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 use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Non-randomized, active-comparator, new-user, retrospective study
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J06BA02) immunoglobulins, normal human, for intravascular adm.
immunoglobulins, normal human, for intravascular adm.

Medical condition to be studied

Chronic inflammatory demyelinating polyradiculoneuropathy
Population studied

Short description of the study population

The study population included adult patients aged ≥ 18 years with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) received treatment with intravenous immunoglobulin in the years 2008 through 2019 identified from IBM MarketScan Research Databases, and Optum Clinformatics Data Mart.
Inclusion criteria
To be eligible for inclusion in either study cohort:
• Have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date (to accurately define patient characteristics). Gaps in continuous enrollment ≤ 31 days are permitted.
• Fulfill the CIDP diagnosis algorithm on or before the index date using all available baseline data for each patient.
To be eligible for the Ig-naive (new-to-class) cohort:
• Be free of any previous recorded use of any Ig product (i.e., study IVIG products, nonstudy IVIG products, or subcutaneous Ig products) at any point before IVIG initiation
To be eligible for the Ig-experienced (new-to-drug) cohort:
• Have any previous recorded use of an Ig product (i.e., study IVIG products, nonstudy IVIG products, or subcutaneous Ig products) at any point before the index date
Exclusion criteria:
Patients in both study cohorts will be excluded if they fulfill any of the following exclusion criteria:
• Having claims for ≥ 2 different IVIG products on the index date, as accurate categorization of the index IVIG product would not be possible
• Recorded diagnosis of any of the following conditions on or before the index date, to reduce the potential for misclassification of CIDP status among patients using IVIG
– PID, as PID is an approved indication for treatment with GGL
– Evidence of secondary immunodeficiency (SID), including patients with recorded diagnoses of hematological malignancy (e.g., diagnosis of multiple
myeloma or chronic lymphocytic leukemia) or treatment with rituximab, as short courses of IVIG may be used for SID treatment
– Idiopathic thrombocytopenic purpura (ITP)

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

Chronic inflammatory demyelinating polyradiculoneuropathy patients

Estimated number of subjects

7000
Study design details

Main study objective

The objective is to study to evaluate the rates of adverse events of special interest (AESIs) (thrombotic events, acute kidney injury AKI, and hemolytic events) among participants with CIDP initiating GGL compared with rates among participants with CIDP initiating comparator intravenous immunoglobulin (IVIG) products.

Outcomes

1. Hazard ratio of Thrombotic Events (TEs) between GGL and comparator IVIG products 2. Hazard ratio of Acute kidney injury (AKI) between GGL and comparator IVIG products 3. Hazard ratio of Hemolytic Events (HEs) between GGL and comparator IVIG products, 1. Hazard ratio of Anaphylaxis between GGL and comparator IVIG products 2. Hazard ratio of Transfusion-related Acute Lung Injury (TRALI) between GGL and comparator IVIG products 3. Hazard ratio of transfusion-associated Circulatory Overload (TACO) between GGL and comparator IVIG products

Data analysis plan

All analyses will be performed separately in the 2 data sources (MarketScan Research Databases, Optum Clinformatics Data Mart) and the data source-specific results will be reported separately. Pooling of the final results across data sources will be performed, if appropriate. Within each data source, the 2 cohorts (Ig naive and Ig experienced) will be analyzed and reported separately, except in secondary analyses combining the 2 cohorts.
Documents
Study results
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