Incidence and prevalence of Antiphospholipid Syndrome in United Kingdom.

Study type
Protocol
Date of Approval
Study reference ID
21_000347
Lay Summary

Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by “sticky” blood resulting in recurrent blood clots (thrombosis) or pregnancy complication. Nowadays, anticoagulants and blood thinners form the cornerstone of treatment, but a significant proportion of patients continue to experience thrombosis or pregnancy complication despite this treatment. In order to develop better treatments for APS, it is important to first understand the epidemiology of the disease including incidence and prevalence in the UK population.
The Clinical Practice Research Datalink (CPRD) database is a large collection of anonymized information on patients in the United Kingdom, that makes it suitable for estimation of incidence and prevalence. In this study we will be measuring incidence and prevalence in the primary care record with linkage to HES in patients and outpatients to determine how the occurrence of APS varies by age and sex.

Technical Summary

The incidence and prevalence of antiphospholipid antibody syndrome (APS) is largely unknown. Duarte-Garcia (2019) has estimated for the population of Olmsted County, Minnesota, with the age- and sex-adjustment to the 2010 US white population: the overall annual incidence rate of adults aged ≥ 18 years was 2.1 (95% CI: 1.4-2.8) per 100,000, and the prevalence was 50 per (95% CI: 42-58) 100,000. Gomez-Puerta (2014) estimated the incidence as 5 cases per 100,000 person-years and prevalence of 40-50 cases per 100,000 persons. Given this lack of data we intend to estimate these rates in the population of UK by using the CPRD database over the period study 2010-2019. The target study population included persons in UK who are registered with a primary care practice included in the CPRD primary care databases (GOLD or Aurum)For practices permitting linkage to the HES datasets, sensitivity analysis will be undertaken to assess the robustness of incidence and prevalence estimates based on primary care records versus hospital; records.
We will estimate for each year age- and sex-specific and age- and sex-standardized incidence rates and prevalence.

Health Outcomes to be Measured

Incidence and prevalence of antiphospholipid syndrome.

Collaborators

Meheni khellaf - Chief Investigator - UCB Biopharma SRL - Belgium Headquarters
Meheni khellaf - Corresponding Applicant - UCB Biopharma SRL - Belgium Headquarters
Paul Dolin - Collaborator - UCB Biopharma SRL - Belgium Headquarters

Linkages

HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data