Trial Outcomes & Findings for Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan (NCT NCT04551989)

NCT ID: NCT04551989

Last Updated: 2024-09-19

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

118 participants

Primary outcome timeframe

Up to 96 weeks

Results posted on

2024-09-19

Participant Flow

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).

A total of 118 participants were enrolled in the study.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	118
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Adverse Event	4
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	3

Baseline Characteristics

Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Age, Customized >=15 years to <65 years	60 Participants n=5 Participants
Age, Customized >=65 years to <75 years	38 Participants n=5 Participants
Age, Customized >=75 years	20 Participants n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) Any AE	69 Participants
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) Any SAE	26 Participants
Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) Any AESI	42 Participants

PRIMARY outcome

Timeframe: Up to 96 weeks

Population: Treated Population

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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Number of Participants With Adverse Drug Reactions (ADRs)	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=101 Participants 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).
Percentage of Participants With Clinical Symptoms Ear, nose, and throat; Active disease + Worsening	15 Percentage of Participants
Percentage of Participants With Clinical Symptoms Chest; None	83 Percentage of Participants
Percentage of Participants With Clinical Symptoms Chest; Active disease	15 Percentage of Participants
Percentage of Participants With Clinical Symptoms Chest; Worsening	2 Percentage of Participants
Percentage of Participants With Clinical Symptoms Chest; Active disease + Worsening	17 Percentage of Participants
Percentage of Participants With Clinical Symptoms Cardiovascular; None	97 Percentage of Participants
Percentage of Participants With Clinical Symptoms Cardiovascular; Active disease	3 Percentage of Participants
Percentage of Participants With Clinical Symptoms Cardiovascular; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Cardiovascular; Active disease + Worsening	3 Percentage of Participants
Percentage of Participants With Clinical Symptoms Abdominal; None	99 Percentage of Participants
Percentage of Participants With Clinical Symptoms Abdominal; Active disease	1 Percentage of Participants
Percentage of Participants With Clinical Symptoms Abdominal; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Abdominal; Active disease + Worsening	1 Percentage of Participants
Percentage of Participants With Clinical Symptoms Renal; None	98 Percentage of Participants
Percentage of Participants With Clinical Symptoms Renal; Active disease	2 Percentage of Participants
Percentage of Participants With Clinical Symptoms Renal; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Renal; Active disease + Worsening	2 Percentage of Participants
Percentage of Participants With Clinical Symptoms Sensory Nervous System; None	55 Percentage of Participants
Percentage of Participants With Clinical Symptoms Sensory Nervous System; Active disease	45 Percentage of Participants
Percentage of Participants With Clinical Symptoms Sensory Nervous System; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Sensory Nervous System; Active disease + Worsening	45 Percentage of Participants
Percentage of Participants With Clinical Symptoms Motor Nervous System; None	70 Percentage of Participants
Percentage of Participants With Clinical Symptoms Motor Nervous System; Active disease	30 Percentage of Participants
Percentage of Participants With Clinical Symptoms Motor Nervous System; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Motor Nervous System; Active disease + Worsening	30 Percentage of Participants
Percentage of Participants With Clinical Symptoms Systemic; None	90 Percentage of Participants
Percentage of Participants With Clinical Symptoms Systemic; Active disease	10 Percentage of Participants
Percentage of Participants With Clinical Symptoms Systemic; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Systemic; Active disease + Worsening	10 Percentage of Participants
Percentage of Participants With Clinical Symptoms Skin; None	92 Percentage of Participants
Percentage of Participants With Clinical Symptoms Skin; Active disease	7 Percentage of Participants
Percentage of Participants With Clinical Symptoms Skin; Worsening	1 Percentage of Participants
Percentage of Participants With Clinical Symptoms Skin; Active disease + Worsening	8 Percentage of Participants
Percentage of Participants With Clinical Symptoms Mucous Membrane and Eye; None	100 Percentage of Participants
Percentage of Participants With Clinical Symptoms Mucous Membrane and Eye; Active disease	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Mucous Membrane and Eye; Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Mucous Membrane and Eye; Active disease + Worsening	0 Percentage of Participants
Percentage of Participants With Clinical Symptoms Ear, nose, and throat; None	85 Percentage of Participants
Percentage of Participants With Clinical Symptoms Ear, nose, and throat; Active disease	14 Percentage of Participants
Percentage of Participants With Clinical Symptoms Ear, nose, and throat; Worsening	1 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: Treated Population

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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse	10 Percentage of Participants

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: Treated Population

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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Annualized Rate of Hospitalization for EGPA-related Events	0.02 Events per Person-year Interval 0.0 to 0.16

SECONDARY outcome

Timeframe: Up to 96 weeks

Population: Treated Population

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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events	0.07 Events per Person-year Interval 0.01 to 0.53

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Week 0	3.00 Milligrams Interval 0.0 to 23.3
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 9-12	3.00 Milligrams Interval 0.0 to 38.4
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 21-24	2.50 Milligrams Interval 0.0 to 32.9
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 33-36	2.00 Milligrams Interval 0.0 to 25.0
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 45-48	2.00 Milligrams Interval 0.0 to 26.6
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 57-60	2.00 Milligrams Interval 0.0 to 25.5
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 69-72	2.00 Milligrams Interval 0.0 to 28.8
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 81-84	2.00 Milligrams Interval 0.0 to 21.4
Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS) Weeks 93-96	2.00 Milligrams Interval 0.0 to 15.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 Participants 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).
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Week 0; 0 mg/day	37 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Week 0; >0 to <=4.0 mg/day	45 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Week 0; >4.0 to <=7.5 mg/day	23 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Week 0; >7.5 mg/day	13 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 9-12; 0 mg/day	36 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 9-12; >0 to <=4.0 mg/day	46 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 9-12; >7.5 mg/day	15 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 21-24; 0 mg/day	39 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 21-24; >0 to <=4.0 mg/day	46 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 21-24; >7.5 mg/day	15 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 33-36; 0 mg/day	41 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 33-36; >0 to <=4.0 mg/day	42 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 33-36; >7.5 mg/day	13 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 45-48; 0 mg/day	42 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 45-48; >0 to <=4.0 mg/day	40 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 45-48; >7.5 mg/day	12 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 57-60; 0 mg/day	41 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 57-60; >0 to <=4.0 mg/day	39 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 57-60; >7.5 mg/day	12 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 69-72; 0 mg/day	42 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 69-72; >0 to <=4.0 mg/day	38 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 69-72; >7.5 mg/day	13 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 81-84; 0 mg/day	41 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 81-84; >0 to <=4.0 mg/day	40 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 81-84; >7.5 mg/day	12 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 93-96; 0 mg/day	43 Participants
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 93-96; >0 to <=4.0 mg/day	37 Participants
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
Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent) Weeks 93-96; >7.5 mg/day	10 Participants

Adverse Events

Participants With EGPA Who Have Received Mepolizumab 300 mg

Serious events: 26 serious events

Other events: 23 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 participants at risk 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).
Infections and infestations COVID-19	1.7% 2/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Pneumonia	1.7% 2/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Bacteraemia	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Enterocolitis viral	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Pneumonia aspiration	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Respiratory syncytial virus infection	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Infections and infestations Urinary tract infection	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Colitis	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Enteritis	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Gastric varices haemorrhage	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Ileus	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Large intestine polyp	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Injury, poisoning and procedural complications Spinal compression fracture	1.7% 2/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Injury, poisoning and procedural complications Subdural haematoma	1.7% 2/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Injury, poisoning and procedural complications Femoral neck fracture	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Injury, poisoning and procedural complications Femur fracture	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Injury, poisoning and procedural complications Radius fracture	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	1.7% 2/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Respiratory, thoracic and mediastinal disorders Asthma	2.5% 3/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Musculoskeletal and connective tissue disorders Pain in extremity	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Vascular disorders Aortic aneurysm	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Vascular disorders Aortic dissection	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Cardiac disorders Acute myocardial infarction	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Endocrine disorders Goitre	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Eye disorders Cataract	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
General disorders Pyrexia	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Hepatobiliary disorders Cholelithiasis	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Metabolism and nutrition disorders Hyponatraemia	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Reproductive system and breast disorders Ovarian cyst	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Gastrointestinal disorders Rectal ulcer	0.85% 1/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.

Other adverse events

Other adverse events
Measure	Participants With EGPA Who Have Received Mepolizumab 300 mg n=118 participants at risk 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).
Infections and infestations COVID-19	12.7% 15/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.
Respiratory, thoracic and mediastinal disorders Asthma	7.6% 9/118 • All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96 Treated Population included all participants in the All Subjects Enrolled (ASE) Population who have received at least 1 injection of NUCALA.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER