- Approval is based on results from the Phase
3 SELECT-AXIS 2 pivotal clinical trial in which RINVOQ delivered
rapid and meaningful disease control, meeting the primary endpoint
of ASAS40 response at week 14 versus
placebo 1
- RINVOQ is the first and only
Janus Kinase (JAK) inhibitor approved to treat patients across the
spectrum of axial spondyloarthritis (nr-axSpA and ankylosing
spondylitis) in Canada 1, 2,
3
MONTREAL, May 9, 2023
/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 non-radiographic axial
spondyloarthritis (nr-axSpA) with objective signs of inflammation
who have had an inadequate response to a biologic disease modifying
anti-rheumatic drug (DMARD) or when use of those therapies is
inadvisable.
This indication follows the July
2022 Health Canada approval of RINVOQ 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,
making RINVOQ the first and only JAK inhibitor approved for the
full spectrum of axial spondyloarthritis.2
Nr-axSpA is a chronic, progressive inflammatory rheumatic
disease that causes joint inflammation leading to back pain and
stiffness.4 It cannot be detected by x-ray, which
makes it extremely difficult to diagnose.5 Nr-axSpA
and AS are considered as two sub-types of a broader condition
called axial spondyloarthritis (axSpA). A recent multi-country
study reported that approximately 16 percent of patients with
nr-axSpA will progress to AS after five years.6
"Non-radiographic axial SpA is a very complex disease that is
difficult to diagnose. And yet early detection and treatment are
critical to improving health outcomes," explained Dr. Denis Choquette, Rheumatologist at the Institut
de Rhumatologie de Montréal and Scientific Director, Rhumadata.
"This new indication for RINVOQ is a significant milestone for
rheumatologists and patients. AxSpA is typically diagnosed in young
people under 45 years old, so it is very encouraging to now have a
new, oral therapeutic choice for patients."
"Today, as a patient, but also as Chair of the
Canadian Spondyloarthritis Association, I can say that we are
thrilled to learn that RINVOQ is now approved for the treatment of
adults with non-radiographic axial spondyloarthritis. When I first
started experiencing symptoms of nr-axSpA, I thought I had a back
sprain from playing sports. That first flare went on for three
months. Over time, I also experienced inflammatory flares in my
ankles, neck, and shoulders. By age 33, I felt like an old man.
Getting my diagnosis was difficult as I didn't have the typical AS
inflammatory markers; my x-rays came back negative. Two years after
the onset of pain, I was prescribed an MRI centered on the
sacroiliac joints, which confirmed that I had nr-axSpA. My story is
truly ironic because I was a doctor specializing in the
musculoskeletal field, working with other experts, and we all
missed my diagnosis for years. And yet comparatively, I was lucky;
it takes, on average, seven to ten years for people to be diagnosed
with this disease. As AS warriors, we can become resistant to
medications with time and so access to new innovative medicines is
crucial. My hope is that RINVOQ's approval is followed by timely
and equitable access for all patients. This access is
essential for people living with this painful and debilitating
condition," said Dr. Élie Karam, Chair, Canadian Spondylitis
Association.
This approval is supported by data from the Phase 3 SELECT-AXIS
2 clinical trial (Study 2), which evaluated the efficacy, safety,
and tolerability of upadacitinib in patients with
nr-axSpA.ii Study results show RINVOQ delivered
rapid and meaningful disease control with nearly half of patients
achieving the primary endpoint of ASAS40* versus placebo, as well
as significant improvement in signs and symptoms of nr-axSpA at
week 14.1
*ASAS40 is a composite index that measures disease
activity.1 To achieve an ASAS40 response, a
patient's disease activity must have improved by at least 40%, as
well as improved by two units (on a 0 to 10 scale) in at least
three of four disease areas assessed, and the remaining area must
not have gotten worse, including back pain, patient global
assessment of disease activity, physical function, and morning
stiffness.1
"For nearly a quarter century, AbbVie has been dedicated to
discovering and delivering innovative therapies for people living
with rheumatic diseases," added Tracey
Ramsay, Vice President and General Manager, AbbVie Canada.
"The needs and experiences of patients drive our relentless pursuit
to improve the standards of care, which is why we are proud to now
offer Canadians the first once-daily oral advanced therapy that
works across the spectrum of axial spondyloarthritis."
About the SELECT-AXIS 2 trial
program 7
SELECT-AXIS 2 was conducted as a master study protocol that
contains two standalone studies with randomization, data
collection, analysis and reporting conducted independently. The
Phase 3, randomized, placebo-controlled, double-blind studies are
evaluating the efficacy and safety of RINVOQ compared with placebo
on reduction of signs and symptoms in adult participants with
active axial spondyloarthritis (axSpA), including bDMARD-IR AS
(Study 1) and non-radiographic axial spondyloarthritis (nr-axSpA)
(Study 2). More information on this trial can be found at
www.clinicaltrials.gov (NCT04169373).
About
RINVOQ® (upadacitinib) 2
Discovered and developed by AbbVie scientists, 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 refractory moderate
to severe atopic dermatitis (AD) who are not adequately controlled
with a systemic treatment or when use of those therapies is
inadvisable, 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, and for adults with active
non-radiographic axial spondyloarthritis (nr-axSpA) with
objective signs of inflammation 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, gynecology and
gastroenterology, in addition to products and services across our
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.
___________________________
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1 Deodhar A,
Van den Bosch F, Poddubnyy D, et al. U Upadacitinib for the
treatment of active non-radiographic axial spondyloarthritis
(SELECT-AXIS 2): a randomized, double-blind, placebo-controlled,
phase 3 trial. Lancet. 2022;400:369–79.
doi:10.1016/S0140-6736(22)01212-0.
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2 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 May 8, 2023.
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3 van der
Heijde D, Baraliakos X, Sieper J, et al. Efficacy and safety of
upadacitinib for active ankylosing spondylitis refractory to
biological therapy: a double-blind, randomized, placebo-controlled
phase 3 trial. Ann Rheum Dis. 2022;0:1–9.
doi:10.1136/annrheumdis-2022-222608.
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4 Sieper J,
Poddubnyy D. Axial spondyloarthritis. Lancet 2017; 390:
73–84.
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5 Deodhar
AA, Understanding Axial Spondyloarthritis: A Primer for Managed
Care. Am J Manag Care. 2019;25:S319-S330.
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6
Poddubnyy D, et al. Radiographic Progression From
Non-radiographic to Radiographic Axial Spondyloarthritis: Results
From a 5-year Multicountry Prospective Observational Study. Ann
Rheum Dis 2022;81:96-97
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7 A Study to
Evaluate Efficacy and Safety of Upadacitinib in Adult Participants
With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov.
Available at: https://clinicaltrials.gov/ct2/show/NCT04169373
Accessed March 30, 2023
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SOURCE AbbVie Canada