Study type

Study type

Non-interventional study

Scope of the study

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

Non-interventional study design

Cohort
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

RITUXIMAB
ELTROMBOPAG
ROMIPLOSTIM

Medical condition to be studied

Immune thrombocytopenia
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

10000
Study design details

Main study objective

To build a national cohort of adult incident persistent or chronic primary ITP patients to describe exposure to available second-line treatments (in 2013, splenectomy, rituximab and TPO-RA).

Outcomes

Delivered data are raw. We will constitute the cohort as follows: 1) exclusion of probable erroneous codes, 2) exclusion of secondary ITP, 3) definition of diagnosis date through drug dispensing, 4) restriction to incident patients, 5) restriction to adults (≥18 years), 6) restriction to persistent or chronic ITP, 7) definition of index date (first persistent ITP treatment). Mortality: the date of death is indicated in the SNIIRAM.Efficacy outcomes: hospitalization for bleeding, ITP drug withdrawal, non-introduction of a new treatment for ITP, cumulative dose of corticosteroids.Safety outcomes: infections (hospitalizations or antibiotics dispensing), hospitalizations for cardio-vascular and venous thrombo-embolic events, cancers (including hematological).

Data analysis plan

Exposure to drugs will be calculated with Defined Daily Doses when applicable. For outcome occurrence assesment, Cox models will be performed. Time-varying analyses will be used to assess drug exposure.