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

NCT05157087 | Completed

• 1 other identifier: CIGE025AUS55
• Study Type: observational
• Target: 16,246
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma,; Omalizumab (Xolair),; Asthma Control,; Corticosteroids,; Pediatric,; Children,; Adolescents,; Healthcare Expenditures

Outcome Measures

Primary Outcomes (9)

• Proportion of patients with uncontrolled asthma (impairment + risk criteria) post omalizumab treatment initiation

  Uncontrolled asthma was based on either impairment or risk criteria in a 12- month consecutive period. * Impairment was identified as ≥6 Short-acting Beta Agonist (SABA) prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. * Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. * The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria) or the first exacerbation outcome during a consecutive 12-months (risk criteria).

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Proportion of patients with excessive SABA use (≥6 SABA prescriptions dispensed in 12 months) (impairment criteria)

  Proportion of patients with uncontrolled asthma (impairment criteria) were reported. Impairment was identified as ≥6 SABA prescriptions dispensed in 12 months. Each prescription should reflect one month days supply. \- The date of uncontrolled asthma assessment was defined as the earliest date between the sixth SABA prescription (impairment criteria).

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Proportion of patients with exacerbations requiring IP visits (risk criteria)

  Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. \- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Proportion of patients with exacerbations requiring ED visits (risk criteria)

  Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. \- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Proportion of patients with exacerbations requiring Oral corticosteroids (OCS) prescriptions (risk criteria)

  Proportion of patients with uncontrolled asthma (risk criteria) were reported. Risk was defined as ≥1 unique exacerbation(s) in 12 months, including asthma-related ED visits or hospitalizations (emergency or hospital care with a diagnosis of asthma in the first position only \[ICD-9 code 493.xx, ICD-10 code J45.xx\]) or an OCS dispensing within 7 days AFTER an outpatient visit with an asthma diagnosis in ANY position. \- The date of uncontrolled asthma assessment was defined as the first exacerbation outcome during a consecutive 12-months (risk criteria).

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Mean daily dose of Inhaled Corticosteroids (ICS) use

  Mean daily dose of Inhaled Corticosteroids (ICS) use was reported during the follow-up

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Mean cumulative dose of OCS use

  Mean cumulative dose of Oral corticosteroids were reported during follow-up

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Mean number of prescriptions of OCS use

  Mean number of prescriptions of OCS use were reported during follow-up

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

• Mean days of supply of OCS use

  Mean days of supply of OC were reported during follow-up

  12 months after index date (Index date defined as the date of the first medical or pharmacy claim of omalizumab between 07/07/2016 - 12/31/2018 index period)

Secondary Outcomes (10)

• Proportion of uncontrolled asthma patients (total: risk and impairment criteria)

  through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)

• Proportion of uncontrolled asthma patients (per impairment criteria)

  through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)

• Proportion of uncontrolled asthma patients (per risk criteria)

  through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)

• Mean difference in the total number of asthma-related prescriptions

  through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)

• Mean difference in daily dose (of days supply) of ICS use

  through study completion, approximately 4 years (Study Period: 07/07/2015 - 12/31/2019)

Study Arms (2)

Commercial Population

Individuals with at least one omalizumab prescription in the Marketscan commercial claims during the identification period (07/07/2016 - 12/31/2018)

Drug: Omalizumab

Medicaid Population

Individuals with at least one omalizumab prescription in the Truven Medicaid claims during the identification period (07/07/2016 - 12/31/2018)

Drug: Omalizumab

Interventions

Omalizumab DRUG

Omalizumab use was analyzed in two categories. First, initiators were defined as individuals with ≥ 1 omalizumab prescription. "Responders" were defined as individuals with at least 4 administrations of omalizumab.

Commercial Population; Medicaid Population

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

asthmatic patients, aged 6-11, with omalizumab use

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigational Site

East Hanover, New Jersey, 07936-1080, United States

Location

Related Links

• Results for CIGE025AUS55 from the Novartis Clinical Trials Website

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 14, 2021
• Study Start: March 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

US (1)