Aletaha D, Smolen JS. Diagnosis and management of rheumatoid arthritis: a review. JAMA. 2018;320:1360–72.

Article  PubMed  Google Scholar 

Shapira Y, Agmon-Levin N, Shoenfeld Y. Geoepidemiology of autoimmune rheumatic diseases. Nat Rev Rheumatol. 2010;6:468–76.

Article  CAS  PubMed  Google Scholar 

Fraenkel L, Bathon JM, England BR, St.Clair EW, Arayssi T, Carandang K, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2021;73:1108–23.

Article  PubMed  Google Scholar 

Smolen JS, Landewé RB, Bergstra SA, Kerschbaumer A, Sepriano A, Aletaha D, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82:3–18.

Article  CAS  PubMed  Google Scholar 

Kerschbaumer A, Sepriano A, Bergstra SA, Smolen JS, Van Der Heijde D, Caporali R, et al. Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2022 update of the EULAR recommendations for the management of rheumatoid arthritis. Ann Rheum Dis. 2023;82:95–106.

Article  CAS  PubMed  Google Scholar 

Ackerman IN, Pratt C, Gorelik A, Liew D. Projected burden of osteoarthritis and rheumatoid arthritis in australia: a population-level analysis. Arthritis Care Res. 2018;70:877–83.

Article  Google Scholar 

Almutairi K, Nossent J, Preen DB, Keen H, Inderjeeth C. The temporal association between hospital admissions, biological therapy usage and direct health care costs in rheumatoid arthritis patients. Rheumatol Int. 2022;42:2027–37.

Article  PubMed  Google Scholar 

Fletcher A, Lassere M, March L, Hill C, Barrett C, Carroll G, et al. Patterns of biologic and targeted-synthetic disease-modifying antirheumatic drug use in rheumatoid arthritis in Australia. Rheumatology. 2022;61:3939–51.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Declerck P, Danesi R, Petersel D, Jacobs I. The Language of Biosimilars: Clarification, Definitions, and Regulatory Aspects. Drugs. 2017;77:671–7.

Article  PubMed  PubMed Central  Google Scholar 

MedicineWise NPS. Biologics, biosimilars and PBS sustainability. 2021.

Pharmaceutical Benefits Scheme. PBS expenditure and prescriptions. https://m.pbs.gov.au/info/statistics/expenditure-prescriptions/pbs-expenditure-and-prescriptions.html.

Therapeutic Goods Administration. Australian public assessment report for etanercept (rch). Australian Government Department of Health and Aged Care; 2017.

Emery P, Vencovskỳ J, Sylwestrzak A, Leszczyński P, Porawska W, Baranauskaite A, et al. A phase III randomised, double-blind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017;76:51–7.

Article  CAS  PubMed  Google Scholar 

Monti S, Grosso V, Todoerti M, Caporali R. Randomized controlled trials and real-world data: differences and similarities to untangle literature data. Rheumatology. 2018;57:vii54–8.

Article  CAS  PubMed  Google Scholar 

Aggarwal S, Topaloglu O, Kumar S. Real world evidence for effectiveness of biologics for rheumatoid arthritis: systematic literature review of population based registry studies. Value Health. 2018;21:S192.

Article  Google Scholar 

Kearsley-Fleet L, Rokad A, Tsoi M-F, Zhao SS, Lunt M, Watson KD, et al. Etanercept originator versus etanercept biosimilar for the treatment of rheumatoid arthritis as a first biologic: results from the BSRBR-RA. Rheumatology. 2023;62:3849–57.

Article  PubMed  PubMed Central  Google Scholar 

Jourdain H, Hoisnard L, Sbidian E, Zureik M. Persistence and safety of anti-TNF biosimilars versus originators in immune-mediated inflammatory diseases: an observational study on the French National Health Data System. RMD Open. 2024;10: e003531.

Article  PubMed  PubMed Central  Google Scholar 

Di Giuseppe D, Lindstrom U, Bower H, Delcoigne B, Frisell T, Chatzidionysiou K, et al. Comparison of treatment retention of originator vs biosimilar products in clinical rheumatology practice in Sweden. Rheumatology. 2022;61:3596–605.

Article  PubMed  Google Scholar 

Deakin CT, Littlejohn GO, Griffiths H, Ciciriello S, O’Sullivan C, Smith T, et al. Comparative effectiveness of etanercept originator and biosimilar for treating rheumatoid arthritis: implications for cost-savings. Intern Med J. 2024;54:795–801.

Article  PubMed  Google Scholar 

Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials? Clin Pharmacol Ther. 2017;102:924–33.

Article  PubMed  Google Scholar 

de Castro CT, de Queiroz MJ, Albuquerque FC, Brandao CC, Gerlack LF, Pereira DCR, et al. Real-world effectiveness of biological therapy in patients with rheumatoid arthritis: systematic review and meta-analysis. Front Pharmacol. 2022;13: 927179.

Article  PubMed  PubMed Central  Google Scholar 

Grijalva CG, Chung CP, Arbogast PG, Stein CM, Mitchel EF Jr, Griffin MR. Assessment of adherence to and persistence on disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis. Med Care. 2007;45:S66-76.

Article  PubMed  Google Scholar 

Weinstein CL, Meehan AG, Lin J, Briscoe SD, Govoni M. Long-term golimumab persistence: five-year treatment retention data pooled from pivotal phase III clinical trials in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Clin Rheumatol. 2023;42:3397–405.

Article  PubMed  PubMed Central  Google Scholar 

Jones G, Hall S, Bird P, Littlejohn G, Tymms K, Youssef P, et al. A retrospective review of the persistence on bDMARD s prescribed for the treatment of rheumatoid arthritis in the Australian population. Int J Rheum Dis. 2018;21:1581–90.

Article  CAS  PubMed  Google Scholar 

Acar M, Juneja P, Handel M. Treatment persistence of subcutaneous TNF inhibitors among Australian patients with immune-mediated rheumatic disease (IMRD). Open Access Rheumatol Res Rev. 2018;10:151–60.

CAS  Google Scholar 

Angeles MR, Crosland P, Hensher M. Challenges for Medicare and universal health care in Australia since 2000. Med J Aust. 2023;218:322–9.

Article  PubMed  Google Scholar 

Australian Institute of Health and Welfare. Medicare subsidised GP, allied health and specialist care across local areas. https://www.aihw.gov.au/reports/primary-health-care/medicare-subsidised-gp-allied-healthspecialist/contents/about.

Mellish L, Karanges EA, Litchfield MJ, Schaffer AL, Blanch B, Daniels BJ, et al. The Australian Pharmaceutical Benefits Scheme data collection: a practical guide for researchers. BMC Res Notes. 2015;8:634.

Article  PubMed  PubMed Central  Google Scholar 

Australian Bureau of Statistics. Microdata: person level integrated data asset (PLIDA) [DataLab].

Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. The lancet. 2007;370:1453–7.

Article  Google Scholar 

Australian Bureau of Statistics. Socio-economic indexes for areas. https://www.abs.gov.au/websitedbs/censushome.nsf/home/seifa.

Australian Bureau of Statistics. Remoteness areas. https://www.abs.gov.au/statistics/standards/australian-statistical-geography-standard-asgs-edition-3/jul2021-jun2026/remoteness-structure/remoteness-areas.

Pratt NL, Kerr M, Barratt JD, Kemp-Casey A, Ellett LMK, Ramsay E, et al. The validity of the Rx-Risk comorbidity index using medicines mapped to the anatomical therapeutic chemical (ATC) classification system. BMJ Open. 2018;8: e021122.

Article  PubMed  PubMed Central  Google Scholar 

Yiu CH, Yau GTY, Wong ZH, Lin C, Day RO, Raubenheimer J, et al. Comparative effectiveness and safety of biosimilars versus reference biologics in rheumatoid arthritis during treatment initiation: a systematic review of real-world evidence. Int J Clin Pharm. 2025. https://doi.org/10.1007/s11096-025-01956-6.

Article  PubMed  Google Scholar 

Harnett J, Gerber R, Gruben D, Koenig AS, Chen C. Evaluation of real-world experience with tofacitinib compared with adalimumab, etanercept, and abatacept in RA patients with 1 previous biologic DMARD: data from a U.S. Administrative Claims Database. J Manag Care Spec Pharm. 2016;22:1457–71.

PubMed  Google Scholar 

Rashid N, Lin AT, Aranda G, Lin KJ, Guerrero VN, Nadkarni A, et al. Rates, factors, reasons, and economic impact associated with switching in rheumatoid arthritis patients newly initiated on biologic disease modifying anti-rheumatic drugs in an integrated healthcare system. J Med Econ. 2016;19:568–75.

Article  PubMed  Google Scholar 

Lamberg T, Sipponen T, Valtanen S, Eklund KK, Mälkönen T, Aalto K, et al. Short interruptions of TNF-inhibitor treatment can be associated with treatment failure in patients with immune-mediated diseases. Autoimmunity. 2022;55:275–84.

Article  CAS  PubMed  Google Scholar 

Stuart EA, Lee BK, Leacy FP. Prognostic score–based balance measures can be a useful diagnostic for propensity score methods in comparative effectiveness research. J Clin Epidemiol. 2013;66:S84