Media Release

AbbVie welcomes registration of RINVOQ® (upadacitinib)for two new indications1

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 non-biological DMARD.
  • Adults with active ankylosing spondylitis.1


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 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 here for further safety information on RINVOQ.

About AbbVie

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.

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://medicines.org.au/files/veprinvo.pdf. Accessed May 7, 2021
  2. Spondylarthritis – what is spondylarthritis. Arthritis Foundation. Available at: https://www.arthritis.org/about-arthritis/types/spondyloarthritis/. Accessed on September 11, 2020
  3. Arthritis Australia website – Available at www.arthritisaustralia.com.au. Accessed May 7, 2021.
  4. 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.
  5. Psoriasis Statistics. 2019. National Psoriasis Foundation. Available at: https://www.psoriasis.org/content/statistics. Accessed on September 11, 2020. 6. 
  6. Strand,V.,et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.
  7. Brown, M. and Bradbury, L. New approaches in ankylosing spondylitis. Med J Aust 2017; 206 (5): 192-194. doi:10.5694/mja16.01111
  8. 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.
  9. RINVOQ Approved Consumer Medicines Information – Available at: https://medicines.org.au/files/vecrinvo.pdf. Accessed May 7, 2021