SYDNEY AUSTRALIA, May 21, 2021 - AbbVie (NYSE: ABBV), a
research-based global biopharmaceutical company, today announced that
RINVOQ® (upadacitinib), a once-daily and selective inhibitor of Janus
Kinase 1 (JAK1), has been registered in Australia for the treatment of
moderate to severe active psoriatic arthritis (PsA) and active
ankylosing spondylitis (AS).1
Psoriatic arthritis causes inflammation in the joints, in turn
leading to pain, stiffness and swelling. 2,3 In addition,
it can cause inflamed, scaly psoriasis patches to appear on the
skin.2,3 It impacts approximately 50 million people worldwide.4,5
Ankylosing spondylitis is a condition which mainly affects the
spine.3 The joints of the neck, back and pelvis can
become inflamed causing pain and stiffness.3
The inflammation of the joints seen across both of these conditions
causes pain and stiffness, as well as changes to bone structure that
can cause disability.2 If left untreated, the inflammation
of the joints and bone changes can cause permanent
disability.2 The painful symptoms of both PsA and AS may
lead to reduced quality of life and significant economic burden due to
missed work and lowered productivity.6
Gaps still remain in diagnosis and disease management. Some people
with PsA and AS fail to achieve adequate disease control despite
having tried various therapies.7,8 Recognising that
patients respond differently to treatments, a deeper understanding of
the diseases and continued scientific research are critical to
improving care.6,7,8 This will also help to provide more
people living with these conditions a chance at adequate disease
control, including relief from pain and functional impairment.6,7,8
Chris Stemple, Vice President and General Manager AbbVie Australia
and New Zealand welcomes the registration saying, “While significant
treatment advances have been made over the years, it is important to
ensure patients continue to have access to additional options. We are
pleased to offer patients in Australia this additional treatment alternative.”
Currently RINVOQ (upadacitinib) is listed on the PBS for severe
active rheumatoid arthritis (refer to the PBS schedule for full
information). RINVOQ (upadacitinib) is not currently listed on the PBS
for either psoriatic arthritis or ankylosing spondylitis.
About RINVOQ (upadacitinib)1
Discovered and developed by AbbVie, RINVOQ is a selective inhibitor
of Janus Kinase 1 (JAK1) for the treatment of:
- Moderate to severe active rheumatoid arthritis in adult
patients who have responded inadequately to, or who are intolerant
to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
RINVOQ may be used as monotherapy or in combination with
methotrexate or other conventional synthetic disease-modifying
anti-rheumatic drugs (csDMARDs).1
- Moderate to
severe active psoriatic arthritis in adult patients who have
responded inadequately to, or are intolerant to one or more DMARDs.
RINVOQ may be used as monotherapy or in combination with a
- Adults with active
Important Safety Information1,9
Therapy with RINVOQ should be started and monitored by a specialist
physician with expertise in the management of rheumatoid arthritis,
psoriatic arthritis, and/or ankylosing spondylitis. RINVOQ must not be
used if the patient has an allergy to upadacitinib or any of its
ingredients, or if the patient has an active, serious infection. In
addition, RINVOQ must not be used in combination with biologic
disease-modifying anti-rheumatic drugs. Patients should tell their
health care professional if they currently have an infection, have had
an infection that keeps coming back, have had herpes zoster infection,
have had chicken pox, hepatitis or blood clots previously.
Prior to using RINVOQ, patients should be checked for current or
previous exposure to tuberculosis (TB) infection. RINVOQ should not be
given to patients with active TB. TB treatment may be required for
patients with TB or have risks of having contracted TB.
Prior to initiating therapy with RINVOQ, completion of all
appropriate immunisations should be considered according to current
immunisation guidelines. However, RINVOQ should not be used with
certain vaccines, such as live vaccines. Check this with the
RINVOQ should be used with caution when certain other medications
are being taken. Patients should inform their healthcare professional
if they are taking any other medications. Some common side effects
include nose or throat infections, nausea, high liver enzyme, blood
creatine phosphokinase or cholesterol level increases, decreased
neutrophil counts, cough, fever, stomach discomfort, and weight gain.
RINVOQ should not be used during pregnancy or breastfeeding.
Please review the Consumer Medicines Information here or the Product Information here for further safety information on RINVOQ.
AbbVie is a global, research-driven biopharmaceutical company
committed to developing innovative advanced therapies for some of the
world’s most complex and critical conditions. Our heritage in
Australia reaches back more than 80 years and we employ more than 450
people with our therapies currently benefiting more than 30,000
Australians. The company’s mission is to use its expertise, dedicated
people and unique approach to innovation to markedly improve
treatments. Recently, we acquired Allergan which immediately
diversified our business across several therapeutic areas: Immunology,
Oncology, Virology, Neuroscience, Eye Care and Aesthetics.
For further information please visit www.abbvie.com.au. Follow
@abbvie_AU on Twitter, Facebook, Instagram or our LinkedIn page.
Communications and Patient Relations Manager
+61 418 419 549
- RINVOQ Approved Product Information – Available at: https://medicines.org.au/files/veprinvo.pdf.
Accessed May 7, 2021
- Spondylarthritis – what is
spondylarthritis. Arthritis Foundation. Available at:
Accessed on September 11, 2020
- Arthritis Australia website
– Available at www.arthritisaustralia.com.au. Accessed May 7,
- Mease PJ and Armstrong AW. Managing patients with
psoriatic disease: the diagnosis and pharmacologic treatment of
psoriatic arthritis in patients with psoriasis. Drugs. 2014
Mar;74(4):423-41. doi: 10.1007/s40265-014-0191-y.
Statistics. 2019. National Psoriasis Foundation. Available at:
https://www.psoriasis.org/content/statistics. Accessed on September
11, 2020. 6.
- Strand,V.,et al. Patient Burden of Axial
Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.
- Brown, M. and Bradbury, L. New approaches in ankylosing
spondylitis. Med J Aust 2017; 206 (5): 192-194.
- Mahmood, F., et al. Current concepts
and unmet needs in psoriatic arthritis. Clin Rheumatol. 2018
Feb;37(2):297-305. doi:10.1007/s10067-017-3908-y. Epub 2017 Nov
- RINVOQ Approved Consumer Medicines Information –
Available at: https://medicines.org.au/files/vecrinvo.pdf.
Accessed May 7, 2021