Last updated: 11/03/2025 09:40:13

Real-World Effectiveness of Mepolizumab in Participants with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in the United States (US)

GSK study ID
218957
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Real-World Effectiveness of Mepolizumab in Patients with Chronic Rhinosinusitis with Nasal Polyps: A Pre/Post Assessment of Oral Corticosteroid Use, Treatment for Nasal Polyps, Healthcare Resource Utilization and Healthcare Costs in the US
Trial description: This study evaluates the real-world clinical and economic burden of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) among participants before and after mepolizumab initiation using the Komodo Health database. The objective of the study is to evaluate Nasal Polyp (NP)-related treatment (i.e., steroid use, sinus surgeries, NP-related medication use), NP-related exacerbations, healthcare resource utilization (HRU) and costs among United States (US) adults (greater than or equal to [≥]18 years old) with CRSwNP before and after mepolizumab initiation in a real-world setting.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Average daily dose per all-cause OCS dispensing

Timeframe: 12 months pre-dose and 12 months post-dose

Secondary outcomes:

Number and proportion of participants with all-cause OCS use

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with NP-related OCS use

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with inpatient (IP) claim, outpatient (OP) claim and medical claim for NP surgery

Timeframe: 12 months pre-dose and 12 months post-dose

Average daily dose of OCS Use

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with continuous OCS use

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with reduction in average daily dose

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with excess OCS use

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants receiving greater than or equal to (≥)1 OCS per period

Timeframe: 12 months pre-dose and 12 months post-dose

Rate of OCS dispensings (reported as mean number of OCS dispensings per-patient year [PPY] per period)

Timeframe: 12 months pre-dose and 12 months post-dose

Proportion of days with OCS on hand per participant per period

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants with chronic OCS Use

Timeframe: 12 months pre-dose and 12 months post-dose

Rate of OCS bursts

Timeframe: 12 months pre-dose and 12 months post-dose

Proportion of participants with ≥1 sinus surgery per period

Timeframe: 12 months pre-dose and 12 months post-dose

Rate of sinus surgeries received per participant (reported as mean number of surgeries PPY per period)

Timeframe: 12 months pre-dose and 12 months post-dose

Number and proportion of participants undergoing different types of sinus surgery

Timeframe: 12 months pre-dose and 12 months post-dose

Proportion of participants with ≥1 initial claim for sinus surgery after mepolizumab initiation

Timeframe: 12 months post dose

Proportion of participants with ≥1 recurrent claim for sinus surgery after mepolizumab initiation

Timeframe: 12 months post-dose

Number of claims for sinus Computer Tomography (CT)

Timeframe: 12 months pre-dose and 12 months post-dose

Proportion of participants receiving NP-related treatments

Timeframe: 12 months pre-dose and 12 months post-dose

Number of claims for NP-related treatment

Timeframe: 12 months pre-dose and 12 months post-dose

Rate of NP-related exacerbations

Timeframe: 12 months pre-dose and 12 months post-dose

Number of inpatient (IP), outpatient (OP) and emergency department (ED) visits

Timeframe: 12 months pre-dose and 12 months post-dose

Number of other visits (e.g., hospice, home health care)

Timeframe: 12 months pre-dose and 12 months post-dose

All cause and NP-related total (medical and pharmacy) costs

Timeframe: 12 months pre-dose and 12 months post-dose

Interventions:
Not applicable
Enrollment:
150
Primary completion date:
2024-31-07
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Juan Carlos Cardet, Jared Silver, Martin Maldonado-Puebla, François Laliberté, Chi Gao, Ramya Ramasubramanian, Annalise Hilts, Kaixin Zhang, Jeremiah Hwee, Waseem Ahmed, Amy G. Edgecomb. Mepolizumab for the Management of CRSwNP Across the US: A Retrospective Study. Journal of Allergy and Clinical Immunology: Global. 2025-7;: 100549. https://doi.org/10.1016/j.jacig.2025.100549 PMID: 40978169 DOI: 10.1016/j.jacig.2025.100549
Medical condition
Nasal Polyps
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
June 2023 to July 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Should have greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after July 29, 2021 (index date).
  • Should have ≥12 months of continuous eligibility prior to the index date (baseline period).
  • ≥1 medical or pharmacy claim for mepolizumab at any time before the index date.
  • ≥1 medical or pharmacy claim for reslizumab, benralizumab, or tezepelumab during the study period.
Inclusion and exclusion criteria
Inclusion criteria:
  • Should have greater than or equal to (≥)1 medical or pharmacy claim for mepolizumab after July 29, 2021 (index date).
  • Should have ≥12 months of continuous eligibility prior to the index date (baseline period).
  • Should have ≥12 months of continuous eligibility after to the index date (observation period).
  • ≥1 diagnosis of CRS during the baseline period or on index date.
  • ≥1 diagnosis of NP during the baseline period or on index date.
  • ≥2 medical or pharmacy claims for mepolizumab in the first 6 months after the index date (including the index date).
Exclusion criteria:
  • ≥1 medical or pharmacy claim for mepolizumab at any time before the index date.
  • ≥1 medical or pharmacy claim for reslizumab, benralizumab, or tezepelumab during the study period.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Clinical study report
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2024-31-07
Actual study completion date
2024-31-07

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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