XOLAIR (Omalizumab) Outcomes in Pediatric Allergic Asthma Patients in the United States

Novartis

Status

Completed

Conditions

Asthma

Treatments

Drug: Omalizumab

Study type

Observational

Funder types

Industry

Identifiers

NCT05157087

CIGE025AUS55

Details and patient eligibility

About

A retrospective database pre-post cohort study, identifying asthmatic patients, aged 6- 11, with omalizumab use over 24 months

Full description

This was a retrospective database pre-post cohort study, identifying asthmatic patients with omalizumab use over 24 months. Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab claims. "Responders" were defined as individuals with at least 4 omalizumab claims. Descriptive statistics are provided for both groups, but outcomes are reported only for responders.

For this study, any persons from the Marketscan database with an asthma diagnosis and >= 1 omalizumab prescription/administration during the index period were identified. From this patient population the inclusion and exclusion criteria were applied, resulting in the final study cohort. Each person was assigned an index date based on their initial use of omalizumab.

Study Period: 07/07/2015 - 12/31/2019 Index Period: 07/07/2016 - 12/31/2018 Index Date: The date of the first medical or pharmacy claim of omalizumab Baseline Period (pre-index): 12 months before index date Follow up Period (post-index): 12 months after index date

The MarketScan® Claims Database (including commercial and Medicaid claims) was used. The claims database included data from 07/08/2015 - 12/31/2019. The MarketScan® Databases capture personspecific clinical utilization, expenditures, and enrollment across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The current study used the Commercial, Medicare Supplemental and Multi-State Medicaid Databases.

Enrollment

16,246 patients

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

We used all eligible Marketscan beneficiaries with an asthma diagnosis and omalizumab use between 07/07/2016 - 12/31/2018 (index period). Continuous enrollment in the Marketscan database was required to ensure the availability of claims data to capture study outcomes and covariates.

Omalizumab cohort was defined as ≥1 prescription claims within the index period, with the date of first dispensing deemed the index date.
Asthma was defined by ≥1 diagnosis code in any available diagnosis field on or prior to index date.

ICD-9-CM: 493.xx OR ICD-10-CM: J45.x

6-11 years of age at the time of index
≥12-months pre-index and ≥12-months post-index continuous eligibility in medical and pharmacy benefits
Enrollment gap of ≤30 days will be considered continuous enrollment

Exclusion criteria

Patients were excluded from the study if they had one or more of the following:

Bronchial Thermoplasty at any time during data capture. Current Procedural Terminology (CPT): 31660, 31661
Prior asthma-indicated biologic use during the 12 months pre or post-index

Omalizumab:

NDC: 50242004062; 50242004201 or HCPCS: J2357; S0107; C9217

Mepolizumab:

NDC: 00173088101, 00173088185 or HCPCS: J2182

Reslizumab:

NDC: 5931061031 or HCPCS: J2786

Benralizumab:

NDC: 0310173030 or HCPCS: C9466

Dupilumab:

NDC: 0024591400 or 0024591800