Oesophagitis, Eosinophilic
Conditions
Keywords
eosinophilic, mepolizumab, esophagitis
Brief summary
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
Interventions
DRUGmepolizumab
Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg), 2.5 mg/kg , or 10 mg/kg by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* A subject will be eligible for inclusion in this study only if all of the following criteria apply. Inclusion criteria pertain to all subjects in both cohorts (treatment and observational) unless otherwise stated. * The subject signs and dates a written assent form (age appropriate) and the parent/guardian signs and dates a written informed consent form prior to the initiation of any study-related activities, including discontinuation of any prohibited medications. * Male or female subjects aged 2 to 17 years (from 2nd birthday up to and not including 18th birthday), who weigh \<=84.9kg (males)/ \<= 72.5 (females) and who have a BMI between 5 and 85% for age, who speak, read and write English as age appropriate and/or parent/guardian. NOTE: If subject is within weight requirements but close to the upper or lower limits at screening and the investigator anticipates that during the study the subject's weight will change a become outside the weight requirements, the subject should be excluded from the study. * To be eligible for entry in the treatment group of the study, a female subject is eligible to enter the study if she is: not pregnant or nursing; of non-childbearing potential. Non-childbearing potential is defined as a pre-menarcheal female who has not yet entered puberty as evidenced by lack of breast development (palpable glandular breast tissue); or a female who has documentation (medical report verification) of hysterectomy and/or bilateral oophorectomy; of childbearing potential. These females subjects must have a negative urine pregnancy test at the screening visit, and agree to consistent and correct use of one of the acceptable methods of birth control from at least the commencement of their last normal period prior to the first dose of study medication and to continue until the first normal period after treatment or after the Week 24 Follow-up visit, whichever is longest. * The subject has a diagnosis of eosinophilic esophagitis and current evidence on biopsy of isolated eosinophilic esophagitis defined as: * Peak esophageal eosinophil counts (highest count of eosinophils per HPF in at least one of all esophageal sites biopsied) of 20 or more eosinophils in a minimum of one HPF at 400X magnification on histology of esophageal biopsies from distal and mid-esophagus within two weeks of commencing study medication, as determined by the central histopathologist. * Inadequate response to or intolerant of therapy for eosinophilic esophagitis * The individual investigators will apply their clinical judgment to define whether a clinical response to therapy for eosinophilic esophagitis is inadequate. As guidance, inadequate response might consist of persistence under current or recent prior therapy, of symptoms of eosinophilic esophagitis such as eosinophilic esophagitis-related pain in stomach, chest or throat; regurgitation; vomiting; pain or difficulties associated with drinking fluids or nutritional supplements; or pain or difficulties associated with eating. An inadequate response might also consist of persistent eosinophilic infiltration of the esophagus, in the presence or in the absence of eosinophilic esophagitis-related symptoms. * Similarly, the individual investigators will apply their clinical judgment to define whether a patient is intolerant to therapy. For guidance, intolerance to therapy for eosinophilic esophagitis may consist of undesirable side-effects of long-term therapy; or side-effects of long-term therapy that are difficult to manage; or marked non-compliance to therapy or rejection of therapy by the individual patient, or by the parent/guardian, which in the opinion of the investigator interferes with the patient's optimal disease management. * The criteria used by the investigator to define inadequate response to or intolerance of therapy for eosinophilic esophagitis will be collected in the CRF.
Exclusion criteria
* A subject will not be eligible for inclusion in this study if any of the following criteria apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE's were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP. |
| Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24) | Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. |
| Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34) | Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit. |
| Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Screening, Weeks 4, 8 and 12 | 12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. any time post Baseline. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24 | SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Heart Rate at the Indicated Time Points | Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24 | Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Temperature at the Indicated Time Points | Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24 | Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Day 1, Weeks 4, 8, 12, 24, and 34 | Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at \>1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit. |
| Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 | Week 12 | A responder was defined as a participant achieving a reduction in esophageal eosinophils to \<5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response. |
| Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34 | Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab. |
| Plasma Clearance (CL) of Mepolizumab | Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34 | Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Difficulty With Eating Solid Foods | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions. |
| Change in Baseline in Pain With Eating Solid Foods Severity Scores | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction. |
| Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction. |
| Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Pain in Stomach Severity Scores | Screening, Weeks 9-12 and Weeks 21-24 | Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction |
| Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value. |
| Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. |
| Absolute Blood Eosinophils Count at the Indicated Time Points | Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34 | Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count. |
| Plasma Concentration of Mepolizumab | Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34 | Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles). |
| Number of Participants With Maintenance of Response | Week 12 and Week 24 | Participants who achieved a response of \<5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of \<20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed. |
| Change From Baseline in Pain in Chest/Throat Severity Scores | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction. |
| Change From Baseline in Percentage of Days With Pain in Stomach | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Percentage of Days With Pain in Chest/Throat | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Regurgitation Bothersome Scores | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions |
| Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Frequency of Vomiting | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction. |
| Change From Baseline in Percentage of Days With Vomiting | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
| Change From Baseline in Daily Degree of Difficulty With Drinking | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction. |
| Change From Baseline in Pain With Drinking Severity Scores | Screening, Weeks 9-12 and Weeks 21-24 | Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction. |
| Change From Baseline in Percentage of Days on Which the Participant Drank | Screening, Weeks 9-12 and Weeks 21-24 | The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis. |
Countries
Australia, Canada, United Kingdom, United States
Participant flow
Recruitment details
Participants (par.) who met the eligibility criteria were randomized in to Treatment Cohort (TC) that consisted of a 2-week Screening Phase, a 12-week Treatment Phase, a 12-week Follow-up Phase and a 10-week Long term Follow-up Phase. Eligible par. who chose not to enter TC could be enrolled in an Observational Cohort to be followed for 24 weeks.
Pre-assignment details
A total of 77 subjects participated in this study. Of this total, 59 par. were randomized into the TC to receive blinded study medication. An additional 18 subjects elected not to participate in the TC and were enrolled in the Observational Cohort. A total of 113 par. were screened for eligibility, of which 36 were screen failures.
Participants by arm
| Arm | Count |
|---|---|
| Mepolizumab 0.55 mg/kg Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8. | 19 |
| Mepolizumab 2.5 mg/kg Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8. | 20 |
| Mepolizumab 10 mg/kg Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8. | 20 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Steriod Inhaler was Increased | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Mepolizumab 0.55 mg/kg | Mepolizumab 2.5 mg/kg | Mepolizumab 10 mg/kg | Total |
|---|---|---|---|---|
| Age, Continuous | 10.4 Years STANDARD_DEVIATION 4.28 | 10.5 Years STANDARD_DEVIATION 5.15 | 10.4 Years STANDARD_DEVIATION 4.66 | 10.4 Years STANDARD_DEVIATION 4.64 |
| Race/Ethnicity, Customized African American/African Heritage | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 18 Participants | 19 Participants | 17 Participants | 54 Participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants | 12 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 17 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 18 / 19 | 14 / 20 | 18 / 20 |
| serious Total, serious adverse events | 0 / 19 | 1 / 20 | 2 / 20 |
Outcome results
Primary
Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab
Volume of distribution is defined as the theoretical volume in which the total amount of drug is uniformly distributed to produce the desired plasma concentration of a drug. Central volume of distribution is a hypothetical volume into which a drug initially distributes upon administration. Peripheral volume of distribution is the sum of all tissue spaces outside the central compartment. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate central (V1) and periperial (V2) and Steady State (Vss) volume of distribution of mepolizumab.
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34
Population: Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Steady-State Volume of distribution (Vss) | 3.37 Liters |
| Mepolizumab 0.55 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Peripheral Volume of distribution (V2) | 1.36 Liters |
| Mepolizumab 0.55 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Central volume of distribution (V1) | 2.00 Liters |
| Mepolizumab 2.5 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Central volume of distribution (V1) | 2.29 Liters |
| Mepolizumab 2.5 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Peripheral Volume of distribution (V2) | 1.55 Liters |
| Mepolizumab 2.5 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Steady-State Volume of distribution (Vss) | 3.84 Liters |
| Mepolizumab 10 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Steady-State Volume of distribution (Vss) | 3.60 Liters |
| Mepolizumab 10 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Peripheral Volume of distribution (V2) | 1.46 Liters |
| Mepolizumab 10 mg/kg | Central (V1), Periperial (V2) and Steady-State (Vss) Volume of Distribution of Mepolizumab | Central volume of distribution (V1) | 2.14 Liters |
Primary
Change From Baseline in Heart Rate at the Indicated Time Points
Heart rate measurements were obtained at the following time points: Screening, pre-infusion, 10m, 30m, 1h, 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 16, n= 15, 19, 20 | -7.1 Beats per minutes | Standard Deviation 14.64 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 30m, n= 19, 19, 18 | -3.8 Beats per minutes | Standard Deviation 12.19 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4 pre-infusion, n= 19, 20, 19 | 0.4 Beats per minutes | Standard Deviation 19.19 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 1h, n= 19, 19, 17 | -6.2 Beats per minutes | Standard Deviation 10.73 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 30m, n= 19, 19, 19 | -1.4 Beats per minutes | Standard Deviation 15.36 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 2h, n= 19, 18, 18 | -5.4 Beats per minutes | Standard Deviation 11.14 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 12, n= 18, 20, 20 | -1.8 Beats per minutes | Standard Deviation 13.58 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 10m, n= 19, 20, 19 | -3.6 Beats per minutes | Standard Deviation 9.39 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 20, n= 15, 18, 18 | -6.1 Beats per minutes | Standard Deviation 17.4 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 24, n= 17, 20, 19 | -2.1 Beats per minutes | Standard Deviation 13.03 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1 pre-infusion, n= 19, 20, 20 | 0.7 Beats per minutes | Standard Deviation 10.29 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 30m, n= 19, 20, 20 | -2.5 Beats per minutes | Standard Deviation 13.02 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 1h, n= 19, 20, 20 | -4.2 Beats per minutes | Standard Deviation 11.51 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 2h, n= 19, 19, 20 | -3.3 Beats per minutes | Standard Deviation 14.63 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 2h, n= 19, 20, 20 | 1.6 Beats per minutes | Standard Deviation 11.31 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 10m, n= 19, 20, 19 | -0.9 Beats per minutes | Standard Deviation 13.56 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 1h, n= 19, 19, 20 | -4.9 Beats per minutes | Standard Deviation 14.08 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8 pre-infusion, n= 19, 20, 19 | -3.1 Beats per minutes | Standard Deviation 12.71 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 10m, n= 19, 20, 19 | -2.8 Beats per minutes | Standard Deviation 11.69 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 2h, n= 19, 18, 18 | 5.7 Beats per minutes | Standard Deviation 10.33 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 16, n= 15, 19, 20 | 6.9 Beats per minutes | Standard Deviation 13.12 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8 pre-infusion, n= 19, 20, 19 | 1.5 Beats per minutes | Standard Deviation 12.15 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 30m, n= 19, 19, 18 | -2.7 Beats per minutes | Standard Deviation 9.52 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 1h, n= 19, 20, 20 | 3.0 Beats per minutes | Standard Deviation 13.56 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 1h, n= 19, 19, 20 | -1.8 Beats per minutes | Standard Deviation 12.88 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 1h, n= 19, 19, 17 | 0.3 Beats per minutes | Standard Deviation 11.09 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 2h, n= 19, 19, 20 | -0.8 Beats per minutes | Standard Deviation 10.58 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 2h, n= 19, 20, 20 | 4.7 Beats per minutes | Standard Deviation 15.08 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4 pre-infusion, n= 19, 20, 19 | 2.0 Beats per minutes | Standard Deviation 13.13 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 12, n= 18, 20, 20 | 0.3 Beats per minutes | Standard Deviation 13.05 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1 pre-infusion, n= 19, 20, 20 | 4.0 Beats per minutes | Standard Deviation 12.21 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 10m, n= 19, 20, 19 | 1.7 Beats per minutes | Standard Deviation 15.36 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 10m, n= 19, 20, 19 | -1.6 Beats per minutes | Standard Deviation 11.93 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 20, n= 15, 18, 18 | 7.8 Beats per minutes | Standard Deviation 14.81 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 30m, n= 19, 20, 20 | 3.5 Beats per minutes | Standard Deviation 14.36 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 10m, n= 19, 20, 19 | -4.6 Beats per minutes | Standard Deviation 15.37 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 24, n= 17, 20, 19 | 0.5 Beats per minutes | Standard Deviation 13.43 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 30m, n= 19, 19, 19 | -4.3 Beats per minutes | Standard Deviation 13.67 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 24, n= 17, 20, 19 | -0.4 Beats per minutes | Standard Deviation 13.41 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 10m, n= 19, 20, 19 | 0.1 Beats per minutes | Standard Deviation 12.34 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 2h, n= 19, 20, 20 | -0.5 Beats per minutes | Standard Deviation 12.53 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 1h, n= 19, 19, 20 | -2.2 Beats per minutes | Standard Deviation 15.1 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 2h, n= 19, 18, 18 | -0.3 Beats per minutes | Standard Deviation 12.3 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4 pre-infusion, n= 19, 20, 19 | 1.4 Beats per minutes | Standard Deviation 14.56 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1 pre-infusion, n= 19, 20, 20 | 2.3 Beats per minutes | Standard Deviation 10.76 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 30m, n= 19, 20, 20 | 1.9 Beats per minutes | Standard Deviation 11.56 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Day 1, 1h, n= 19, 20, 20 | 0.9 Beats per minutes | Standard Deviation 15.4 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 10m, n= 19, 20, 19 | -4.8 Beats per minutes | Standard Deviation 14.83 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 30m, n= 19, 19, 19 | -4.0 Beats per minutes | Standard Deviation 9.71 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 4, 2h, n= 19, 19, 20 | -5.3 Beats per minutes | Standard Deviation 14.26 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8 pre-infusion, n= 19, 20, 19 | 7.1 Beats per minutes | Standard Deviation 21.13 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 10m, n= 19, 20, 19 | 0.1 Beats per minutes | Standard Deviation 16.18 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 30m, n= 19, 19, 18 | -2.1 Beats per minutes | Standard Deviation 18.73 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 8, 1h, n= 19, 19, 17 | 0.9 Beats per minutes | Standard Deviation 12.46 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 12, n= 18, 20, 20 | 1.1 Beats per minutes | Standard Deviation 14.37 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 16, n= 15, 19, 20 | 2.9 Beats per minutes | Standard Deviation 12.62 |
| Mepolizumab 10 mg/kg | Change From Baseline in Heart Rate at the Indicated Time Points | Week 20, n= 15, 18, 18 | 1.7 Beats per minutes | Standard Deviation 15.5 |
Primary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points
SBP and DBP measurements were obtained at the following time points: screening, pre-infusion, 10 minutes (m), 30m, 1 hour (h), 2h post-infusion on Day 1, Week 4, Week 8; and Weeks 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Screening, Day 1, Weeks 4, 8, 12, 16, 20, and 24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 1h, n= 19, 20, 20 | 1.1 Millimeters of mercury (mmHg) | Standard Deviation 13.68 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 2h, n= 19, 19, 20 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 10.21 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 2h, n= 19, 19, 20 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 8.69 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 12, n= 18, 20, 20 | -1.9 Millimeters of mercury (mmHg) | Standard Deviation 9.09 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 1h, n= 19, 19, 20 | -2.0 Millimeters of mercury (mmHg) | Standard Deviation 7.54 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8 pre-infusion, n= 19, 20, 19 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 11.18 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 10m, n= 19, 20, 19 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 8.82 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 30m, n= 19, 19, 19 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 10.31 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 24, n= 17, 20, 19 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 9.26 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 1h, n= 19, 20, 20 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 8.41 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 30m, n= 19, 19, 18 | -2.7 Millimeters of mercury (mmHg) | Standard Deviation 10.29 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 30m, n= 19, 20, 20 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 7.93 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 1h, n= 19, 19, 17 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 13.3 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1 pre-infusion, n= 19, 20, 20 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 10.65 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1 pre-infusion, n= 19, 20, 20 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 8.81 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 2h, n= 19, 18, 18 | 0.4 Millimeters of mercury (mmHg) | Standard Deviation 12.97 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 16, n= 15, 19, 20 | 0.6 Millimeters of mercury (mmHg) | Standard Deviation 10.06 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 24, n= 17, 20, 19 | 2.1 Millimeters of mercury (mmHg) | Standard Deviation 9.23 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 12, n= 18, 20, 20 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 12.27 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 2h, n= 19, 18, 18 | -4.4 Millimeters of mercury (mmHg) | Standard Deviation 9.66 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 20, n= 15, 18, 18 | 0.7 Millimeters of mercury (mmHg) | Standard Deviation 8.8 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 16, n= 15, 19, 20 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 10.33 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 10m, n= 19, 20, 19 | -3.2 Millimeters of mercury (mmHg) | Standard Deviation 10.82 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 10m, n= 19, 20, 19 | -1.5 Millimeters of mercury (mmHg) | Standard Deviation 9.03 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 1h, n= 19, 19, 17 | -2.3 Millimeters of mercury (mmHg) | Standard Deviation 11.44 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 2h, n= 19, 20, 20 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 10.32 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 20, n= 15, 18, 18 | -2.5 Millimeters of mercury (mmHg) | Standard Deviation 7.9 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 30m, n= 19, 19, 18 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 9.08 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4 pre-infusion, n= 19, 20, 19 | 4.2 Millimeters of mercury (mmHg) | Standard Deviation 8.74 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 2h, n= 19, 20, 20 | -0.1 Millimeters of mercury (mmHg) | Standard Deviation 7.39 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 10m, n= 19, 20, 19 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 7.72 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 10m, n= 19, 20, 19 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 11.32 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 10m, n= 19, 20, 19 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 10.58 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8 pre-infusion, n= 19, 20, 19 | 0.9 Millimeters of mercury (mmHg) | Standard Deviation 7.92 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 30m, n= 19, 19, 19 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 10.71 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4 pre-infusion, n= 19, 20, 19 | -0.2 Millimeters of mercury (mmHg) | Standard Deviation 7.79 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 30m, n= 19, 20, 20 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 11.94 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 1h, n= 19, 19, 20 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 9.91 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 2h, n= 19, 19, 20 | 1.6 Millimeters of mercury (mmHg) | Standard Deviation 9.42 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 30m, n= 19, 20, 20 | 1.6 Millimeters of mercury (mmHg) | Standard Deviation 12.75 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 1h, n= 19, 20, 20 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 13.45 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 30m, n= 19, 19, 18 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 15.9 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1 pre-infusion, n= 19, 20, 20 | 2.0 Millimeters of mercury (mmHg) | Standard Deviation 11.23 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 10m, n= 19, 20, 19 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 11.37 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 2h, n= 19, 20, 20 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 14.34 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4 pre-infusion, n= 19, 20, 19 | 1.3 Millimeters of mercury (mmHg) | Standard Deviation 9.97 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 10m, n= 19, 20, 19 | -1.6 Millimeters of mercury (mmHg) | Standard Deviation 11.97 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1 pre-infusion, n= 19, 20, 20 | 3.4 Millimeters of mercury (mmHg) | Standard Deviation 16.1 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 10m, n= 19, 20, 19 | 0.8 Millimeters of mercury (mmHg) | Standard Deviation 12.16 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 2h, n= 19, 20, 20 | 2.8 Millimeters of mercury (mmHg) | Standard Deviation 10.08 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4 pre-infusion, n= 19, 20, 19 | 0.2 Millimeters of mercury (mmHg) | Standard Deviation 11.04 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 10m, n= 19, 20, 19 | -0.8 Millimeters of mercury (mmHg) | Standard Deviation 15.93 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 30m, n= 19, 19, 19 | -4.1 Millimeters of mercury (mmHg) | Standard Deviation 15.26 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 1h, n= 19, 19, 20 | -4.8 Millimeters of mercury (mmHg) | Standard Deviation 12.69 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 2h, n= 19, 19, 20 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 12.99 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8 pre-infusion, n= 19, 20, 19 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 13.74 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 10m, n= 19, 20, 19 | -1.0 Millimeters of mercury (mmHg) | Standard Deviation 17.12 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 1h, n= 19, 19, 17 | -0.6 Millimeters of mercury (mmHg) | Standard Deviation 14.18 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 2h, n= 19, 18, 18 | 0.3 Millimeters of mercury (mmHg) | Standard Deviation 13.11 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 12, n= 18, 20, 20 | 2.1 Millimeters of mercury (mmHg) | Standard Deviation 15.37 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 16, n= 15, 19, 20 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 11.98 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 20, n= 15, 18, 18 | 2.8 Millimeters of mercury (mmHg) | Standard Deviation 14.96 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 24, n= 17, 20, 19 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 12.33 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 30m, n= 19, 20, 20 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 10.89 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 1h, n= 19, 20, 20 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 10.94 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 30m, n= 19, 19, 19 | -1.7 Millimeters of mercury (mmHg) | Standard Deviation 11.51 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 1h, n= 19, 19, 20 | -3.9 Millimeters of mercury (mmHg) | Standard Deviation 9.14 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8 pre-infusion, n= 19, 20, 19 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 9.5 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 10m, n= 19, 20, 19 | -2.2 Millimeters of mercury (mmHg) | Standard Deviation 11.28 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 30m, n= 19, 19, 18 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 13.68 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 1h, n= 19, 19, 17 | -1.1 Millimeters of mercury (mmHg) | Standard Deviation 11.97 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 2h, n= 19, 18, 18 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 11.69 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 12, n= 18, 20, 20 | -1.8 Millimeters of mercury (mmHg) | Standard Deviation 5.21 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 16, n= 15, 19, 20 | 3.2 Millimeters of mercury (mmHg) | Standard Deviation 12.39 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 20, n= 15, 18, 18 | 3.4 Millimeters of mercury (mmHg) | Standard Deviation 10.05 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 24, n= 17, 20, 19 | 2.3 Millimeters of mercury (mmHg) | Standard Deviation 10.02 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 2h, n= 19, 20, 20 | -0.4 Millimeters of mercury (mmHg) | Standard Deviation 12.96 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 10m, n= 19, 20, 19 | -0.3 Millimeters of mercury (mmHg) | Standard Deviation 12.71 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8 pre-infusion, n= 19, 20, 19 | 10.4 Millimeters of mercury (mmHg) | Standard Deviation 13.08 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 20, n= 15, 18, 18 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 11.26 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 30m, n= 19, 19, 19 | -0.9 Millimeters of mercury (mmHg) | Standard Deviation 12.1 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 2h, n= 19, 19, 20 | 2.9 Millimeters of mercury (mmHg) | Standard Deviation 15.79 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 12, n= 18, 20, 20 | 5.5 Millimeters of mercury (mmHg) | Standard Deviation 14.48 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 1h, n= 19, 19, 20 | 1.5 Millimeters of mercury (mmHg) | Standard Deviation 13.45 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 1h, n= 19, 19, 20 | 4.2 Millimeters of mercury (mmHg) | Standard Deviation 16.44 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 30m, n= 19, 19, 19 | 2.5 Millimeters of mercury (mmHg) | Standard Deviation 16.33 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4, 2h, n= 19, 19, 20 | 0.5 Millimeters of mercury (mmHg) | Standard Deviation 14.38 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4, 10m, n= 19, 20, 19 | 3.2 Millimeters of mercury (mmHg) | Standard Deviation 13.62 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1 pre-infusion, n= 19, 20, 20 | 1.4 Millimeters of mercury (mmHg) | Standard Deviation 9.36 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8 pre-infusion, n= 19, 20, 19 | 4.1 Millimeters of mercury (mmHg) | Standard Deviation 12.01 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 4 pre-infusion, n= 19, 20, 19 | 5.7 Millimeters of mercury (mmHg) | Standard Deviation 12.67 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 30m, n= 19, 20, 20 | 5.4 Millimeters of mercury (mmHg) | Standard Deviation 15.53 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 10m, n= 19, 20, 19 | 1.7 Millimeters of mercury (mmHg) | Standard Deviation 15.01 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 2h, n= 19, 20, 20 | 2.7 Millimeters of mercury (mmHg) | Standard Deviation 15.92 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 16, n= 15, 19, 20 | 3.1 Millimeters of mercury (mmHg) | Standard Deviation 12.33 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 30m, n= 19, 19, 18 | -3.3 Millimeters of mercury (mmHg) | Standard Deviation 14.15 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 10m, n= 19, 20, 19 | 4.8 Millimeters of mercury (mmHg) | Standard Deviation 15.27 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1, 1h, n= 19, 20, 20 | 3.6 Millimeters of mercury (mmHg) | Standard Deviation 14.55 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 1h, n= 19, 19, 17 | 0.1 Millimeters of mercury (mmHg) | Standard Deviation 14.61 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 16, n= 15, 19, 20 | 9.7 Millimeters of mercury (mmHg) | Standard Deviation 18.97 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 12, n= 18, 20, 20 | 12.1 Millimeters of mercury (mmHg) | Standard Deviation 15.12 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Day 1 pre-infusion, n= 19, 20, 20 | 7.4 Millimeters of mercury (mmHg) | Standard Deviation 14.09 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 20, n= 15, 18, 18 | 13.1 Millimeters of mercury (mmHg) | Standard Deviation 14.55 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 2h, n= 19, 18, 18 | 4.6 Millimeters of mercury (mmHg) | Standard Deviation 14.41 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 24, n= 17, 20, 19 | 3.5 Millimeters of mercury (mmHg) | Standard Deviation 8.42 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 24, n= 17, 20, 19 | 6.9 Millimeters of mercury (mmHg) | Standard Deviation 15.13 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 1h, n= 19, 19, 17 | 8.7 Millimeters of mercury (mmHg) | Standard Deviation 15.73 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 10m, n= 19, 20, 19 | 2.1 Millimeters of mercury (mmHg) | Standard Deviation 11.98 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 30m, n= 19, 19, 18 | 2.2 Millimeters of mercury (mmHg) | Standard Deviation 15.89 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 8, 2h, n= 19, 18, 18 | -1.2 Millimeters of mercury (mmHg) | Standard Deviation 13.53 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 30m, n= 19, 20, 20 | -0.7 Millimeters of mercury (mmHg) | Standard Deviation 12.11 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | SBP, Week 8, 10m, n= 19, 20, 19 | 3.3 Millimeters of mercury (mmHg) | Standard Deviation 14.31 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Week 4 pre-infusion, n= 19, 20, 19 | 1.2 Millimeters of mercury (mmHg) | Standard Deviation 11.46 |
| Mepolizumab 10 mg/kg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points | DBP, Day 1, 1h, n= 19, 20, 20 | -2.4 Millimeters of mercury (mmHg) | Standard Deviation 13.43 |
Primary
Change From Baseline in Temperature at the Indicated Time Points
Temperature measurements were obtained at the following time points: Screening, Day 1, and Weeks 4, 8, 12, 16, 20 and 24. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Screening, Day 1, Weeks 4, 8, 12, 16, 20 and 24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 16, n=15, 17, 20 | -0.01 Degree Celsius (°C) | Standard Deviation 0.518 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Day 1, n=19, 20, 20 | -0.18 Degree Celsius (°C) | Standard Deviation 0.472 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 20, n=15, 18, 18 | 0.00 Degree Celsius (°C) | Standard Deviation 0.626 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 12, n=18, 20, 20 | 0.03 Degree Celsius (°C) | Standard Deviation 0.661 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 24, n=17, 20, 19 | -0.11 Degree Celsius (°C) | Standard Deviation 0.506 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 8, n=19, 20, 19 | -0.44 Degree Celsius (°C) | Standard Deviation 0.49 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 4, n=19, 20, 20 | -0.44 Degree Celsius (°C) | Standard Deviation 1.023 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 20, n=15, 18, 18 | -0.12 Degree Celsius (°C) | Standard Deviation 0.696 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 4, n=19, 20, 20 | -0.30 Degree Celsius (°C) | Standard Deviation 0.614 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 8, n=19, 20, 19 | -0.13 Degree Celsius (°C) | Standard Deviation 0.696 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 16, n=15, 17, 20 | 0.05 Degree Celsius (°C) | Standard Deviation 0.491 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Day 1, n=19, 20, 20 | 0.01 Degree Celsius (°C) | Standard Deviation 0.824 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 24, n=17, 20, 19 | -0.31 Degree Celsius (°C) | Standard Deviation 0.668 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 12, n=18, 20, 20 | -0.09 Degree Celsius (°C) | Standard Deviation 0.671 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 24, n=17, 20, 19 | -0.12 Degree Celsius (°C) | Standard Deviation 0.826 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 16, n=15, 17, 20 | 0.02 Degree Celsius (°C) | Standard Deviation 0.753 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 8, n=19, 20, 19 | -0.06 Degree Celsius (°C) | Standard Deviation 0.819 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 4, n=19, 20, 20 | -0.14 Degree Celsius (°C) | Standard Deviation 0.909 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Day 1, n=19, 20, 20 | -0.07 Degree Celsius (°C) | Standard Deviation 0.758 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 20, n=15, 18, 18 | -0.12 Degree Celsius (°C) | Standard Deviation 0.644 |
| Mepolizumab 10 mg/kg | Change From Baseline in Temperature at the Indicated Time Points | Week 12, n=18, 20, 20 | -0.08 Degree Celsius (°C) | Standard Deviation 0.914 |
Primary
Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12
A responder was defined as a participant achieving a reduction in esophageal eosinophils to \<5 cells per HPF as the highest count of eosinophils per HPF in all the esophageal sites biopsied at Week 12, confirmed by biopsy at Week 12 or at an early withdrawal visit prior to Week 12. A worst case (WC) approach was considered, if a particiapant withdrew prematurely : If a particiapnt dropped out of the study without having a biopsy taken, due to lack of efficacy or an adverse event, their response was imputed as not achieved. Participants who withdrew, without a biopsy, for other reasons (e.g. lost to follow-up) were considered non-evaluable for the primary analysis. For participants who withdrew early from the study and had a biopsy, the biopsy was used to determine their response.
Time frame: Week 12
Population: ITT Population-WC
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 | 2 Participants |
| Mepolizumab 10 mg/kg | Number of Participants Achieving a Reduction in Peak Esophageal Eosinophil Count to < 5 Cells Per High Power Field (HPF) at Week 12 | 0 Participants |
p-value: 0.86595% CI: [0.04, 5.44]Regression, Logistic
p-value: 0.1995% CI: [0.01, 2.07]Regression, Logistic
Primary
Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP)
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event is defined as any untoward medical occurrence that, at any dose that Results in death, life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; a congenital anomaly/birth defect. Drug-related AE's were considered to have a reasonable possibility of being related to treatment by the investigator. AE, SAE and drug-related AEs are summarized by TP and FP.
Time frame: From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)
Population: Intention-to-Treat (ITT) Population: all participants who gave informed consent, were randomized and received at least one dose of medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, TP | 18 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, FP | 15 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, TP | 6 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, FP | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, TP | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, FP | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, FP | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, TP | 15 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, FP | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, TP | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, FP | 9 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, TP | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, FP | 10 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, TP | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, FP | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Drug-Related AE, FP | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any AE, TP | 18 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Any Adverse Events (AE), Any Serious Adverse Event (SAE) and Drug-related AE During Treatment Phase (TP) and Follow-up Phase (FP) | Any SAE, TP | 2 Participants |
Primary
Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period.
Blood samples were collected at Day 1, Weeks 4, 8, 12, 16, 20 and 24 to estimate the following biochemistry parameters: alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (Ab), total protein (ToP), creatinine (Cr), total bilirubin (TB), calcium (Ca), bicarbonate (Bi), chloride (Cl), glucose (Glu), potassium (Pot), and sodium (Sod). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.
Time frame: From first dose of study treatment (Day 1) up to Follow-up Phase (Week 24)
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR High, n=19, 19, 20 | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR High, n=19, 20, 20 | 4 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR Low, n=19, 20, 20 | 9 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR Low, n=19, 20, 20 | 2 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR Low, n=19, 20, 20 | 4 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR Low, n=19, 20, 20 | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR High, n=19, 20, 20 | 8 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR Low, n=19, 20, 20 | 6 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR Low, n=19, 20, 20 | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR High, n=19, 20, 20 | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR High, n=19, 20, 20 | 5 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR High, n=19 ,20, 20 | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR High, n=19, 20, 20 | 2 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR Low, n=19, 20, 20 | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR High, n=19, 20, 20 | 5 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR High, n=19, 20, 20 | 6 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR Low, n=19, 19, 20 | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR Low, n=19, 20, 20 | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR High, n=19, 20, 20 | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR Low, n=19, 20, 20 | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR High, n=19, 20, 20 | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR Low, n=19, 20, 20 | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR High, n=19, 20, 20 | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR Low, n=19, 20, 20 | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR Low, n=19, 20, 20 | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR High, n=19, 20, 20 | 7 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR High, n=19, 20, 20 | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR Low, n=19, 20, 20 | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR High, n=19, 20, 20 | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR High, n=19, 20, 20 | 8 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR Low, n=19, 20, 20 | 7 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR High, n=19, 19, 20 | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR Low, n=19, 19, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR High, n=19 ,20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR Low, n=19, 20, 20 | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR High, n=19, 20, 20 | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR High, n=19, 19, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR High, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR Low, n=19, 20, 20 | 5 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Pot - RR Low, n=19, 19, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR Low, n=19, 20, 20 | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Sod - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR Low, n=19, 20, 20 | 6 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cr - RR High, n=19, 20, 20 | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR High, n=19 ,20, 20 | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ToP - RR High, n=19, 20, 20 | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR High, n=19, 20, 20 | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ab - RR High, n=19, 20, 20 | 2 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Cl - RR Low, n=19, 20, 20 | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Bi - RR High, n=19, 20, 20 | 2 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | ALT - RR Low, n=19, 20, 20 | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR High, n=19, 20, 20 | 7 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Ca - RR High, n=19, 20, 20 | 7 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | AST - RR High, n=19, 20, 20 | 7 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | Glu - RR Low, n=19, 20, 20 | 8 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Biochemistry Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During Study Period. | TB - RR Low, n=19, 20, 20 | 4 Participants |
Primary
Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period.
Blood samples were collected pre-infusion at Day 1, Week 4 and Week 8; and 24h and 72h post-infusion at Day 1, Week 4 and Week 8 time points and at Weeks 2, 6, 10, 12, 16, 20, 24, and 34 to estimate the following hematology parameters: basophils (Bas), percentage of basophils (% Bas), lymphocytes (Lym), percentage of Lym (% Lym), monocytes (Mon), percentage of Mon (% Mon), platelet count (PC), total neutrophils (TN), percentage of TN (% TN), white blood cell count (WBC), hematocrit (He), hemoglobin (Hg), and red blood cell count (RBC). Laboratory abnormalities outside the reference range (high and low values) at any time post baseline were presented. Any time post Baseline = all visits (including scheduled and unscheduled). If participant had given both high and low value at least once then participant is counted under both high and low category for this visit.
Time frame: From first dose of study treatment (Day 1) up to Long-term Follow-up Phase (Week 34)
Population: ITT Population. Only those participants available at specified time points are analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN - RR High | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR High | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN -RR Low | 15 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR High | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR High | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR High | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR Low | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon - RR Low | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR High | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR High | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR Low | 4 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR High | 14 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR Low | 4 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR Low | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR High | 12 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR Low | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR Low | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR Low | 2 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon -RR High | 6 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR Low | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR High | 3 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR High | 2 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR High | 2 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR Low | 7 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR Low | 5 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR Low | 6 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR High | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN - RR High | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR Low | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon - RR Low | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN -RR Low | 11 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR High | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR High | 5 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR High | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR Low | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR Low | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR High | 12 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR High | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR Low | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR Low | 6 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR Low | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR High | 10 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR High | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR High | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR Low | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR Low | 4 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR High | 3 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR High | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR Low | 5 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon -RR High | 7 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR Low | 7 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR Low | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR Low | 7 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR Low | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR High | 15 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR Low | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR High | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Bas - RR Low | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR High | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Bas - RR Low | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR High | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Lym - RR Low | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Lym -RR High | 12 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon -RR High | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Mon - RR Low | 5 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % Mon -RR Low | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | PC - RR High | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR High | 6 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | TN - RR Low | 3 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN - RR High | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | % TN -RR Low | 13 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR High | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | WBC - RR Low | 7 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR High | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | He - RR Low | 5 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR High | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | Hg - RR Low | 1 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Indicated Hematology Parameters Falling Outside of Reference Range (RR) in Any Vist Post-Basline During the Study Period. | RBC - RR High | 1 Participants |
Primary
Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit.
Blood samples for testing anti-mepolizumab antibodies were collected on Day 1, Week 4 and 8 Infusion Visit (before the IV infusion) and at Week 12, 24 and 34 Week follow-up visits. The presence of anti-human mepolizumab antibodies was assessed using an immunoelectrochemiluminescent (ECL) assay. To address transient positive results, an assessment of repeated results were made. For any visit category: results were considered as positive if it was positive at any visit during the study, and results were considered as negative if it were negative at all visits during the study. For repeat visit category: results were considered as postive if the result was positive at \>1 visit, and results were considered as negative if the result was negative at all visits or was positive at only one visit.
Time frame: Day 1, Weeks 4, 8, 12, 24, and 34
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Positive | 13 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Negative | 4 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Negative | 6 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Positive | 15 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Positive | 15 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Negative | 5 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Positive | 5 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Negative | 15 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Positive | 16 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Negative | 13 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Any Visit- ECL Screening Negative | 4 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Positive and Negative Anti-mepolizumab Antibody Results at Any Visit and Repeat Visit. | Repeat Visit-ECL Screening Positive | 7 Participants |
Primary
Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline
12-lead ECG assessments were obtained at the following time points: screening, and Weeks 4, 8 and 12.. Overall ECG findings were summarized using the worst case findings without regard to visits ie. any time post Baseline. Change from Baseline in ECG findings were categorized as clinically significant change from Baseline; no clinically significant change from Baseline and not applicable.
Time frame: Screening, Weeks 4, 8 and 12
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Clinically significant change from | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Not applicable | 0 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | No clinically significant change from | 18 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | No clinically significant change from | 20 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Not applicable | 0 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Clinically significant change from | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Not applicable | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | Clinically significant change from | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With the Indicated Change From Baseline in ECG Findings at Any Time Post-Baseline | No clinically significant change from | 20 Participants |
Primary
Plasma Clearance (CL) of Mepolizumab
Clearance is defined as the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 from each participant to estimate plasma clearance of mepolizumab.
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 34
Population: Pharmacokinetic Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Mepolizumab 0.55 mg/kg | Plasma Clearance (CL) of Mepolizumab | 0.14 Liters per Day (L/day) |
| Mepolizumab 2.5 mg/kg | Plasma Clearance (CL) of Mepolizumab | 0.15 Liters per Day (L/day) |
| Mepolizumab 10 mg/kg | Plasma Clearance (CL) of Mepolizumab | 0.14 Liters per Day (L/day) |
Secondary
Absolute Blood Eosinophils Count at the Indicated Time Points
Blood samples were obtained at Screening, pre-infusion and 24h and 72-96h post-infusion at Day 1, Weeks 4 and 8; and at Week 2, 6, 10, 12, 16, 20, 24 and 34 visits or Early Withdrawal Visit to estimate blood eosinophil count.
Time frame: Screening, Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Screening, n=17,16,20 | 0.441 Giga cells per liter (GI/L) | Standard Deviation 0.2358 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 10, n= 18,18,18 | 0.100 Giga cells per liter (GI/L) | Standard Deviation 0.0872 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 24h postdose, n=16,14,14 | 0.093 Giga cells per liter (GI/L) | Standard Deviation 0.069 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 24, n=15,20,18 | 0.706 Giga cells per liter (GI/L) | Standard Deviation 0.4513 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 72-96h postdose, n= 16,15,13 | 0.070 Giga cells per liter (GI/L) | Standard Deviation 0.0803 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 72-96h postdose, n=15,15,15 | 0.081 Giga cells per liter (GI/L) | Standard Deviation 0.0666 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 24h postdose, n=12,10,14 | 0.147 Giga cells per liter (GI/L) | Standard Deviation 0.0623 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 predose, n=19,19,19 | 0.113 Giga cells per liter (GI/L) | Standard Deviation 0.091 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 6, n=19,16,20 | 0.099 Giga cells per liter (GI/L) | Standard Deviation 0.0897 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 34, n=14,18,16 | 0.650 Giga cells per liter (GI/L) | Standard Deviation 0.3025 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 20, n=15,17,18 | 0.478 Giga cells per liter (GI/L) | Standard Deviation 0.3944 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 72-96h postdose, n=14,11,11 | 0.123 Giga cells per liter (GI/L) | Standard Deviation 0.093 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 24h postdose, n=17,14,14 | 0.077 Giga cells per liter (GI/L) | Standard Deviation 0.0645 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 16, n=15,18,19 | 0.261 Giga cells per liter (GI/L) | Standard Deviation 0.2097 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 2, n=19,18,20 | 0.139 Giga cells per liter (GI/L) | Standard Deviation 0.1531 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 predose, n= 17,19,20 | 0.419 Giga cells per liter (GI/L) | Standard Deviation 0.162 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 12, n=16,18,20 | 0.091 Giga cells per liter (GI/L) | Standard Deviation 0.0686 |
| Mepolizumab 0.55 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 predose, n=19,16,20 | 0.165 Giga cells per liter (GI/L) | Standard Deviation 0.1635 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 72-96h postdose, n=14,11,11 | 0.151 Giga cells per liter (GI/L) | Standard Deviation 0.0823 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 24h postdose, n=17,14,14 | 0.055 Giga cells per liter (GI/L) | Standard Deviation 0.0494 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Screening, n=17,16,20 | 0.524 Giga cells per liter (GI/L) | Standard Deviation 0.2579 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 predose, n= 17,19,20 | 0.476 Giga cells per liter (GI/L) | Standard Deviation 0.266 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 24h postdose, n=12,10,14 | 0.158 Giga cells per liter (GI/L) | Standard Deviation 0.1156 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 2, n=19,18,20 | 0.114 Giga cells per liter (GI/L) | Standard Deviation 0.0815 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 predose, n=19,16,20 | 0.072 Giga cells per liter (GI/L) | Standard Deviation 0.0571 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 24h postdose, n=16,14,14 | 0.097 Giga cells per liter (GI/L) | Standard Deviation 0.0548 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 72-96h postdose, n=15,15,15 | 0.089 Giga cells per liter (GI/L) | Standard Deviation 0.0721 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 6, n=19,16,20 | 0.060 Giga cells per liter (GI/L) | Standard Deviation 0.0678 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 predose, n=19,19,19 | 0.081 Giga cells per liter (GI/L) | Standard Deviation 0.0517 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 72-96h postdose, n= 16,15,13 | 0.045 Giga cells per liter (GI/L) | Standard Deviation 0.0566 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 10, n= 18,18,18 | 0.059 Giga cells per liter (GI/L) | Standard Deviation 0.0537 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 12, n=16,18,20 | 0.070 Giga cells per liter (GI/L) | Standard Deviation 0.1116 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 16, n=15,18,19 | 0.076 Giga cells per liter (GI/L) | Standard Deviation 0.0619 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 20, n=15,17,18 | 0.191 Giga cells per liter (GI/L) | Standard Deviation 0.0893 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 24, n=15,20,18 | 0.389 Giga cells per liter (GI/L) | Standard Deviation 0.2756 |
| Mepolizumab 2.5 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 34, n=14,18,16 | 0.569 Giga cells per liter (GI/L) | Standard Deviation 0.2599 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 predose, n=19,16,20 | 0.062 Giga cells per liter (GI/L) | Standard Deviation 0.0381 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 predose, n= 17,19,20 | 0.559 Giga cells per liter (GI/L) | Standard Deviation 0.2987 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 10, n= 18,18,18 | 0.043 Giga cells per liter (GI/L) | Standard Deviation 0.0412 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 2, n=19,18,20 | 0.111 Giga cells per liter (GI/L) | Standard Deviation 0.068 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 34, n=14,18,16 | 0.575 Giga cells per liter (GI/L) | Standard Deviation 0.4268 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 12, n=16,18,20 | 0.048 Giga cells per liter (GI/L) | Standard Deviation 0.0411 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 72-96h postdose, n=14,11,11 | 0.179 Giga cells per liter (GI/L) | Standard Deviation 0.1319 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 24, n=15,20,18 | 0.147 Giga cells per liter (GI/L) | Standard Deviation 0.1167 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 16, n=15,18,19 | 0.078 Giga cells per liter (GI/L) | Standard Deviation 0.0517 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Day 1 24h postdose, n=12,10,14 | 0.230 Giga cells per liter (GI/L) | Standard Deviation 0.112 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 6, n=19,16,20 | 0.146 Giga cells per liter (GI/L) | Standard Deviation 0.3902 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 72-96h postdose, n=15,15,15 | 0.053 Giga cells per liter (GI/L) | Standard Deviation 0.0377 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Screening, n=17,16,20 | 0.493 Giga cells per liter (GI/L) | Standard Deviation 0.2218 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 predose, n=19,19,19 | 0.052 Giga cells per liter (GI/L) | Standard Deviation 0.0385 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 24h postdose, n=17,14,14 | 0.061 Giga cells per liter (GI/L) | Standard Deviation 0.0305 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 4 24h postdose, n=16,14,14 | 0.079 Giga cells per liter (GI/L) | Standard Deviation 0.0285 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 20, n=15,17,18 | 0.124 Giga cells per liter (GI/L) | Standard Deviation 0.0658 |
| Mepolizumab 10 mg/kg | Absolute Blood Eosinophils Count at the Indicated Time Points | Week 8 72-96h postdose, n= 16,15,13 | 0.075 Giga cells per liter (GI/L) | Standard Deviation 0.0285 |
Secondary
Change From Baseline in Daily Degree of Difficulty With Drinking
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned days the participant did not drink. The amount of difficulty with drinking was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average difficulty for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the drinking difficulty scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 9-12, n=15,18,13 | 0.008 Scores on a Scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 21-24, n=13,16,11 | -0.137 Scores on a Scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 9-12, n=15,18,13 | 0.046 Scores on a Scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 21-24, n=13,16,11 | -0.049 Scores on a Scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 9-12, n=15,18,13 | -0.152 Scores on a Scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Daily Degree of Difficulty With Drinking | Weeks 21-24, n=13,16,11 | -0.070 Scores on a Scale |
p-value: 0.76295% CI: [-0.217, 0.294]ANCOVA
p-value: 0.23595% CI: [-0.426, 0.108]ANCOVA
p-value: 0.60795% CI: [-0.259, 0.436]ANCOVA
p-value: 0.71695% CI: [-0.308, 0.443]ANCOVA
Secondary
Change From Baseline in Difficulty With Eating Solid Foods
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP and FP. A score of 6 was assigned for that symptom when Par. did not eat solid foods. When Par.eat solid foods, the amount of difficulty was assessed as 1=no difficulty, 2=a little difficulty, 3=some difficulty, 4=quite a bit of difficulty, 5=a whole lot of difficulty. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interactions.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 9-12, n=15,18,13 | -0.474 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 21-24, n=13,16,11 | -0.427 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 21-24, n=13,16,11 | -0.245 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 9-12, n=15,18,13 | -0.174 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 9-12, n=15,18,13 | -0.119 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Difficulty With Eating Solid Foods | Weeks 21-24, n=13,16,11 | -0.305 Scores on a scale |
p-value: 0.14295% CI: [-0.105, 0.704]ANCOVA
p-value: 0.11595% CI: [-0.09, 0.798]ANCOVA
p-value: 0.46595% CI: [-0.319, 0.683]ANCOVA
p-value: 0.64995% CI: [-0.417, 0.66]ANCOVA
Secondary
Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only)
Par. and/or parent/guardian recorded daily symptoms of the feeling like something is stuck in throat on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom of feeling of something stuck was not experienced. On days that feeling of something stuck in the throat was experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. Average bothersome score was calculated as the sum of the respective scores for that interval divided by the number of days. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 9-12, n=12,12,8 | -0.751 Scores on a Scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 21-24, n=11,11,8 | -0.785 Scores on a Scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 9-12, n=12,12,8 | -0.238 Scores on a Scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 21-24, n=11,11,8 | -0.075 Scores on a Scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 9-12, n=12,12,8 | -0.510 Scores on a Scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Feeling of Something Stuck in Throat Bothersome Scores (for Par. 8-17 Years Only) | Weeks 21-24, n=11,11,8 | -0.535 Scores on a Scale |
p-value: 0.06295% CI: [-0.028, 1.055]ANCOVA
p-value: 0.42595% CI: [-0.369, 0.852]ANCOVA
p-value: 0.08295% CI: [-0.096, 1.516]ANCOVA
p-value: 0.56495% CI: [-0.631, 1.132]ANCOVA
Secondary
Change From Baseline in Frequency of Vomiting
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A participant vomiting any time was counted as one episode of vomiting, irrespective of how close they are to each other. The daily frequency of vomiting was calculated as the total number of times the participant vomited during the interval divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 9-12, n=15, 18, 13 | -0.048 Occurrences of vomiting per day |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 21-24, n=13, 16, 11 | -0.009 Occurrences of vomiting per day |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 9-12, n=15, 18, 13 | 0.040 Occurrences of vomiting per day |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 21-24, n=13, 16, 11 | -0.004 Occurrences of vomiting per day |
| Mepolizumab 10 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 21-24, n=13, 16, 11 | 0.096 Occurrences of vomiting per day |
| Mepolizumab 10 mg/kg | Change From Baseline in Frequency of Vomiting | Weeks 9-12, n=15, 18, 13 | -0.060 Occurrences of vomiting per day |
p-value: 0.57295% CI: [-0.224, 0.4]ANCOVA
p-value: 0.94295% CI: [-0.35, 0.326]ANCOVA
p-value: 0.9695% CI: [-0.188, 0.197]ANCOVA
p-value: 0.31795% CI: [-0.105, 0.315]ANCOVA
Secondary
Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24
Participants underwent an EGD with biopsies at Screening and at Weeks 12 and 24. Mean esophageal eosinophils were calculated as the mean number across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline, Weeks 12 and 24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -27.34 Cells/HPF | Standard Error 6.323 |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16, 19, 19 | -8.23 Cells/HPF | Standard Error 6.449 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -29.97 Cells/HPF | Standard Error 6.184 |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16, 19, 19 | -17.48 Cells/HPF | Standard Error 7.446 |
| Mepolizumab 10 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -34.04 Cells/HPF | Standard Error 5.984 |
| Mepolizumab 10 mg/kg | Change From Baseline in Mean Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16, 19, 19 | -26.03 Cells/HPF | Standard Error 5.677 |
p-value: 0.74795% CI: [-20.68, 15.41]van Elteren test
p-value: 0.35295% CI: [-24.41, 11.01]van Elteren test
p-value: 0.52595% CI: [-29.69, 11.2]van Elteren test
p-value: 0.07195% CI: [-35.21, -0.38]Van Elteren test
Secondary
Change From Baseline in Pain in Chest/Throat Severity Scores
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in chest/throat was not experienced. If pain in chest/throat was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 9-12, n=15,18,13 | -0.419 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 21-24, n=13,16,11 | -0.524 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 21-24, n=13,16,11 | -0.091 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 9-12, n=15,18,13 | -0.063 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 21-24, n=13,16,11 | -0.181 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain in Chest/Throat Severity Scores | Weeks 9-12, n=15,18,13 | -0.049 Scores on a scale |
p-value: 0.13995% CI: [-0.121, 0.833]ANCOVA
p-value: 0.14595% CI: [-0.133, 0.874]ANCOVA
p-value: 0.09595% CI: [-0.08, 0.946]ANCOVA
p-value: 0.21995% CI: [-0.214, 0.899]ANCOVA
Secondary
Change From Baseline in Pain in Stomach Severity Scores
Par.and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A severity score of 0 was assigned for days on which pain in stomach was not experienced. If pain in stomach was reported, severity of pain was assessed as: 1=hurt a little, 2=hurt somewhat, 3=hurt quite a bit, and 4=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as the Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric Analysis of Covariance (ANCOVA) models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The observed case (OC) datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 9-12, n= 15,18,13 | -0.277 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 21-24, n=13,16,11 | -0.479 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 21-24, n=13,16,11 | -0.144 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 9-12, n= 15,18,13 | -0.149 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 9-12, n= 15,18,13 | -0.157 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain in Stomach Severity Scores | Weeks 21-24, n=13,16,11 | -0.268 Scores on a scale |
p-value: 0.55195% CI: [-0.303, 0.56]ANCOVA
p-value: 0.59395% CI: [-0.331, 0.572]ANCOVA
p-value: 0.23995% CI: [-0.232, 0.901]ANCOVA
p-value: 0.48895% CI: [-0.401, 0.823]ANCOVA
Secondary
Change From Baseline in Pain With Drinking Severity Scores
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned the day participant did not drink. The severity of pain was assessed as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average difficulty and pain severity scores was calculated as the sum of the respective scores for that interval divided by the number of days in the interval. . Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The OC datasets with incorrect questionnaires excluded were used for the analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 9-12, n=15,18,13 | -0.005 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 21-24, n=13,16,11 | -0.193 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 21-24, n=13,16,11 | -0.006 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 9-12, n=15,18,13 | 0.085 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 21-24, n=13,16,11 | -0.118 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Pain With Drinking Severity Scores | Weeks 9-12, n=15,18,13 | -0.166 Scores on a scale |
p-value: 0.69195% CI: [-0.365, 0.545]ANCOVA
p-value: 0.595% CI: [-0.639, 0.317]ANCOVA
p-value: 0.56895% CI: [-0.474, 0.849]ANCOVA
p-value: 0.83295% CI: [-0.643, 0.794]ANCOVA
Secondary
Change From Baseline in Percentage of Days on Which the Participant Drank
The percentage of days with the symptom of difficulty and pain when participant drank during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 9-12, n=15,18,13 | -0.24 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 21-24, n=13,16,11 | -0.04 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 9-12, n=15,18,13 | -1.08 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 21-24, n=13,16,11 | -1.09 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 9-12, n=15,18,13 | 0.66 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days on Which the Participant Drank | Weeks 21-24, n=13,16,11 | -1.05 Percentage of days |
p-value: 0.51595% CI: [-3.45, 1.76]ANCOVA
p-value: 0.49695% CI: [-1.74, 3.54]ANCOVA
p-value: 0.65795% CI: [-5.82, 3.72]ANCOVA
p-value: 0.69195% CI: [-6.11, 4.09]ANCOVA
Secondary
Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years)
The percentage of days with feeling of something stuck in throat during each analysis period (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 9-12, n=12,12,8 | -21.56 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 21-24, n=11,11,8 | -21.33 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 9-12, n=12,12,8 | -12.11 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 21-24, n=11,11,8 | -10.76 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 9-12, n=12,12,8 | -17.44 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Feeling of Something Stuck in Throat (for Par. 8-17 Years) | Weeks 21-24, n=11,11,8 | -15.84 Percentage of days |
p-value: 0.2795% CI: [-7.77, 26.67]ANCOVA
p-value: 0.66495% CI: [-15.11, 23.36]ANCOVA
p-value: 0.38195% CI: [-13.81, 34.94]ANCOVA
p-value: 0.67295% CI: [-20.87, 31.86]ANCOVA
Secondary
Change From Baseline in Percentage of Days With Pain in Chest/Throat
The percentage of days with the symptom of pain in chest/throat during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 9-12, n=15,18,13 | -24.37 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 21-24, n=13,16,11 | -27.12 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 21-24, n=13,16,11 | -9.43 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 9-12, n=15,18,13 | -5.09 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 9-12, n=15,18,13 | -10.16 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Pain in Chest/Throat | Weeks 21-24, n=13,16,11 | -6.01 Percentage of days |
p-value: 0.04695% CI: [0.39, 38.18]ANCOVA
p-value: 0.1695% CI: [-5.83, 34.25]ANCOVA
p-value: 0.07895% CI: [-2.1, 37.48]ANCOVA
p-value: 0.05595% CI: [-0.51, 42.74]ANCOVA
Secondary
Change From Baseline in Percentage of Days With Pain in Stomach
The percentage of days with the symptom of pain in stomach during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 9-12, n=15,18,13 | -14.02 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 21-24, n=13,16,11 | -22.80 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 9-12, n=15,18,13 | -12.44 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 21-24, n=13,16,11 | -10.97 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 21-24, n=13,16,11 | -7.70 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Pain in Stomach | Weeks 9-12, n=15,18,13 | -10.11 Percentage of days |
p-value: 0.83295% CI: [-13.47, 16.65]ANCOVA
p-value: 0.62295% CI: [-12.01, 19.84]ANCOVA
p-value: 0.31795% CI: [-11.86, 35.52]ANCOVA
p-value: 0.24695% CI: [-10.91, 41.11]ANCOVA
Secondary
Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores
The percentage of days with the symptom of pain in regurgitation bothersome during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | -13.77 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | -10.26 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | 3.80 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | 2.28 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | -4.64 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | -19.19 Percentage of days |
p-value: 0.12395% CI: [-4, 32.13]ANCOVA
p-value: 0.55195% CI: [-13.29, 24.54]ANCOVA
p-value: 0.14195% CI: [-5.61, 37.7]ANCOVA
p-value: 0.66695% CI: [-30.74, 19.9]ANCOVA
Secondary
Change From Baseline in Percentage of Days With Vomiting
The percentage of days with the symptom of vomiting during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 9-12, n=15,18,13 | -2.40 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 21-24, n=13,16,11 | 1.62 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 9-12, n=15,18,13 | -3.54 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 21-24, n=13,16,11 | -2.98 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 9-12, n=15,18,13 | -4.56 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in Percentage of Days With Vomiting | Weeks 21-24, n=13,16,11 | 1.11 Percentage of days |
p-value: 0.66695% CI: [-6.39, 4.12]ANCOVA
p-value: 0.4595% CI: [-7.87, 3.56]ANCOVA
p-value: 0.21595% CI: [-12, 2.81]ANCOVA
p-value: 0.89895% CI: [-8.61, 7.58]ANCOVA
Secondary
Change From Baseline in Regurgitation Bothersome Scores
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 0 was assigned for days on which the symptom regurgitation was not experienced. The days regurgitation experienced, the amount the symptom bothered the Par. was assessed as 1=not bothered at all, 2=bothered a little, 3=somewhat bothered, 4=bothered quite a bit, 5=bothered a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 0) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for Baseline score, treatment group, age group interactions
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. The OC datasets with incorrect questionnaires excluded were the primary analysis. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | -0.307 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | -0.387 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | 0.017 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | -0.034 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 9-12, n=15,18,13 | -0.047 Scores on a scale |
| Mepolizumab 10 mg/kg | Change From Baseline in Regurgitation Bothersome Scores | Weeks 21-24, n=13,16,10 | -0.563 Scores on a scale |
p-value: 0.24195% CI: [-0.226, 0.873]ANCOVA
p-value: 0.37195% CI: [-0.32, 0.839]ANCOVA
p-value: 0.29195% CI: [-0.317, 1.023]ANCOVA
p-value: 0.65395% CI: [-0.965, 0.614]ANCOVA
Secondary
Change From Baseline in the Percentage of Days Participants Ate Solid Foods
The percentage of days with the symptom of difficulty and pain when eating solid foods during each analysis interval (Baseline, Weeks 9-12 and Weeks 21-24) was calculated as the number of days the symptom was experienced divided by the number of days in the analysis interval, and presented as a percentage (ie, the proportion X 100%). Screening phase was considered as Baseline interval. Change from Baseline for each analysis interval was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA model with terms for Baseline score, treatment group, age group and treatment by age group interaction. The OC datasets with incorrect questionnaires excluded were used for the analysis.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 21-24, n=13,16,11 | 2.26 Percentage of days |
| Mepolizumab 0.55 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 9-12, n=15,18,13 | 3.64 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 9-12, n=15,18,13 | 1.85 Percentage of days |
| Mepolizumab 2.5 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 21-24, n=13,16,11 | 0.65 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 9-12, n=15,18,13 | 3.05 Percentage of days |
| Mepolizumab 10 mg/kg | Change From Baseline in the Percentage of Days Participants Ate Solid Foods | Weeks 21-24, n=13,16,11 | 1.81 Percentage of days |
p-value: 0.60995% CI: [-8.79, 5.22]ANCOVA
p-value: 0.88295% CI: [-8.55, 7.38]ANCOVA
p-value: 0.59595% CI: [-7.68, 4.47]ANCOVA
p-value: 0.89595% CI: [-7.34, 6.44]ANCOVA
Secondary
Change in Baseline in Pain With Eating Solid Foods Severity Scores
Par. and/or parent/guardian recorded daily symptoms of eosinophilic esophagitis on a hand held personal digital assistant (electronic diary) during the Screening Phase, TP, and FP. A score of 6 was assigned for that symptom when Par. did not eat. The severity of pain was assessed when Par. eats food as: 1=didn't hurt at all, 2=hurt a little, 3=hurt somewhat, 4=hurt quite a bit, and 5=hurt a whole lot. The average pain severity for the interval (Baseline, Weeks 9-12, Weeks 21-24) was calculated as the sum of the pain severity scores for that interval (including days assigned as 6) divided by the number of days in the interval. Screening phase was considered as Baseline interval. Change from Baseline was calculated as the value for that interval minus the value for the Baseline interval. Analysis was performed using parametric ANCOVA models with terms for the relevant Baseline score, treatment group, age group and treatment by age group interaction.
Time frame: Screening, Weeks 9-12 and Weeks 21-24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 21-24, n=13,16,11 | -0.399 Scores on a scale |
| Mepolizumab 0.55 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 9-12, n=15,18,13 | -0.493 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 9-12, n=15,18,13 | -0.123 Scores on a scale |
| Mepolizumab 2.5 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 21-24, n=13,16,11 | -0.109 Scores on a scale |
| Mepolizumab 10 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 9-12, n=15,18,13 | -0.137 Scores on a scale |
| Mepolizumab 10 mg/kg | Change in Baseline in Pain With Eating Solid Foods Severity Scores | Weeks 21-24, n=13,16,11 | -0.271 Scores on a scale |
p-value: 0.07795% CI: [-0.042, 0.782]ANCOVA
p-value: 0.1295% CI: [-0.097, 0.809]ANCOVA
p-value: 0.34595% CI: [-0.326, 0.906]ANCOVA
p-value: 0.795% CI: [-0.541, 0.798]ANCOVA
Secondary
Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24
Participants underwent an esophagogastroduodenoscopy (EGD) with biopsies at Screening and at Weeks 12 and 24. Peak esophageal eosinophils were calculated as the maximum count across all esophageal biopsies at each time point. Screening value was considered as the Baseline value. Change from baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline, Weeks 12 and 24
Population: ITT Population. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -76.8 Cells/HPF | Standard Error 16.13 |
| Mepolizumab 0.55 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16,19,19 | -26.3 Cells/HPF | Standard Error 16.52 |
| Mepolizumab 2.5 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -95.2 Cells/HPF | Standard Error 19.63 |
| Mepolizumab 2.5 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16,19,19 | -41.6 Cells/HPF | Standard Error 23.71 |
| Mepolizumab 10 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 12, n=17,20,20 | -78.9 Cells/HPF | Standard Error 13.62 |
| Mepolizumab 10 mg/kg | Mean Change From Baseline in Peak Esophageal Eosinophil Counts at Weeks 12 and 24 | Week 24, n=16,19,19 | -60.1 Cells/HPF | Standard Error 15.01 |
p-value: 0.42195% CI: [-71.1, 34.4]van Elteren test
p-value: 0.63395% CI: [-44.6, 40.5]van Elteren test
p-value: 0.9295% CI: [-76.3, 45.7]van Elteren test
p-value: 0.10595% CI: [-79.2, 11.6]van Elteren test
Secondary
Number of Participants With Maintenance of Response
Participants who achieved a response of \<5 esophageal eosinophils/HPF at Week 12 by worst case analysis, were evaluated for maintenance of response of \<20 cells/HPF at Week 24. Response categories were defined as: non-responder (did not respond at Week 12 or Week 24); delayed responder (did not respond at Week 12 but responded at Week 24); relapsed (responded at Week 12 but not at Week 24); maintained (responded at Week 12 and Week 24). The following assumptions were made for worst case: if a Participant dropped out of the study due to lack of efficacy or an adverse event and had a missing response, their response was imputed as not achieved (i.e. failure). However for Participants withdrawn for other reasons (e.g. lost to follow-up) with a missing response (i.e. did not have the biopsy) the response was made as missing and not imputed.
Time frame: Week 12 and Week 24
Population: ITT Population. Only those participants were responders at Week 12 were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Number of Participants With Maintenance of Response | Delayed responder | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Maintenance of Response | Non-responder | 12 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Maintenance of Response | Maintained | 1 Participants |
| Mepolizumab 0.55 mg/kg | Number of Participants With Maintenance of Response | Relapsed | 2 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Maintenance of Response | Non-responder | 18 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Maintenance of Response | Maintained | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Maintenance of Response | Relapsed | 1 Participants |
| Mepolizumab 2.5 mg/kg | Number of Participants With Maintenance of Response | Delayed responder | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Maintenance of Response | Maintained | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Maintenance of Response | Relapsed | 0 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Maintenance of Response | Delayed responder | 2 Participants |
| Mepolizumab 10 mg/kg | Number of Participants With Maintenance of Response | Non-responder | 18 Participants |
p-value: 0.4Cochran-Mantel-Haenszel
p-value: 0.111Cochran-Mantel-Haenszel
Secondary
Plasma Concentration of Mepolizumab
Blood samples were obtained at pre-infusion and 5m, 2h, 24h, 72-96h post-infusion at Day 1, Weeks 4, 8; and Weeks 2, 6 10, 12, 16, 20, 24 and 34 to estimate the plasma concentration of mepolizumab. Only those participants available at specified time points are analyzed (represented as n=X,X,X in the category titles).
Time frame: Day 1, Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24 and 34
Population: Pharmacokinetic Population: all participants who received study medication and for whom mepolizumab sample was obtained and analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 2, n=17,16,18 | 3.42 Microgram per milliliter (µg/mL) | Standard Deviation 1.381 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 5 min postdose, n=19,19,18 | 9.69 Microgram per milliliter (µg/mL) | Standard Deviation 3.097 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Day 1 5mins postdose, n=18,20,19 | 11.3 Microgram per milliliter (µg/mL) | Standard Deviation 7.172 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 8 2h postdose, n=19,19,19 | 12.45 Microgram per milliliter (µg/mL) | Standard Deviation 3.386 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 4 2h postdose, n=19,19,20 | 10.04 Microgram per milliliter (µg/mL) | Standard Deviation 3.241 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 20, n=11,14,15 | 0.27 Microgram per milliliter (µg/mL) | Standard Deviation 0.16 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Day 1 2h postdose, n=18,19,17 | 11.34 Microgram per milliliter (µg/mL) | Standard Deviation 3.516 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 4 24h postdose, n=19,15,20 | 8.07 Microgram per milliliter (µg/mL) | Standard Deviation 2.515 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 12, n=14,18,15 | 2.57 Microgram per milliliter (µg/mL) | Standard Deviation 0.965 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 4 Predose,n=19,20,19 | 1.83 Microgram per milliliter (µg/mL) | Standard Deviation 0.643 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 72-96h postdose, n=19,18,17 | 6.35 Microgram per milliliter (µg/mL) | Standard Deviation 2.497 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 24, n=8,14,12 | 0.11 Microgram per milliliter (µg/mL) | Standard Deviation 0.056 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Day 1 24h postdose, n=18,19,16 | 8.32 Microgram per milliliter (µg/mL) | Standard Deviation 2.428 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 10, n=19,15,16 | 4.56 Microgram per milliliter (µg/mL) | Standard Deviation 1.192 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 8 predose, n=17,16,16 | 2.48 Microgram per milliliter (µg/mL) | Standard Deviation 0.69 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 8 72-96h postdose, n=17,19,19 | 6.89 Microgram per milliliter (µg/mL) | Standard Deviation 1.651 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 34, n=1,5,7 | 0.06 Microgram per milliliter (µg/mL) | — |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 8 5 min postdose, n=19,20,18 | 12.44 Microgram per milliliter (µg/mL) | Standard Deviation 3.285 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 16, n=14,16,17 | 0.79 Microgram per milliliter (µg/mL) | Standard Deviation 0.474 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 6, n=17,13,17 | 3.69 Microgram per milliliter (µg/mL) | Standard Deviation 1.031 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Day 1 72-96h postdose, n=15,19,17 | 6.08 Microgram per milliliter (µg/mL) | Standard Deviation 1.907 |
| Mepolizumab 0.55 mg/kg | Plasma Concentration of Mepolizumab | Week 8 24 h postdose, n=18,18,17 | 9 Microgram per milliliter (µg/mL) | Standard Deviation 2.554 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 4 2h postdose, n=19,19,20 | 50.75 Microgram per milliliter (µg/mL) | Standard Deviation 12.992 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Day 1 72-96h postdose, n=15,19,17 | 22.62 Microgram per milliliter (µg/mL) | Standard Deviation 7.306 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 8 72-96h postdose, n=17,19,19 | 36.49 Microgram per milliliter (µg/mL) | Standard Deviation 11.133 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 6, n=17,13,17 | 20.13 Microgram per milliliter (µg/mL) | Standard Deviation 6.602 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 10, n=19,15,16 | 20.7 Microgram per milliliter (µg/mL) | Standard Deviation 6.977 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 12, n=14,18,15 | 11.19 Microgram per milliliter (µg/mL) | Standard Deviation 3.395 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 2, n=17,16,18 | 16.08 Microgram per milliliter (µg/mL) | Standard Deviation 4.68 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 16, n=14,16,17 | 4.04 Microgram per milliliter (µg/mL) | Standard Deviation 1.768 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 20, n=11,14,15 | 1.27 Microgram per milliliter (µg/mL) | Standard Deviation 0.535 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 24, n=8,14,12 | 0.67 Microgram per milliliter (µg/mL) | Standard Deviation 0.389 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 4 Predose,n=19,20,19 | 9.43 Microgram per milliliter (µg/mL) | Standard Deviation 2.884 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 34, n=1,5,7 | 0.08 Microgram per milliliter (µg/mL) | Standard Deviation 0.025 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Day 1 5mins postdose, n=18,20,19 | 39.56 Microgram per milliliter (µg/mL) | Standard Deviation 19.041 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 5 min postdose, n=19,19,18 | 61.56 Microgram per milliliter (µg/mL) | Standard Deviation 18.021 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 8 24 h postdose, n=18,18,17 | 47.13 Microgram per milliliter (µg/mL) | Standard Deviation 12.09 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 4 24h postdose, n=19,15,20 | 42.89 Microgram per milliliter (µg/mL) | Standard Deviation 11.337 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Day 1 2h postdose, n=18,19,17 | 42.38 Microgram per milliliter (µg/mL) | Standard Deviation 14.895 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 72-96h postdose, n=19,18,17 | 34.54 Microgram per milliliter (µg/mL) | Standard Deviation 8.188 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Day 1 24h postdose, n=18,19,16 | 30.05 Microgram per milliliter (µg/mL) | Standard Deviation 7.974 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 8 predose, n=17,16,16 | 10.97 Microgram per milliliter (µg/mL) | Standard Deviation 4.072 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 8 5 min postdose, n=19,20,18 | 57.3 Microgram per milliliter (µg/mL) | Standard Deviation 18.132 |
| Mepolizumab 2.5 mg/kg | Plasma Concentration of Mepolizumab | Week 8 2h postdose, n=19,19,19 | 58.28 Microgram per milliliter (µg/mL) | Standard Deviation 16.981 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 34, n=1,5,7 | 1.14 Microgram per milliliter (µg/mL) | Standard Deviation 1.882 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 8 5 min postdose, n=19,20,18 | 213.05 Microgram per milliliter (µg/mL) | Standard Deviation 51.882 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Day 1 2h postdose, n=18,19,17 | 192.99 Microgram per milliliter (µg/mL) | Standard Deviation 49.243 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Day 1 5mins postdose, n=18,20,19 | 177.94 Microgram per milliliter (µg/mL) | Standard Deviation 70.581 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Day 1 24h postdose, n=18,19,16 | 144.26 Microgram per milliliter (µg/mL) | Standard Deviation 43.87 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Day 1 72-96h postdose, n=15,19,17 | 111.87 Microgram per milliliter (µg/mL) | Standard Deviation 30.046 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 2, n=17,16,18 | 59.2 Microgram per milliliter (µg/mL) | Standard Deviation 16.636 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 4 Predose,n=19,20,19 | 37.29 Microgram per milliliter (µg/mL) | Standard Deviation 21.978 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 5 min postdose, n=19,19,18 | 204.93 Microgram per milliliter (µg/mL) | Standard Deviation 69.325 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 4 2h postdose, n=19,19,20 | 212.5 Microgram per milliliter (µg/mL) | Standard Deviation 71.48 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 4 24h postdose, n=19,15,20 | 189.92 Microgram per milliliter (µg/mL) | Standard Deviation 55.81 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 4, 72-96h postdose, n=19,18,17 | 143.47 Microgram per milliliter (µg/mL) | Standard Deviation 38.414 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 6, n=17,13,17 | 88.14 Microgram per milliliter (µg/mL) | Standard Deviation 42.311 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 8 predose, n=17,16,16 | 50.96 Microgram per milliliter (µg/mL) | Standard Deviation 17.244 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 8 2h postdose, n=19,19,19 | 217.71 Microgram per milliliter (µg/mL) | Standard Deviation 51.983 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 8 24 h postdose, n=18,18,17 | 173.41 Microgram per milliliter (µg/mL) | Standard Deviation 43.848 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 8 72-96h postdose, n=17,19,19 | 145.75 Microgram per milliliter (µg/mL) | Standard Deviation 35.48 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 10, n=19,15,16 | 90.38 Microgram per milliliter (µg/mL) | Standard Deviation 26.77 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 12, n=14,18,15 | 48.8 Microgram per milliliter (µg/mL) | Standard Deviation 20.314 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 16, n=14,16,17 | 16.38 Microgram per milliliter (µg/mL) | Standard Deviation 6.523 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 20, n=11,14,15 | 5.76 Microgram per milliliter (µg/mL) | Standard Deviation 2.477 |
| Mepolizumab 10 mg/kg | Plasma Concentration of Mepolizumab | Week 24, n=8,14,12 | 2.13 Microgram per milliliter (µg/mL) | Standard Deviation 2.368 |