Last updated: 02/05/2024 07:30:13

Annual trends in eosinophilic granulomatosis with polyangiitis (EGPA) prevalence and characteristics in oral corticosteroid (OCS) dose of mepolizumab users in Japan

GSK study ID
218083
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: Annual changes in prevalence of eosinophilic granulomatosis with polyangiitis and characteristics, disease burden, and changes in oral corticosteroid dose in mepolizumab 300 mg new users
Trial description: This study will estimate the annual changes in prevalence of EGPA and also describe the characteristics, disease burden, and changes in OCS doses in mepolizumab new users for EGPA. Mepolizumab initiation date for EGPA will be the index date (from May 2018 to 1 year before the latest data).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Annual prevalence of EGPA

Timeframe: One year

Secondary outcomes:

Summary of demographic characteristics including age and sex of participants

Timeframe: One year prior to index date

Number of participants receiving treatment for EGPA

Timeframe: One year prior to index date

Change in OCS daily dose

Timeframe: Thirty days prior to index date and up to 1 year after index date

All-cause health care resource utilization

Timeframe: One year prior to index date

Proportion of participants with comorbidities

Timeframe: One year prior to index date

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2022-10-08
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Ken-Ei Sada, Takeo Suzuki, Sandra Joksaite, Shinyoung Ju, John Logie, George Mu, Jeremiah Hwee, Hideaki Kunishige, Takeo Ishii, Amit Adlak, Harini Vadlamudi, Rafael Alfonso-Cristancho. Trends in prevalence, treatment use, and disease burden in patients with eosinophilic granulomatosis with polyangiitis in Japan: real-world database analysis.. Modern rheumatology. 2023-Nov-01 DOI: 10.1093/mr/road104 PMID: 37930840
Medical condition
Eosinophilic Granulomatosis with Polyangiitis, Churg-Strauss Syndrome
Product
mepolizumab
Collaborators
NA
Study date(s)
March 2022 to August 2022
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
0 - 74 Years
Accepts healthy volunteers
No
  • 1. Assessing prevalence:
  • Inclusion criteria:
  • Participants with MPA or GPA in the observation period or before.
  • Participants who had been using mepolizumab (regardless of dose) in 1 year before and 1 year after the index.
Inclusion and exclusion criteria
Inclusion criteria:
  • 1. Assessing prevalence: Inclusion criteria:
  • Subscribers with the health insurance society throughout the full year of interest. Exclusion criteria:
  • None 2. Assessing mepolizumab new users: a. Mepolizumab cohort: Inclusion criteria:
  • Participants who initiated mepolizumab for EGPA after May 2018.
  • Participants with health insurance throughout the 1 year before and 1 year after the initiation of mepolizumab.
  • Participants with records of EGPA in 1 year before and 1 year after the initiation of mepolizumab.
  • Participants with either record of allergic rhinitis, eosinophilic chronic sinusitis, or asthma, in the observation period or before.
  • Participants dependent on OCS (proportion of days covered greater than or equal to [>=]80 percent [%]) in 3 months before the initiation of mepolizumab. Exclusion criteria:
  • Participants with either record of microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) in the observation period or before.
  • Participants who had been using mepolizumab (regardless of dose) within 1 year before the start of mepolizumab (other than mepolizumab on index date). b. Reference cohort Inclusion criteria:
  • Participants with a record of EGPA who visited the same month as the index date of mepolizumab cohort.
  • Participants who joined the health insurance society in 1 year before and 1 year after the index.
  • Participants with records of EGPA in 1 year before and 1 year after the index.
  • Participants with either allergic rhinitis, eosinophilic chronic sinusitis, or asthma in the observation period or before.
  • Participants dependent on OCS (proportion of days covered >=80%) in 3 months before the index.
Exclusion criteria:
  • Participants with MPA or GPA in the observation period or before.
  • Participants who had been using mepolizumab (regardless of dose) in 1 year before and 1 year after the index.
  • Participants included in the mepolizumab cohort.

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Study report synopsis
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
2022-10-08
Actual study completion date
2022-10-08

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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