Last updated: 11/28/2022 08:10:05
Changes in oral corticosteroid use (OCS) post initiation of mepolizumab therapy in subjects with asthma
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Changes in Oral Corticosteroid Use Following Initiation of Mepolizumab Therapy in Patients with Asthma
Trial description: Asthma is a common chronic respiratory disorder that affects millions of children and adults in the United States (U.S). Asthma is characterized by periodic exacerbations by chronically hyperactive and inflamed airways that can be mild, moderate, or severe. The U.S. Food and Drug Administration (FDA) approved Nucala (mepolizumab) in November-2015 for add-on maintenance treatment in subjects 12 years or older with severe asthma. Mepolizumab is a humanized interleukin-5 antagonist monoclonal antibody administered by subcutaneous injection by a health care professional via subcutaneous injection in a hospital outpatient setting, infusion center, or physician’s office. It is critical to understand the real-world impact of mepolizumab on OCS. This retrospective observational study will investigate impact of mepolizumab on OCS use by comparing the year prior to the administration of mepolizumab to the year after using a commercial insurance database. The MarketScan Commercial Claims and Encounters Database will be used for this study.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects with any OCS use
Timeframe: Up to 12 Months post-dose of mepolizumab
Mean number of OCS pharmacy claims per subject
Timeframe: Up to 12 Months post-dose of mepolizumab
Number of subjects with chronic OCS use
Timeframe: Up to 12 Months post-dose of mepolizumab
Secondary outcomes:
Number of subjects with changes in the rate of asthma exacerbations
Timeframe: Up to 12 Months post-dose of mepolizumab
Number of subjects with asthma exacerbation-related healthcare resource use
Timeframe: Up to 12 Months post-dose of mepolizumab
Number of subjects with asthma exacerbation-related healthcare resource cost
Timeframe: Up to 12 Months post-dose of mepolizumab
Number of subjects who experience an exacerbation resulting in a hospitalization
Timeframe: Up to 12 Months post-dose of mepolizumab
Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2019-26-09
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Silver J, Bogart M, Packnett E, Wu J, McMorrow D, Hahn B. Real-World Reductions in Oral Corticosteroid Use Following Mepolizumab Therapy for Severe Asthma. J Asthma Allergy. 2020;13:689-699
DOI: 10.2147/JAA.S275944
PMID: 33364788
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
August 2019 to September 2019
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12 - 64 Years
Accepts healthy volunteers
No
- Subjects with mepolizumab administration between 01-November-2015 and 30-September-2017. The date of the first claim for mepolizumab during the patient identification period will be considered as the index date.
- Subjects with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (baseline period).
- Subjects with evidence of mepolizumab use during the 12-month baseline period.
- Subjects with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) codes) during the 12-month baseline or follow-up period.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with mepolizumab administration between 01-November-2015 and 30-September-2017. The date of the first claim for mepolizumab during the patient identification period will be considered as the index date.
- Subjects with at least 12 months of continuous enrollment with medical and pharmacy benefits before the index date (baseline period).
- Subjects with least 12 months of continuous enrollment with medical and pharmacy benefits after the index date (follow-up period).
- Subjects with at least 12 years of age on the index date.
- Subjects with more than 1 asthma diagnosis (International Classification of Diseases ([CD]-9: 493.xx, ICD-10: J45.xx) in any position on a non-diagnostic medical claim during the 12-month baseline period.
- Subjects with more than or equal to 2 mepolizumab administrations during the first 6 months of the follow-up period.
Exclusion criteria:
- Subjects with evidence of mepolizumab use during the 12-month baseline period.
- Subjects with evidence of omalizumab, reslizumab, benralizumab, or dupilumab use (as assessed by Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) codes) during the 12-month baseline or follow-up period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2019-26-09
Actual study completion date
2019-26-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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