- Approval is supported by efficacy and
safety data of two pivotal studies in which RINVOQ demonstrated
improvements in disease activity and function1
-
Milestone marks the fourth Health Canada-approved indication for
RINVOQ2
MONTREAL, July 20,
2022 /CNW/ - AbbVie (NYSE: ABBV), today
announced that Health Canada has approved RINVOQ®
(upadacitinib, 15 mg), the first oral, once-daily selective and
reversible JAK inhibitor for the treatment of adults with active
ankylosing spondylitis (AS) who have had an inadequate response to
a biologic disease modifying anti-rheumatic drug (DMARD) or when
use of those therapies is inadvisable. RINVOQ may be used as
monotherapy or in combination with nonsteroidal anti-inflammatory
drugs (NSAIDS).2
"Ankylosing spondylitis is a lifelong, progressive inflammatory
disease that affects young people. AS is difficult to diagnose, and
causes patients constant symptoms including pain and stiffness,
particularly in the spine, which results in significant impairment
of a person's quality of life4-5," said Walter Maksymowych, Professor of Medicine,
University of Alberta, and Chief
Medical Officer, CARE Arthritis. "To date, there have been limited
treatments options for people living with AS, so it is very
encouraging to now have a new, oral therapeutic choice available
for patients."
"Living with AS for most of my adult life, I have gotten used to
living with pain. I had muscle spasms, and I couldn't walk. It was
hard to move. The pain in my back and my glutes made everyday
movement, particularly anything that involved hip movement, really
difficult. Finding a treatment that works for me has been life
changing and has allowed me to get back to normal and simply focus
on living. This is why I am happy to know that Canadians with AS
now have a new therapeutic option," explained Marianne Skippings,
of Edmonton, Alberta.
This approval is supported by data from two pivotal studies with
more than 600 patients: SELECT-AXIS 1, a Phase 2/3 study in adult
patients with active AS who were naïve to biologic DMARDs and had
an inadequate response or intolerance to nonsteroidal
anti-inflammatory drugs (NSAIDS)1 and SELECT-AXIS 2, a
Phase 3 study in adult patients with active AS who were
biologic-inadequate responders3. In both studies, a
significantly greater proportion of patients treated with RINVOQ 15
mg achieved an Assessment of Spondyloarthritis International
Society (ASAS) 40 response compared to placebo at Week 14. Onset of
efficacy was seen as early as Week 2 in SELECT-AXIS 1 and Week 4 in
SELECT-AXIS 2.
"We are pleased to learn that RINVOQ has received Health
Canada approval for the treatment of adults with ankylosing
spondylitis. Our hope is that this approval is followed by timely
and equitable access for all patients. Diverse and affordable
treatment options are essential for those living with this painful
and debilitating condition affecting both physical and mental
health. It is a promising and hopeful time to know there are new
treatment options available to people living with AS," said
Dr. Elie Karam, Chair, Canadian
Spondylitis Association.
"At AbbVie, we are deeply committed to improving the standard of
care for people living with inflammatory arthritis. For more than
two decades, we have been dedicated to discovering and delivering
innovative therapies for people with rheumatic diseases," said
Tracey Ramsey, Vice President and
General Manager, AbbVie Canada. "We are proud to expand our
portfolio of treatment options for Canadians impacted by ankylosing
spondylitis, in particular, offering patients the first once-daily
oral advanced therapy in AS."
About SELECT-AXIS
11
SELECT-AXIS 1 is a Phase 2/3, multicenter, randomized,
double-blind, parallel-group, placebo-controlled study designed to
evaluate the safety and efficacy of RINVOQ in adult patients with
active ankylosing spondylitis who are bDMARD-naïve and had
inadequate response to at least two NSAIDs or intolerance
to/contraindication for NSAIDs. More information on this trial can
be found at www.clinicaltrials.gov (NCT03178487).
About SELECT-AXIS
23
SELECT-AXIS 2 (Study 1) is a Phase 3 randomized, double-blind,
placebo-controlled study designed to evaluate the safety and
efficacy of RINVOQ in adult patients with active ankylosing
spondylitis who had an inadequate response to one or two biologic
DMARDs. More information on this trial can be found at
www.clinicaltrials.gov (NCT04169373).
About
RINVOQ® (upadacitinib)2
RINVOQ is a once-daily oral medication in an extended-release
tablet. It is a Janus kinase (JAK) inhibitor that interferes with
the JAK-STAT signaling pathway, which is thought to play a role in
inflammatory response.
RINVOQ is indicated for the treatment of adults with moderately
to severely active rheumatoid arthritis (RA) who have had an
inadequate response or intolerance to methotrexate, for adults with
active psoriatic arthritis (PsA) who have had an inadequate
response or intolerance to methotrexate or other DMARDs, for adults
and adolescents 12 years of age and older with moderate to severe
atopic dermatitis (AD) who are not adequately controlled with a
systemic treatment or when use of those therapies is inadvisable,
and for adults with active ankylosing spondylitis (AS) who have had
an inadequate response to a biologic DMARD or when use of those
therapies is inadvisable.
For important safety information, please consult the RINVOQ
Product Monograph at www.abbvie.ca.
About AbbVie in
Rheumatology
For more than 20 years, AbbVie has been dedicated to improving
care for people living with rheumatic diseases. Anchored by a
longstanding commitment to discovering and delivering
transformative therapies, we pursue cutting-edge science that
improves our understanding of promising new pathways and targets,
ultimately helping more people living with rheumatic diseases reach
their treatment goals.
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. Follow @abbviecanada on Twitter
and Instagram, or find us on LinkedIn.
References
- Van der Heijde D, et al. Efficacy and safety of upadacitinib in
patients with active ankylosing spondylitis (SELECT-AXIS 1): a
multicentre, randomised, double-blind, placebo-controlled, phase
2/3 trial. The Lancet 2019; 394: 2108-2117.
- RINVOQ (upadacitinib) product monograph. AbbVie Corporation.
Available at:
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf
Accessed July 19, 2022.
- Van der Heijde, D, et al.
Efficacy and Safety of Upadacitinib in Patients With Active
Ankylosing Spondylitis Refractory to Biologic Therapy: a
Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial. EULAR
2022 Congress; 2518.
- Creaky Joints. What is Ankylosing Spondylitis? Available at:
https://creakyjoints.org/education/ankylosing-spondylitis/#:~:text=Ankylosing%20spondylitis%20(AS)%2C%20also,tailbone%2C%20called%20the%20sacroiliac%20joints.
Accessed June 30, 2022.
- Canadian Spondylitis Association. Ankylosing Spondylitis.
Available at:
https://spondylitis.ca/spondyloarthritis/spondyloarthritis-diseases/ankylosing-spondylitis/.
Accessed June 30, 2022.
SOURCE AbbVie Canada