Churg-Strauss Syndrome, Eosinophilic Granulomatosis With Polyangiitis
Conditions
Keywords
NUCALA, Eosinophilic granulomatosis with polyangiitis, Real world setting, Long term safety and efficacy
Brief summary
Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams \[mg\], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial \[NCT\]03557060) will be enrolled in the study. NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Interventions
None listed
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants with EGPA of \>=20 years of age inclusive, at the time of signing the informed consent. * Participants must have a current clinical diagnosis of EGPA by physician. * Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan. • Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study. * Physician's decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan. * Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
Exclusion criteria
* Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks. * Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product. * Participants with any reasons that in physician's opinion would place the participants at risk. * Participants who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | Up to 96 weeks | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors. |
| Number of Participants With Adverse Drug Reactions (ADRs) | Up to 96 weeks | An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as Yes. ADRs related to NUCALA were collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of Hospitalization for EGPA-related Events | Up to 96 weeks | Annualized rate of hospitalization = (Number of corresponding hospital visits \* 365)/ (number of days in the observation period). The annualized rate and associated 95 percent (%) confidence intervals (CIs) were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. |
| Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events | Up to 96 weeks | Annualized rate of Emergency Room/Unscheduled Visit = (Number of corresponding Emergency Room/Unscheduled Visits \* 365)/(number of days in the observation period). The annualized rate and associated 95% CIs were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported. |
| Percentage of Participants With Clinical Symptoms | At 96 weeks | Clinical symptoms as assessed by 9 organ-systems (i.e. systemic, skin, mucous membranes/eyes, ears/nose/throat, chest, cardiovascular, abdominal, renal, nervous system \[motor and sensory\]) relevant to EGPA in systemic vasculitis were assessed. Data were summarized for following categories; none, active, worsening, active + worsening. None is defined as absence of clinical symptoms. Active disease is defined as follows: The participant has clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as None. Worsening is defined as follows: The participant has worsening clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as Active disease or Worsening. Percentage values are rounded off. |
| Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 | Number of participants by each category of average daily prednisolone-equivalent of OCS were assessed. The dosing categories included: zero, greater than (\>)0 to less than or equal to (\<=) 4.0 milligrams per day (mg/day), \>4.0 to \<=7.5 mg/day, \>7.5 mg/day. |
| Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96 | Average daily dose of OCS for each participant was calculated by 12-weekly periods as: Total dosage of OCS (mg) / Total duration of administration of OCS (day). Total duration of administration is defined as: Last date of period minus later date of (first date of each period or start date of OCS) +1. |
| Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | Up to 96 weeks | EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization. Percentage of participants with EGPA relapse were reported. Percentage values are rounded off. |
Countries
Japan
Participant flow
Recruitment details
This non-interventional study aims to assess the long-term safety and effectiveness of NUCALA in the real-world setting in participants with Eosinophilic granulomatosis with polyangiitis (EGPA) who have already used NUCALA for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study 208505 (NCT03557060).
Pre-assignment details
A total of 118 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg Participants with EGPA who have already received mepolizumab 300 milligrams (mg) subcutaneously (SC) for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study (Protocol 208505 \[NCT03557060\]) were included in this observational study. No study treatment was administered in current study (NCT04551989). | 118 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 3 |
Baseline characteristics
| Characteristic | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Age, Customized >=15 years to <65 years | 60 Participants |
| Age, Customized >=65 years to <75 years | 38 Participants |
| Age, Customized >=75 years | 20 Participants |
| Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE | 118 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 118 |
| other Total, other adverse events | 23 / 118 |
| serious Total, serious adverse events | 26 / 118 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions (ADRs)
An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as Yes. ADRs related to NUCALA were collected.
Time frame: Up to 96 weeks
Population: Treated Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants With Adverse Drug Reactions (ADRs) | 0 Participants |
Primary
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors.
Time frame: Up to 96 weeks
Population: Treated Population (TP) included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | Any AE | 69 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | Any SAE | 26 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) | Any AESI | 42 Participants |
Secondary
Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events
Annualized rate of Emergency Room/Unscheduled Visit = (Number of corresponding Emergency Room/Unscheduled Visits \* 365)/(number of days in the observation period). The annualized rate and associated 95% CIs were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported.
Time frame: Up to 96 weeks
Population: Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events | 0.07 Events per Person-year |
Secondary
Annualized Rate of Hospitalization for EGPA-related Events
Annualized rate of hospitalization = (Number of corresponding hospital visits \* 365)/ (number of days in the observation period). The annualized rate and associated 95 percent (%) confidence intervals (CIs) were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported.
Time frame: Up to 96 weeks
Population: Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Annualized Rate of Hospitalization for EGPA-related Events | 0.02 Events per Person-year |
Secondary
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS)
Average daily dose of OCS for each participant was calculated by 12-weekly periods as: Total dosage of OCS (mg) / Total duration of administration of OCS (day). Total duration of administration is defined as: Last date of period minus later date of (first date of each period or start date of OCS) +1.
Time frame: Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96
Population: Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Week 0 | 3.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 9-12 | 3.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 21-24 | 2.50 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 33-36 | 2.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 45-48 | 2.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 57-60 | 2.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 69-72 | 2.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 81-84 | 2.00 Milligrams |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) | Weeks 93-96 | 2.00 Milligrams |
Secondary
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent)
Number of participants by each category of average daily prednisolone-equivalent of OCS were assessed. The dosing categories included: zero, greater than (\>)0 to less than or equal to (\<=) 4.0 milligrams per day (mg/day), \>4.0 to \<=7.5 mg/day, \>7.5 mg/day.
Time frame: Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96
Population: Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 45-48; >7.5 mg/day | 12 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 57-60; 0 mg/day | 41 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 57-60; >0 to <=4.0 mg/day | 39 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 57-60; >4.0 to <=7.5 mg/day | 18 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 57-60; >7.5 mg/day | 12 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 69-72; 0 mg/day | 42 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 69-72; >0 to <=4.0 mg/day | 38 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 69-72; >4.0 to <=7.5 mg/day | 16 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 69-72; >7.5 mg/day | 13 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 81-84; 0 mg/day | 41 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 81-84; >0 to <=4.0 mg/day | 40 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 81-84; >4.0 to <=7.5 mg/day | 12 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 81-84; >7.5 mg/day | 12 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 93-96; 0 mg/day | 43 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 93-96; >0 to <=4.0 mg/day | 37 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 93-96; >4.0 to <=7.5 mg/day | 14 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 93-96; >7.5 mg/day | 10 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Week 0; 0 mg/day | 37 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Week 0; >0 to <=4.0 mg/day | 45 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Week 0; >4.0 to <=7.5 mg/day | 23 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Week 0; >7.5 mg/day | 13 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 9-12; 0 mg/day | 36 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 9-12; >0 to <=4.0 mg/day | 46 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 9-12; >4.0 to <=7.5 mg/day | 20 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 9-12; >7.5 mg/day | 15 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 21-24; 0 mg/day | 39 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 21-24; >0 to <=4.0 mg/day | 46 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 21-24; >4.0 to <=7.5 mg/day | 15 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 21-24; >7.5 mg/day | 15 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 33-36; 0 mg/day | 41 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 33-36; >0 to <=4.0 mg/day | 42 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 33-36; >4.0 to <=7.5 mg/day | 17 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 33-36; >7.5 mg/day | 13 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 45-48; 0 mg/day | 42 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 45-48; >0 to <=4.0 mg/day | 40 Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) | Weeks 45-48; >4.0 to <=7.5 mg/day | 18 Participants |
Secondary
Percentage of Participants With Clinical Symptoms
Clinical symptoms as assessed by 9 organ-systems (i.e. systemic, skin, mucous membranes/eyes, ears/nose/throat, chest, cardiovascular, abdominal, renal, nervous system \[motor and sensory\]) relevant to EGPA in systemic vasculitis were assessed. Data were summarized for following categories; none, active, worsening, active + worsening. None is defined as absence of clinical symptoms. Active disease is defined as follows: The participant has clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as None. Worsening is defined as follows: The participant has worsening clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as Active disease or Worsening. Percentage values are rounded off.
Time frame: At 96 weeks
Population: Treated Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Sensory Nervous System; Active disease + Worsening | 45 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Motor Nervous System; Active disease + Worsening | 30 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Cardiovascular; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Systemic; None | 90 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Systemic; Active disease | 10 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Systemic; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Systemic; Active disease + Worsening | 10 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Skin; None | 92 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Skin; Active disease | 7 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Skin; Worsening | 1 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Skin; Active disease + Worsening | 8 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Mucous Membrane and Eye; None | 100 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Mucous Membrane and Eye; Active disease | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Mucous Membrane and Eye; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Mucous Membrane and Eye; Active disease + Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Ear, nose, and throat; None | 85 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Ear, nose, and throat; Active disease | 14 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Ear, nose, and throat; Worsening | 1 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Ear, nose, and throat; Active disease + Worsening | 15 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Chest; None | 83 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Chest; Active disease | 15 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Chest; Worsening | 2 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Chest; Active disease + Worsening | 17 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Cardiovascular; None | 97 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Cardiovascular; Active disease | 3 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Cardiovascular; Active disease + Worsening | 3 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Abdominal; None | 99 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Abdominal; Active disease | 1 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Abdominal; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Abdominal; Active disease + Worsening | 1 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Renal; None | 98 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Renal; Active disease | 2 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Renal; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Renal; Active disease + Worsening | 2 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Sensory Nervous System; None | 55 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Sensory Nervous System; Active disease | 45 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Sensory Nervous System; Worsening | 0 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Motor Nervous System; None | 70 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Motor Nervous System; Active disease | 30 Percentage of Participants |
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Clinical Symptoms | Motor Nervous System; Worsening | 0 Percentage of Participants |
Secondary
Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse
EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization. Percentage of participants with EGPA relapse were reported. Percentage values are rounded off.
Time frame: Up to 96 weeks
Population: Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | 10 Percentage of Participants |