Descriptive Study of the Incidence of Malignancy in Patients with Severe Asthma Overall and Among Those Receiving Benralizumab and Other Therapies, a Post Authorization Safety Study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies

Study drug and medical condition

• Name of medicine:
  Fasenra
• Study drug International non-proprietary name (INN) or common name:
  BENRALIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (R03DX10) benralizumab
• Medical condition to be studied:
  Neoplasm malignant

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:
  14000

Study design details

• Main study objective:
  To measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics.
• Outcomes:
  Incidence of malignancy, Describing malignancy cases that occurred
• Data analysis plan:
  This is a descriptive study with primary objective to estimate the incidence rate for malignancies in 3 cohorts of the overall severe asthma population: patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving any biologics. Observed incidence rates will be presented together with nominal 95% exact confidence intervals (Clopper-Pearson). Difference in incidence rates between the cohorts will be presented with nominal 95% confidence intervals.

Documents

Study report

D3250R00042 - Protocol v.2_Redacted

D3250R00042 - Protocol v.3_Redacted

D3250R00042 EUPAS26310-PASS-Interim study report_Redacted

D3250R00042- Second Interim Study Report_Redacted

D3250R00042-protocol-v1_Redacted

EUPAS26310_Malignancy PASS_ Third Interim Report_Redacted.pdf

Study, other information

D3250R00042 - Protocol v.2_Redacted.pdf

D3250R00042 - Protocol v.3_Redacted.pdf

D3250R00042 EUPAS26310-PASS-Interim study report_Redacted.pdf

D3250R00042-protocol-v1_Redacted.pdf