Project Summary

Janus kinase inhibitors (JAKi) are a relatively new class of biological medicine and major development in treatment for patients with inflammatory diseases, who have not responded to conventional medicines. However, the long-term safety of JAKi is uncertain; a recent safety trial* reported that JAKi are associated with increased cardiovascular risks compared to tumour necrosis factor inhibitors (TNFi). This has led to warnings issued worldwide by regulatory authorities. This project will describe how JAKi are used in Australian patients with inflammatory diseases, and it will use novel data infrastructure developed by UNSW researchers to analyse the long-term safety of JAKi medicines in terms of cardiovascular outcomes compared to TNFi.  

Project Date

September 2023 - June 2025


Project Lead


Dr Michael Falster – UNSW Sydney

Prof Sallie Pearson – UNSW Sydney

Prof Nicole Pratt – University of South Australia


Research Question

This research will comprise two separate studies on the utilisation of JAKi medicines and long-term safety associated with JAKi medicines. 
1.     Describe the utilisation of JAKi medicines including duration of treatment and characteristics of patients initiating JAKi
2.     Describe the incidence of major adverse cardiovascular events associated with JAKi treatment relative to TNFi treatment

Data Sources

This project benefits from existing data holdings at UNSW.

The PBS 10% sample is based on a random 10% sample of the PBS-eligible population provided by Services Australia, and includes each individual’s dispensing records for all PBS-listed medicines with data from 2005-2023. 

The Medicines Intelligence Data Platform was recently established and includes the Commonwealth and NSW data sources needed to identify cardiovascular hospitalisation events associated with JAKi medicines (hospitalisation and PBS claims datasets from NSW Health and Services Australia, respectively). 

Policy Implications

Decisions of the TGA based on the ORAL Surveillance trial highlight the importance of evidence on this topic, both to understand the implications of the TGA warnings and to build a more complete understanding of the long-term safety of JAKi as a new class of high-cost medicines. There has been high uptake of JAKi medicines in Australia, with approval for multiple indications including the current indications of moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis, as well as new indications which include severe juvenile idiopathic arthritis and alopecia areata. However, there is no evidence to date about how these medicines have been used or long-term safety risks in the Australian population to inform policy.

For patients with inflammatory diseases, the chronic disease burden includes lifelong immunosuppression, increased risk of comorbid conditions such as cardiovascular disease, absences from work and reduced quality of life impacted by pain and fatigue. While new medicines such as the JAKi class may offer improved disease control, reduced functional disability and a more comfortable oral mode of administration, these potential benefits need to be balanced against possible safety risks. 

End Users

The intended audience/end-users of this research are:

  • rheumatologists, gastroenterologists and other specialists who prescribe JAKi 
  • policy-makers 
  • patients with inflammatory disease.


Stay tuned

This section will be updated throughout the project. Please return in the future to see the impact from this project.


* Ytterberg, S. R., Bhatt, D. L., Mikuls, T. R., Koch, G. G., Fleischmann, R., Rivas, J. L., … Connell, C. A. (2022). Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. New England Journal of Medicine, 386(4), 316–326. doi:10.1056/nejmoa2109927