Asthma
Conditions
Keywords
Severe eosinophilic asthma, Extension study, Expanded access, Safety, Mepolizumab, Eosinophils
Brief summary
This is a multi-center, open-label, long-term study of subcutaneously (SC) administered mepolizumab 100mg in addition to standard of care (SOC), in subjects with severe eosinophilic asthma. This study will enroll a subset of subjects from Study MEA115661 who have demonstrated clear benefit from therapy and who without continuation of mepolizumab therapy are individuals at greatest risk of serious deterioration of their health status. In order to target individuals at greatest risk for serious deterioration of their health status, only subjects from the MEA115661 study with a history of life-threatening or seriously debilitating asthma, will be allowed to participate. Subjects meeting all of the eligibility criteria for the study will be offered the opportunity to consent for this study of up to 128 weeks in length (including the Follow-Up Visit). This study will give opportunity to extend the collection of clinical data for long-term use and further assess the sustainability of efficacy in a population likely to experience significant loss of asthma control and the need for higher doses of systemic steroids if returned to SOC only.
Interventions
BIOLOGICALMepolizumab
Mepolizumab is a fully humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks. Mepolizumab will be supplied as a lyophilised cake in sterile vials for individual use.
DRUGSOC
Standard of Care (SOC) will differ by participant, however it will generally include oral corticosteroids and an inhaled controller medicine (an inhaled corticosteroid plus a long acting beta agonist) and/or short acting beta agonists
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed Consent: Prior to commencing any study related activities, subjects must be able and willing to provide written informed consent. * Male or Eligible Female Subjects: To be eligible for the study, females of child-bearing potential must commit to consistent and correct use of an acceptable method of birth control and for 4 months after the last study drug administration. A urine pregnancy test is required of all females of childbearing potential at the initial Baseline Visit (Visit 1). * French Subjects Only: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. * MEA115661 Participation: Subjects must have completed Visit 14 of MEA115661. * Current Anti-Asthma Therapy: The subject's asthma has been treated with an ICS controller medication for the last 8 months with fluticasone propionate (FP) \>=500 mcg/day (or equivalent). * Disease Severity: Subjects must be assessed as having life-threatening /serious debilitating asthma in order to enroll, as defined by the following: Subjects enrolled in MEA115588 must meet one of the following criteria: a) Subject has a history of at least one intubation during their lifetime; b) \>=3 asthma exacerbations in the 12 months prior to screening for MEA115588; c) \>=1 or more hospitalization for asthma exacerbation in the 12 months prior to screening for MEA115588. Subjects enrolled in MEA115575 must meet one of the following criteria: d) Subject has a history of at least one intubation during their lifetime; e) Their optimized dose at randomization in MEA115575 was \>=10mg of prednisone; f) \>=1 or more hospitalization for asthma exacerbation in the 12 months prior to screening for MEA115575. * Clinical Benefit: Subjects must have experienced documented clinical benefit to enroll. Subjects must meet the following criteria demonstrating clinical benefit: Subjects enrolled in MEA115588 who received mepolizumab must meet all of the following criteria: a) Subject must have had a reduction in their exacerbation frequency by \>=50% during MEA115588. The baseline for comparison is the total number of exacerbations reported in the 12 months prior to screening for MEA115588. b) The investigator response on the Clinician-Rated Response to Therapy questionnaire at Visit 10 was either: mildly improved, moderately improved or significantly improved. Subjects enrolled in MEA115588 who received placebo must meet all of the following criteria: c) Subject must have had a reduction in their exacerbation frequency by \>=50% during the first 8 months of MEA115661. The baseline for comparison is the total number of exacerbations reported in the 12 months prior to screening for MEA115588; d) The investigator confirms that the subject demonstrated improvement during MEA115661. Subjects enrolled in MEA115575 who received mepolizumab must meet all of the following criteria: e) Subject must have reduced their oral corticosteroid dose by \>=50% during MEA115575. The baseline for comparison is the subject's optimized oral corticosteroid (OCS) dose at randomization in MEA115575; f) The investigator response on the Clinician-Rated Response to Therapy questionnaire at Visit 9 was either: mildly improved, moderately improved or significantly improved. Subjects enrolled in MEA115575 who received placebo must meet all of the following criteria: g) Subject must have reduced their oral corticosteroid dose at randomization by \>=50% in the first 6 months of MEA115661. The baseline for comparison is the subject's optimized OCS dose at randomization in MEA115575; h) The investigator confirms that the subject demonstrated improvement during MEA115661.
Exclusion criteria
* Health Status: Clinically significant change in health status during MEA115661 which in the opinion of the investigator would make the subject unsuitable for participation in this long-term study. * Pregnancy: Subjects who are pregnant or breastfeeding. Subjects should not be enrolled if they plan to become pregnanDeart during the time of study participation. * Exacerbation History: Subjects who received placebo in MEA115588 and had NO exacerbations during the study. * Oral Corticosteroid Use: Subjects who received placebo in MEA115575 and were able to discontinue oral corticosteroid therapy by the end of the study. * Smoking Status: Current smokers * Previous Significant Protocol Deviation: Subjects who were excluded from the per protocol analysis due to significant protocol deviations in either study MEA115575 or MEA115588. * Electrocardiogram (ECG) Assessment: A clinically significant ECG abnormality at the exit visit of MEA115661, as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Rate of On-treatment Exacerbations Per Year | Baseline (Week 0) to Week 172 | Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model. |
| Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) | Baseline (Week 0) to Week 172 | An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events | Baseline (Week 0) to Week 172 | AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented. |
| Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations | Baseline (Week 0) to Week 172 | AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days. |
| Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions | Baseline (Week 0) to Week 172 | AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented. |
| Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | Baseline (Week 0) to Week 172 | Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).. |
| Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | Baseline (Week 0) to Week 172 | Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories \<-60, \>=-60 to \<-30, \>=-30 to \<0, \>=0 to \<30, \>=30 to \<60 and \>=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial. |
| Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Baseline (Week 0) to Week 168 | The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. |
| Change From Baseline in Pulse Rate | Baseline (Week 0) to Week 168 | Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. |
| Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) | Baseline (Week 0) to Week 172 | Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Baseline (Week 0) to Week 172 | Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). |
| Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Baseline (Week 0) to Week 172 | Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category. |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | Baseline (Week 0) to Week 168 | Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. |
| Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Baseline (Week 0) to Week 168 | FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment. |
Countries
Argentina, Australia, Belgium, Canada, Chile, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
This was an open-label, long-term study of mepolizumab 100 milligram (mg) administered subcutaneously (SC), in addition to standard of care (SOC), in eligible participants with severe eosinophilic asthma, who completed the MEA115661 Exit Visit (Visit 14). The study enrolled participants across 18 countries.
Pre-assignment details
A total of 340 participants were screened for the study, of which one participant was screening failure, and 339 participants received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Mepolizumab 100 mg SC Participants received mepolizumab 100 mg administered via SC injection into the upper arm or thigh approximately every 4 weeks for 172 weeks. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician. | 339 |
| Total | 339 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Product commercially available | 159 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Study closed/terminated | 153 |
| Overall Study | Subject met Liver Stopping Criteria | 1 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Mepolizumab 100 mg SC |
|---|---|
| Age, Continuous | 52.9 Years STANDARD_DEVIATION 13.08 |
| Race/Ethnicity, Customized Race/ Ethnicity Asian-Central/South Asian Heritage | 2 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Asian-East Asian Heritage | 19 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Asian-Japanese Heritage | 26 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Asian-South East Asian Heritage | 4 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity White-Arabic/North African Heritage | 7 Participants |
| Race/Ethnicity, Customized Race/ Ethnicity White-White/Caucasian/European Heritage | 277 Participants |
| Sex: Female, Male Female | 178 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 339 |
| other Total, other adverse events | 288 / 339 |
| serious Total, serious adverse events | 84 / 339 |
Outcome results
Primary
Annualized Rate of On-treatment Exacerbations Per Year
Exacerbations are defined as the worsening of asthma which requires use of systemic corticosteroids intravenous (IV) or oral steroid like prednisone, for at least 3 days or a single intramuscular (IM) corticosteroid (CS) dose is required. For maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days was required) and/or hospitalization and/or emergency department (ED) visit. On-Treatment data between first dose date and earliest of Withdrawal date/last dose + 28 days was considered for analysis. Analysis of the number of exacerbations was performed using a negative binomial generalized linear model.
Time frame: Baseline (Week 0) to Week 172
Population: As Treated (AT) Population. AT Population included all participants who received at least one dose of mepolizumab within study 201312.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mepolizumab 100 mg SC | Annualized Rate of On-treatment Exacerbations Per Year | 0.93 Exacerbations per year |
Primary
Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE)
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. On-treatment AEs and on-treatment SAEs are the events occurring on/after the first dose of open-label mepolizumab date and before/on last dose+28 days.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) | Any AE | 315 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Any On-treatment Adverse Event (AE) or On-treatment Serious AE (SAE) | Any SAE | 84 Participants |
Secondary
Change From Baseline in Pulse Rate
Vital sign measurements including pulse rate was done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Time frame: Baseline (Week 0) to Week 168
Population: AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 164, n=8 | 1.4 Beats per minute | Standard Deviation 21.23 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 4, n=334 | 2.1 Beats per minute | Standard Deviation 9.98 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 8, n=333 | 2.3 Beats per minute | Standard Deviation 10.65 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 12, n=337 | 2.6 Beats per minute | Standard Deviation 11.05 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 16, n=334 | 2.1 Beats per minute | Standard Deviation 11.03 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 20, n=327 | 2.7 Beats per minute | Standard Deviation 11.1 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 24, n=333 | 1.2 Beats per minute | Standard Deviation 11.22 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 28, n=330 | 2.8 Beats per minute | Standard Deviation 10.43 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 32, n=324 | 2.7 Beats per minute | Standard Deviation 11.44 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 36, n=330 | 2.6 Beats per minute | Standard Deviation 11.02 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 40, n=327 | 2.7 Beats per minute | Standard Deviation 11.09 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 44, n=327 | 2.7 Beats per minute | Standard Deviation 12.05 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 48, n=329 | 0.4 Beats per minute | Standard Deviation 10.63 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 52, n=325 | 1.7 Beats per minute | Standard Deviation 10.48 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 56, n=324 | 2.1 Beats per minute | Standard Deviation 11.36 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 60, n=315 | 2.1 Beats per minute | Standard Deviation 10.97 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 64, n=307 | 2.7 Beats per minute | Standard Deviation 10.96 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 68, n=286 | 2.9 Beats per minute | Standard Deviation 11.32 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 72, n=281 | 2.0 Beats per minute | Standard Deviation 11.15 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 76, n=274 | 2.8 Beats per minute | Standard Deviation 11.15 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 80, n=265 | 3.3 Beats per minute | Standard Deviation 11.45 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 84, n=255 | 3.2 Beats per minute | Standard Deviation 12.21 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 88, n=245 | 2.4 Beats per minute | Standard Deviation 11.98 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 92, n=218 | 2.4 Beats per minute | Standard Deviation 12.42 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 96, n=208 | 0.0 Beats per minute | Standard Deviation 11.16 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 100, n=199 | 1.8 Beats per minute | Standard Deviation 12.3 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 104, n=197 | 2.3 Beats per minute | Standard Deviation 12.29 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 108, n=192 | 2.2 Beats per minute | Standard Deviation 11.34 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 112, n=182 | 2.3 Beats per minute | Standard Deviation 12.35 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 116, n=177 | 2.0 Beats per minute | Standard Deviation 12.06 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 120, n=167 | 1.2 Beats per minute | Standard Deviation 12.19 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 124, n=152 | 2.3 Beats per minute | Standard Deviation 12.56 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 128, n=151 | 1.5 Beats per minute | Standard Deviation 11.69 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 132, n=139 | 2.2 Beats per minute | Standard Deviation 12.46 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 136, n=112 | 2.0 Beats per minute | Standard Deviation 11.68 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 140, n=92 | 0.7 Beats per minute | Standard Deviation 11.45 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 144, n=77 | -1.5 Beats per minute | Standard Deviation 11.92 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 148, n=62 | -0.5 Beats per minute | Standard Deviation 11.68 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 152, n=35 | -0.6 Beats per minute | Standard Deviation 13.8 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 156, n=32 | -0.4 Beats per minute | Standard Deviation 12.94 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 160, n=14 | 1.5 Beats per minute | Standard Deviation 13.24 |
| Mepolizumab 100 mg SC | Change From Baseline in Pulse Rate | Pulse rate, Week 168, n=1 | 36.0 Beats per minute | — |
Secondary
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Vital sign measurements including systolic blood pressure (SBP) and diastolic blood pressure (DBP) were done pre-injection with the participants sitting, having rested in this position for at least 5 minutes before each reading. They were taken before measurement of any clinic lung function tests or ECGs at the specified time point. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Time frame: Baseline (Week 0) to Week 168
Population: AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 4, n=333 | 1.8 Millimeter of mercury | Standard Deviation 11.26 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 8, n=334 | 0.6 Millimeter of mercury | Standard Deviation 11.75 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 12, n=337 | 1.5 Millimeter of mercury | Standard Deviation 12.48 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 16, n=334 | 2.0 Millimeter of mercury | Standard Deviation 12.35 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 20, n=327 | 1.2 Millimeter of mercury | Standard Deviation 13.69 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 24, n=333 | 1.8 Millimeter of mercury | Standard Deviation 13.35 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 28, n=330 | 1.4 Millimeter of mercury | Standard Deviation 13.56 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 32, n=324 | 1.0 Millimeter of mercury | Standard Deviation 13.43 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 36, n=330 | 0.8 Millimeter of mercury | Standard Deviation 13 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 40, n=327 | 1.6 Millimeter of mercury | Standard Deviation 13.44 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 44, n=327 | 1.2 Millimeter of mercury | Standard Deviation 12.75 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 48, n=329 | 1.8 Millimeter of mercury | Standard Deviation 13.22 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 52, n=325 | 1.5 Millimeter of mercury | Standard Deviation 13.31 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 56, n=324 | 2.0 Millimeter of mercury | Standard Deviation 13.52 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 60, n=315 | 2.0 Millimeter of mercury | Standard Deviation 13.17 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 64, n=307 | 2.5 Millimeter of mercury | Standard Deviation 13.37 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 68, n=286 | 2.5 Millimeter of mercury | Standard Deviation 13.46 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 72, n=281 | 2.3 Millimeter of mercury | Standard Deviation 13.35 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 76, n=274 | 2.3 Millimeter of mercury | Standard Deviation 12.31 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 80, n=265 | 3.5 Millimeter of mercury | Standard Deviation 13.58 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 84, n=255 | 2.7 Millimeter of mercury | Standard Deviation 14.01 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 88, n=245 | 1.5 Millimeter of mercury | Standard Deviation 13.7 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 92, n=218 | 0.7 Millimeter of mercury | Standard Deviation 13.24 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 96, n=208 | 1.2 Millimeter of mercury | Standard Deviation 13.39 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 100, n=199 | 1.0 Millimeter of mercury | Standard Deviation 12.43 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 104, n=197 | 2.4 Millimeter of mercury | Standard Deviation 13.38 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 108, n=192 | 1.7 Millimeter of mercury | Standard Deviation 12.76 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 112, n=182 | 1.8 Millimeter of mercury | Standard Deviation 14.12 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 116, n=177 | 1.9 Millimeter of mercury | Standard Deviation 14.66 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 120, n=167 | 1.9 Millimeter of mercury | Standard Deviation 13.63 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 124, n=152 | 2.5 Millimeter of mercury | Standard Deviation 14.88 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 128, n=151 | 2.6 Millimeter of mercury | Standard Deviation 14.15 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 132, n=139 | 1.0 Millimeter of mercury | Standard Deviation 14.37 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 136, n=112 | 2.3 Millimeter of mercury | Standard Deviation 14.94 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 140, n=91 | -0.9 Millimeter of mercury | Standard Deviation 16.53 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 144, n=77 | 2.3 Millimeter of mercury | Standard Deviation 14.13 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 148, n=62 | 0.6 Millimeter of mercury | Standard Deviation 13.02 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 152, n=35 | 0.6 Millimeter of mercury | Standard Deviation 11.33 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 156, n=32 | 1.5 Millimeter of mercury | Standard Deviation 15.73 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 160, n=14 | 4.4 Millimeter of mercury | Standard Deviation 9.48 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 164, n=8 | 7.0 Millimeter of mercury | Standard Deviation 15.07 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | SBP, Week 168, n=1 | -4.0 Millimeter of mercury | — |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 4, n=333 | 0.1 Millimeter of mercury | Standard Deviation 8.41 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 8, n=334 | -0.8 Millimeter of mercury | Standard Deviation 8.81 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 12, n=337 | 0.2 Millimeter of mercury | Standard Deviation 9.25 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 16, n=334 | 0.5 Millimeter of mercury | Standard Deviation 9.3 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 20, n=327 | -0.7 Millimeter of mercury | Standard Deviation 10.35 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 24, n=333 | -0.2 Millimeter of mercury | Standard Deviation 9.4 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 28, n=330 | 0.1 Millimeter of mercury | Standard Deviation 8.88 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 32, n=324 | -0.1 Millimeter of mercury | Standard Deviation 10.44 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 36, n=330 | -0.4 Millimeter of mercury | Standard Deviation 10.12 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 40, n=327 | -0.6 Millimeter of mercury | Standard Deviation 9.24 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 44, n=327 | 0.1 Millimeter of mercury | Standard Deviation 9.39 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 48, n=329 | 0.2 Millimeter of mercury | Standard Deviation 9.71 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 52, n=325 | -0.1 Millimeter of mercury | Standard Deviation 9.83 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 56, n=324 | 0.7 Millimeter of mercury | Standard Deviation 9.77 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 60, n=315 | -0.5 Millimeter of mercury | Standard Deviation 10.4 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 64, n=307 | -0.4 Millimeter of mercury | Standard Deviation 9.92 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 68, n=286 | -0.1 Millimeter of mercury | Standard Deviation 10.04 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 72, n=281 | -0.3 Millimeter of mercury | Standard Deviation 10.13 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 76, n=274 | -0.2 Millimeter of mercury | Standard Deviation 9.92 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 80, n=265 | 0.7 Millimeter of mercury | Standard Deviation 9.83 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 84, n=255 | -0.6 Millimeter of mercury | Standard Deviation 10.05 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 88, n=245 | -0.3 Millimeter of mercury | Standard Deviation 9.22 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 92, n=218 | -0.9 Millimeter of mercury | Standard Deviation 9.1 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 96, n=208 | -0.2 Millimeter of mercury | Standard Deviation 9.17 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 100, n=199 | -0.7 Millimeter of mercury | Standard Deviation 10.04 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 104, n=197 | 0.1 Millimeter of mercury | Standard Deviation 10.21 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 108, n=192 | 0.1 Millimeter of mercury | Standard Deviation 9.89 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 112, n=182 | 0.0 Millimeter of mercury | Standard Deviation 10.17 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 116, n=177 | -0.1 Millimeter of mercury | Standard Deviation 10.31 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 120, n=167 | 0.4 Millimeter of mercury | Standard Deviation 9.74 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 124, n=152 | -0.3 Millimeter of mercury | Standard Deviation 11.11 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 128, n=151 | 0.6 Millimeter of mercury | Standard Deviation 9.58 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 132, n=139 | -0.5 Millimeter of mercury | Standard Deviation 10.1 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 136, n=112 | 0.1 Millimeter of mercury | Standard Deviation 9.89 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 140, n=91 | -1.8 Millimeter of mercury | Standard Deviation 9.68 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 144, n=77 | -0.6 Millimeter of mercury | Standard Deviation 10.92 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 148, n=62 | -0.7 Millimeter of mercury | Standard Deviation 11.03 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 152, n=35 | -1.0 Millimeter of mercury | Standard Deviation 8.97 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 156, n=32 | -2.0 Millimeter of mercury | Standard Deviation 10.42 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 160, n=14 | 2.9 Millimeter of mercury | Standard Deviation 7.92 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 164, n=8 | 1.9 Millimeter of mercury | Standard Deviation 8.06 |
| Mepolizumab 100 mg SC | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure | DBP, Week 168, n=1 | 5.0 Millimeter of mercury | — |
Secondary
Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score
The ACQ-5 is a five-item questionnaire developed as a measure of participants asthma control. The five questions enquire about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, shortness of breath, wheeze). The response options for all these questions consist of a 0 (no impairment/limitation) to 6 (total impairment/ limitation) scale. The overall ACQ score is calculated as the mean of the 5 questions and therefore ranges between 0 (totally controlled) and 6 (severely uncontrolled). Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value.
Time frame: Baseline (Week 0) to Week 168
Population: AT Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 12, n=333 | -0.16 Scores on a scale | Standard Deviation 1.096 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 72, n=282 | -0.08 Scores on a scale | Standard Deviation 1.145 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 24, n=333 | -0.15 Scores on a scale | Standard Deviation 1.131 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 36, n=326 | -0.21 Scores on a scale | Standard Deviation 1.089 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 48, n=328 | -0.17 Scores on a scale | Standard Deviation 0.965 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 60, n=307 | -0.18 Scores on a scale | Standard Deviation 1.066 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 84, n=254 | -0.03 Scores on a scale | Standard Deviation 1.151 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 96, n=212 | -0.12 Scores on a scale | Standard Deviation 0.976 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 108, n=190 | -0.06 Scores on a scale | Standard Deviation 1.057 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 120, n=164 | -0.01 Scores on a scale | Standard Deviation 1.244 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 132, n=135 | -0.09 Scores on a scale | Standard Deviation 1.089 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 144, n=73 | 0.34 Scores on a scale | Standard Deviation 1.22 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 156, n=23 | 0.07 Scores on a scale | Standard Deviation 0.962 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in Asthma Control Questionnaire (ACQ)-5 On-treatment Score | Week 168, n=6 | -0.33 Scores on a scale | Standard Deviation 0.935 |
Secondary
Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1
FEV1 is defined as the volume of air forcefully expelled from the lungs in 1 second. Pre-bronchodilator FEV1 measurements were taken by spirometry at Baseline and Weeks 24, 48, 72, 96, 120, 144 and 168. Spirometry was performed within 1 hour of the Baseline assessment. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). Data between first dose date and earliest of Withdrawal date/last dose + 28 days considered on-treatment.
Time frame: Baseline (Week 0) to Week 168
Population: AT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 24, n=332 | 67 Milliliter | Standard Deviation 382.9 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 48, n=325 | 27 Milliliter | Standard Deviation 404.6 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 72, n=289 | 30 Milliliter | Standard Deviation 406 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 96, n=223 | 47 Milliliter | Standard Deviation 433.7 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 120, n=169 | 34 Milliliter | Standard Deviation 369.9 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 144, n=88 | 14 Milliliter | Standard Deviation 374.9 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in On-treatment Clinic Pre-bronchodilator FEV1 | Week 168, n=15 | 78 Milliliter | Standard Deviation 302.9 |
Secondary
Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG)
Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)..
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 24, n=301 | 0.1 Milliseconds | Standard Deviation 16.9 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 48, n=294 | -0.9 Milliseconds | Standard Deviation 17.27 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 72, n=269 | -2.9 Milliseconds | Standard Deviation 18.13 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 96, n=221 | -0.6 Milliseconds | Standard Deviation 17.96 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 144, n=131 | 0.5 Milliseconds | Standard Deviation 21.07 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcB, Week 172, n=16 | 1.8 Milliseconds | Standard Deviation 22.08 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 24, n=301 | -1.1 Milliseconds | Standard Deviation 14.61 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 48, n=294 | -1.3 Milliseconds | Standard Deviation 14.08 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 72, n=269 | -3.7 Milliseconds | Standard Deviation 15.68 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 96, n=221 | -0.8 Milliseconds | Standard Deviation 16.18 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 144, n=131 | -0.0 Milliseconds | Standard Deviation 17.88 |
| Mepolizumab 100 mg SC | Mean Change From Baseline in QT Interval Corrected by Bazett's Method (QTcB) and QT Interval Corrected by Fridericia's Method (QTcF) Values for 12-lead Electrocardiogram (ECG) | QTcF, Week 172, n=16 | 1.7 Milliseconds | Standard Deviation 17.06 |
Secondary
Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant or all events of possible drug induced liver injury with hyperbilirubinemia. Number of participants requiring hospitalization due to an on-treatment serious adverse event including asthma exacerbations are presented. On-treatment SAEs are the events occurring on/after the first dose of mepolizumab date and before/on last dose of mepolizumab + 28 days.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants Hospitalized Due to Adverse Events Including Asthma Exacerbations | 78 Participants |
Secondary
Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions
AEs were collected from the Baseline visit until the follow-up visit (Week 172). Participants were monitored to evaluate the AEs of systemic and local site reaction. AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. On treatment AEs were defined as events occurring from the first dose until 28 days after the last dose of mepolizumab. Number of participants with AEs including both systemic (i.e. allergic/immunoglobulin (Ig)E-mediated and non-allergic) and local site reactions have been presented.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions | Any systemic events | 2 Participants |
| Mepolizumab 100 mg SC | Number of Participants With AEs Including Both Systemic (Allergic and Non-allergic) and Local Site Reactions | Any local site reactions | 14 Participants |
Secondary
Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Number of participants withdrawn due to lack of efficacy and adverse events from the study have been presented.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events | Withdrawals due to lack of efficacy | 2 Participants |
| Mepolizumab 100 mg SC | Number of Participants Withdrawn From the Study Due to Lack of Efficacy and Adverse Events | Withdrawals due to adverse events | 3 Participants |
Secondary
Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline
Twelve-lead ECG measurements were recorded after the participant has rested in the supine position for 5 minutes. The ECG was obtained before lung function testing followed by other study procedures. Baseline was considered as the latest assessment prior to first dose of mepolizumab in this study. The change from Baseline is defined as the difference between the value of the endpoint at the time point of interest and Baseline value. Participants with maximum change from Baseline were summarised at any time post Baseline for the following categories \<-60, \>=-60 to \<-30, \>=-30 to \<0, \>=0 to \<30, \>=30 to \<60 and \>=60. QTc intervals shown at any time post Baseline are the maximum seen in each participant over the course of the trial.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, >=-60 to <-30 | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, <-60 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, >=-60 to <-30 | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, >=-30 to < 0 | 70 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, >= 0 to < 30 | 196 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, >= 30 to < 60 | 35 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcB, >=60 | 3 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, <-60 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, >=-30 to < 0 | 77 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, >= 0 to < 30 | 199 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, >= 30 to < 60 | 28 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Maximum Change From Baseline in QTcB and QTcF Interval for ECG Assessed at Any Time Post Baseline | QTcF, >=60 | 0 Participants |
Secondary
Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb)
Blood samples were collected for the determination of ADA just prior to administration of mepolizumab. Samples that tested positive for anti-mepolizumab antibodies were further tested for the presence of NAb. The highest value post-Baseline visit are based on each participant's highest post-Baseline titer. NAb assay result was only presented for participants with positive ADA assay. Highest value post-Baseline would be positive for a participant who had both negative and positive post-Baseline results. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) | Highest value post-Baseline, ADA, positive, n=335 | 6 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) | Highest value post-Baseline, ADA, Negative, n=335 | 329 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) | Highest value post-Baseline, NAb, positive, n=6 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Positive Anti-mepolizumab Binding Antibodies (ADA) and Neutralizing Antibodies (NAb) | Highest value post-Baseline, NAb, Negative, n=6 | 6 Participants |
Secondary
Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline
Blood samples were collected to assess clinical chemistry laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category. Alanine Aminotransferase=ALT. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Glucose, To low, n=336 | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Glucose, To Normal or No Change, n=336 | 334 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Glucose, To high, n=336 | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | ALT, To low, n=337 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | ALT, To Normal or No Change, n=337 | 337 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | ALT, To high, n=337 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Calcium, To low, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Calcium, To Normal or No Change, n=336 | 336 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Calcium, To high, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Phosphate, To low, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Phosphate, To Normal or No Change, n=336 | 336 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Phosphate, To high, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Potassium, To low, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Potassium, To Normal or No Change, n=336 | 336 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Potassium, To high, n=336 | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Sodium, To low, n=336 | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Sodium, To Normal or No Change, n=336 | 335 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Clinical Chemistry Parameters at Any Time Post-Baseline | Sodium, To high, n=336 | 0 Participants |
Secondary
Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline
Blood samples were collected to assess hematology laboratory parameters. Number of participants with Potential Clinical Importance values for change from Baseline relative to the reference range at any time post-Baseline are presented. Any time post Baseline = all visits (including scheduled and unscheduled) post-Baseline. Participants are counted in the category that their value changes to (low, normal or high), unless there was no change in their category. If lab value category was unchanged, participants were recorded in the To Normal or No Change category.
Time frame: Baseline (Week 0) to Week 172
Population: AT Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hematocrit, To low | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hematocrit, To Normal or No Change | 335 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hematocrit, To high | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hemoglobin, To low | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hemoglobin, To Normal or No Change | 335 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Hemoglobin, To high | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Leukocytes, To low | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Leukocytes, To Normal or No Change | 335 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Leukocytes, To high | 0 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Platelets, To low | 1 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Platelets, To Normal or No Change | 335 Participants |
| Mepolizumab 100 mg SC | Number of Participants With Potential Clinical Importance Values for Change From Baseline Relative to the Reference Range for Hematology Parameters at Any Time Post-Baseline | Platelets, To high | 0 Participants |