Impact of Mepolizumab on Systemic Corticosteroid (SCS)-related Complications, Healthcare Resource Utilization (HRU) and Costs in Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES)
Trial overview
Rate of any systemic corticosteroid (SCS)-related complications among participants with eosinophilic granulomatosis with polyangiitis (EGPA) treated with 300 milligrams (mg) mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any SCS-related complications among participants with hypereosinophilic syndrome (HES) treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any acute and chronic SCS-related complications among participants with EGPA treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any acute and chronic SCS-related complications among participants with HES treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of all-cause healthcare resource utilization (HRU) and HRU associated with SCS-related complications among participants with EGPA treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of all-cause HRU and HRU associated with SCS-related complications among participants with HES treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
All-cause healthcare costs and healthcare costs associated with SCS-related complications among participants with EGPA treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
All-cause healthcare costs and healthcare costs associated with SCS-related complications among participants with HES treated with 300 mg mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any SCS-related complications among participants with EGPA treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any SCS-related complications among participants with HES treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any acute and chronic SCS-related complications among participants with EGPA treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of any acute and chronic SCS-related complications among participants with HES treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of all-cause HRU and HRU associated with SCS-related complications among participants with EGPA treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Rate of all-cause HRU and HRU associated with SCS-related complications among participants with HES treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
All-cause healthcare costs and healthcare costs associated with SCS-related complications among participants with EGPA treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
All-cause healthcare costs and healthcare costs associated with SCS-related complications among participants with HES treated with any of the 2 doses of mepolizumab versus chronic SCS
Timeframe: 6 months after mepolizumab or chronic SCS initiation up to 18 months after mepolizumab or chronic SCS initiation
Participation criteria
- Inclusion Criteria for participants with eosinophilic granulomatosis with polyangiitis (EGPA):
- For mepolizumab users –
- Exclusion Criteria for participants with EGPA:
- For mepolizumab users –
- Inclusion Criteria for participants with eosinophilic granulomatosis with polyangiitis (EGPA): For mepolizumab users – -Greater than or equal to (>=) 2 medical or pharmacy claims for 300 milligrams (mg) mepolizumab within 6 months following the index date (the date of the first dispensing of mepolizumab after 12 December 2017). ->=2 medical or pharmacy claims for 100 mg or 300 mg mepolizumab within 6 months following the index date. ->=12 months of continuous health plan enrolment prior to the index date (baseline period). ->=6 months of continuous health plan enrolment after the index date (including the landmark period). The landmark period will be defined as the 6-month period following the index date. ->=1 diagnosis of EGPA during the baseline period. ->=18 years of age at the index date. For chronic systemic corticosteroid (SCS) users – ->=6 months of continuous use of oral or parenteral SCS with an average daily dose equivalent to greater than (>) 7.5 mg of prednisone after 12 December 2017. The first dispensing or administration of this continuous use period will be defined as the index date. ->=12 months of continuous health plan enrolment before the index date. ->=6 months of continuous health plan enrolment after the index date (including the landmark period). ->=1 diagnosis of EGPA at any time during the baseline period. ->=18 years of age at the index date. Inclusion Criteria for participants with hypereosinophilic syndrome (HES): For mepolizumab users – ->=2 medical or pharmacy claims for 300 mg mepolizumab within 6 months following the index date (the date of the first dispensing of mepolizumab after 25 September 2020). ->=2 medical or pharmacy claims for 100mg or 300mg mepolizumab within 6 months following the index date. ->=12 months of continuous health plan enrolment prior to the index date. ->= 6 months of continuous health plan enrolment after the index date (including the landmark period). ->=1 diagnosis of HES during the baseline period. ->=12 years of age at the index date. For chronic SCS users – ->=6 months of continuous use of oral or parenteral SCS with an average daily dose equivalent to >10 mg of prednisone after 25 September 2020. The first dispensing/administration of this continuous use period will be defined as the index date. ->=12 months of continuous health plan enrolment before the index date. ->=6 months of continuous health plan enrolment after the index date (including the landmark period). ->=1 diagnosis of HES at any time during the baseline period. ->=12 years of age at the index date.
- Exclusion Criteria for participants with EGPA: For mepolizumab users – ->=1 medical or pharmacy claim for 300 mg mepolizumab any time before the index date. ->=1 medical or pharmacy claim for 100mg or 300mg mepolizumab any time before the index date. -Initiated on any mepolizumab dose other than 100 mg or 300 mg dose. ->=1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the eligibility period. For chronic SCS users – ->=1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the eligibility period. Exclusion Criteria for participants with HES: For mepolizumab users – ->= 1 medical or pharmacy claim for 300 mg mepolizumab any time before the index date. ->=1 medical or pharmacy claim for 100mg or 300mg mepolizumab any time before the index date. -Initiated on any mepolizumab dose other than 100 mg or 300 mg dose. ->=1 medical or pharmacy claim for omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the eligibility period. For chronic SCS users – ->=1 medical or pharmacy claim for mepolizumab, omalizumab, reslizumab, benralizumab, dupilumab, or tezepelumab during the eligibility period.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.