Trial Outcomes & Findings for Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921 (NCT NCT03298061)

Last Updated: 2024-03-12

Results Overview

An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; other important medical events based on medical or scientific judgment; and is associated with liver injury and impaired liver function. Additionally, systemic (that is, allergic/hypersensitivity and non-allergic) reactions and local injection site reactions were recorded throughout the treatment and follow-up period.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Up to approximately 89 Months

Results posted on

2024-03-12

Participant Flow

Participants who participated in clinical study MEA115921 and required a dose of prednisolone (or equivalent) of greater than or equal to (\>=) 5 milligrams per day (mg/day) for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) were included in this study based on their eligibility. Eligible participants received subcutaneous (SC) injection of mepolizumab 300 milligrams (mg) every 4 weeks.

A total of 100 participants entered the study and received mepolizumab.

Participant milestones

Participant milestones
Measure	Mepolizumab 300 mg Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Overall Study STARTED	100
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Mepolizumab 300 mg Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	6
Overall Study Protocol Violation	1
Overall Study Physician Decision	7
Overall Study Withdrawal by Subject	10

Baseline Characteristics

Long-term Access Program (LAP) of Mepolizumab for Subjects Who Participated in Study MEA115921

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mepolizumab 300 mg n=100 Participants Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Age, Continuous	49.6 YEARS STANDARD_DEVIATION 13.90 • n=5 Participants
Sex: Female, Male Female	57 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race/Ethnicity, Customized AMERICAN INDIAN OR ALASKA NATIVE	1 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE	6 Participants n=5 Participants
Race/Ethnicity, Customized ASIAN - SOUTH EAST ASIAN HERITAGE	2 Participants n=5 Participants
Race/Ethnicity, Customized WHITE - ARABIC/NORTH AFRICAN HERITAGE	1 Participants n=5 Participants
Race/Ethnicity, Customized WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to approximately 89 Months

Population: Safety Population consisted of all participants who received at least one dose of open label mepolizumab. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose of mepolizumab + 28 days.

Outcome measures

Outcome measures
Measure	Mepolizumab 300 mg n=100 Participants Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AE	98 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	38 Participants

Adverse Events

Mepolizumab 300 mg

Serious events: 38 serious events

Other events: 97 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Mepolizumab 300 mg n=100 participants at risk Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Cardiac disorders Arrhythmia	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Cardiac disorders Atrial fibrillation	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Cardiac disorders Cardiac arrest	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Cardiac disorders Cardiac failure	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Cardiac disorders Coronary artery disease	1.0% 1/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Cardiac disorders Myocardial infarction	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Abdominal pain	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Anal incontinence	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Colitis ulcerative	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Food poisoning	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Rectal prolapse	1.0% 1/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Rectal ulcer	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Chest pain	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Immune system disorders Eosinophilic granulomatosis with polyangiitis	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Bronchitis	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Bursitis infective	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations COVID-19	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Cellulitis	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Chronic sinusitis	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Coronavirus infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Folliculitis	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Gastroenteritis	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Hepatitis E	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Herpes zoster	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Influenza	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Lower respiratory tract infection	1.0% 1/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pneumonia	3.0% 3/100 • Number of events 7 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pneumonia pneumococcal	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pneumonia staphylococcal	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Respiratory syncytial virus infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Salpingitis	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Sepsis	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Skin infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Urinary tract infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Viral infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Viral upper respiratory tract infection	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Abdominal injury	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Humerus fracture	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Lower limb fracture	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Post procedural fever	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Metabolism and nutrition disorders Hyperglycaemia	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Back pain	2.0% 2/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Cervical cord compression	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Transient ischaemic attack	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Psychiatric disorders Stress	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Renal and urinary disorders Nephrolithiasis	1.0% 1/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Renal and urinary disorders Renal colic	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Renal and urinary disorders Ureterolithiasis	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Reproductive system and breast disorders Heavy menstrual bleeding	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Asthma	6.0% 6/100 • Number of events 7 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.0% 1/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.0% 1/100 • Number of events 2 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Respiratory distress	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Vocal cord dysfunction	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Skin and subcutaneous tissue disorders Dermal cyst	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Skin and subcutaneous tissue disorders Skin ulcer	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Vascular disorders Vasculitis	1.0% 1/100 • Number of events 1 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.

Other adverse events

Other adverse events
Measure	Mepolizumab 300 mg n=100 participants at risk Participants who participated in clinical study MEA115921, who required additional dose of \>=5 milligrams per day (mg/day) prednisolone for adequate control of their Eosinophilic Granulomatosis with Polyangiitis (EGPA) received 300 milligrams (mg) mepolizumab subcutaneous (SC) injection every 4 weeks.
Blood and lymphatic system disorders Anaemia	4.0% 4/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Eye disorders Cataract	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Abdominal distension	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Abdominal pain	6.0% 6/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Abdominal pain upper	4.0% 4/100 • Number of events 26 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Diarrhoea	14.0% 14/100 • Number of events 16 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Gastritis	4.0% 4/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Nausea	14.0% 14/100 • Number of events 18 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Gastrointestinal disorders Vomiting	10.0% 10/100 • Number of events 10 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Asthenia	3.0% 3/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Fatigue	10.0% 10/100 • Number of events 12 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Influenza like illness	6.0% 6/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Injection site haematoma	4.0% 4/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Injection site reaction	13.0% 13/100 • Number of events 29 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Oedema peripheral	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
General disorders Pyrexia	7.0% 7/100 • Number of events 14 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Immune system disorders Eosinophilic granulomatosis with polyangiitis	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Acute sinusitis	8.0% 8/100 • Number of events 14 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Bronchitis	29.0% 29/100 • Number of events 47 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations COVID-19	6.0% 6/100 • Number of events 7 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Conjunctivitis	3.0% 3/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Cystitis	3.0% 3/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Ear infection	8.0% 8/100 • Number of events 9 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Gastroenteritis	8.0% 8/100 • Number of events 11 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Herpes simplex	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Influenza	10.0% 10/100 • Number of events 12 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Lower respiratory tract infection	7.0% 7/100 • Number of events 21 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Nasopharyngitis	33.0% 33/100 • Number of events 113 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Oral candidiasis	5.0% 5/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Otitis media	4.0% 4/100 • Number of events 9 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pharyngitis	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pneumonia	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Pulpitis dental	3.0% 3/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Respiratory tract infection	13.0% 13/100 • Number of events 15 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Rhinitis	3.0% 3/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Sinusitis	30.0% 30/100 • Number of events 52 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Tooth abscess	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Upper respiratory tract infection	31.0% 31/100 • Number of events 43 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Urinary tract infection	13.0% 13/100 • Number of events 16 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Viral infection	7.0% 7/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Infections and infestations Viral upper respiratory tract infection	8.0% 8/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Arthropod bite	5.0% 5/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Bone contusion	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Contusion	5.0% 5/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Fall	8.0% 8/100 • Number of events 10 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Foot fracture	5.0% 5/100 • Number of events 7 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Hand fracture	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Ligament sprain	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Muscle strain	4.0% 4/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Injury, poisoning and procedural complications Rib fracture	6.0% 6/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Investigations Weight decreased	5.0% 5/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Metabolism and nutrition disorders Vitamin D deficiency	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 20/100 • Number of events 29 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Arthritis	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Back pain	16.0% 16/100 • Number of events 19 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Bursitis	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	5.0% 5/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.0% 5/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Myalgia	13.0% 13/100 • Number of events 18 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Neck pain	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Musculoskeletal and connective tissue disorders Pain in extremity	10.0% 10/100 • Number of events 13 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Dizziness	8.0% 8/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Headache	14.0% 14/100 • Number of events 42 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Hypoaesthesia	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Migraine	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Paraesthesia	8.0% 8/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Nervous system disorders Sciatica	4.0% 4/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Psychiatric disorders Depression	6.0% 6/100 • Number of events 6 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Psychiatric disorders Insomnia	7.0% 7/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Renal and urinary disorders Dysuria	4.0% 4/100 • Number of events 4 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Asthma	26.0% 26/100 • Number of events 87 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Cough	9.0% 9/100 • Number of events 10 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.0% 7/100 • Number of events 10 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.0% 3/100 • Number of events 5 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Nasal congestion	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Nasal polyps	6.0% 6/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.0% 6/100 • Number of events 8 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Sinus congestion	4.0% 4/100 • Number of events 9 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Respiratory, thoracic and mediastinal disorders Wheezing	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Skin and subcutaneous tissue disorders Eczema	3.0% 3/100 • Number of events 3 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Skin and subcutaneous tissue disorders Erythema	3.0% 3/100 • Number of events 17 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.
Skin and subcutaneous tissue disorders Rash	15.0% 15/100 • Number of events 22 • Up to approximately 89 Months Adverse events (AEs) and Serious adverse event (SAEs) were collected for all participants within the safety population which comprised of all participants who received at least one dose of open-label mepolizumab.

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