Biologics register for psoriatic arthritis (BSRBR-PSA)
Psoriatic arthritis (PsA) presents a unique clinical challenge. Characterised by synovitis, enthesitis, osteis, and skin and nail disease, it is also associated with vascular risk and increased likelihood of metabolic syndrome. It has important (including psychological) co‐morbidities, and can have significant impact on working status. The introduction of biologic therapies in the last couple of decades has significantly improved outcomes for patients with PsA, and anti-TNFα therapy is now established in the management of PsA. More recently, a number of other important molecules have been identified and therapeutics are developing apace, targeting different biological mechanism. In addition to inhibitors of TNFα (including biosimilars of existing agents) the rheumatologist now has access to IL‐12 / 23, IL‐17A, and phosphodiesterase (PDE4) inhibitors, some of which have already demonstrated impressive results in psoriasis. Although there a number of novel pharmaceuticals available for the treatment of PsA, including biologicoriginal, biosimilar, and targeted synthetic DMARDs (boDMARDs, bsDMARDs and tsDMARDs, respectively) for many of these agents, good quality long‐term data on effectiveness, cost‐effectiveness, safety, and other important outcomes is limited. Although data from clinical trials has been extremely informative, it is often collected on a narrow subset of patients. There remains a need for a large, high quality, prospective cohort study to complement such data, and to address questions not able to be answered in clinical trials
The overall aim of the BSRBR‐PsA is to provide ‘real‐world’ data, with respect to:
- The impact of PsA on the individual, including function, work, quality of life and economic impact;
- The natural history of PsA, including clinical and social (e.g. work) outcomes in the medium to longterm and the impact of disease phenotype on disease outcome;
The use of novel pharmacological agents (including boDMARDs, bsDMARDs and tsDMARDs), their use, effectiveness and predictors (including biomolecular predictors) of treatment response;
In addition, the study will:
Provide health economic data relevant to the evaluation of cost-effectiveness of different therapy options; and
Provide the infrastructure to support the collection, analysis and reporting of adverse events amongst patients on novel pharmacological agents.
We believe there is a need for a well characterised cohort study in PsA, specifically designed to be able to examine a number of research questions, and to provide real-world evidence with respect to treatment effectiveness; predictors of treatment response; impact of disease phenotype on outcome; and cost-effectiveness of therapy. In a non‐randomised study, there may be important differences between patient sub‐populations to be examined – i.e. differences between patients who are / are not commencing therapy with novel therapeutic agents. Such differences may be prognostic, and may (consciously or unconsciously) influence treatment decisions and, thus, it may be that patients with increased risk of poor outcome are enriched in one cohort over the other. Therefore, the collection of extensive baseline (and historical) data is crucial, to allow adequate control for these differences in any analysis, and to control for confounding by indication, and to minimise the likelihood of biased estimates of effect.
HERU researchers involved in this research project: Paul McNamee
External Collaborators: Jones, G., MacFarlane, G. (Other Applied Health Sciences); and Neilson, A. (University of Edinburgh)