Treatment patterns and drug utilisation for medicines of regulatory interest in autoimmune disease

Study type
Protocol
Date of Approval
Study reference ID
23_003161
Lay Summary

The 'Data Analysis and Real World Interrogation Network (DARWIN EU)' is an initiative created by the European Medicines Agency (EMA) to generate timely evidence from healthcare data sources from across Europe. One area of research relates to estimating how often and for how long specific medicines of interest are prescribed and/or dispensed. For regulators it is important to have access to this information as it provides insight in the uptake of specific medicines in the community and whether use of these medicines changes over time influenced by regulatory measures to protect public health such as withdrawal of medication, change in labelling, safety warnings etc.
The objective of this study is to describe the treatment patterns of specific medicines of interest. We will describe these patterns, in particular time of starting medication from diagnosis, combination of medication types, and sequence of treatment. All these will be calculated in specific populations of interest based on age and sex groups, and over calendar years to look at possible changes over time. Secondly, we will look at the indications or reasons for these medicines, and how long and at what strength they are prescribed. We will also explore characteristics of patients prescribed/dispensed the drugs in terms of medical conditions and concomitant medicine use.

Technical Summary

Primary care records provide a unique source of data for describing treatment patterns and medication use in the community, as most medicines are prescribed by general practitioners. The DARWIN EU initiative created by the European Medicines Agency (EMA) intends to draw upon such data to inform regulatory decision-making. To understand the uptake of specific drugs of interest and to study routine clinical practice and the effect of regulatory actions on drug prescribing/dispensing, EMA will commission several drug utilisation and treatment pattern studies to the DARWIN Coordination Centre. Data sources will be mapped to the OMOP common data model (CDM) prior to analysis.
Study design: Cohort study
Population: All people in CPRD GOLD or CPRD Aurum with >=1 year of prior history will be eligible, with sensitivity analyses using different prior history requirements.
Variables: Drug exposure based on prescription data as available within CPRD GOLD or CPRD Aurum. Drugs will be selected by means of the respective RxNorm codes.
In addition, the characteristics of patients being diagnosed with condition(s) of interest and prescribed/dispensed the drug(s) of interest will be described, and the use of the prescribed medicine over time assessed in terms of indication of
use, duration, strength and/or dose. Treatment patterns will also be described in terms of time of initiation from diagnosis, combination types and sequence of therapy.
Population and Drug of interest as expressed by EMA:
• Systemic lupus erythematosus (SLE) and treatments of SLE in paediatric and adult population
Additional study populations and medicines will be declared in future protocol amendments upon by EMA to the DARWIN Coordination Centre.
Analyses: Drug utilisation and treatment patterns stratified by age, sex, and calendar year. Description of
patient characteristics at diagnosis or therapy initiation, and use of medicine/s over time.

Health Outcomes to be Measured

Drug utilisation and treatment patterns

Collaborators

Daniel Prieto-Alhambra - Chief Investigator - University of Oxford
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Albert Prats Uribe - Collaborator - University of Oxford
Annika Jodicke - Collaborator - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Hezekiah Omulo - Collaborator - University of Oxford
Junqing Xie - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Martí Català Sabaté - Collaborator - University of Oxford
Mike Du - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Xintong Li - Collaborator - University of Oxford

Linkages

HES Admitted Patient Care