- With this approval, HUMIRA, an anti-TNF monoclonal antibody,
offers pediatric patients from five years of age with moderately to
severely active ulcerative colitis (UC) the first subcutaneous
anti-TNF treatment option1
- Approval based on results from the pivotal Phase 3 ENVISION
I study, the largest clinical trial in pediatric ulcerative colitis
to date, showing HUMIRA provided significant rates of response and
remission both at week 8 and 521,2
MONTREAL, April 22, 2021 /CNW/ - AbbVie (NYSE: ABBV), a
research-based global biopharmaceutical company, today announced
that Health Canada has approved HUMIRA® (adalimumab) for
inducing and maintaining clinical remission in pediatric patients
five years of age and older with moderately to severely active
ulcerative colitis (UC) who have had an inadequate response to
conventional therapy including corticosteroids and/or azathioprine
or 6-mercaptopurine or who are intolerant to such
therapies.1 With this approval, HUMIRA offers pediatric
patients with moderately to severely active ulcerative colitis the
first subcutaneous anti-TNF therapeutic option.1
"Ulcerative colitis is a miserable illness when it is not well
controlled, and it has a significant impact on the lives of
children and adolescents. When the disease is active, it is
disabling and embarrassing, and affects how children can engage in
their normal lives with peers and at school. Although we are able
to treat a lot of children who have ulcerative colitis today, there
is still a group of children and adolescents that we cannot help as
well as we would like, which is why we do need access to new
therapies," said Dr. Anne Griffiths,
Co-Lead, Inflammatory Bowel Disease Centre at the Hospital for Sick
Children.
Ulcerative colitis is characterized by inflammation of the large
intestine with symptoms ranging from mild to severe bowel urgency
and bowel incontinence as well as weight loss and
fatigue.4,5 It remains a lifelong condition that is not
adequately controlled in many patients, underscoring the need for
more treatment options.3,4 Children with ulcerative
colitis may fail to develop or grow properly due to malabsorption
of nutrients by the diseased bowel.5 Significant unmet
needs remain in moderate to severe pediatric ulcerative colitis,
compared to adults, as pediatric patients tend to have more
extensive disease often causing significant illness in
children.4,6
Cal Spellman, who is now 17,
remembers getting diagnosed when he was 11 years old. "It was very
scary for me. As a kid, it can be intimidating when a doctor says
you have a chronic illness, and even though it is treatable, it can
be hard to manage. I remember having a really difficult time when I
was about 12. I was hospitalized twice, four months apart from each
other. I was having uncontrollable symptoms, which is particularly
hard for someone going through puberty, when you are feeling
self-conscious about things. But for anyone who is newly diagnosed,
know that it does get better. It will be hard, but it is something
you can manage, and it is possible to live a normal life," he
explained.
"Canada has one of the highest
rates of inflammatory bowel disease (IBD) in the world5.
With the number of cases increasing in children, it is important
that we continue to expand the number of pediatric treatment
options available" said Susan Cowan,
CEO of Crohn's and Colitis Canada. "Ulcerative colitis, one of the
main forms of IBD, is an unpredictable disease often requiring
medication to manage debilitating symptoms. The introduction of a
new therapy for children living with ulcerative colitis is an
important advancement."
"This approval marks an important milestone for children and
adolescents living with ulcerative colitis, who often struggle to
control this lifelong condition, particularly because pediatric
patients tend to have more extensive disease," added Tracey Ramsay, Vice President and General
Manager, AbbVie Canada. "AbbVie is proud of our heritage and
dedication to discovering and delivering innovative therapies that
help adults and children living with inflammatory bowel
disease."
About the ENVISION I Phase 3 Study2,7
The Health Canada approval is based on results from the ENVISION
I study, a Phase 3, randomized, double-blind, multicenter study
designed to evaluate the efficacy, safety and the pharmacokinetics
of HUMIRA in pediatric patients (ages 4-17) with moderate to severe
ulcerative colitis, administered subcutaneously.
The ENVISION I study showed that HUMIRA met the co-primary
endpoints of clinical remission at week 8 and, among those who
responded at week 8, clinical remission at one year (52
weeks).1,2
No new safety signals for HUMIRA were observed in this
study.1,2 In patients exposed to HUMIRA during the
study, 23 percent experienced a serious adverse
event.1,2 The most frequently reported (greater than or
equal to five percent) treatment-emergent adverse events during
induction and maintenance periods were headache and ulcerative
colitis.1,2 No deaths, malignancies, active tuberculosis
or demyelinating disease were observed in this
study.1,2
More information on this trial can be found at
www.clinicaltrials.gov (NCT02065557).
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.
For further information, please see the HUMIRA Product
Monograph available on www.abbvie.ca.
About AbbVie in Gastroenterology
AbbVie has focused on improving care in gastroenterology for
more than 10 years. With a robust clinical trial program in
inflammatory bowel disease (IBD), we are committed to cutting-edge
research to drive exciting discoveries and developments in Crohn's
disease and ulcerative colitis. By innovating, learning, and
adapting, AbbVie aspires to eliminate the burden of IBD and make a
long-term impact on the lives of people with IBD.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.ca and www.abbvie.com. Follow
@abbviecanada on Twitter or find us on Facebook, LinkedIn and
Instagram.
References:
- HUMIRA (adalimumab) Product Monograph. AbbVie Corporation.
Available at:
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/HUMIRA_PM_EN.pdf.
Accessed on April 21, 2021.
- Croft N.M., et al. Efficacy and safety of adalimumab in
pediatric patients with moderate to severe ulcerative colitis:
results of a randomized-controlled phase 3 study.
UEGJ. 2020;8(8S):98-99.
- The Economic Costs of Crohn's Disease and Ulcerative Colitis.
Access Economics Pty Limited. 2007. Available at:
https://www.crohnsandcolitis.com.au/site/wp-content/uploads/Deloitte-Access-Economics-Report.pdf.
- Romano, C., et al., Management of Acute Severe Colitis in
Children With Ulcerative Colitis in the Biologics Era. Pediatrics.
2016;137(5):e20151184.
- Crohn's and Colitis Canada. 2018 Impact of Inflammatory Bowel
Disease Report. Available at :
https://crohnsandcolitis.ca/Crohns_and_Colitis/documents/reports/2018-Impact-Report-LR.pdf.
Accessed March 29, 2020.
- Jakobsen C., et al. Differences in phenotype and disease course
in adult and paediatric inflammatory bowel disease—a
population-based study. Aliment Pharmacol Ther.
2011;34(10):1217–1224pmid:21981762.
- Efficacy and Safety of Adalimumab in Pediatric Subjects With
Moderate to Severe Ulcerative Colitis. ClinicalTrials.gov. 2020.
Available at:
https://clinicaltrials.gov/ct2/show/record/NCT02065557. Accessed on
October 6, 2020.
SOURCE AbbVie Canada