Media Release

New treatment for debilitating rheumatic
diseases listed on the PBS

  • RINVOQ is a JAK1 selective inhibitor reimbursed for eligible patients with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) 1,2,3
  • The medication is taken orally, once a day for both conditions15
     

SYDNEY AUSTRALIA, 1st October 2021 – Today, AbbVie (NYSE: ABBV) announced that eligible Australian adults living with severe active psoriatic arthritis (PsA) and active ankylosing spondylitis (AS) will now have access to RINVOQ® (upadacitinib), a Janus Kinase 1 (JAK1) inhibitor, via the Pharmaceutical Benefits Scheme (PBS).1

In Australia, approximately 177,520 people live with AS or PsA, which are chronic and debilitating rheumatic diseases.4,5 These conditions are part of a group of rheumatic diseases called spondyloarthropathies, which amongst other features share in common painful symptoms due to inflammation.6

  • Ankylosing spondylitis is a condition which mainly affects the spine.7 The joints of the neck, back and pelvis can become inflamed causing pain and stiffness.7 Typically, symptoms develop when patients are young, between the ages of 15-40. However, it can take years to obtain a diagnosis.7 Studies reveal a high mental health burden for younger patients as a result of the reduced quality of life and the impact of their condition on their social life and relationships.8,9
  • Psoriatic arthritis causes inflammation in the joints, in turn leading to pain, stiffness and swelling.10 In addition, it can cause inflamed, scaly psoriasis patches to appear on the skin.10


Rob Anderson, CEO of patient organisation, Musculoskeletal Australia
said, “The physical and emotional burden of AS and PsA is relentless. These conditions typically affect individuals during their prime years and have a profound impact on work, social and family life, and mental health. Due to the progressive nature of these inflammatory conditions, it takes ongoing management to help alleviate symptoms and to avoid permanent disability. People with AS and PsA simply want to get on with their lives and not suffer with pain and disability on a daily basis. Symptom control is key and we welcome more treatment options for the AS and PsA patient community.

There are multiple barriers for people living with AS to live a good quality of life. Firstly, the condition is easily mistaken for mechanical back pain and it can take up five to seven years11 to receive a diagnosis. Once the rheumatic disease is diagnosed, many people are required to cycle between treatments in order to get control of their symptoms.

Despite various treatment options being available, people living with AS and PsA still face challenges and many don't achieve adequate disease control,14,15 Greater understanding into immune and inflammatory mechanisms has led to the expansion of management strategiesaiming to help patients minimise disease activity.12,15

Rheumatologist Associate Professor, Andrew Östör said, “Patients are searching for options to control their disease in order to live a normal life. However, the management pathway for rheumatic diseases can often be complicated and confusing. As every patient is different, it is imperative we have access to additional therapies to maximise long term outcomes.

Chris Stemple, Vice President and General Manager AbbVie Australia and New Zealand said, “For more than 20 years, AbbVie has been dedicated to understanding the burden of rheumatic diseases to improve care for people living with these conditions. We are proud to be able to support the patient and clinician community in managing the debilitating symptoms associated with AS and PsA.

Important Safety Information1,15
Therapy with RINVOQ should be initiated and monitored by a rheumatologist or specialist physician with expertise in the management of the indicated conditions.

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 healthcare professional.

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 (for healthcare professionals) here for further safety information on RINVOQ.1,15

About AS
AS is a type of inflammatory arthritis that predominately affects the spine and lower back causing pain and stiffness.6 Approximately 50,720 Australians have some form of AS, with symptoms developing early between the ages of 15 and 40.4,7

About PsA
PsA is a progressive condition that causes joint problems, swelling, stiffness. It can also result in scaly psoriasis patches on the skin.10 Approximately 126,800 Australians live with PsA, with symptoms often appearing between the ages of 30 and 50.5

About RINVOQ (upadacitinib)1
Rinvoq contains the active ingredient upadacitinib, which is a Janus Kinase (JAK) inhibitor. JAK enzymes create signals in the body's immune system that result in inflammation.

Discovered and developed by AbbVie, RINVOQ is indicated 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).
  • 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 non-biological DMARD.
  • Adults with active ankylosing spondylitis.
  • PBS reimbursed treatment is only available for patients meeting the PBS eligibility criteria.


About AbbVie
AbbVie is a global, research-driven biopharmaceutical company committed to developinginnovative advanced therapies for some of the world’s most complex and critical conditions. Ourheritage in Australia reaches back more than 80 years and we employ more than 450 peoplewith our therapies currently benefiting more than 30,000 Australians. The company’s mission isto use its expertise, dedicated people and unique approach to innovation to markedly improvetreatments. Recently, we acquired Allergan which immediately diversified our business acrossseveral therapeutic areas: Immunology, Oncology, Virology, Neuroscience, Eye Care andAesthetics.

For further information please visit http://www.abbvie.com.au.  Follow @abbvie_AU or follow us on Facebook or our LinkedIn page.

For all media enquiries:

Sam Pearson
Communications and Patient Relations Manager
+61 418 419 549
Sam.pearson@abbvie.com

References:
1 RINVOQ Approved Product Information – Available at: https://apps.medicines.org.au/files/veprinvo.pdf Accessed 11 August 2021
2 PBS Listing - https://www.pbs.gov.au/medicinestatus/document/477.html Accessed 16 September 2021
3 PBS Listing - https://www.pbs.gov.au/medicinestatus/document/461.html Accessed 16 September 2021
4 Khan MA, 2002 and Dean, L. E. et al. Global prevalence of ankylosing spondylitis. Rheumatology 53, 650–657 (2014)).
5 Gladman D et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome.
6 Arthritis Australia. Spondyloarthritis. Available at: https://arthritisaustralia.com.au/wordpress/wpcontent/uploads/2017/12/ArthAus_Spondyloarthritis_1805.pdf. Accessed August 2021
7 Arthritis Australia. Taking Control of Your Ankylosing Spondylitis. Available at: https://arthritisaustralia.com.au/wordpress/wpcontent/uploads/2020/01/Ankylosing-Spondylitis-2019-Arthritis_DIGITAL.pdf. Accessed July 2021.
8 Sieper J, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis. 2002 Nov; 61(Suppl 3): iii8–iii18. doi: 10.1136/ard.61.suppl_3.iii8.
9 Ozgul, A., et al. Effect of ankylosing spondylitis on health-related quality of life and
different aspects of social life in young patients. Clin Rheumatol. 2006 Mar;25(2):168-74. Epub 2005 Aug 10
10 Arthritis Australia. Psoriatic Arthritis. Available at: https://arthritisaustralia.com.au/wordpress/wpcontent/uploads/2017/09/ArthAus_PsoriaticArthritis_1805.pdf Accessed July 2021.
11 Reed MD, Dharmage S, Boers A, Martin BJ, Buchanan RR, Schachna L. Ankylosing spondylitis: an Australian experience. Intern Med J 2008;38:321–27.
12 Banerjee, S., et al. JAK–STAT signaling as a target for inflammatory and autoimmune diseases: current and future prospects. Drugs 77.5 (2017): 521-546.
13 Schwartz, D., et al. JAK inhibition as a therapeutic strategy for immune and inflammatory diseases. Nature Reviews Drug Discovery 16.12 (2017): 843
14 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 13.
15 Brown, M. and Bradbury, L. New approaches in ankylosing spondylitis. Med J Aust 2017; 206 (5): 192-194. doi: 10.5694/mja16.01111
15 RINVOQ Approved Consumer Medicines Information – Available at: https://medicines.org.au/files/vecrinvo.pdf Accessed May 7, 2021