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 101. 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 201.
"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
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 Week 2 (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
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 effects2. 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 Monograph2 available at www.abbvie.ca.
Important Safety Information2
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
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 Monograph2 at: www.abbvie.ca
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 www.abbvie.com or www.abbvie.ca. Follow @AbbVienews on Twitter or check out careers on our Facebook
1 The Impact of Inflammatory Bowel Disease in Canada: 2012 Final Report and
Recommendations, Crohn's and Colitis Foundation of Canada. http://www.isupportibd.ca/pdf/ccfc-ibd-impact-report-2012.pdf
2 HUMIRA® (adalimumab) Product Monograph. Date of Revision: August 21, 2013
For further information: