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Media Release

AbbVie welcomes the registration of SKYRIZI® (risankizumab) for psoriatic arthritis

SYDNEY, AUSTRALIA, 16 MAY 2022 – AbbVie (NYSE: ABBV) announced today that SKYRIZI® (risankizumab) has been registered in Australia for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). SKYRIZI may be used with or without conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs)1.

Psoriatic arthritis is a heterogenous, systemic inflammatory disease which causes inflammation in the joints, leading to pain, stiffness and swelling2,3. In addition, it can cause inflamed, scaly psoriasis patches to appear on the skin2. It can occur at any age but is more common in adults between the ages of 30 and 504, with approximately 126,800 Australians living with the condition5.

Due to the progressive nature of PsA, if left untreated, patients can be left with permanent joint and bone damage, which may result in permanent disability6. The condition can have a widespread impact on the body and in turn lead to reduced quality of life and a significant economic burden due to missed work and lowered productivity7.

Greater understanding of immune and inflammatory mechanisms has led to the expansion of management strategies to help patients minimise disease activity8,9,10. Despite advances in both management and treatment options, gaps remain in diagnosis impacting patients’ ability to achieve adequate disease control11.   

Chris Stemple, Vice President and General Manager of AbbVie Australia and New Zealand welcomed the SKYRIZI® registration saying, “People living with psoriatic arthritis continue to face challenges with many not achieving adequate disease control. AbbVie has been committed to better understanding the burden of rheumatic and dermatologic diseases for 20 years and continues to innovate to improve care for patients. We are proud to bring an additional treatment option to patients in Australia.”

“We will continue working with government stakeholders to ensure timely access via the Pharmaceutical Benefits Scheme.”

SKYRIZI is currently listed on the PBS for adults with severe chronic plaque psoriasis (refer to the PBS schedule for full information)12. SKYRIZI is not currently listed on the PBS for psoriatic arthritis.

About SKYRIZI® (Risankizumab)1

SKYRIZI is an interleukin 23 (IL-23) inhibitor and is indicated for the treatment of moderate to severe plaque psoriasis in adults (18 years or older) who are candidates for phototherapy or systemic therapy1. SKYRIZI is also indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs)1.

Important Safety Information1, 13

In patients with a chronic infection or a history of recurrent infection, the risks and benefits should be considered prior to prescribing SKYRIZI. Patients should be instructed to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy for the infection, the patient should be closely monitored and SKYRIZI should not be administered until the infection resolves.

Prior to initiating treatment with SKYRIZI, patients should be evaluated for TB infection. SKYRIZI must not be given to patients with active TB. Patients receiving SKYRIZI should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with SKYRIZI, completion of all appropriate immunisations should be considered according to current immunisation guidelines. SKYRIZI should not be used with live vaccines.

If a serious hypersensitivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.

Common side effects include upper respiratory infections with symptoms such as a sore throat and stuffy nose, feeling tired, fungal skin infection, injection site reactions, headache, small raised red bumps on the skin.

Please review the Consumer Medicines Information here (for consumers) or the Product Information here (for healthcare professionals) for further safety information on SKYRIZI.

About AbbVie in Australia
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, in addition to products and services across its Allergan Aesthetics portfolio.

For more information about AbbVie, please visit us at www.abbvie.com.au. Follow @abbvie_AU on Twitter, Facebook, Instagram or our LinkedIn page.

Media Enquiries:

Clara Hinds
Senior Communications and Patient Relations Manager
+61 (0)479 188 228
Clara.hinds@abbvie.com

References

1 SKYRIZI Approved Product Information – Available at: http://www.medicines.org.au/files/vepskyri.pdf. Accessed 4 May 2022.
Arthritis Australia. Psoriatic Arthritis. Available at: https://arthritisaustralia.com.au/wordpress/wp-content/uploads/2017/09/ArthAus_PsoriaticArthritis_1805.pdf. Accessed May 2022.
Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi:10.1016/j.berh.2012.01.003.
Psoriatic Arthritis American College of Rheumatology (v1.0)
Gladman D et al. Psoriatic arthritis: epidemiology, clinical features, course, and outcome.
MSK website: https://msk.org.au/psoriatic-arthritis/. Accessed May 2022.
Philip S Helliwell, Eric M Ruderman, Natural History, Prognosis, and Socioeconomic Aspects of Psoriatic Arthritis. 2015 Nov;41(4):581-91. doi: 10.1016/j.rdc.2015.07.004.
Gladman D. Recent advances in understanding and managing psoriatic arthritis. Version 1. F1000Res. 2016; 5: 2670.
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.
10 Hasan Tahir & Simran Grewal (2022) Current unmet needs and emerging novel pharmacotherapies in psoriatic arthritis, Expert Opinion on Pharmacotherapy, 23:4, 417-420, DOI: 10.1080/14656566.2021.2006184
11 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.
12 https://www.pbs.gov.au/pbs/home
13 SKYRIZI Approved Consumer Medicines Information – Available at: https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-CMI-01703-1