Nasal Polyps
Conditions
Keywords
Quality of Life, Intranasal Steroids, Severe Nasal Polyposis, Polyp Relapse, Endoscopic Polyp Score, Surgery
Brief summary
A two-part, randomised, double-blind, placebo controlled, multi-centre study to investigate the use of mepolizumab (SB-240563) in reducing the need for surgery in subjects with severe bilateral nasal polyposis.
Detailed description
Nasal polyposis has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. These symptoms can impact greatly upon a patient's quality of life.The etiology of nasal polyposis is currently unknown. The aim of this present study is to investigate the use of mepolizumab in reducing the potential need for surgery in subjects with severe bilateral nasal polyposis. The study is split into two parts: Part A is the treatment phase and focuses on the reduction of the need for surgery by exploring the efficacy of six doses of mepolizumab (one dose every four weeks) on nasal polyposis. This dosing regime will build upon the previous PoC study by exploring the potential for increased clinical efficacy as assessed by the potential need for surgery, and also and increased duration of action as assessed by time to relapse. Part B is the follow-up phase and will assess post-treatment nasal polyposis dynamics with a focus on time to relapse. All subjects participating in this study will undergo a run-in period on a low dose of intranasal steroids (INS) prior to first dosing. INS will be continued throughout the study up until study exit. This is to reflect the real life circumstances in which mepolizumab is intended to be used as a therapy. The overall aim of the study design is to further assess the impact in the potential need for surgery and explore an appropriate mepolizumab therapeutic regimen strategy for the treatment of nasal polyposis. In this study, the assessment of nasal polyposis will be performed by means of combining endoscopic polyp score with subject reported symptoms. This approach reflects real-life clinical assessment of nasal polyposis. Also, this study incorporates condition specific and general medical questionnaires in order to obtain a better understanding of the impact of severe nasal polyposis of the subject's quality of life (QOL). This is in line with increasing focus in the medical field on the effects of medical conditions and treatments on the quality of life of patients (Fokkens et al 2007).
Interventions
DRUGMepolizumab
750 mg of mepolizumab by IV infusion
DRUGPlacebo
Placebo by IV infusion
DRUGRun In Medication
subjects will undergo a run-in period of 10 - 14 days on a low dose of Intranasal Steroids (INS).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Subjects have a diagnosis of severe bilateral nasal polyposis at the screening visit and Visit 1 (i.e. at end of run-in period) which meets the definition of the situation indicative of the need for surgery as described in Decision Table 1 in Appendix 3. 2. Subjects must have had at least one previous surgery for the removal of nasal polyps. 3. Subjects must have an history of refractory response to steroid therapy as shown by being deemed potentially eligible for surgery despite having been on a regular/continuous course of nasal corticosteroids for the treatment of nasal polyposis for at least 3 months and/or have received a short course of oral steroids in the past for nasal polyp treatment. 4. Male or female between 18 and 70 years of age, inclusive at time of signing informed consent. 5. BMI within the range 19.0 to 31.0 kg/m2 (inclusive). 6. Subjects must be free of any clinically significant disease that would interfere with the study schedule or procedures or compromise his/her safety. 7. Subjects with concurrent asthma must be maintained on no more than 10mg/day of Prednisolone or the equivalent. 8. Female subjects of childbearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from 1 month prior to first dose of study medication until four months after last dose of study medication. Females of non -childbearing potential are defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study (from 1 month prior to first dose of study medication until four months after last dose of study medication). Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2- 4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. 9. Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until four months after last dose of study medication. 10. Subjects are capable of giving written informed consent, which includes agreeing to be compliant with the study requirements and restrictions listed in the consent form. 11. Subjects are willing and available to complete the study and all measurements. 12. Subjects are capable of reading, comprehending, and writing the local language at a sufficient level to complete study related materials. Exclusion: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. As a result of medical interview, physical examination, or screening investigation the physician responsible considers the subject unfit for the study. 2. Subjects requiring oral corticosteroids at a dose greater than 10mg Prednisolone or equivalent during the study will be terminated from the study. 3. Subjects who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening. 4. Subjects who have received immunotherapy within the previous 12 months. 5. Subjects with a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines. 6. Subjects with a known medical history of Hepatitis B, Hepatitis C, or HIV infection. 7. Subjects with a history or suspicion of drug abuse or alcohol abuse within the last 6 months. 8. Subjects who are currently receiving, or have received within 3 months prior to first mepolizumab dose, chemotherapy, radiotherapy or investigational medications/therapies. 9. Subjects with one or more of the following abnormal laboratory values: * Serum creatinine ≥ 3 times institutional ULN * AST or/ALT ≥ 5 times institutional ULN * Platelet count \< 50,000/μL 10. Subjects with a history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. Aspirin-sensitive subjects are acceptable. 11. Subjects with a history of allergic reaction to anti-IL-5 or other antibody therapy. 12. Pregnant females as determined by positive serum pregnancy test at screening or positive urine pregnancy test prior to each dosing occasion. 13. Breastfeeding/Lactating females. 14. Subjects who currently smoke or have smoked in the last 6 months. 15. Subjects who are unwilling or unable to follow the procedures outlined in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Reduced Need for Surgery at Week 25 | Week 25 | Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp (ENP) scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of \>=3, or an ENP score of 2 and a VAS symptom score of \>7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of \>=3, or ENP scores of 2 and a VAS symptom score of \>7. |
| Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. |
| Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25 | Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value. |
| Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | ALT, AST, ALP, and GGT were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Albumin and protein were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Total bilirubin (TB) and direct bilirubin (DB), creatinine, and uric acid were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Hemoglobin and MCHC were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | RBC count and RC were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | MCH was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | MCV was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose) | Reticulocyte count was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose). |
| Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance by physician. Clinically relevant positive results are presented. Clinically relevant positive results are defined as those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE) | Up to 11 months | 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. 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function. |
| Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Weeks 2, 5, 9, 13, 17, 21, and 25 | FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values. |
| Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Weeks 2, 5, 9, 13, 17, 21, and 25 | FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values. |
| Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Each nostril was assessed for polyps and graded at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The right and left nostrils were scored from 0 to 4, where, 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis. The ENP score ranges from 0 to 4, with a higher score indicating a larger polyp. |
| Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of nasal polyposis and its four symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents not troublesome, and the right hand side of the scale (10) represents worst possible troublesome. Hence the score ranges between 0 to 10, with higher scores indicating greater severity. |
| Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Weeks 2, 5, 9, 13, 17, 21, and 25 | Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values. |
| Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Weeks 2, 5, 9, 13, 17, 21, and 25 | Sniffin'Sticks were used to assess each participant's sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values. |
| Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline) | Week 1 (Baseline) and Week 25 | SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (resp); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores. |
| Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | Week 1 (Baseline) and Week 25 | The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point by taking sum of weights. Index score ranges from -0.718 to 1, with lower scores indicating poor health. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25. |
| VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | Week 1 (Baseline) and Week 25 | The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25. |
| Systemic Clearance of Mepolizumab 750 mg | Weeks 1, 2, 5, 9, 13, and 25 | Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Volume of Distribution of Mepolizumab 750 mg | Weeks 1, 2, 5, 9, 13, and 25 | Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Bodyweight-adjusted Clearance | Weeks 1, 2, 5, 9, 13, and 25 | Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Steady-State Volume of Distribution | Weeks 1, 2, 5, 9, 13, and 25 | Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS) | Weeks 1, 2, 5, 9, 13, and 25 | Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) | Weeks 1, 2, 5, 9, 13, and 25 | Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC\[0-inf\] is derived from individual systemic clearance estimates using the expression AUC\[0-inf\] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC\[0-inf\]. |
| Half-life (Alpha) and Half-life (Beta) | Weeks 1, 2, 5, 9, 13, and 25 | Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline | Weeks 1, 2, 5, 9, 13, 17, 21 and 25 | Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability. |
| PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual | Weeks 1, 2, 5, 9, 13, 17, 21 and 25 | A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability. |
| PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50) | Weeks 1, 2, 5, 9, 13, 17, 21 and 25 | Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability. |
| PK/PD Model Derived Maximum Inhibition | Weeks 1, 2, 5, 9, 13, 17, 21 and 25 | Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability. |
| Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 1 pre-dose, Week 5 pre-dose, Week 13 pre-dose and Week 25 (4 weeks post last dose) | Blood samples were collected at Week 1 pre-dose, Week 5 pre-dose, Week 13 pre-dose and Week 25 (4 weeks post last dose) for anti-mepolizumab antibody testing using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. |
| Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Weeks 2, 5, 9, 13, 17, 21, and 25 | PEFR is defined as the maximum airflowrate generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values. |
Countries
Belgium, Netherlands, United Kingdom
Participant flow
Pre-assignment details
At the end of a 10- to 14-day Run-in Period, participants (par.) were assessed for entry into the Treatment Period, comprised of 8 outpatient visits. For 6 of these visits, participants received a 4-weekly dose of either 750 milligrams (mg) mepolizumab or placebo. Four of the par. withdrew prior to 1st dose and are not included in the par. flow.
Participants by arm
| Arm | Count |
|---|---|
| Mepolizumab 750 mg Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion | 54 |
| Placebo Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion. | 51 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 5 |
| Overall Study | Did not Meet Continuation Criteria | 17 | 11 |
| Overall Study | Lack of Efficacy | 5 | 11 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Defined Stopping Criteria | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Mepolizumab 750 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 50.6 Years STANDARD_DEVIATION 10.73 | 49.7 Years STANDARD_DEVIATION 10.38 | 50.2 Years STANDARD_DEVIATION 10.52 |
| Race/Ethnicity, Customized Central/South Asian Heritage (Htg) | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Japanese/East Asian Heritage/ South East Asian Htg | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 50 Participants | 102 Participants |
| Sex: Female, Male Female | 13 Participants | 17 Participants | 30 Participants |
| Sex: Female, Male Male | 41 Participants | 34 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 32 / 53 | 38 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
Primary
Number of Participants With a Reduced Need for Surgery at Week 25
Assessment of the nasal polyposis condition was performed after six months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp (ENP) scores and a severity of condition as measured by a visual analogue scale (VAS). Surgery was still deemed required for a participant with an ENP score of \>=3, or an ENP score of 2 and a VAS symptom score of \>7. The number of participants with reduced need for polyp surgery are presented as missing data set to non-responders (NR) and missing data last observation carry forward (LOCF). LOCF is defined as missing responses at Week 25 imputed with the last non-missing post-dose observation for that participant.
Time frame: Week 25
Population: Per Protocol Population: all randomized participants who received at least one dose of study treatment and who complied with the protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With a Reduced Need for Surgery at Week 25 | NR, Responders | 16 Participants |
| Mepolizumab 750 mg | Number of Participants With a Reduced Need for Surgery at Week 25 | NR, Non-Responders | 33 Participants |
| Mepolizumab 750 mg | Number of Participants With a Reduced Need for Surgery at Week 25 | LOCF, Responders | 17 Participants |
| Mepolizumab 750 mg | Number of Participants With a Reduced Need for Surgery at Week 25 | LOCF, Non- Responders | 32 Participants |
| Placebo | Number of Participants With a Reduced Need for Surgery at Week 25 | LOCF, Non- Responders | 43 Participants |
| Placebo | Number of Participants With a Reduced Need for Surgery at Week 25 | NR, Responders | 5 Participants |
| Placebo | Number of Participants With a Reduced Need for Surgery at Week 25 | LOCF, Responders | 8 Participants |
| Placebo | Number of Participants With a Reduced Need for Surgery at Week 25 | NR, Non-Responders | 46 Participants |
Comparison: Statistical data is presented for NRp-value: 0.003Fisher Exact
Comparison: Statistical data is presented for LOCFp-value: 0.016Fisher Exact
Secondary
Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Reticulocyte count was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=19, 16 | 0.1723 Ratio | Standard Deviation 0.16091 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=15, 16 | 0.1483 Ratio | Standard Deviation 0.12563 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=19, 16 | 0.1731 Ratio | Standard Deviation 0.16016 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=19, 16 | 0.1710 Ratio | Standard Deviation 0.15032 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=15, 13 | 0.1446 Ratio | Standard Deviation 0.1135 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=18, 16 | 0.1556 Ratio | Standard Deviation 0.12224 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose, n=15, 12 | 0.1465 Ratio | Standard Deviation 0.12045 |
| Mepolizumab 750 mg | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=15, 14 | 0.1645 Ratio | Standard Deviation 0.17438 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose, n=15, 12 | 0.1402 Ratio | Standard Deviation 0.0966 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=19, 16 | 0.1053 Ratio | Standard Deviation 0.0575 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=19, 16 | 0.1271 Ratio | Standard Deviation 0.09305 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=19, 16 | 0.1464 Ratio | Standard Deviation 0.13471 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=18, 16 | 0.1299 Ratio | Standard Deviation 0.10015 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=15, 16 | 0.1324 Ratio | Standard Deviation 0.10103 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=15, 14 | 0.1423 Ratio | Standard Deviation 0.13603 |
| Placebo | Absolute Value of the Hematology Parameter of Reticulocyte Count/Erythrocyte Uncorrected at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=15, 13 | 0.1395 Ratio | Standard Deviation 0.11754 |
Secondary
Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
BUN, glucose fasting, chloride, sodium, potassium, carbon dioxide (CO2), and calcium were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 21, pre-dose, n=42, 34 | 103.6 Millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 2, n=53, 52 | 2.34262 Millimoles per liter (mmol/L) | Standard Deviation 0.07908 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 5, pre-dose, n=52, 49 | 2.31874 Millimoles per liter (mmol/L) | Standard Deviation 0.09841 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 9, pre-dose, n=52, 46 | 2.31885 Millimoles per liter (mmol/L) | Standard Deviation 0.07624 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 13, pre-dose, n=44, 40 | 2.32566 Millimoles per liter (mmol/L) | Standard Deviation 0.07731 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 17, pre-dose, n=45, 35 | 2.31207 Millimoles per liter (mmol/L) | Standard Deviation 0.09495 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 21, pre-dose, n=42, 34 | 2.30473 Millimoles per liter (mmol/L) | Standard Deviation 0.08874 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 25, 4 weeks post last dose, n=41, 32 | 2.31374 Millimoles per liter (mmol/L) | Standard Deviation 0.13942 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 1, pre-dose, n=50, 51 | 103.7 Millimoles per liter (mmol/L) | Standard Deviation 2.57 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 2, n=50, 51 | 103.8 Millimoles per liter (mmol/L) | Standard Deviation 2.23 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 5, pre-dose, n=51, 49 | 103.5 Millimoles per liter (mmol/L) | Standard Deviation 3.24 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 9, pre-dose, n=51, 44 | 103.7 Millimoles per liter (mmol/L) | Standard Deviation 2.85 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 13, pre-dose, n=45, 40 | 103.4 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 17, pre-dose, n=45, 34 | 103.6 Millimoles per liter (mmol/L) | Standard Deviation 2.72 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 1, pre-dose, n=46, 46 | 2.33529 Millimoles per liter (mmol/L) | Standard Deviation 0.0792 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 25, 4 weeks post last dose, n=40,32 | 103.0 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 1, pre-dose, n=47, 51 | 27.3 Millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 2, n=50, 50 | 26.5 Millimoles per liter (mmol/L) | Standard Deviation 2.71 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 5, pre-dose, n=50, 50 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 9, pre-dose, n=51, 45 | 27.2 Millimoles per liter (mmol/L) | Standard Deviation 2.63 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 13, pre-dose, n=45, 38 | 27.4 Millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 17, pre-dose, n=45, 34 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.98 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 21, pre-dose, n=40, 34 | 27.2 Millimoles per liter (mmol/L) | Standard Deviation 2.05 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 25, 4 weeks post last dose, n=41, 32 | 27.2 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 1, pre-dose, n=49, 51 | 5.02333 Millimoles per liter (mmol/L) | Standard Deviation 1.06419 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 2, n=49, 45 | 5.07525 Millimoles per liter (mmol/L) | Standard Deviation 0.94855 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 5, pre-dose, n=52, 49 | 4.97329 Millimoles per liter (mmol/L) | Standard Deviation 0.75574 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 9, pre-dose, n=50, 44 | 5.07978 Millimoles per liter (mmol/L) | Standard Deviation 0.82661 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 13, pre-dose, n=45, 40 | 5.09957 Millimoles per liter (mmol/L) | Standard Deviation 0.90555 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 17, pre-dose, n=44, 34 | 5.19291 Millimoles per liter (mmol/L) | Standard Deviation 1.20604 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 21, pre-dose, n=40, 33 | 5.12557 Millimoles per liter (mmol/L) | Standard Deviation 1.14974 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 25, 4 weeks post last dose, n=40, 31 | 5.31222 Millimoles per liter (mmol/L) | Standard Deviation 1.55173 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 1, pre-dose, n=52, 52 | 4.11 Millimoles per liter (mmol/L) | Standard Deviation 0.352 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 2, n=53, 51 | 4.26 Millimoles per liter (mmol/L) | Standard Deviation 0.345 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 5, pre-dose, n=51, 49 | 4.10 Millimoles per liter (mmol/L) | Standard Deviation 0.42 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 9, pre-dose, n=52, 45 | 4.13 Millimoles per liter (mmol/L) | Standard Deviation 0.364 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 13, pre-dose, n=45, 40 | 4.09 Millimoles per liter (mmol/L) | Standard Deviation 0.325 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 17, pre-dose, n=44, 35 | 4.15 Millimoles per liter (mmol/L) | Standard Deviation 0.389 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 21, pre-dose, n=40, 34 | 4.19 Millimoles per liter (mmol/L) | Standard Deviation 0.428 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 25,4 weeks post last dose, n=41,32 | 4.19 Millimoles per liter (mmol/L) | Standard Deviation 0.404 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 1, pre-dose, n=52, 52 | 141.9 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 2, n=53, 51 | 142.1 Millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 5, pre-dose, n=52, 49 | 141.7 Millimoles per liter (mmol/L) | Standard Deviation 2.16 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 9, pre-dose, n=52, 46 | 142.0 Millimoles per liter (mmol/L) | Standard Deviation 2.27 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 13, pre-dose, n=45, 40 | 141.8 Millimoles per liter (mmol/L) | Standard Deviation 1.93 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 17, pre-dose, n=45, 35 | 141.6 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 21, pre-dose, n=42, 34 | 141.5 Millimoles per liter (mmol/L) | Standard Deviation 2.04 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 25, 4 weeks post last dose, n=41, 32 | 141.4 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 1, pre-dose, n=51, 51 | 7.6929 Millimoles per liter (mmol/L) | Standard Deviation 3.6977 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 2, n=52, 52 | 7.8847 Millimoles per liter (mmol/L) | Standard Deviation 3.86054 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 5, pre-dose, n=52, 49 | 7.9122 Millimoles per liter (mmol/L) | Standard Deviation 3.86267 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 9, pre-dose, n=51, 46 | 7.5806 Millimoles per liter (mmol/L) | Standard Deviation 3.77958 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 13, pre-dose, n=45, 40 | 7.4124 Millimoles per liter (mmol/L) | Standard Deviation 3.50688 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 17, pre-dose, n=45, 35 | 7.3499 Millimoles per liter (mmol/L) | Standard Deviation 3.6194 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 21, pre-dose, n=42, 34 | 7.7361 Millimoles per liter (mmol/L) | Standard Deviation 3.58351 |
| Mepolizumab 750 mg | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 25, 4 weeks post last dose, n=41, 32 | 7.8770 Millimoles per liter (mmol/L) | Standard Deviation 3.86299 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 13, pre-dose, n=45, 40 | 7.5311 Millimoles per liter (mmol/L) | Standard Deviation 3.68104 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 1, pre-dose, n=46, 46 | 2.31724 Millimoles per liter (mmol/L) | Standard Deviation 0.08132 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 13, pre-dose, n=45, 40 | 4.95848 Millimoles per liter (mmol/L) | Standard Deviation 0.63337 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 2, n=53, 52 | 2.35237 Millimoles per liter (mmol/L) | Standard Deviation 0.09561 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 5, pre-dose, n=52, 49 | 141.7 Millimoles per liter (mmol/L) | Standard Deviation 1.91 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 5, pre-dose, n=52, 49 | 2.34182 Millimoles per liter (mmol/L) | Standard Deviation 0.09948 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 17, pre-dose, n=44, 34 | 4.99349 Millimoles per liter (mmol/L) | Standard Deviation 0.65387 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 9, pre-dose, n=52, 46 | 2.36803 Millimoles per liter (mmol/L) | Standard Deviation 0.18232 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 2, n=52, 52 | 7.1870 Millimoles per liter (mmol/L) | Standard Deviation 3.81593 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 13, pre-dose, n=44, 40 | 2.34848 Millimoles per liter (mmol/L) | Standard Deviation 0.08552 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 21, pre-dose, n=40, 33 | 5.01559 Millimoles per liter (mmol/L) | Standard Deviation 0.55765 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 17, pre-dose, n=45, 35 | 2.35610 Millimoles per liter (mmol/L) | Standard Deviation 0.10049 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 9, pre-dose, n=52, 46 | 141.5 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 21, pre-dose, n=42, 34 | 2.32699 Millimoles per liter (mmol/L) | Standard Deviation 0.10993 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 25, 4 weeks post last dose, n=40, 31 | 5.08589 Millimoles per liter (mmol/L) | Standard Deviation 0.57875 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Calcium, Week 25, 4 weeks post last dose, n=41, 32 | 2.36884 Millimoles per liter (mmol/L) | Standard Deviation 0.08507 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 21, pre-dose, n=42, 34 | 7.2357 Millimoles per liter (mmol/L) | Standard Deviation 3.21507 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 1, pre-dose, n=50, 51 | 103.8 Millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 1, pre-dose, n=52, 52 | 4.17 Millimoles per liter (mmol/L) | Standard Deviation 0.353 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 2, n=50, 51 | 103.5 Millimoles per liter (mmol/L) | Standard Deviation 2.39 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 13, pre-dose, n=45, 40 | 141.4 Millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 5, pre-dose, n=51, 49 | 103.6 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 2, n=53, 51 | 4.23 Millimoles per liter (mmol/L) | Standard Deviation 0.312 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 9, pre-dose, n=51, 44 | 103.6 Millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 5, pre-dose, n=52, 49 | 7.2488 Millimoles per liter (mmol/L) | Standard Deviation 4.02159 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 13, pre-dose, n=45, 40 | 103.2 Millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 5, pre-dose, n=51, 49 | 4.15 Millimoles per liter (mmol/L) | Standard Deviation 0.357 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 17, pre-dose, n=45, 34 | 103.4 Millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 17, pre-dose, n=45, 35 | 141.5 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 21, pre-dose, n=42, 34 | 103.4 Millimoles per liter (mmol/L) | Standard Deviation 2.53 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 9, pre-dose, n=52, 45 | 4.19 Millimoles per liter (mmol/L) | Standard Deviation 0.432 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Chloride, Week 25, 4 weeks post last dose, n=40,32 | 103.2 Millimoles per liter (mmol/L) | Standard Deviation 2.73 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 17, pre-dose, n=45, 35 | 7.9377 Millimoles per liter (mmol/L) | Standard Deviation 3.595 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 1, pre-dose, n=47, 51 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 13, pre-dose, n=45, 40 | 4.19 Millimoles per liter (mmol/L) | Standard Deviation 0.378 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 2, n=50, 50 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 21, pre-dose, n=42, 34 | 141.6 Millimoles per liter (mmol/L) | Standard Deviation 2.48 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 5, pre-dose, n=50, 50 | 26.1 Millimoles per liter (mmol/L) | Standard Deviation 2.66 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 17, pre-dose, n=44, 35 | 4.28 Millimoles per liter (mmol/L) | Standard Deviation 0.438 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 9, pre-dose, n=51, 45 | 26.1 Millimoles per liter (mmol/L) | Standard Deviation 2.81 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 9, pre-dose, n=51, 46 | 7.0658 Millimoles per liter (mmol/L) | Standard Deviation 3.40683 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 13, pre-dose, n=45, 38 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 21, pre-dose, n=40, 34 | 4.27 Millimoles per liter (mmol/L) | Standard Deviation 0.415 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 17, pre-dose, n=45, 34 | 26.3 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 25, 4 weeks post last dose, n=41, 32 | 141.7 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 21, pre-dose, n=40, 34 | 26.4 Millimoles per liter (mmol/L) | Standard Deviation 2.39 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Potassium, Week 25,4 weeks post last dose, n=41,32 | 4.29 Millimoles per liter (mmol/L) | Standard Deviation 0.376 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CO2, Week 25, 4 weeks post last dose, n=41, 32 | 27.0 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 25, 4 weeks post last dose, n=41, 32 | 6.9864 Millimoles per liter (mmol/L) | Standard Deviation 3.01889 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 1, pre-dose, n=49, 51 | 4.90943 Millimoles per liter (mmol/L) | Standard Deviation 0.55713 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 1, pre-dose, n=52, 52 | 141.7 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 2, n=49, 45 | 4.85985 Millimoles per liter (mmol/L) | Standard Deviation 0.69818 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Urea, Week 1, pre-dose, n=51, 51 | 7.1568 Millimoles per liter (mmol/L) | Standard Deviation 3.35084 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 5, pre-dose, n=52, 49 | 4.97545 Millimoles per liter (mmol/L) | Standard Deviation 0.68857 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Sodium, Week 2, n=53, 51 | 141.5 Millimoles per liter (mmol/L) | Standard Deviation 2.25 |
| Placebo | Absolute Values of Clinical Chemistry Parameters Including Blood Urea Nitrogen (BUN), Glucose Fasting, Chloride, Sodium, Potassium, Carbon Dioxide, and Calcium at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Glucose, Week 9, pre-dose, n=50, 44 | 5.01449 Millimoles per liter (mmol/L) | Standard Deviation 0.70049 |
Secondary
Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
ALT, AST, ALP, and GGT were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 1, pre-dose, n=52, 52 | 27.5 International units per liter (IU/L) | Standard Deviation 13.33 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 2, n=53, 52 | 75.3 International units per liter (IU/L) | Standard Deviation 15.92 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 5, pre-dose, n=51, 50 | 75.1 International units per liter (IU/L) | Standard Deviation 17.31 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 9, pre-dose, n=51, 45 | 75.9 International units per liter (IU/L) | Standard Deviation 17.63 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 13, pre-dose, n=45, 40 | 75.1 International units per liter (IU/L) | Standard Deviation 16.92 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 17, pre-dose, n=45, 35 | 72.5 International units per liter (IU/L) | Standard Deviation 16.3 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 21, pre-dose, n=41, 34 | 72.4 International units per liter (IU/L) | Standard Deviation 14.75 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 25, 4 weeks post last dose, n=41, 32 | 73.9 International units per liter (IU/L) | Standard Deviation 14.56 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 1, pre-dose, n=52, 52 | 76.0 International units per liter (IU/L) | Standard Deviation 17.09 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 2, n=53, 51 | 26.3 International units per liter (IU/L) | Standard Deviation 11.6 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 5, pre-dose, n=51, 50 | 26.5 International units per liter (IU/L) | Standard Deviation 15.11 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 9, pre-dose, n=52, 45 | 26.4 International units per liter (IU/L) | Standard Deviation 10.78 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 13, pre-dose, n=45, 40 | 29.1 International units per liter (IU/L) | Standard Deviation 18.21 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 17, pre-dose, n=45, 35 | 25.7 International units per liter (IU/L) | Standard Deviation 11.98 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 21, pre-dose, n=42, 34 | 26.2 International units per liter (IU/L) | Standard Deviation 14.32 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 25, 4 weeks post last dose, n=41, 32 | 28.4 International units per liter (IU/L) | Standard Deviation 15.43 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 1, pre-dose, n=52, 52 | 24.6 International units per liter (IU/L) | Standard Deviation 7.73 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 2, n=51, 51 | 24.2 International units per liter (IU/L) | Standard Deviation 5.54 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 5, pre-dose, n=51, 50 | 24.3 International units per liter (IU/L) | Standard Deviation 6.51 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 9, pre-dose, n=51, 45 | 24.6 International units per liter (IU/L) | Standard Deviation 6.06 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 13, pre-dose, n=45, 40 | 25.4 International units per liter (IU/L) | Standard Deviation 6.86 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 17, pre-dose, n=44, 34 | 24.0 International units per liter (IU/L) | Standard Deviation 8.34 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 21, pre-dose, n=40, 34 | 24.5 International units per liter (IU/L) | Standard Deviation 6.2 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 25, 4 weeks post last dose, n=41, 32 | 25.1 International units per liter (IU/L) | Standard Deviation 5.63 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 1, pre-dose, n=50, 51 | 34.4 International units per liter (IU/L) | Standard Deviation 49.18 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 2, n=53, 52 | 32.6 International units per liter (IU/L) | Standard Deviation 46.31 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 5, pre-dose, n=50, 50 | 33.9 International units per liter (IU/L) | Standard Deviation 59.91 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 9, pre-dose, n=50, 44 | 33.7 International units per liter (IU/L) | Standard Deviation 41.07 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 13, pre-dose, n=45, 40 | 37.2 International units per liter (IU/L) | Standard Deviation 69.6 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 17, pre-dose, n=44,34 | 34.8 International units per liter (IU/L) | Standard Deviation 57.83 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 21, pre-dose, n=41, 34 | 38.6 International units per liter (IU/L) | Standard Deviation 78.78 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 25, 4 weeks post last dose, n=41, 32 | 37.0 International units per liter (IU/L) | Standard Deviation 54.09 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 25, 4 weeks post last dose, n=41, 32 | 28.4 International units per liter (IU/L) | Standard Deviation 17.24 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 1, pre-dose, n=52, 52 | 67.8 International units per liter (IU/L) | Standard Deviation 20 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 1, pre-dose, n=52, 52 | 25.5 International units per liter (IU/L) | Standard Deviation 9.13 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 2, n=53, 52 | 69.0 International units per liter (IU/L) | Standard Deviation 20.91 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 1, pre-dose, n=50, 51 | 26.6 International units per liter (IU/L) | Standard Deviation 20.37 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 5, pre-dose, n=51, 50 | 68.5 International units per liter (IU/L) | Standard Deviation 21.84 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 2, n=51, 51 | 24.3 International units per liter (IU/L) | Standard Deviation 7.51 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 9, pre-dose, n=51, 45 | 69.8 International units per liter (IU/L) | Standard Deviation 20.88 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 13, pre-dose, n=45, 40 | 29.2 International units per liter (IU/L) | Standard Deviation 21.56 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 13, pre-dose, n=45, 40 | 69.7 International units per liter (IU/L) | Standard Deviation 21.27 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 5, pre-dose, n=51, 50 | 23.6 International units per liter (IU/L) | Standard Deviation 6.61 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 17, pre-dose, n=45, 35 | 69.5 International units per liter (IU/L) | Standard Deviation 19.58 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 2, n=53, 52 | 28.3 International units per liter (IU/L) | Standard Deviation 24.67 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 21, pre-dose, n=41, 34 | 70.4 International units per liter (IU/L) | Standard Deviation 21.81 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 9, pre-dose, n=51, 45 | 23.6 International units per liter (IU/L) | Standard Deviation 5.94 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALP, Week 25, 4 weeks post last dose, n=41, 32 | 72.4 International units per liter (IU/L) | Standard Deviation 22.05 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 21, pre-dose, n=41, 34 | 32.9 International units per liter (IU/L) | Standard Deviation 27.27 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 1, pre-dose, n=52, 52 | 26.1 International units per liter (IU/L) | Standard Deviation 14.85 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 13, pre-dose, n=45, 40 | 23.9 International units per liter (IU/L) | Standard Deviation 6.04 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 2, n=53, 51 | 26.9 International units per liter (IU/L) | Standard Deviation 15.89 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 5, pre-dose, n=50, 50 | 28.0 International units per liter (IU/L) | Standard Deviation 25.08 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 5, pre-dose, n=51, 50 | 25.0 International units per liter (IU/L) | Standard Deviation 13.36 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 17, pre-dose, n=44, 34 | 23.9 International units per liter (IU/L) | Standard Deviation 6.42 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 9, pre-dose, n=52, 45 | 24.7 International units per liter (IU/L) | Standard Deviation 12.41 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 17, pre-dose, n=44,34 | 34.6 International units per liter (IU/L) | Standard Deviation 32.72 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 13, pre-dose, n=45, 40 | 25.2 International units per liter (IU/L) | Standard Deviation 11.18 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 21, pre-dose, n=40, 34 | 23.8 International units per liter (IU/L) | Standard Deviation 5.18 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 17, pre-dose, n=45, 35 | 27.1 International units per liter (IU/L) | Standard Deviation 15.11 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | GGT, Week 9, pre-dose, n=50, 44 | 29.5 International units per liter (IU/L) | Standard Deviation 24.86 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 21, pre-dose, n=42, 34 | 27.6 International units per liter (IU/L) | Standard Deviation 14.02 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | AST, Week 25, 4 weeks post last dose, n=41, 32 | 24.0 International units per liter (IU/L) | Standard Deviation 7.77 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma Glutamyltransferase (GGT) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | ALT, Week 25, 4 weeks post last dose, n=41, 32 | 26.4 International units per liter (IU/L) | Standard Deviation 13.18 |
Secondary
Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Albumin and protein were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 1, pre-dose, n=50, 48 | 73.1 Grams per liter (g/L) | Standard Deviation 5.09 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 9, pre-dose, n=52, 46 | 45.3 Grams per liter (g/L) | Standard Deviation 2.71 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 2, n=52, 49 | 72.4 Grams per liter (g/L) | Standard Deviation 5.27 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 2, n=53, 52 | 45.2 Grams per liter (g/L) | Standard Deviation 2.74 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 5, pre-dose, n=50, 49 | 72.8 Grams per liter (g/L) | Standard Deviation 5.33 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 13, pre-dose, n=45, 40 | 45.1 Grams per liter (g/L) | Standard Deviation 2.26 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 9, pre-dose, n=51, 46 | 73.0 Grams per liter (g/L) | Standard Deviation 5.39 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 1, pre-dose, n=52, 52 | 46.0 Grams per liter (g/L) | Standard Deviation 3 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 13, pre-dose, n=44, 40 | 73.1 Grams per liter (g/L) | Standard Deviation 4.76 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 17, pre-dose, n=44, 35 | 44.8 Grams per liter (g/L) | Standard Deviation 2.45 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 17, pre-dose, n=45, 35 | 71.3 Grams per liter (g/L) | Standard Deviation 4.08 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 5, pre-dose, n=52, 50 | 45.2 Grams per liter (g/L) | Standard Deviation 2.46 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 21, pre-dose, n=42, 34 | 71.3 Grams per liter (g/L) | Standard Deviation 4.3 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 21, pre-dose, n=42, 34 | 45.0 Grams per liter (g/L) | Standard Deviation 2.69 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 25, 4 weeks post last dose, n=41, 32 | 72.1 Grams per liter (g/L) | Standard Deviation 4.41 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 25, 4 weeks post last dose, n=41, 32 | 45.7 Grams per liter (g/L) | Standard Deviation 2.55 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 25, 4 weeks post last dose, n=41, 32 | 71.7 Grams per liter (g/L) | Standard Deviation 4.53 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 1, pre-dose, n=52, 52 | 46.1 Grams per liter (g/L) | Standard Deviation 2.4 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 2, n=53, 52 | 46.3 Grams per liter (g/L) | Standard Deviation 3.17 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 5, pre-dose, n=52, 50 | 45.8 Grams per liter (g/L) | Standard Deviation 2.4 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 9, pre-dose, n=52, 46 | 45.2 Grams per liter (g/L) | Standard Deviation 2.51 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 13, pre-dose, n=45, 40 | 45.8 Grams per liter (g/L) | Standard Deviation 2.97 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 17, pre-dose, n=44, 35 | 45.6 Grams per liter (g/L) | Standard Deviation 2.13 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 25, 4 weeks post last dose, n=41, 32 | 45.3 Grams per liter (g/L) | Standard Deviation 2.5 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 1, pre-dose, n=50, 48 | 73.7 Grams per liter (g/L) | Standard Deviation 4.54 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 2, n=52, 49 | 73.7 Grams per liter (g/L) | Standard Deviation 5.3 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 5, pre-dose, n=50, 49 | 72.6 Grams per liter (g/L) | Standard Deviation 4.75 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 9, pre-dose, n=51, 46 | 72.6 Grams per liter (g/L) | Standard Deviation 4.5 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 13, pre-dose, n=44, 40 | 72.8 Grams per liter (g/L) | Standard Deviation 5.11 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 17, pre-dose, n=45, 35 | 72.1 Grams per liter (g/L) | Standard Deviation 4.26 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Protein, Week 21, pre-dose, n=42, 34 | 71.4 Grams per liter (g/L) | Standard Deviation 3.88 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Albumin and Protein at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Albumin, Week 21, pre-dose, n=42, 34 | 45.1 Grams per liter (g/L) | Standard Deviation 2.81 |
Secondary
Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Total bilirubin (TB) and direct bilirubin (DB), creatinine, and uric acid were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 1, pre-dose, n=52, 52 | 80.2445 Micromoles per liter | Standard Deviation 15.71113 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 2, n=49, 49 | 7734.39 Micromoles per liter | Standard Deviation 50942.24 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 5, pre-dose, n=50, 49 | 12991.02 Micromoles per liter | Standard Deviation 65048.95 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 9, pre-dose, n=49, 44 | 13147.62 Micromoles per liter | Standard Deviation 62976.19 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 13, pre-dose, n=45, 40 | 14802.92 Micromoles per liter | Standard Deviation 69028.68 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 17, pre-dose, n=45, 35 | 15378.37 Micromoles per liter | Standard Deviation 70783.69 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 21, pre-dose, n=40, 34 | 10414.21 Micromoles per liter | Standard Deviation 63827.1 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 25, 4 weeks post last dose, n=40, 32 | 9602.10 Micromoles per liter | Standard Deviation 58607.26 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 1, pre-dose, n=48, 50 | 6280.75 Micromoles per liter | Standard Deviation 40503.47 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 2, n=53, 51 | 80.5450 Micromoles per liter | Standard Deviation 14.66619 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 5, pre-dose, n=52, 49 | 79.0978 Micromoles per liter | Standard Deviation 14.80378 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 9, pre-dose, n=52, 46 | 81.0171 Micromoles per liter | Standard Deviation 15.27077 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 13, pre-dose, n=45, 40 | 81.5454 Micromoles per liter | Standard Deviation 17.47683 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 17, pre-dose, n=45, 35 | 81.5074 Micromoles per liter | Standard Deviation 17.96973 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 21, pre-dose, n=42, 34 | 80.8093 Micromoles per liter | Standard Deviation 17.58041 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 25,4 weeks post last dose,n=41, 32 | 81.9687 Micromoles per liter | Standard Deviation 17.48642 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 1, pre-dose, n=52, 52 | 9.878 Micromoles per liter | Standard Deviation 3.2705 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 2, n=53, 52 | 10.016 Micromoles per liter | Standard Deviation 4.5747 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 5, pre-dose, n=51, 50 | 10.189 Micromoles per liter | Standard Deviation 4.0635 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 9, pre-dose, n=51, 45 | 10.145 Micromoles per liter | Standard Deviation 3.5212 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 13, pre-dose, n=45, 40 | 9.918 Micromoles per liter | Standard Deviation 3.6143 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 17, pre-dose, n=44, 35 | 10.624 Micromoles per liter | Standard Deviation 4.0522 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 21, pre-dose, n=40, 34 | 10.266 Micromoles per liter | Standard Deviation 3.6078 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 25, 4 weeks post last dose, n=41, 32 | 9.820 Micromoles per liter | Standard Deviation 3.0792 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 1, pre-dose, n=50, 50 | 2.6685 Micromoles per liter | Standard Deviation 0.91566 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 2, n=53, 51 | 2.9160 Micromoles per liter | Standard Deviation 1.0256 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 5, pre-dose, n=49, 49 | 2.7981 Micromoles per liter | Standard Deviation 0.90148 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 9, pre-dose, n=51, 43 | 2.9203 Micromoles per liter | Standard Deviation 1.10282 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 13, pre-dose, n=43, 40 | 2.7958 Micromoles per liter | Standard Deviation 0.82254 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 17, pre-dose, n=43, 35 | 2.9931 Micromoles per liter | Standard Deviation 0.85581 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 21, pre-dose, n=39, 34 | 2.9267 Micromoles per liter | Standard Deviation 0.98861 |
| Mepolizumab 750 mg | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 25, 4 weeks post last dose, n=41, 32 | 3.0011 Micromoles per liter | Standard Deviation 0.95645 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 25, 4 weeks post last dose, n=41, 32 | 2.9864 Micromoles per liter | Standard Deviation 1.42919 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 1, pre-dose, n=48, 50 | 9943.59 Micromoles per liter | Standard Deviation 47675.43 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 1, pre-dose, n=52, 52 | 10.595 Micromoles per liter | Standard Deviation 6.2074 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 2, n=49, 49 | 10906.56 Micromoles per liter | Standard Deviation 51211.16 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 1, pre-dose, n=50, 50 | 2.8818 Micromoles per liter | Standard Deviation 1.54541 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 5, pre-dose, n=50, 49 | 13352.52 Micromoles per liter | Standard Deviation 64149.31 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 2, n=53, 52 | 10.520 Micromoles per liter | Standard Deviation 4.1684 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 9, pre-dose, n=49, 44 | 24031.30 Micromoles per liter | Standard Deviation 90312.49 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 13, pre-dose, n=43, 40 | 3.0299 Micromoles per liter | Standard Deviation 1.55388 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 13, pre-dose, n=45, 40 | 25208.07 Micromoles per liter | Standard Deviation 90067.04 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 5, pre-dose, n=51, 50 | 10.878 Micromoles per liter | Standard Deviation 4.4865 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 17, pre-dose, n=45, 35 | 21723.77 Micromoles per liter | Standard Deviation 89724.11 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 2, n=53, 51 | 3.0690 Micromoles per liter | Standard Deviation 1.25759 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 21, pre-dose, n=40, 34 | 22994.49 Micromoles per liter | Standard Deviation 94463.05 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 9, pre-dose, n=51, 45 | 10.484 Micromoles per liter | Standard Deviation 4.2254 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | UA, Week 25, 4 weeks post last dose, n=40, 32 | 24506.63 Micromoles per liter | Standard Deviation 96050.66 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 21, pre-dose, n=39, 34 | 3.0561 Micromoles per liter | Standard Deviation 1.33234 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 1, pre-dose, n=52, 52 | 77.5162 Micromoles per liter | Standard Deviation 14.87768 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 13, pre-dose, n=45, 40 | 10.012 Micromoles per liter | Standard Deviation 5.0501 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 2, n=53, 51 | 78.3620 Micromoles per liter | Standard Deviation 13.55791 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 5, pre-dose, n=49, 49 | 2.9939 Micromoles per liter | Standard Deviation 1.12944 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 5, pre-dose, n=52, 49 | 77.7282 Micromoles per liter | Standard Deviation 13.97357 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 17, pre-dose, n=44, 35 | 9.877 Micromoles per liter | Standard Deviation 4.6822 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 9, pre-dose, n=52, 46 | 75.9868 Micromoles per liter | Standard Deviation 13.78284 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 17, pre-dose, n=43, 35 | 2.8714 Micromoles per liter | Standard Deviation 1.18421 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 13, pre-dose, n=45, 40 | 77.5522 Micromoles per liter | Standard Deviation 13.18623 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 21, pre-dose, n=40, 34 | 10.622 Micromoles per liter | Standard Deviation 6.0172 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 17, pre-dose, n=45, 35 | 76.7809 Micromoles per liter | Standard Deviation 12.15771 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | DB, Week 9, pre-dose, n=51, 43 | 2.9693 Micromoles per liter | Standard Deviation 1.03703 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 21, pre-dose, n=42, 34 | 75.1511 Micromoles per liter | Standard Deviation 11.77313 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | TB, Week 25, 4 weeks post last dose, n=41, 32 | 10.162 Micromoles per liter | Standard Deviation 6.3294 |
| Placebo | Absolute Values of the Clinical Chemistry Parameters of Total and Direct Bilirubin, Creatinine (CRT), and Uric Acid (UA) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | CRT, Week 25,4 weeks post last dose,n=41, 32 | 77.7839 Micromoles per liter | Standard Deviation 12.25219 |
Secondary
Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
MCH was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=52, 51 | 30.44 Picograms (pg) | Standard Deviation 1.215 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=52, 52 | 30.46 Picograms (pg) | Standard Deviation 1.359 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=53, 50 | 30.37 Picograms (pg) | Standard Deviation 1.301 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=51, 46 | 30.23 Picograms (pg) | Standard Deviation 1.378 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=44, 40 | 30.22 Picograms (pg) | Standard Deviation 1.292 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=45, 35 | 30.29 Picograms (pg) | Standard Deviation 1.339 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=42, 34 | 30.33 Picograms (pg) | Standard Deviation 1.354 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose,n=40, 32 | 30.41 Picograms (pg) | Standard Deviation 1.196 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose,n=40, 32 | 30.26 Picograms (pg) | Standard Deviation 1.243 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=52, 51 | 30.26 Picograms (pg) | Standard Deviation 1.804 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=44, 40 | 29.94 Picograms (pg) | Standard Deviation 2.187 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=52, 52 | 29.94 Picograms (pg) | Standard Deviation 1.631 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=42, 34 | 30.00 Picograms (pg) | Standard Deviation 2.035 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=53, 50 | 30.10 Picograms (pg) | Standard Deviation 1.686 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=45, 35 | 30.10 Picograms (pg) | Standard Deviation 1.951 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Hemoglobin (MCH) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=51, 46 | 30.07 Picograms (pg) | Standard Deviation 1.793 |
Secondary
Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
MCV was assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=52, 52 | 90.04 Femtoliters | Standard Deviation 3.85 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=53, 52 | 90.06 Femtoliters | Standard Deviation 3.997 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=53, 50 | 89.85 Femtoliters | Standard Deviation 3.911 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=51, 46 | 89.81 Femtoliters | Standard Deviation 3.897 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=45, 40 | 89.19 Femtoliters | Standard Deviation 3.934 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=45, 35 | 89.50 Femtoliters | Standard Deviation 3.714 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=42, 34 | 89.46 Femtoliters | Standard Deviation 3.673 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose, n=41, 32 | 89.68 Femtoliters | Standard Deviation 3.364 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25,4 weeks post last dose, n=41, 32 | 89.91 Femtoliters | Standard Deviation 3.831 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, pre-dose, n=52, 52 | 89.43 Femtoliters | Standard Deviation 5.051 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, pre-dose, n=45, 40 | 89.12 Femtoliters | Standard Deviation 5.358 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=53, 52 | 89.41 Femtoliters | Standard Deviation 4.765 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, pre-dose, n=42, 34 | 89.23 Femtoliters | Standard Deviation 5.542 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, pre-dose, n=53, 50 | 89.38 Femtoliters | Standard Deviation 4.876 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, pre-dose, n=45, 35 | 89.33 Femtoliters | Standard Deviation 5.469 |
| Placebo | Absolute Values of the Hematology Parameter of Mean Corpuscular Volume (MCV) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, pre-dose, n=51, 46 | 89.07 Femtoliters | Standard Deviation 5.019 |
Secondary
Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
RBC count and RC were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 1, pre-dose, n=52, 52 | 4.889 10^12 cells per litre | Standard Deviation 0.3758 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 2, n=53, 52 | 4.868 10^12 cells per litre | Standard Deviation 0.4024 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 5, pre-dose, n=53, 50 | 4.876 10^12 cells per litre | Standard Deviation 0.3494 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 9, pre-dose, n=51, 46 | 4.875 10^12 cells per litre | Standard Deviation 0.3792 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 13, pre-dose, n=45, 40 | 4.889 10^12 cells per litre | Standard Deviation 0.3511 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 17, pre-dose, n=45, 35 | 4.824 10^12 cells per litre | Standard Deviation 0.3735 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 21, pre-dose, n=42, 34 | 4.840 10^12 cells per litre | Standard Deviation 0.3743 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 25,4 weeks post last dose,n=41, 32 | 4.902 10^12 cells per litre | Standard Deviation 0.3551 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 1, pre-dose, n=28, 32 | 0.0537 10^12 cells per litre | Standard Deviation 0.01651 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 2, n=33, 35 | 0.0495 10^12 cells per litre | Standard Deviation 0.01682 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 5, pre-dose, n=33, 33 | 0.0461 10^12 cells per litre | Standard Deviation 0.01416 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 9, pre-dose, n=29, 29 | 0.0443 10^12 cells per litre | Standard Deviation 0.01327 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 13, pre-dose, n=28, 23 | 0.0473 10^12 cells per litre | Standard Deviation 0.0153 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 17, pre-dose, n=28, 20 | 0.0482 10^12 cells per litre | Standard Deviation 0.01604 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 21, pre-dose, n=26, 19 | 0.0459 10^12 cells per litre | Standard Deviation 0.01592 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 25,4 weeks post last dose,n=24, 20 | 0.0489 10^12 cells per litre | Standard Deviation 0.0164 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 25,4 weeks post last dose,n=24, 20 | 0.0580 10^12 cells per litre | Standard Deviation 0.02625 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 1, pre-dose, n=52, 52 | 4.930 10^12 cells per litre | Standard Deviation 0.483 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 1, pre-dose, n=28, 32 | 0.0495 10^12 cells per litre | Standard Deviation 0.01666 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 2, n=53, 52 | 4.937 10^12 cells per litre | Standard Deviation 0.434 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 13, pre-dose, n=28, 23 | 0.0528 10^12 cells per litre | Standard Deviation 0.0178 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 5, pre-dose, n=53, 50 | 4.867 10^12 cells per litre | Standard Deviation 0.5115 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 2, n=33, 35 | 0.0506 10^12 cells per litre | Standard Deviation 0.01879 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 9, pre-dose, n=51, 46 | 4.879 10^12 cells per litre | Standard Deviation 0.4758 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 21, pre-dose, n=26, 19 | 0.0521 10^12 cells per litre | Standard Deviation 0.01594 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 13, pre-dose, n=45, 40 | 4.923 10^12 cells per litre | Standard Deviation 0.4828 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 5, pre-dose, n=33, 33 | 0.0496 10^12 cells per litre | Standard Deviation 0.0253 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 17, pre-dose, n=45, 35 | 4.938 10^12 cells per litre | Standard Deviation 0.5058 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 17, pre-dose, n=28, 20 | 0.0493 10^12 cells per litre | Standard Deviation 0.01847 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 21, pre-dose, n=42, 34 | 4.910 10^12 cells per litre | Standard Deviation 0.5165 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RC, Week 9, pre-dose, n=29, 29 | 0.0513 10^12 cells per litre | Standard Deviation 0.02581 |
| Placebo | Absolute Values of the Hematology Parameter of Red Blood Cell (RBC) Count and Reticulocyte Count (RC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | RBC, Week 25,4 weeks post last dose,n=41, 32 | 4.901 10^12 cells per litre | Standard Deviation 0.3343 |
Secondary
Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Hemoglobin and MCHC were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 1, pre-dose, n=51, 52 | 148.445 Grams per liter (g/L) | Standard Deviation 11.5174 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 2, n=53, 52 | 148.013 Grams per liter (g/L) | Standard Deviation 12.2563 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 5, pre-dose, n=53, 50 | 147.955 Grams per liter (g/L) | Standard Deviation 10.886 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 9, pre-dose, n=51, 46 | 147.135 Grams per liter (g/L) | Standard Deviation 11.0248 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 13, pre-dose, n=45, 40 | 147.498 Grams per liter (g/L) | Standard Deviation 10.951 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 17, pre-dose, n=45, 35 | 145.988 Grams per liter (g/L) | Standard Deviation 11.4327 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 21, pre-dose, n=42, 34 | 146.597 Grams per liter (g/L) | Standard Deviation 11.8831 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin,Week 25,4 weeks post last dose,n=41, 32 | 148.927 Grams per liter (g/L) | Standard Deviation 10.5835 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 1, pre-dose, n=52, 51 | 338.3 Grams per liter (g/L) | Standard Deviation 8.71 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 2, n=52, 52 | 338.1 Grams per liter (g/L) | Standard Deviation 10.34 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 5, pre-dose, n=53, 50 | 338.1 Grams per liter (g/L) | Standard Deviation 7.71 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 9, pre-dose, n=51, 46 | 336.5 Grams per liter (g/L) | Standard Deviation 10.4 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 13, pre-dose, n=44, 40 | 338.7 Grams per liter (g/L) | Standard Deviation 9.52 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 17, pre-dose, n=45, 35 | 338.6 Grams per liter (g/L) | Standard Deviation 9.56 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 21, pre-dose, n=42, 34 | 338.9 Grams per liter (g/L) | Standard Deviation 9.35 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 25,4 weeks post last dose,n=40, 32 | 338.9 Grams per liter (g/L) | Standard Deviation 9.23 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 25,4 weeks post last dose,n=40, 32 | 339.3 Grams per liter (g/L) | Standard Deviation 18.86 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 1, pre-dose, n=51, 52 | 145.566 Grams per liter (g/L) | Standard Deviation 22.1192 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 1, pre-dose, n=52, 51 | 338.6 Grams per liter (g/L) | Standard Deviation 16.71 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 2, n=53, 52 | 147.625 Grams per liter (g/L) | Standard Deviation 11.1436 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 13, pre-dose, n=44, 40 | 339.6 Grams per liter (g/L) | Standard Deviation 17.77 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 5, pre-dose, n=53, 50 | 146.071 Grams per liter (g/L) | Standard Deviation 12.7175 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 2, n=52, 52 | 335.2 Grams per liter (g/L) | Standard Deviation 9.33 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 9, pre-dose, n=51, 46 | 146.252 Grams per liter (g/L) | Standard Deviation 12.0539 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 21, pre-dose, n=42, 34 | 336.4 Grams per liter (g/L) | Standard Deviation 9.84 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 13, pre-dose, n=45, 40 | 147.427 Grams per liter (g/L) | Standard Deviation 11.9305 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 5, pre-dose, n=53, 50 | 338.6 Grams per liter (g/L) | Standard Deviation 15.85 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 17, pre-dose, n=45, 35 | 148.045 Grams per liter (g/L) | Standard Deviation 12.0595 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 17, pre-dose, n=45, 35 | 337.0 Grams per liter (g/L) | Standard Deviation 10.02 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin, Week 21, pre-dose, n=42, 34 | 146.953 Grams per liter (g/L) | Standard Deviation 10.9213 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | MCHC, Week 9, pre-dose, n=51, 46 | 337.7 Grams per liter (g/L) | Standard Deviation 9.52 |
| Placebo | Absolute Values of the Hematology Parameters of Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Hemoglobin,Week 25,4 weeks post last dose,n=41, 32 | 147.940 Grams per liter (g/L) | Standard Deviation 8.989 |
Secondary
Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Platelet count, WBC count, basophils, eosinophils, lymphocytes, monocytes, and neutrophils were assessed at Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose).
Time frame: Week 1 pre-dose, Week 2, Week 5 pre-dose, Week 9 pre-dose, Week 13 pre-dose, Week 17 pre-dose, Week 21 pre-dose, and Week 25 (4 Weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 21, pre-dose, n=42, 34 | 5.86 10^9 cells per liter | Standard Deviation 1.143 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 2, n=53, 52 | 250.1 10^9 cells per liter | Standard Deviation 47.25 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 5, pre-dose, n=53, 50 | 240.7 10^9 cells per liter | Standard Deviation 46.67 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 9, pre-dose, n=51, 46 | 239.1 10^9 cells per liter | Standard Deviation 43.29 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 13, pre-dose, n=45, 40 | 242.7 10^9 cells per liter | Standard Deviation 53.68 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 17, pre-dose, n=45, 35 | 236.4 10^9 cells per liter | Standard Deviation 45.59 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 21, pre-dose, n=42, 34 | 233.0 10^9 cells per liter | Standard Deviation 44.39 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelet, Week 25, 4 weeks post last dose, n=41,32 | 242.1 10^9 cells per liter | Standard Deviation 48.64 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 1, pre-dose, n=52, 52 | 7.16 10^9 cells per liter | Standard Deviation 1.794 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 2, n=53, 52 | 6.20 10^9 cells per liter | Standard Deviation 1.535 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 5, pre-dose, n=53, 50 | 6.17 10^9 cells per liter | Standard Deviation 1.58 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 9, pre-dose, n=51, 46 | 5.90 10^9 cells per liter | Standard Deviation 1.508 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 13, pre-dose, n=45, 40 | 5.93 10^9 cells per liter | Standard Deviation 1.541 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 17, pre-dose, n=45, 35 | 6.03 10^9 cells per liter | Standard Deviation 1.78 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 1, pre-dose, n=52, 52 | 246.1 10^9 cells per liter | Standard Deviation 45.91 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 25, 4 weeks post last dose, n=41, 32 | 5.93 10^9 cells per liter | Standard Deviation 1.357 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 1, pre-dose, n=52, 52 | 0.05 10^9 cells per liter | Standard Deviation 0.029 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 2, n=53, 51 | 0.03 10^9 cells per liter | Standard Deviation 0.021 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 5, pre-dose, n=53, 50 | 0.02 10^9 cells per liter | Standard Deviation 0.013 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 9, pre-dose, n=51, 45 | 0.03 10^9 cells per liter | Standard Deviation 0.017 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 13, pre-dose, n=45, 40 | 0.03 10^9 cells per liter | Standard Deviation 0.024 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 17, pre-dose, n=45, 35 | 0.03 10^9 cells per liter | Standard Deviation 0.021 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 21, pre-dose, n=42, 34 | 0.03 10^9 cells per liter | Standard Deviation 0.021 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophil, Week 25, 4 weeks post last dose, n=41,32 | 0.03 10^9 cells per liter | Standard Deviation 0.021 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 1, pre-dose, n=52, 52 | 0.63 10^9 cells per liter | Standard Deviation 0.496 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 2, n=53, 52 | 0.10 10^9 cells per liter | Standard Deviation 0.079 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 5, pre-dose, n=53, 50 | 0.05 10^9 cells per liter | Standard Deviation 0.03 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 9, pre-dose, n=51, 46 | 0.04 10^9 cells per liter | Standard Deviation 0.027 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 13, pre-dose, n=45, 40 | 0.07 10^9 cells per liter | Standard Deviation 0.196 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 17, pre-dose, n=45, 35 | 0.05 10^9 cells per liter | Standard Deviation 0.125 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 21, pre-dose, n=42, 34 | 0.04 10^9 cells per liter | Standard Deviation 0.023 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophil, Week 25,4 weeks post last dose,n=41,32 | 0.04 10^9 cells per liter | Standard Deviation 0.029 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 1, pre-dose, n=52, 52 | 1.94 10^9 cells per liter | Standard Deviation 0.568 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 2, n=53, 52 | 1.84 10^9 cells per liter | Standard Deviation 0.531 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 5, pre-dose, n=53, 50 | 1.83 10^9 cells per liter | Standard Deviation 0.635 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 9, pre-dose, n=51, 46 | 1.83 10^9 cells per liter | Standard Deviation 0.596 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 13, pre-dose, n=45, 40 | 1.80 10^9 cells per liter | Standard Deviation 0.457 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 17, pre-dose, n=45, 35 | 1.77 10^9 cells per liter | Standard Deviation 0.466 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 21, pre-dose, n=42, 34 | 1.83 10^9 cells per liter | Standard Deviation 0.541 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocyte,Week 25,4 weeks post last dose,n=41, 32 | 1.88 10^9 cells per liter | Standard Deviation 0.604 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 1, pre-dose, n=52, 51 | 0.56 10^9 cells per liter | Standard Deviation 0.166 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 2, n=53, 52 | 0.56 10^9 cells per liter | Standard Deviation 0.175 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 5, pre-dose, n=53, 50 | 0.53 10^9 cells per liter | Standard Deviation 0.17 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 9, pre-dose, n=51, 46 | 0.50 10^9 cells per liter | Standard Deviation 0.14 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 13, pre-dose, n=45, 40 | 0.50 10^9 cells per liter | Standard Deviation 0.188 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 17, pre-dose, n=45, 35 | 0.51 10^9 cells per liter | Standard Deviation 0.172 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 21, pre-dose, n=42, 34 | 0.50 10^9 cells per liter | Standard Deviation 0.15 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 25,4 weeks post last dose,n=41, 32 | 0.51 10^9 cells per liter | Standard Deviation 0.13 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 1, pre-dose, n=52, 52 | 3.96481 10^9 cells per liter | Standard Deviation 1.374461 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 2, n=53, 52 | 3.65642 10^9 cells per liter | Standard Deviation 1.295348 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 5, pre-dose, n=53, 50 | 3.73509 10^9 cells per liter | Standard Deviation 1.238233 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 9, pre-dose, n=51, 45 | 3.49333 10^9 cells per liter | Standard Deviation 1.160355 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 13, pre-dose, n=45, 39 | 3.52400 10^9 cells per liter | Standard Deviation 1.287322 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 17, pre-dose, n=45, 35 | 3.65711 10^9 cells per liter | Standard Deviation 1.624295 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 21, pre-dose, n=42, 34 | 3.45738 10^9 cells per liter | Standard Deviation 0.907831 |
| Mepolizumab 750 mg | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophil,Week 25,4 weeks post last dose,n=41, 32 | 3.46854 10^9 cells per liter | Standard Deviation 1.045869 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 13, pre-dose, n=45, 39 | 3.96169 10^9 cells per liter | Standard Deviation 1.563461 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 1, pre-dose, n=52, 52 | 262.9 10^9 cells per liter | Standard Deviation 53.61 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 13, pre-dose, n=45, 40 | 0.56 10^9 cells per liter | Standard Deviation 0.476 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 2, n=53, 52 | 264.6 10^9 cells per liter | Standard Deviation 56.54 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 5, pre-dose, n=53, 50 | 0.51 10^9 cells per liter | Standard Deviation 0.138 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 5, pre-dose, n=53, 50 | 266.4 10^9 cells per liter | Standard Deviation 61.2 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 17, pre-dose, n=45, 35 | 0.45 10^9 cells per liter | Standard Deviation 0.314 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 9, pre-dose, n=51, 46 | 267.0 10^9 cells per liter | Standard Deviation 57.64 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 2, n=53, 52 | 3.80635 10^9 cells per liter | Standard Deviation 1.525888 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 13, pre-dose, n=45, 40 | 273.2 10^9 cells per liter | Standard Deviation 56.18 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 21, pre-dose, n=42, 34 | 0.49 10^9 cells per liter | Standard Deviation 0.411 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 17, pre-dose, n=45, 35 | 270.2 10^9 cells per liter | Standard Deviation 52.58 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 9, pre-dose, n=51, 46 | 0.53 10^9 cells per liter | Standard Deviation 0.163 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelets, Week 21, pre-dose, n=42, 34 | 271.2 10^9 cells per liter | Standard Deviation 53.89 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophil, Week 25,4 weeks post last dose,n=41,32 | 0.44 10^9 cells per liter | Standard Deviation 0.256 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Platelet, Week 25, 4 weeks post last dose, n=41,32 | 279.3 10^9 cells per liter | Standard Deviation 60.44 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 21, pre-dose, n=42, 34 | 3.83824 10^9 cells per liter | Standard Deviation 1.137039 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 1, pre-dose, n=52, 52 | 6.81 10^9 cells per liter | Standard Deviation 1.634 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 1, pre-dose, n=52, 52 | 1.99 10^9 cells per liter | Standard Deviation 0.615 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 2, n=53, 52 | 6.90 10^9 cells per liter | Standard Deviation 2.014 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 13, pre-dose, n=45, 40 | 0.55 10^9 cells per liter | Standard Deviation 0.159 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 5, pre-dose, n=53, 50 | 6.77 10^9 cells per liter | Standard Deviation 1.574 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 2, n=53, 52 | 1.96 10^9 cells per liter | Standard Deviation 0.516 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 9, pre-dose, n=51, 46 | 6.92 10^9 cells per liter | Standard Deviation 1.553 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 5, pre-dose, n=53, 50 | 3.78720 10^9 cells per liter | Standard Deviation 1.237163 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 13, pre-dose, n=45, 40 | 7.18 10^9 cells per liter | Standard Deviation 2.095 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 5, pre-dose, n=53, 50 | 1.90 10^9 cells per liter | Standard Deviation 0.466 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 17, pre-dose, n=45, 35 | 6.99 10^9 cells per liter | Standard Deviation 1.916 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 17, pre-dose, n=45, 35 | 0.52 10^9 cells per liter | Standard Deviation 0.142 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 21, pre-dose, n=42, 34 | 6.92 10^9 cells per liter | Standard Deviation 1.576 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 9, pre-dose, n=51, 46 | 2.03 10^9 cells per liter | Standard Deviation 0.616 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | WBC, Week 25, 4 weeks post last dose, n=41, 32 | 7.00 10^9 cells per liter | Standard Deviation 1.922 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 17, pre-dose, n=45, 35 | 4.06657 10^9 cells per liter | Standard Deviation 1.550068 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 1, pre-dose, n=52, 52 | 0.05 10^9 cells per liter | Standard Deviation 0.026 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 13, pre-dose, n=45, 40 | 2.02 10^9 cells per liter | Standard Deviation 0.555 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 2, n=53, 51 | 0.05 10^9 cells per liter | Standard Deviation 0.026 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 21, pre-dose, n=42, 34 | 0.55 10^9 cells per liter | Standard Deviation 0.158 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 5, pre-dose, n=53, 50 | 0.05 10^9 cells per liter | Standard Deviation 0.032 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 17, pre-dose, n=45, 35 | 1.92 10^9 cells per liter | Standard Deviation 0.453 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 9, pre-dose, n=51, 45 | 0.05 10^9 cells per liter | Standard Deviation 0.028 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 9, pre-dose, n=51, 45 | 3.76333 10^9 cells per liter | Standard Deviation 1.095441 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 13, pre-dose, n=45, 40 | 0.06 10^9 cells per liter | Standard Deviation 0.082 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocytes, Week 21, pre-dose, n=42, 34 | 1.98 10^9 cells per liter | Standard Deviation 0.514 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 17, pre-dose, n=45, 35 | 0.05 10^9 cells per liter | Standard Deviation 0.027 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 25,4 weeks post last dose,n=41, 32 | 0.57 10^9 cells per liter | Standard Deviation 0.201 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophils, Week 21, pre-dose, n=42, 34 | 0.05 10^9 cells per liter | Standard Deviation 0.041 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Lymphocyte,Week 25,4 weeks post last dose,n=41, 32 | 1.91 10^9 cells per liter | Standard Deviation 0.523 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Basophil, Week 25, 4 weeks post last dose, n=41,32 | 0.05 10^9 cells per liter | Standard Deviation 0.023 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophil,Week 25,4 weeks post last dose,n=41, 32 | 4.03125 10^9 cells per liter | Standard Deviation 1.452175 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 1, pre-dose, n=52, 52 | 0.54 10^9 cells per liter | Standard Deviation 0.305 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 1, pre-dose, n=52, 51 | 0.50 10^9 cells per liter | Standard Deviation 0.131 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 2, n=53, 52 | 0.55 10^9 cells per liter | Standard Deviation 0.346 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Neutrophils, Week 1, pre-dose, n=52, 52 | 3.72673 10^9 cells per liter | Standard Deviation 1.085727 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 5, pre-dose, n=53, 50 | 0.51 10^9 cells per liter | Standard Deviation 0.276 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Monocytes, Week 2, n=53, 52 | 0.54 10^9 cells per liter | Standard Deviation 0.19 |
| Placebo | Absolute Values of the Hematology Parameters of Platelet Count and White Blood Cell (WBC) Count, Basophils, Eosinophils, Lymphocytes, Monocytes, and Neutrophils at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Eosinophils, Week 9, pre-dose, n=51, 46 | 0.55 10^9 cells per liter | Standard Deviation 0.392 |
Secondary
Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf])
Blood samples were scheduled to be collected for the assessment of AUC(0-inf) at Weeks 1, 2, 5, 9, 13, and 25 AUC\[0-inf\] is derived from individual systemic clearance estimates using the expression AUC\[0-inf\] = Dose/CL. Hence all data are incorporated into the estimation of CL and by implication AUC\[0-inf\].
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Area Under the Plasma Drug Concentration Versus Time Curve From Time 0 Extrapolated to Infinite Time (AUC[0-inf]) | 3456.69 Day*Microgram per milliliter | Standard Error 152.11 |
Secondary
Bodyweight-adjusted Clearance
Clearance is the volume of plasma that would contain the amount of drug excreted per day. Blood samples were collected for the assessment of bodyweight-adjusted clearance at Weeks 1, 2, 5, 9, 13, and 25. Clearance was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Bodyweight-adjusted Clearance | 0.2170 Liters per day | Standard Error 0.009547 |
Secondary
Half-life (Alpha) and Half-life (Beta)
Half-life (Alpha) is the rate of decline in plasma concentrations due to the process of drug redistribution from the central to the peripheral compartment and half-life (Beta ) is the rate of decline due to the process of drug elimination due to metabolism. Blood samples were collected for the assessment of half-life (Alpha) and half-life (Beta) at Weeks 1, 2, 5, 9, 13, and 25. Half-life was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Half-life (Alpha) and Half-life (Beta) | Half-life (Alpha) | 1.5456 Days | Standard Error 0.4108 |
| Mepolizumab 750 mg | Half-life (Alpha) and Half-life (Beta) | Half-life (Beta) | 24.1258 Days | Standard Error 1.025 |
Secondary
Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)
The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The first part contains descriptions of the following five components: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses to each of the five domains are measured on a 3-point scale (1-no problems, 2-some problems, and 3-severe problems). An index for the descriptive scores was derived using the general European weights, obtained for each of the countries in this study. Index scores were derived for each participant at each time point by taking sum of weights. Index score ranges from -0.718 to 1, with lower scores indicating poor health. ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.
Time frame: Week 1 (Baseline) and Week 25
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | 0.91 Scores on a scale | Standard Error 0.02 |
| Placebo | Index Score of the EuroQoL Quality of Life-5D (EQ-5D) Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | 0.91 Scores on a scale | Standard Error 0.02 |
95% CI: [-0.06, 0.07]
Secondary
Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Participants were asked to indicate on a VAS (0 to 10 centimeters) the severity of nasal polyposis and its four symptoms (one VAS for each symptom): rhinorrhea; mucus in the throat; nasal blockage; loss of smell. The left-hand side of the scale (0) represents not troublesome, and the right hand side of the scale (10) represents worst possible troublesome. Hence the score ranges between 0 to 10, with higher scores indicating greater severity.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Population: PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 5, n=49, 49 | 4.98 Scores on a scale | Standard Deviation 3.365 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 2, n=49, 51 | 7.91 Scores on a scale | Standard Deviation 1.766 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 5, n=49, 49 | 7.10 Scores on a scale | Standard Deviation 2.31 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 9, n=47, 46 | 6.14 Scores on a scale | Standard Deviation 3.022 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 13, n=45, 39 | 5.79 Scores on a scale | Standard Deviation 3.524 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 17, n=44, 34 | 5.00 Scores on a scale | Standard Deviation 3.518 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 21, n=42, 33 | 4.70 Scores on a scale | Standard Deviation 3.513 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 25, n=42, 31 | 4.16 Scores on a scale | Standard Deviation 3.582 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 1, n=49, 51 | 6.60 Scores on a scale | Standard Deviation 2.694 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 2, n=49, 51 | 5.59 Scores on a scale | Standard Deviation 2.863 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 1, n=49, 51 | 8.51 Scores on a scale | Standard Deviation 0.928 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 9, n=48, 46 | 4.65 Scores on a scale | Standard Deviation 3.309 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 13, n=45, 39 | 4.18 Scores on a scale | Standard Deviation 3.34 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 17, n=44, 34 | 3.33 Scores on a scale | Standard Deviation 3.338 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 21, n=42, 34 | 3.50 Scores on a scale | Standard Deviation 3.408 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 25, n=42, 31 | 3.03 Scores on a scale | Standard Deviation 3.428 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 1, n=49, 51 | 5.92 Scores on a scale | Standard Deviation 2.878 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 2, n=49, 51 | 5.27 Scores on a scale | Standard Deviation 2.807 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 5, n=49, 49 | 4.92 Scores on a scale | Standard Deviation 3.012 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 9, n=48, 46 | 3.93 Scores on a scale | Standard Deviation 3.232 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 13, n=45, 39 | 4.11 Scores on a scale | Standard Deviation 3.079 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 17, n=44, 34 | 3.28 Scores on a scale | Standard Deviation 3.19 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 21, n=42, 34 | 3.30 Scores on a scale | Standard Deviation 3.356 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 25, n=42, 31 | 3.24 Scores on a scale | Standard Deviation 3.263 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 1, n=49, 51 | 7.76 Scores on a scale | Standard Deviation 2.459 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 2, n=49, 51 | 6.41 Scores on a scale | Standard Deviation 3.02 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 5, n=49, 49 | 5.66 Scores on a scale | Standard Deviation 3.169 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 9, n=48, 46 | 5.03 Scores on a scale | Standard Deviation 3.387 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 13, n=45, 39 | 4.66 Scores on a scale | Standard Deviation 3.729 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 17, n=44, 34 | 4.18 Scores on a scale | Standard Deviation 3.556 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 21, n=42, 34 | 4.04 Scores on a scale | Standard Deviation 3.563 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 25, n=42, 31 | 3.61 Scores on a scale | Standard Deviation 3.464 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 1, n=49, 51 | 9.03 Scores on a scale | Standard Deviation 1.739 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 2, n=49, 51 | 8.79 Scores on a scale | Standard Deviation 1.823 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 5, n=49, 49 | 8.28 Scores on a scale | Standard Deviation 2.243 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 9, n=48, 46 | 7.43 Scores on a scale | Standard Deviation 3.192 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 13, n=45, 39 | 7.42 Scores on a scale | Standard Deviation 3.296 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 17, n=44, 34 | 6.85 Scores on a scale | Standard Deviation 3.648 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 21, n=42, 34 | 6.74 Scores on a scale | Standard Deviation 3.562 |
| Mepolizumab 750 mg | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 25, n=42, 31 | 6.02 Scores on a scale | Standard Deviation 4.069 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 17, n=44, 34 | 8.18 Scores on a scale | Standard Deviation 2.682 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 1, n=49, 51 | 8.64 Scores on a scale | Standard Deviation 1.101 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 13, n=45, 39 | 5.49 Scores on a scale | Standard Deviation 3.28 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 2, n=49, 51 | 8.47 Scores on a scale | Standard Deviation 1.326 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 21, n=42, 34 | 5.77 Scores on a scale | Standard Deviation 3.397 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 5, n=49, 49 | 7.75 Scores on a scale | Standard Deviation 2.083 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 17, n=44, 34 | 5.16 Scores on a scale | Standard Deviation 3.482 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 9, n=47, 46 | 7.74 Scores on a scale | Standard Deviation 2.112 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 9, n=48, 46 | 8.67 Scores on a scale | Standard Deviation 2.647 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 13, n=45, 39 | 7.21 Scores on a scale | Standard Deviation 2.563 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 21, n=42, 34 | 4.84 Scores on a scale | Standard Deviation 3.457 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 17, n=44, 34 | 6.44 Scores on a scale | Standard Deviation 3.164 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 25, n=42, 31 | 5.81 Scores on a scale | Standard Deviation 3.494 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 21, n=42, 33 | 6.47 Scores on a scale | Standard Deviation 3.098 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 25, n=42, 31 | 5.23 Scores on a scale | Standard Deviation 3.405 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Polyposis, Week 25, n=42, 31 | 6.21 Scores on a scale | Standard Deviation 3.357 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 25, n=42, 31 | 7.90 Scores on a scale | Standard Deviation 3.378 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 1, n=49, 51 | 6.17 Scores on a scale | Standard Deviation 3.086 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 1, n=49, 51 | 8.36 Scores on a scale | Standard Deviation 1.783 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 2, n=49, 51 | 6.28 Scores on a scale | Standard Deviation 2.992 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 1, n=49, 51 | 9.22 Scores on a scale | Standard Deviation 1.912 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 5, n=49, 49 | 5.98 Scores on a scale | Standard Deviation 2.926 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 2, n=49, 51 | 7.84 Scores on a scale | Standard Deviation 2.466 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 9, n=48, 46 | 6.28 Scores on a scale | Standard Deviation 3.129 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 13, n=45, 39 | 8.59 Scores on a scale | Standard Deviation 2.318 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 13, n=45, 39 | 5.19 Scores on a scale | Standard Deviation 3.106 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 5, n=49, 49 | 7.33 Scores on a scale | Standard Deviation 2.489 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 17, n=44, 34 | 4.82 Scores on a scale | Standard Deviation 3.399 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 2, n=49, 51 | 9.02 Scores on a scale | Standard Deviation 1.942 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 21, n=42, 34 | 4.70 Scores on a scale | Standard Deviation 3.512 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 9, n=48, 46 | 7.22 Scores on a scale | Standard Deviation 2.959 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Rhinorrhea, Week 25, n=42, 31 | 4.71 Scores on a scale | Standard Deviation 3.812 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 21, n=42, 34 | 8.20 Scores on a scale | Standard Deviation 2.835 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 1, n=49, 51 | 6.53 Scores on a scale | Standard Deviation 2.732 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 13, n=45, 39 | 6.27 Scores on a scale | Standard Deviation 3.268 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 2, n=49, 51 | 6.15 Scores on a scale | Standard Deviation 2.764 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Loss of Smell, Week 5, n=49, 49 | 8.69 Scores on a scale | Standard Deviation 2.511 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 5, n=49, 49 | 5.92 Scores on a scale | Standard Deviation 2.64 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Nasal Blockage, Week 17, n=44, 34 | 5.71 Scores on a scale | Standard Deviation 3.597 |
| Placebo | Individual Symptoms Visual Analogue Scale (VAS) Scores at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Mucus in Throat, Week 9, n=48, 46 | 6.37 Scores on a scale | Standard Deviation 2.942 |
Secondary
Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS)
Blood samples were collected for the assessment of Cmax, Cav(0-inf), and Cmax SS at Weeks 1, 2, 5, 9, 13, and 25. These parameters were estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS) | Cmax | 193.22 Micrograms per milliliter | Standard Error 7.8536 |
| Mepolizumab 750 mg | Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS) | Cav(0-inf) | 123.45 Micrograms per milliliter | Standard Error 5.4324 |
| Mepolizumab 750 mg | Maximum Observed Plasma Drug Concentration (Cmax), Average Concentration (Cav[0-inf]), and Steady State Maximum Observed Plasma Drug Concentration (Cmax SS) | Cmax SS | 268.40 Micrograms per milliliter | Standard Error 10.3703 |
Secondary
Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25
Pulse rate was measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Time frame: Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=45, 40 | -0.4 beats per minute | Standard Deviation 11.05 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=41, 32 | -0.4 beats per minute | Standard Deviation 9.29 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=45, 36 | -0.4 beats per minute | Standard Deviation 9.71 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=53, 50 | -1.1 beats per minute | Standard Deviation 9.09 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=41, 34 | -2.0 beats per minute | Standard Deviation 9.56 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=53, 52 | 0.2 beats per minute | Standard Deviation 8.88 |
| Mepolizumab 750 mg | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=51, 46 | -1.7 beats per minute | Standard Deviation 8.4 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=41, 32 | 0.0 beats per minute | Standard Deviation 8.29 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=53, 52 | 0.0 beats per minute | Standard Deviation 7.86 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=53, 50 | -1.0 beats per minute | Standard Deviation 7.91 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=45, 40 | -2.4 beats per minute | Standard Deviation 9.42 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=45, 36 | -0.6 beats per minute | Standard Deviation 9.35 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=41, 34 | -1.2 beats per minute | Standard Deviation 8.7 |
| Placebo | Mean Change From Baseline in Pulse Rate at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=51, 46 | -0.8 beats per minute | Standard Deviation 7.5 |
Secondary
Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25
SBP and DBP were measured at Baseline (Week 1) and at Weeks 2, 5, 9, 13, 17, 21, and 25. Baseline is defined as the Week 1 pre-dose assessment. Change from Baseline is defined as the difference between the post-dose post-Baseline visit value and the Baseline value.
Time frame: Baseline and Weeks 2, 5, 9, 13, 17, 21, and 25
Population: Safety Population: participants who received \>=1 dose of study treatment (based on actual treatment received). One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 2, n=53, 52 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 14.14 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 5, n=53, 49 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 11.74 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 9, n=51, 46 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 15.01 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 13, n=45, 40 | -2.9 millimeters of mercury (mmHg) | Standard Deviation 12.17 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 17, n=45, 36 | -1.9 millimeters of mercury (mmHg) | Standard Deviation 13.15 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 21, n=42, 34 | -2.0 millimeters of mercury (mmHg) | Standard Deviation 14.55 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 25, n=42, 32 | -2.4 millimeters of mercury (mmHg) | Standard Deviation 15.47 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 2, n=53, 52 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 7.97 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 5, n=53, 49 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 8.56 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 9, n=51, 46 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 12.05 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 13, n=45, 40 | -0.6 millimeters of mercury (mmHg) | Standard Deviation 9.99 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 17, n=45, 36 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 8.9 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 21, n=42, 34 | -0.3 millimeters of mercury (mmHg) | Standard Deviation 7.95 |
| Mepolizumab 750 mg | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 25, n=42, 32 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 10.27 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 13, n=45, 40 | -0.5 millimeters of mercury (mmHg) | Standard Deviation 9.56 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 2, n=53, 52 | 4.6 millimeters of mercury (mmHg) | Standard Deviation 13.33 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 2, n=53, 52 | -0.9 millimeters of mercury (mmHg) | Standard Deviation 10.44 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 5, n=53, 49 | 0.5 millimeters of mercury (mmHg) | Standard Deviation 10.5 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 21, n=42, 34 | -1.5 millimeters of mercury (mmHg) | Standard Deviation 9.32 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 9, n=51, 46 | 1.0 millimeters of mercury (mmHg) | Standard Deviation 12.84 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 5, n=53, 49 | -0.1 millimeters of mercury (mmHg) | Standard Deviation 7.98 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 13, n=45, 40 | 0.9 millimeters of mercury (mmHg) | Standard Deviation 11.97 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 17, n=45, 36 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 9.43 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 17, n=45, 36 | 0.3 millimeters of mercury (mmHg) | Standard Deviation 11.72 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 9, n=51, 46 | 0.0 millimeters of mercury (mmHg) | Standard Deviation 7.29 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 21, n=42, 34 | -1.7 millimeters of mercury (mmHg) | Standard Deviation 12.14 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | DBP, Week 25, n=42, 32 | -2.2 millimeters of mercury (mmHg) | Standard Deviation 9.58 |
| Placebo | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 2, 5, 9, 13, 17, 21, and 25 | SBP, Week 25, n=42, 32 | -1.8 millimeters of mercury (mmHg) | Standard Deviation 15.39 |
Secondary
Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25
FVC is defined as the maximum amount of air that can forcibly be blown out after a maximum inspiration. FVC was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.
Time frame: Weeks 2, 5, 9, 13, 17, 21, and 25
Population: ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 4.51 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 4.59 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 44 | 4.52 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 4.66 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 4.55 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 4.59 Liters |
| Mepolizumab 750 mg | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 4.62 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 4.41 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 4.49 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 4.45 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 4.43 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 4.37 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 4.38 Liters |
| Placebo | Mean of Forced Vital Capacity (FVC) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 44 | 4.46 Liters |
p-value: 0.48695% CI: [-0.1, 0.22]repeated measures model
p-value: 0.38495% CI: [-0.08, 0.22]repeated measures model
p-value: 0.54695% CI: [-0.14, 0.26]repeated measures model
p-value: 0.0595% CI: [0, 0.39]repeated measures model
p-value: 0.06195% CI: [-0.01, 0.45]repeated measures model
p-value: 0.01695% CI: [0.05, 0.51]repeated measures model
p-value: 0.09495% CI: [-0.03, 0.4]repeated measures model
Secondary
Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25
FEV1 is defined as the volume of air forcefully expelled from the lungs in one second. FEV1 measurements were taken by spirometry at each clinic visit. FEV1 was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.
Time frame: Weeks 2, 5, 9, 13, 17, 21, and 25
Population: ITT Population: all randomized participants who received at least one dose of study treatment. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 44 | 3.32 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 3.33 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 3.33 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 3.41 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 3.35 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 3.35 Liters (L) |
| Mepolizumab 750 mg | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 3.24 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 3.18 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 3.20 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 3.28 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 44 | 3.23 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 3.18 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 3.12 Liters (L) |
| Placebo | Mean of the Forced Expiratory Volume in 1 Second (FEV1) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 3.18 Liters (L) |
p-value: 0.56795% CI: [-0.1, 0.19]repeated measures model
p-value: 0.49595% CI: [-0.1, 0.21]repeated measures model
p-value: 0.36595% CI: [-0.1, 0.28]repeated measures model
p-value: 0.05895% CI: [-0.01, 0.34]repeated measures model
p-value: 0.05695% CI: [-0.01, 0.43]repeated measures model
p-value: 0.02895% CI: [0.03, 0.42]repeated measures model
p-value: 0.07795% CI: [-0.02, 0.34]repeated measures model
Secondary
Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25
PEFR is defined as the maximum airflowrate generated during a forced expiration beginning with the lungs fully inflated. PEFR was calculated as the maximum of three readings taken at each time point for each participant. Spirometry data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.
Time frame: Weeks 2, 5, 9, 13, 17, 21, and 25
Population: ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 45 | 487.07 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 493.68 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 489.08 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 501.88 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 494.04 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 481.05 Liters/minute (L/min) |
| Mepolizumab 750 mg | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 472.81 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 466.93 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 467.70 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 474.53 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 45 | 478.16 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=44, 37 | 470.81 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=43, 34 | 455.52 Liters/minute (L/min) |
| Placebo | Mean Peak Expiratory Flow Rate (PEFR) at Indicated Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 32 | 463.17 Liters/minute (L/min) |
p-value: 0.68695% CI: [-19.91, 30.12]repeated measures model
p-value: 0.32195% CI: [-14.4, 43.5]repeated measures model
p-value: 0.62295% CI: [-26.79, 44.6]repeated measures model
p-value: 0.17895% CI: [-10.75, 57.22]repeated measures model
p-value: 0.05295% CI: [-0.33, 76.66]repeated measures model
p-value: 0.04295% CI: [1.41, 76.02]repeated measures model
p-value: 0.48495% CI: [-25.76, 54.02]repeated measures model
Secondary
Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25
Participants used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken, and the largest measurement was recorded in the electronic diary. PNIF data is plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.
Time frame: Weeks 2, 5, 9, 13, 17, 21, and 25
Population: ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 46 | 123.91 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=44, 34 | 132.41 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 127.21 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 33 | 143.03 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=45, 37 | 137.50 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 137.02 L/min |
| Mepolizumab 750 mg | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 120.82 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 25, n=42, 32 | 110.37 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 2, n=54, 51 | 99.66 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 5, n=54, 49 | 110.32 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 9, n=47, 46 | 116.71 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 13, n=45, 37 | 109.79 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 17, n=44, 34 | 117.02 L/min |
| Placebo | Mean Peak Nasal Inspiratory Flow (PNIF) at Weeks 2, 5, 9, 13, 17, 21, and 25 | Week 21, n=42, 33 | 113.52 L/min |
p-value: 0.00595% CI: [6.49, 35.83]repeated measures model
p-value: 0.02995% CI: [1.77, 32.01]repeated measures model
p-value: 0.47295% CI: [-12.64, 27.03]repeated measures model
p-value: 0.00995% CI: [7.19, 48.23]repeated measures model
p-value: 0.11495% CI: [-3.8, 34.59]repeated measures model
p-value: 0.01495% CI: [6.06, 52.96]repeated measures model
p-value: 0.02795% CI: [3.1, 50.21]repeated measures model
Secondary
Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Assessment of the nasal polyposis condition was performed after 6 months of dosing to determine the situation indicative of a reduction in the need for surgery. The components used to determine the need for surgery were endoscopic polyp scores and a severity of condition as measured by a VAS. Surgery was required for participants with ENP scores of \>=3, or ENP scores of 2 and a VAS symptom score of \>7.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Population: PP Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 | 49 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2 | 48 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5 | 44 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9 | 39 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13 | 38 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17 | 37 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21 | 35 Participants |
| Mepolizumab 750 mg | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25 | 33 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25 | 46 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1 | 51 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13 | 50 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2 | 51 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21 | 46 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5 | 49 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17 | 46 Participants |
| Placebo | Number of Participants Who Required Polyp Surgery at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9 | 48 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE)
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. 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. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
Time frame: Up to 11 months
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAE | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE) | Any AE | 40 Participants |
| Placebo | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE) | Any AE | 42 Participants |
| Placebo | Number of Participants With Any Treatment-emergent Adverse Event (AE) and Serious Adverse Event (SAE) | Any SAE | 0 Participants |
Secondary
Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Each nostril was assessed for polyps and graded at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. The right and left nostrils were scored from 0 to 4, where, 0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction/congestion of the inferior meatus. The ENP score was recorded for both the right and the left nostril. The higher of the two scores was derived and used for the analysis. The ENP score ranges from 0 to 4, with a higher score indicating a larger polyp.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Population: PP Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 0, n=49, 48 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 1, n=49, 51 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 2, n=49, 51 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score >=3, n=49, 51 | 49 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 0, n=48, 51 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 1, n=48, 51 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 2, n=48, 51 | 1 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score >=3, n=48, 51 | 47 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 0, n=49, 51 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 1, n=49, 48 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 2, n=49, 48 | 8 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score >=3, n=49, 48 | 41 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 0, n=49, 45 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 1, n=49, 45 | 5 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 2, n=49, 45 | 8 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score >=3, n=49, 45 | 36 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 0, n=44, 37 | 3 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 1, n=44, 37 | 5 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 2, n=44, 37 | 5 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score >=3, n=44, 37 | 31 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 0, n=43, 34 | 3 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 1, n=43, 34 | 4 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 2, n=43, 34 | 7 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score >=3, n=43, 34 | 29 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 0, n=42, 34 | 4 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 1, n=42, 34 | 6 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 2, n=42, 34 | 5 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score >=3, n=42, 34 | 27 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 0, n=42, 31 | 3 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 1, n=42, 31 | 7 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 2, n=42, 31 | 7 Participants |
| Mepolizumab 750 mg | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score >=3, n=42, 31 | 25 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score >=3, n=42, 31 | 24 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 0, n=49, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 0, n=44, 37 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 1, n=49, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 0, n=42, 34 | 1 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score 2, n=49, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 1, n=44, 37 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, ENP score >=3, n=49, 51 | 51 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 0, n=42, 31 | 1 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 0, n=48, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score 2, n=44, 37 | 2 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 1, n=48, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 1, n=42, 34 | 2 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score 2, n=48, 51 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, ENP score >=3, n=44, 37 | 35 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, ENP score >=3, n=48, 51 | 51 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 2, n=42, 31 | 4 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 0, n=49, 48 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 0, n=43, 34 | 1 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 1, n=49, 48 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score 2, n=42, 34 | 4 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score 2, n=49, 48 | 6 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 1, n=43, 34 | 1 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, ENP score >=3, n=49, 48 | 42 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, ENP score 1, n=42, 31 | 2 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 0, n=49, 45 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score 2, n=43, 34 | 6 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 1, n=49, 45 | 0 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, ENP score >=3, n=42, 34 | 27 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score 2, n=49, 45 | 5 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, ENP score >=3, n=43, 34 | 26 Participants |
| Placebo | Number of Participants With Endoscopic Nasal Polyp (ENP) Score Dynamics at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, ENP score >=3, n=49, 45 | 40 Participants |
p-value: 0.7195% CI: [0.15, 3.64]Regression, Logistic
p-value: 0.67495% CI: [0.29, 6.87]Regression, Logistic
p-value: 0.94295% CI: [0.2, 4.49]Regression, Logistic
p-value: 0.09195% CI: [0.8, 18.96]Regression, Logistic
p-value: 0.00495% CI: [2.18, 62.33]Regression, Logistic
p-value: 0.22495% CI: [0.54, 13.9]Regression, Logistic
p-value: 0.03795% CI: [1.11, 30.69]Regression, Logistic
p-value: 0.05195% CI: [0.99, 27.44]Regression, Logistic
Secondary
Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Specific gravity, power of hydrogen (pH), glucose, protein, blood, and ketones were assessed at Weeks (Wk) 1, 2, 5, 9, 13, 17, 21, and 25. Results for all urinalysis parameters were assessed for clinical relevance by physician. Clinically relevant positive results are presented. Clinically relevant positive results are defined as those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 1, n=53,52 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 2, n=46,49 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 5, n=53,50 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 9, n=51,46 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 13,n=45,40 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 17,n=45,36 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 21,n=42,34 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 25,n=39,31 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 25,n=39,31 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 1, n=53,52 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 13,n=45,40 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 2, n=46,49 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 21,n=42,34 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 5, n=53,50 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 17,n=45,36 | 0 Participants |
| Placebo | Number of Participants With Positive Clinically Relevant Urinalysis Results at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Clinically relevant positive results Wk 9, n=51,46 | 0 Participants |
Secondary
Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing)
Blood samples were collected at Week 1 pre-dose, Week 5 pre-dose, Week 13 pre-dose and Week 25 (4 weeks post last dose) for anti-mepolizumab antibody testing using a validated electrochemiluminescent (ECL) immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'.
Time frame: Week 1 pre-dose, Week 5 pre-dose, Week 13 pre-dose and Week 25 (4 weeks post last dose)
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 1, pre-dose, n=53, 52 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 5, pre-dose, n=53, 50 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 13, pre-dose, n=45, 40 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 25, 4 weeks post last dose, n=40, 31 | 0 Participants |
| Placebo | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 25, 4 weeks post last dose, n=40, 31 | 0 Participants |
| Placebo | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 1, pre-dose, n=53, 52 | 2 Participants |
| Placebo | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 13, pre-dose, n=45, 40 | 2 Participants |
| Placebo | Number of Participants With Positive Immunogenicity (Anti-mepolizumab Antibody Testing) | Week 5, pre-dose, n=53, 50 | 2 Participants |
Secondary
Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25
A single safety 12-lead ECG was performed using a standard 12-lead ECG machine at Weeks 1, 2, 5, 9, 13, 17, 21, and 25. Any abnormal clinically significant (CS) and not clinically significant (NCS) findings were identified. ECG abnormaility with respect to CS and NCS findings were judged by the investigator or appropriately qualified designee. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21, and 25
Population: Safety Population. One participant randomized to mepolizumab took placebo in error. Thus, N for the placebo arm of the SP is greater than for the ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, NCS, n=53, 52 | 8 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, CS, n=53, 52 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, NCS, n=52, 52 | 7 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, CS, n=52, 52 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, NCS, n=53, 50 | 8 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, CS, n=53, 50 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, NCS, n=52, 46 | 5 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, CS, n=52, 46 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, NCS, n=45, 40 | 6 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, CS, n=45, 40 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, NCS, n=45, 36 | 9 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, CS, n=45, 36 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, NCS, n=42, 34 | 3 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, CS, n=42, 34 | 0 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, NCS, n=41, 31 | 2 Participants |
| Mepolizumab 750 mg | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, CS, n=41, 31 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, CS, n=41, 31 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, NCS, n=53, 52 | 8 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, NCS, n=45, 40 | 4 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 1, CS, n=53, 52 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, NCS, n=42, 34 | 1 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, NCS, n=52, 52 | 9 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 13, CS, n=45, 40 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 2, CS, n=52, 52 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 25, NCS, n=41, 31 | 3 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, NCS, n=53, 50 | 8 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, NCS, n=45, 36 | 4 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 5, CS, n=53, 50 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 21, CS, n=42, 34 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, NCS, n=52, 46 | 3 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 17, CS, n=45, 36 | 0 Participants |
| Placebo | Number of Participants With the Indicated Electrocardiogram (ECG) Findings at Weeks 1, 2, 5, 9, 13, 17, 21, and 25 | Week 9, CS, n=52, 46 | 0 Participants |
Secondary
Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25
Sniffin'Sticks were used to assess each participant's sense of smell (olfaction). Olfaction testing results were recorded for both the right and left nostrils The worst nostril score (number of correct answers for the worst nostril) and the mean nostril score (mean number of correct answers across both nostrils) were recorded. Scores range from 0 to 12 (high score indicating normal olfactory sensation). Olfaction data are plotted and analyzed using a repeated measures model to calculate treatment difference, confidence intervals and p-values.
Time frame: Weeks 2, 5, 9, 13, 17, 21, and 25
Population: ITT Population. Only those participants available at the specified time points (represented by n=X, X) were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 2, n=54, 51 | 3.78 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 5, n=54, 49 | 4.20 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 9, n=47, 45 | 4.48 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 13, n=45, 37 | 4.39 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 17, n=43, 34 | 4.64 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 21, n=42, 33 | 4.77 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 25, n=41, 32 | 4.40 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 2, n=54, 51 | 3.18 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 5, n=54, 49 | 3.72 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 9, n=47, 45 | 3.85 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 13, n=45, 37 | 3.76 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 17, n=43, 34 | 3.93 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 21, n=42, 33 | 4.16 Scores on a scale |
| Mepolizumab 750 mg | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 25, n=41, 32 | 3.75 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 13, n=45, 37 | 3.14 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 2, n=54, 51 | 3.68 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 2, n=54, 51 | 2.89 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 5, n=54, 49 | 3.07 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 21, n=42, 33 | 3.52 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 9, n=47, 45 | 3.69 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 5, n=54, 49 | 2.41 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 13, n=45, 37 | 3.66 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 17, n=43, 34 | 3.74 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 17, n=43, 34 | 4.26 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 9, n=47, 45 | 3.17 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 21, n=42, 33 | 4.12 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | WNS, Week 25, n=41, 32 | 3.30 Scores on a scale |
| Placebo | Olfaction Testing: Worst Nostril Score (WNS) and Mean Nostril Score (MNS) at Weeks 2, 5, 9, 13, 17, 21, and 25 | MNS, Week 25, n=41, 32 | 3.69 Scores on a scale |
p-value: 0.7995% CI: [-0.61, 0.79]repeated measures model
p-value: 0.00895% CI: [0.3, 1.97]repeated measures model
p-value: 0.06695% CI: [-0.05, 1.64]repeated measures model
p-value: 0.12795% CI: [-0.21, 1.67]repeated measures model
p-value: 0.48195% CI: [-0.69, 1.46]repeated measures model
p-value: 0.30895% CI: [-0.61, 1.9]repeated measures model
p-value: 0.23395% CI: [-0.46, 1.88]repeated measures model
p-value: 0.44495% CI: [-0.45, 1.02]repeated measures model
p-value: 0.00295% CI: [0.5, 2.12]repeated measures model
p-value: 0.14395% CI: [-0.24, 1.6]repeated measures model
p-value: 0.2495% CI: [-0.42, 1.65]repeated measures model
p-value: 0.7595% CI: [-0.98, 1.35]repeated measures model
p-value: 0.32495% CI: [-0.64, 1.91]repeated measures model
p-value: 0.46895% CI: [-0.77, 1.66]repeated measures model
Secondary
Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline
Blood samples were collected for the assessment of PK/PD model derived Baseline at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available blood eosinophil count data were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21 and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Pharmacokinetic/Pharmacodynamic (PK/PD) Model Derived Baseline | 0.4231 Giga units per liter | Standard Error 0.02873 |
Secondary
PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual
A residual is the difference between the observed and predicted values. Blood samples were collected for the assessment of PK/PD model derived CV(Baseline), CV(Emax), and residual at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated subjects). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21 and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Mepolizumab 750 mg | PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual | CV(Baseline) | 51.9951 Percentage of variation | Standard Error 6.5318 |
| Mepolizumab 750 mg | PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual | CV(Emax) | 52.8910 Percentage of variation | Standard Error 6.6193 |
| Mepolizumab 750 mg | PK/PD Model Derived Coefficient of Variation of Baseline (CV[Baseline]), Variation of Maximal Effect of Drug (CV[Emax]), and Residual | Residual | 41.3787 Percentage of variation | Standard Error 1.3763 |
Secondary
PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50)
Blood samples were collected for the assessment of PK/PD model derived EC50 at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-partcipant variability.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21 and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | PK/PD Model Derived Half Maximal Effective Drug Concentration (EC50) | 4.4303 Microgram per liter | Standard Error 0.4404 |
Secondary
PK/PD Model Derived Maximum Inhibition
Blood samples were collected for the assessment of Maximum Inhibition at Weeks 1, 2, 5, 9, 13, 17, 21 and 25. An exploratory Emax direct response model was fitted to serial blood eosinophil count data (including placebo) using model-predicted mepolizumab concentrations (with zero imputed for placebo treated participants). All available datapoints were incorporated into the model. Individual values are estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, 17, 21 and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | PK/PD Model Derived Maximum Inhibition | 90.0748 Percentage of inhibition | Standard Error 1.0096 |
Secondary
Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline)
SNOT-22 questionnaire is a modification of the SNOT-20 and contains the questions (ques) related to smell and nasal obstruction. Each ques is graded with a numerical score for each response (resp); scores range from 0 for no symptoms to 5 for as bad as things could be. Scores for each of the ques is summed to derive the total score for that par. at that visit. If the par. did not complete any ques at a visit, then he/she were not to have any missing values imputed, and his/her total score for that visit was set to missing. If a par. had some missing scores (but no more than 50% missing at that visit), then scores for the missing resp were imputed as the mean of the non-missing resp for that par. at that visit. The SNOT-22 total score ranges from 0 to 110, with higher scores representing a worse quality of life. Questionnaire data analysis was done using an ANCOVA to obtain the LS-means, treatment difference and confidence interval at Week 25, adjusting for Week 1 Baseline scores.
Time frame: Week 1 (Baseline) and Week 25
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline) | 27.13 Scores on a scale | Standard Error 2.96 |
| Placebo | Sino-Nasal Outcome Test (SNOT)-22 Questionnaire Total Score at Week 25 (Adjusted for Week 1 Baseline) | 40.36 Scores on a scale | Standard Error 3.39 |
p-value: 0.00595% CI: [-22.2, -4.22]ANCOVA
Secondary
Steady-State Volume of Distribution
Steady-state volume of distribution is the blood and tissue volume into which a drug is distributed and the relative binding of drug to protein in these spaces. Blood samples were collected for the assessment of steady-state volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. Steady-state volume of distribution was estimated using a population-pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Steady-State Volume of Distribution | 7.0958 Liters | Standard Error 0.3226 |
Secondary
Systemic Clearance of Mepolizumab 750 mg
Blood samples were collected for the assessment of systemic clearance at Weeks 1, 2, 5, 9, 13, and 25. Systemic Clearance (CL) is estimated using a population-Pharmacokinetic model incorporating all available data points from all participants. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: Pharmacokinetic (PK) Population: participants in the Safety Population for whom at least one PK sample was obtained and analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Systemic Clearance of Mepolizumab 750 mg | 0.250 Liters per day | Standard Deviation 0.0659 |
Secondary
VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores)
The EQ-5D is a standardized, 2-part questionnaire used to measure health outcomes. The second part of the questionnaire is a VAS question, requiring the participant to self rate his/her health score on a scale of 0 (worst imaginable health state) to 100 (best imaginable health state). ANCOVA model with treatment, Baseline (Week 1 scores) and country as factors was used to calculate treatment difference and confidence intervals at Week 25.
Time frame: Week 1 (Baseline) and Week 25
Population: ITT Population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | 81.13 Scores on a scale | Standard Error 2.3 |
| Placebo | VAS Score of the EQ-5D Questionnaire at Week 25 (Adjusting for Week 1 Baseline Scores) | 75.45 Scores on a scale | Standard Error 2.64 |
95% CI: [-1.33, 12.68]
Secondary
Volume of Distribution of Mepolizumab 750 mg
Volume of distribution at steady-state was derived from pharmacokinetic parameter estimates of a population pharmacokinetic model. Blood samples were collected for analysis of volume of distribution at Weeks 1, 2, 5, 9, 13, and 25. All available concentrations at all available datapoints from all participants were incorporated into the model. Individual values were estimated from the model as post-hoc values after incorporating between-participant variability.
Time frame: Weeks 1, 2, 5, 9, 13, and 25
Population: PK Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mepolizumab 750 mg | Volume of Distribution of Mepolizumab 750 mg | 8.387 Liters | Standard Deviation 2.0062 |