Rates for Anaphylaxis for Patients with Rheumatoid Arthritis Treated with Tocilizumab or Other Biologics: An Analysis Based on Health Claims Data

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective database study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TOCILIZUMAB
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  Patients with rheumatoid arthritis treated with Tocilizumab or other biologics.
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Rheumatoid arthritis patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  Incidence rate of anaphylaxis and fatal anaphylaxis
• Outcomes:
  - Incidence rate of anaphylaxis and fatal anaphylaxis- Incidence rate of fatal anaphylaxis
• Data analysis plan:
  For IV drugs, anaphylaxis rates will be calculated for events occurring within 7 days, 14 days and 30 days following anaphylaxis. The primary analysis is that of events occurring within 7 days of drug infusion. The rest are sensitivity analyses.Fatal Anaphylaxis rates will be calculated for events occurring within 7 days, 14 days and 30 days following anaphylaxis. The primary analysis will be for fatal events occurring within 7 days of anaphylaxis. Fatal events occurring with 14 and 30 days will be conducted as sensitivity analyses.Descriptive statistics including patient numbers and proportions will be calculated for all study cohorts by patient age, gender, insurance plan, and region. Duration of enrollment (i.e. database history) will be calculated from enrollment date to index date and from index date to disenrollment or database cutoff date. Means with standard deviation (SD) and medians with interquartile range (IQR) will be presented where appropriate.