
results in death. If using TNF blockers including HUMIRA(®), the chance of 
getting two types of skin cancer (basal cell and squamous cell) may increase. 
These types are generally not life threatening if treated. 
Other possible serious side effects with HUMIRA(®) include hepatitis B 
infection in carriers of the virus, allergic reactions, nervous system 
problems, blood problems, certain immune reactions, including a lupus-like 
syndrome, liver problems, and new or worsening heart failure or psoriasis. The 
use of HUMIRA(®) with anakinra or abatacept is not recommended. People using 
HUMIRA(®) should not receive live vaccines. 
Common side effects of HUMIRA(®) include injection site reactions (redness, 
rash, swelling, itching, or bruising), upper respiratory infections (including 
sinus infections), headaches, rash, and nausea. 
HUMIRA(®) is given by injection under the skin. The benefits and risks of 
HUMIRA(®) should be carefully considered before starting therapy. 
This is not a complete list of the Important Safety Information for 
HUMIRA(®). For additional important safety information, please consult the 
HUMIRA(®) Product Monograph(2) at: 
About AbbVie
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company 
formed in 2013 following separation from Abbott. AbbVie combines the focus and 
passion of a leading-edge biotech with the expertise and structure of a 
long-established pharmaceutical leader. The company's mission is to use its 
expertise, dedicated people and unique approach to innovation to develop and 
market advanced therapies that address some of the world's most complex and 
serious diseases. AbbVie aims to help patients live healthier lives and 
collaborate on sustainable healthcare solutions. AbbVie employs approximately 
21,000 people worldwide and markets medicines in more than 170 countries. For 
further information on the company and its people, portfolio and commitments, 
please visit or Follow @AbbVienews on Twitter or 
check out careers on our Facebook page. 
(1) The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and Recommendations, Crohn's and Colitis 
Foundation of Canada. 
(2) HUMIRA(®) (adalimumab) Product Monograph. Date of Revision: August 21, 2013 
Media inquiries Eileen Murphy AbbVie 514-832-7788 
Ashleigh Cartier Media Profile 416-342-1826 
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CO: AbbVie
ST: Quebec
-0- Aug/27/2013 11:00 GMT
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