Effect of treatment with biological agents for arthritis in Australia: the Australian Rheumatology Association Database

Abstract

Evidence-based information about the long-term outcome of bDMARD therapy is essential for clinicians, consumers, policy-makers, drug development companies and approval agencies, to enable better care and improved outcomes for patients with inflammatory arthritis.

How many life years are lost in patients with rheumatoid arthritis? Secular cause‐specific and all‐cause mortality in rheumatoid arthritis, and their predictors in a long‐term Australian cohort study

“…ARAD has been operating since 2003. 16 However, large, long-term international bDMARD cohorts have published early data on the relationship between TNF-a treatment and mortality. 17,18 The South Swedish Arthritis Treatment Group (established in 1999) registry and the British Society for Rheumatology Biologics Register (BSRBR, established in 2001) examined whether TNF-a inhibitor treatment was associated with increased mortality compared with patients on conventional DMARD.…”

Monitoring drug safety with registries: useful components of postmarketing pharmacovigilance systems

“…Launched in 2001, the BSRBR has provided important data on the long-term safety of antitumor necrosis factor therapies and their relationships with serious infections, myocardial infarction, and congenital malformations in pregnant patients [12]. The ARAD was established to obtain more representative data on the use of biological disease-modifying antirheumatic drugs (DMARDS) in Australia and provide better estimates of the incidence of ADRs in RA patients treated with DMARDS [13]. This national registry has become a useful tool for monitoring quality of life, health care utilization, and the impact of therapy switching in a clinically representative cohort of patients, of whom just 5% meet the inclusion criteria of published RCTs [14].…”

Stakeholder Satisfaction with the Australian Rheumatology Association Database (ARAD)

“…[5] This national database is partially funded by an Australian National Health and Medical Research Council (NHMRC) Enabling Grant, and by industry through unrestricted grants paid to the ARA. The background, structure, and governance of the ARAD have been described previously.…”

“…The background, structure, and governance of the ARAD have been described previously. [5] As of May 2008, there were 2334 patients and 178 rheumatologists actively participating (67.9% of ARA member rheumatologists active in clinical practice) in the ARAD. While we cannot completely verify the generalizability of ARAD data to all Australians receiving biological therapy, the ARAD participants are drawn from all over Australia and from a variety of settings including hospital-and community-based care, and metropolitan, regional, and rural practices.…”

“…For this reason, several countries, including Australia, have established long-term observational studies in the form of health registries for the purpose of monitoring the long-term safety and efficacy of bDMARDs used in routine clinical care. [5] Health registries provide an ideal means of monitoring drug safety and efficacy in a 'real world' context since consumer participation is not restricted by rigid inclusion criteria, as is the case in randomized controlled trials (RCTs). For example, a recent study [6] reported that only 5% of patients typically seen in practice would be eligible for inclusion in a bDMARD RCT.…”