DARWIN EU® - Assessment of immunoglobulin use in clinical practice

Study type

• Study topic:
  Human medicinal product
• Study topic, other:
  Immunoglobulins
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  mmunoglobulins: respiratory syncytial virus immune globulin intravenous, ; immunoglobulin G, freeze-dried pepsin-treated human normal immunoglobulin, ph4; treated acidic human normal immunoglobulin, ph4-treated acidic human normal ; immunoglobulin (for s.c. injection), polyethylene glycol-treated human normal ; immunoglobulin, freeze-dried ph4-treated human normal immunoglobulin, freeze; dried sulfonated human normal immunoglobulin, freeze-dried polyethylene glycol; treated human normal immunoglobulin, immunoglobulin M human, immunoglobulin A, ; Rho(D) immune globulin, tetanus immune globulin, varicella-zoster immune globulin, ; hepatitis B immune globulin, rabies immune globulin human, Immunoglobulin Anti; Rubella, human vaccinia immune globulin, staphylococcus epidermidis immunoserum ; rabbit, staphylococcus aureus immunoserum, cytomegalovirus immune globulin, ; diphtheria antitoxin, hepatitis A immunoglobulin (systemic), Immunoglobulin Anti; Tickborne Encephalitis, pertussis immunoglobulin; systemic, measles immunoglobulin; ; systemic mumps immunoglobulin; systemic, anthrax immune globulin, Bacillus ; anthracis immunoserum rabbit, Nebacumab, raxibacumab, bezlotoxumab, ; obiltoxaximab, palivizumab, MOTAVIZUMAB, tixagevimab, ansuvimab, sotrovimab, ; REGDANVIMAB, casirivimab, nirsevimab, Sipavibart

Population studied

• Short description of the study population:
  The study population included all individuals present in the data source (objective 1), those with a drug prescription or dispensing record of immunoglobulin (objective 2), or individuals with a first drug prescription or dispensing record of immunoglobulin (objectives 3 and 4) during the study period, between 01/01/2017 and 31/12/2024.

Study design details

• Study design:
  A descriptive retrospective cohort study will be conducted.
• Main study objective:
  1. To describe clinical treatment of patients that receive immunoglobulin, including:; a) Type of immunoglobulin use and route of administration (IV, SC, IM); b) Dose and frequency of dosing; ; 2. To characterise patients using immunoglobulins:; a) while on treatment, including:; - common infections and antibiotics used ; b) at baseline, including:; - any prior vaccinations (ATC J07); - comorbidities (auto-immune disorders); - pre-specified indications of use (authorized and off-label)
• Outcomes:
  The outcomes of interest were as follows: ; • Prevalence of individuals with a recorded immunoglobulin prescription among the general population, including type of immunoglobulin, route of administration (objective 1). ; • Proportion of individuals with a prespecified immunoglobulin brands prescription among prevalent immunoglobulin users (objective 2). ; • Initial and cumulative dose, number of prescriptions, and treatment duration of prespecified immunoglobulin brands among treatment initiators (objective 3). ; • Characterisation of individuals initiating treatment with prespecified immunoglobulin brands (objective 4).