Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Psoriatic arthropathy
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

1446
Study design details

Main study objective

The overall aim is 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 long-term and the impact of disease phenotype on disease outcome,• The use of bDMARDs/tsDMARDs, including effectiveness and predictors of treatment response,

Outcomes

As described above, the BSR-PsA is set up to answer a number of questions related to natural history, outcome, treatment effectiveness and co-morbidities. Different analyses will have different end points, including:• Minimum disease activity,• Incidence of serious infection,• Adverse work outcome, and• Quality of life.

Data analysis plan

Initial analyses will consist of comparisons in between cohorts. The precise analysis will depend on the specific question being addressed, but all analyses will have a detailed pre-specified analysis plan. As an indicative example of the sort of analysis to be conducted.Differences in treatment outcome (Minimal Disease Activity) between exposed / non-exposed groups would be examined with simple descriptive statistics. A logistic model would then be fitted to estimate the odds ratio for MDA between patients. The model would be statistically adjusted for other exposures and patient characteristics associated with both the primary exposure and the outcome, to control for potential confounding.