A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Takeda

Status: Completed

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05363358

EUPAS46101 (Other Identifier)

TAK-771-4002

Details and patient eligibility

About

The main aim of this study is 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.

No study medicines will be provided to participants in this study.

Enrollment: 6,086 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date. Gaps in continuous enrollment less than or equal to (<=) 31 days are permitted.
• Fulfill the Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) diagnosis algorithm on or before the index date using all available baseline data for each participant.
• Additionally, to be eligible for the Ig-naive (new-to-class) cohort, participants will be required to meet the following inclusion criterion:
• Be free of any previous recorded use of any Ig product at any point before IVIG initiation.
• To be eligible for the Ig-experienced (new-to-drug) cohort, participants will be required to meet the following inclusion criterion:
• Have any previous recorded use of an Ig product at any point before the index date.

Exclusion criteria

• Having claims for greater than or equal to (>=) 2 different IVIG products on the index date.

• Recorded diagnosis of any of the following conditions where Ig products are used for treatment on or before the index date

  1. Primary immunodeficiency disease (PID).
  2. Evidence of secondary immunodeficiency (SID), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab.
  3. Idiopathic thrombocytopenic purpura (ITP).
  4. Dermatomyositis or polymyositis.
  5. Systemic sclerosis/scleroderma.
  6. Myasthenia gravis.

Trial design

6,086 participants in 2 patient groups

Ig-naive (New-to-class) Cohort

Description:

Participants who initiate GGL or one of the comparator IVIG products who have no record of previous use of any Ig product (Ig naive) for at least 6 months before study initiation will be include in this cohort.

Ig-experienced (New-to-drug) Cohort

Description:

Participants who initiate either GGL or a comparator IVIG product with no record of previous use of that specific IVIG product but with previous use of any other Ig product (Ig experienced) in all available study data will be included in this cohort.