Trial Outcomes & Findings for Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma (NCT NCT01290887)

NCT ID: NCT01290887

Last Updated: 2016-06-06

Results Overview

An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1052 participants
• Primary outcome timeframe: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
• Results posted on: 2016-06-06

Participant Flow

A total of 1052 patients with eosinophilic asthma at 201 centers in 30 countries were enrolled in this study.

Four hundred-eighty (46%) patients received reslizumab for the first time in Study 3085, having previously received placebo in Studies 3081, 3082, or 3083.

Participant milestones

Measure	Previous Placebo-Treated Subpopulation The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Overall Study STARTED	481	571
Overall Study Safety Analysis Set	480	571
Overall Study COMPLETED	15	35
Overall Study NOT COMPLETED	466	536

Reasons for withdrawal

Measure	Previous Placebo-Treated Subpopulation The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
Overall Study Adverse Event	6	11
Overall Study Lack of Efficacy	4	5
Overall Study Withdrawal by Subject	26	32
Overall Study Protocol Violation	2	1
Overall Study Lost to Follow-up	4	4
Overall Study Non-compliance to study procedures	0	1
Overall Study Non-compliance to study medications	1	0
Overall Study Sponsor closure of study	420	476
Overall Study Other	3	6

Baseline Characteristics

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Baseline characteristics by cohort

Measure	Previous Placebo-Treated Subpopulation n=481 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Total n=1052 Participants Total of all reporting groups
Forced Expiratory Volume in 1 Second (FEV1)	2.096 liters STANDARD_DEVIATION 0.7856 • n=93 Participants	2.285 liters STANDARD_DEVIATION 0.8222 • n=4 Participants	2.199 liters STANDARD_DEVIATION 0.8108 • n=27 Participants
% Predicted Expiratory Volume In 1 Second	70.739 percentage of predicted FEV1 STANDARD_DEVIATION 19.7560 • n=93 Participants	75.116 percentage of predicted FEV1 STANDARD_DEVIATION 19.9404 • n=4 Participants	73.115 percentage of predicted FEV1 STANDARD_DEVIATION 19.9664 • n=27 Participants
Forced Vital Capacity (FVC)	3.163 liters STANDARD_DEVIATION 1.0357 • n=93 Participants	3.366 liters STANDARD_DEVIATION 1.0779 • n=4 Participants	3.273 liters STANDARD_DEVIATION 1.0632 • n=27 Participants
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%)	1.467 liters/second STANDARD_DEVIATION 0.8890 • n=93 Participants	1.634 liters/second STANDARD_DEVIATION 0.9045 • n=4 Participants	1.558 liters/second STANDARD_DEVIATION 0.9009 • n=27 Participants
Age, Continuous	47.4 years STANDARD_DEVIATION 14.53 • n=93 Participants	47.1 years STANDARD_DEVIATION 13.58 • n=4 Participants	47.2 years STANDARD_DEVIATION 14.02 • n=27 Participants
Sex: Female, Male Female	314 Participants n=93 Participants	332 Participants n=4 Participants	646 Participants n=27 Participants
Sex: Female, Male Male	167 Participants n=93 Participants	239 Participants n=4 Participants	406 Participants n=27 Participants
Race/Ethnicity, Customized White	371 participants n=93 Participants	437 participants n=4 Participants	808 participants n=27 Participants
Race/Ethnicity, Customized Black	22 participants n=93 Participants	22 participants n=4 Participants	44 participants n=27 Participants
Race/Ethnicity, Customized Asian	39 participants n=93 Participants	48 participants n=4 Participants	87 participants n=27 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	4 participants n=93 Participants	6 participants n=4 Participants	10 participants n=27 Participants
Race/Ethnicity, Customized Pacific Islander	1 participants n=93 Participants	1 participants n=4 Participants	2 participants n=27 Participants
Race/Ethnicity, Customized Other	44 participants n=93 Participants	57 participants n=4 Participants	101 participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	83 participants n=93 Participants	118 participants n=4 Participants	201 participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic or Latino	187 participants n=93 Participants	178 participants n=4 Participants	365 participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic and non-Latino	208 participants n=93 Participants	272 participants n=4 Participants	480 participants n=27 Participants
Race/Ethnicity, Customized Unknown	3 participants n=93 Participants	3 participants n=4 Participants	6 participants n=27 Participants
Weight	75.4 kg STANDARD_DEVIATION 16.67 • n=93 Participants	76.5 kg STANDARD_DEVIATION 17.85 • n=4 Participants	76.0 kg STANDARD_DEVIATION 17.32 • n=27 Participants
Height	165.3 cm STANDARD_DEVIATION 10.03 • n=93 Participants	166.0 cm STANDARD_DEVIATION 9.96 • n=4 Participants	165.7 cm STANDARD_DEVIATION 9.99 • n=27 Participants
Body Mass Index	27.6 kg/m^2 STANDARD_DEVIATION 5.42 • n=93 Participants	27.7 kg/m^2 STANDARD_DEVIATION 6.04 • n=4 Participants	27.7 kg/m^2 STANDARD_DEVIATION 5.77 • n=27 Participants
Asthma Control Questionnaire (ACQ)	1.832 units on a scale STANDARD_DEVIATION 1.0912 • n=93 Participants	1.450 units on a scale STANDARD_DEVIATION 0.9870 • n=4 Participants	1.624 units on a scale STANDARD_DEVIATION 1.0527 • n=27 Participants
Asthma Quality of Life Questionnaire (AQLQ)	5.170 units on a scale STANDARD_DEVIATION 1.2160 • n=93 Participants	5.496 units on a scale STANDARD_DEVIATION 1.1431 • n=4 Participants	5.347 units on a scale STANDARD_DEVIATION 1.1875 • n=27 Participants
Asthma Symptom Utility Index (ASUI)	0.803 units on a scale STANDARD_DEVIATION 0.1910 • n=93 Participants	0.861 units on a scale STANDARD_DEVIATION 0.1479 • n=4 Participants	0.832 units on a scale STANDARD_DEVIATION 0.1728 • n=27 Participants
Blood Eosinophil Count	0.528 10^9 blood eosinophil/L STANDARD_DEVIATION 0.3792 • n=93 Participants	0.078 10^9 blood eosinophil/L STANDARD_DEVIATION 0.1480 • n=4 Participants	0.284 10^9 blood eosinophil/L STANDARD_DEVIATION 0.3577 • n=27 Participants
Used Beta Agonist in Past 3 Days Yes	300 participants n=93 Participants	297 participants n=4 Participants	597 participants n=27 Participants
Used Beta Agonist in Past 3 Days No	180 participants n=93 Participants	274 participants n=4 Participants	454 participants n=27 Participants
Daily average number of puffs in past 3 days	2.130 puffs/day STANDARD_DEVIATION 2.4996 • n=93 Participants	1.568 puffs/day STANDARD_DEVIATION 2.3982 • n=4 Participants	1.827 puffs/day STANDARD_DEVIATION 2.4604 • n=27 Participants

PRIMARY outcome

Timeframe: Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

Population: Safety analysis set

An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Participants With Treatment-Emergent Adverse Events At least 1 AE	359 participants	385 participants	744 participants
Participants With Treatment-Emergent Adverse Events Severe AE	31 participants	47 participants	78 participants
Participants With Treatment-Emergent Adverse Events Treatment-related AE	49 participants	41 participants	90 participants
Participants With Treatment-Emergent Adverse Events AE causing patient discontinuation	6 participants	12 participants	18 participants
Participants With Treatment-Emergent Adverse Events Serious AE	33 participants	45 participants	78 participants
Participants With Treatment-Emergent Adverse Events Death	1 participants	2 participants	3 participants
Participants With Treatment-Emergent Adverse Events AE up to follow-up period	344 participants	367 participants	711 participants
Participants With Treatment-Emergent Adverse Events AE during follow-up period	78 participants	82 participants	160 participants

PRIMARY outcome

Timeframe: Weeks 4, 8, 24 and 48

Population: Safety analysis set, including participants who contributed to the analysis

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses.

Significance criteria:

• Blood urea nitrogen: >=10.71 mmol/L
• Creatinine: >=177 μmol/L
• Uric acid: M>=625, F>=506 μmol/L
• Aspartate aminotransferase: >=3*upper limit of normal (ULN). Normal range is 10-43 U/L
• Alanine aminotransferase: >=3*ULN. Normal range is 10-40 U/L
• GGT = gamma-glutamyl transpeptidase: >= 3*upper limit of normal. Normal range is 5-49 U/L.
• Total bilirubin: >=34.2 μmol/L
• White blood cells- low: <=3.0*10^9/L
• White blood cells-high: >=20*10^9/L
• Hemoglobin: M<=115, F<=95 g/dL
• Hematocrit: M<0.37, F<0.32 L/L
• Platelets: >=700*10^9/L
• Absolute neutrophil count: <=1.0*10^9/L
• Eosinophils: >=10
• Urinalysis: ketones, blood, glucose, and total protein: >=2 unit increase from baseline

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=477 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=567 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1044 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Blood urea nitrogen	13 participants	10 participants	23 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Creatinine	3 participants	2 participants	5 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Uric acid	8 participants	5 participants	13 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Aspartate aminotransferase	6 participants	5 participants	11 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Alanine aminotransferase	7 participants	7 participants	14 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values GGT	24 participants	15 participants	39 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Total bilirubin	3 participants	3 participants	6 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values White blood cells- low	10 participants	8 participants	18 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values White blood cells- high	2 participants	1 participants	3 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Hemoglobin	10 participants	9 participants	19 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Hematocrit	13 participants	13 participants	26 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Platelets	1 participants	1 participants	2 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Absolute neutrophil count	7 participants	7 participants	14 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Eosinophils	24 participants	27 participants	51 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Ketones in urine	15 participants	9 participants	24 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Blood (hemaglobin) in urine	52 participants	55 participants	107 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Glucose in urine	22 participants	32 participants	54 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values Total protein in urine	71 participants	85 participants	156 participants

PRIMARY outcome

Timeframe: Week 4 to Week 65

Population: Safety analysis set, including participants who contributed to the analysis

Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit.

Significance criteria

• Sitting heart rate-high: >100 and increase of >= 30 beats/min (all ages)
• Sitting heart rate-low: <50 and decrease of >=30 beats/min
• Sitting systolic blood pressure (BP)-high: >130 and increase of >=30 mmHg (ages 12-17)
• Systolic BP-low: <90 and decrease of >=30 mmHg (ages >=18)
• Systolic BP-high: >160 and increase of >=30 mmHg (ages >=18)
• Sitting diastolic BP-low: <55 and decrease of >=12 mmHg (ages 12-17)
• Diastolic BP-high: >85 and increase of >=12 mmHg (ages 12-17)
• Diastolic BP-low: <50 and decrease of >=12 mmHg (ages >=18)
• Diastolic BP-high: >100 and increase of >=12 mmHg (ages >=18)
• Respiration rate: >20 and increase of >=10 breaths/minute (ages 12-17)
• Respiration rate: >24 and increase of >=10 breaths/minute (ages >=18)
• Body temperature-low: <96.5° Fahrenheit (all ages)
• Body temp-high: >100.5° F (all ages)

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=478 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=569 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1047 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Heart rate - high (ages 12-17)	1 participants	2 participants	3 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Heart rate - low (ages >=18)	2 participants	1 participants	3 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Heart rate - high (ages >=18)	8 participants	8 participants	16 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Systolic BP - high (ages 12-17)	0 participants	1 participants	1 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Systolic BP - low (ages >=18)	1 participants	0 participants	1 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Systolic BP - high (ages >=18)	8 participants	8 participants	16 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Diastolic BP - low (ages 12-17)	1 participants	1 participants	2 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Diastolic BP - high (ages 12-17)	2 participants	1 participants	3 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Diastolic BP - low (ages >=18)	2 participants	4 participants	6 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Diastolic - high (ages >=18)	13 participants	12 participants	25 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Respiration rate - high (ages 12-17)	0 participants	1 participants	1 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Respiration rate - high (ages >=18)	6 participants	2 participants	8 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Body temperature - low (ages 12-17)	3 participants	3 participants	6 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Body temperature - high (ages 12-17)	0 participants	1 participants	1 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Body temperature - low (ages >=18)	102 participants	121 participants	223 participants
Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values Body temperature - high (ages >=18)	3 participants	1 participants	4 participants

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=478, 569, 1047)	2.174 liters Standard Deviation 0.7798	2.273 liters Standard Deviation 0.8127	2.228 liters Standard Deviation 0.7989
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=457, 552, 1009)	2.155 liters Standard Deviation 0.7636	2.277 liters Standard Deviation 0.7999	2.222 liters Standard Deviation 0.7857
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=437, 518, 955)	2.162 liters Standard Deviation 0.7966	2.270 liters Standard Deviation 0.8179	2.220 liters Standard Deviation 0.8096
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=426, 499, 925)	2.171 liters Standard Deviation 0.7690	2.267 liters Standard Deviation 0.8114	2.223 liters Standard Deviation 0.7932
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=418, 488, 906)	2.169 liters Standard Deviation 0.7761	2.267 liters Standard Deviation 0.8101	2.222 liters Standard Deviation 0.7957
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=386, 458, 844)	2.188 liters Standard Deviation 0.7966	2.289 liters Standard Deviation 0.8032	2.243 liters Standard Deviation 0.8013
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=291, 354, 645)	2.234 liters Standard Deviation 0.8240	2.278 liters Standard Deviation 0.8133	2.258 liters Standard Deviation 0.8178
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=198, 250, 448)	2.167 liters Standard Deviation 0.7905	2.336 liters Standard Deviation 0.8189	2.261 liters Standard Deviation 0.8099
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=101, 143, 244)	2.234 liters Standard Deviation 0.9214	2.360 liters Standard Deviation 0.8292	2.308 liters Standard Deviation 0.8689
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	2.424 liters Standard Deviation 0.9093	2.367 liters Standard Deviation 0.8150	2.387 liters Standard Deviation 0.8466
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 88, 133)	2.496 liters Standard Deviation 0.8496	2.384 liters Standard Deviation 0.8411	2.422 liters Standard Deviation 0.8425
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	2.748 liters Standard Deviation 0.8963	2.383 liters Standard Deviation 0.7737	2.505 liters Standard Deviation 0.8283
Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 54, 82)	2.505 liters Standard Deviation 0.9386	2.237 liters Standard Deviation 0.8736	2.329 liters Standard Deviation 0.8997

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The percent predicted FEV1 is the ratio of the volume of air expired in the first second of a forced expiration to the patient's predicted FEV based on a similar population without asthma. Percent predicted lung function values were transcribed directly from the lung function report to the CRF, without any calculation by Teva.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=457, 552, 1009)	73.295 percentage of predicted FEV1 Standard Deviation 19.7933	74.808 percentage of predicted FEV1 Standard Deviation 19.1560	74.123 percentage of predicted FEV1 Standard Deviation 19.4521
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=437, 518, 955)	73.056 percentage of predicted FEV1 Standard Deviation 19.9848	74.765 percentage of predicted FEV1 Standard Deviation 20.3570	73.983 percentage of predicted FEV1 Standard Deviation 20.1949
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=426, 499, 925)	73.797 percentage of predicted FEV1 Standard Deviation 19.2586	74.690 percentage of predicted FEV1 Standard Deviation 19.8973	74.279 percentage of predicted FEV1 Standard Deviation 19.6002
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=418, 488, 906)	73.797 percentage of predicted FEV1 Standard Deviation 19.5962	74.668 percentage of predicted FEV1 Standard Deviation 20.2025	74.266 percentage of predicted FEV1 Standard Deviation 19.9188
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=386, 458, 844)	74.284 percentage of predicted FEV1 Standard Deviation 19.5601	75.208 percentage of predicted FEV1 Standard Deviation 19.9621	74.785 percentage of predicted FEV1 Standard Deviation 19.7729
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=291, 354, 645)	74.805 percentage of predicted FEV1 Standard Deviation 20.5634	75.487 percentage of predicted FEV1 Standard Deviation 20.4589	75.179 percentage of predicted FEV1 Standard Deviation 20.4930
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=198, 250, 448)	73.654 percentage of predicted FEV1 Standard Deviation 19.9535	76.627 percentage of predicted FEV1 Standard Deviation 19.8890	75.313 percentage of predicted FEV1 Standard Deviation 19.9500
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=101, 143, 244)	74.511 percentage of predicted FEV1 Standard Deviation 22.5211	76.613 percentage of predicted FEV1 Standard Deviation 20.2416	75.743 percentage of predicted FEV1 Standard Deviation 21.1950
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	76.856 percentage of predicted FEV1 Standard Deviation 20.1821	76.812 percentage of predicted FEV1 Standard Deviation 17.1937	76.827 percentage of predicted FEV1 Standard Deviation 18.2256
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 88, 133)	79.017 percentage of predicted FEV1 Standard Deviation 18.5149	77.945 percentage of predicted FEV1 Standard Deviation 18.4383	78.308 percentage of predicted FEV1 Standard Deviation 18.4011
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	83.245 percentage of predicted FEV1 Standard Deviation 14.9074	76.746 percentage of predicted FEV1 Standard Deviation 16.2345	78.912 percentage of predicted FEV1 Standard Deviation 15.9949
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 54, 82)	79.672 percentage of predicted FEV1 Standard Deviation 18.6997	70.633 percentage of predicted FEV1 Standard Deviation 20.2554	73.719 percentage of predicted FEV1 Standard Deviation 20.0902
Percent Predicted Forced Expiratory Volume In 1 Second (% Predicted FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=478, 569, 1047)	74.195 percentage of predicted FEV1 Standard Deviation 19.8134	75.107 percentage of predicted FEV1 Standard Deviation 19.8530	74.690 percentage of predicted FEV1 Standard Deviation 19.8307

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The FVC is the volume of air that can be forcibly blown out after full inspiration, measured in liters.

.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=457, 552, 1009)	3.222 liters Standard Deviation 0.9929	3.372 liters Standard Deviation 1.0619	3.304 liters Standard Deviation 1.0334
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=437, 518, 955)	3.226 liters Standard Deviation 1.0228	3.358 liters Standard Deviation 1.0836	3.297 liters Standard Deviation 1.0577
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=426, 499, 925)	3.238 liters Standard Deviation 0.9788	3.339 liters Standard Deviation 1.0584	3.292 liters Standard Deviation 1.0232
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=418, 488, 906)	3.238 liters Standard Deviation 0.9949	3.349 liters Standard Deviation 1.0835	3.298 liters Standard Deviation 1.0444
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=386, 458, 844)	3.233 liters Standard Deviation 1.0095	3.369 liters Standard Deviation 1.0709	3.307 liters Standard Deviation 1.0449
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=291, 353, 644)	3.324 liters Standard Deviation 1.0571	3.346 liters Standard Deviation 1.0416	3.336 liters Standard Deviation 1.0479
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=198, 250, 448)	3.229 liters Standard Deviation 1.0334	3.414 liters Standard Deviation 1.0348	3.332 liters Standard Deviation 1.0371
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=101, 143, 244)	3.323 liters Standard Deviation 1.1874	3.422 liters Standard Deviation 1.0428	3.381 liters Standard Deviation 1.1037
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	3.500 liters Standard Deviation 1.1839	3.398 liters Standard Deviation 1.0795	3.434 liters Standard Deviation 1.1143
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 88, 133)	3.606 liters Standard Deviation 1.1403	3.406 liters Standard Deviation 1.1535	3.474 liters Standard Deviation 1.1487
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	3.849 liters Standard Deviation 1.2342	3.381 liters Standard Deviation 1.1145	3.537 liters Standard Deviation 1.1680
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 54, 82)	3.524 liters Standard Deviation 1.1842	3.321 liters Standard Deviation 1.2443	3.390 liters Standard Deviation 1.2206
Forced Vital Capacity (FVC) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=478, 569, 1047)	3.250 liters Standard Deviation 1.0194	3.355 liters Standard Deviation 1.0675	3.307 liters Standard Deviation 1.0466

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The FEF 25%-75% is the force expiratory flow at 25% to 75% of the Forced Vital Capacity (FVC), measured in liters/second

.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=446, 545, 991)	1.558 liters/second Standard Deviation 0.9363	1.614 liters/second Standard Deviation 0.9055	1.589 liters/second Standard Deviation 0.9195
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=429, 513, 942)	1.546 liters/second Standard Deviation 0.9279	1.618 liters/second Standard Deviation 0.9255	1.585 liters/second Standard Deviation 0.9268
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=418, 494, 912)	1.587 liters/second Standard Deviation 0.9833	1.624 liters/second Standard Deviation 0.9367	1.607 liters/second Standard Deviation 0.9580
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=408, 483, 891)	1.561 liters/second Standard Deviation 0.9427	1.620 liters/second Standard Deviation 0.9068	1.593 liters/second Standard Deviation 0.9234
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=377, 453, 830)	1.619 liters/second Standard Deviation 0.9967	1.637 liters/second Standard Deviation 0.9227	1.629 liters/second Standard Deviation 0.9565
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=285, 349, 634)	1.642 liters/second Standard Deviation 1.1087	1.650 liters/second Standard Deviation 0.9193	1.646 liters/second Standard Deviation 1.0080
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=191, 249, 440)	1.628 liters/second Standard Deviation 1.0408	1.691 liters/second Standard Deviation 0.9450	1.664 liters/second Standard Deviation 0.9871
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=99, 143, 242)	1.605 liters/second Standard Deviation 1.0869	1.791 liters/second Standard Deviation 1.1508	1.715 liters/second Standard Deviation 1.1265
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	1.810 liters/second Standard Deviation 1.0239	1.766 liters/second Standard Deviation 1.0341	1.781 liters/second Standard Deviation 1.0276
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 88, 133)	1.848 liters/second Standard Deviation 0.9047	1.892 liters/second Standard Deviation 1.1499	1.877 liters/second Standard Deviation 1.0700
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	2.120 liters/second Standard Deviation 1.0597	1.942 liters/second Standard Deviation 1.0453	2.001 liters/second Standard Deviation 1.0457
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 54, 82)	1.939 liters/second Standard Deviation 1.1105	1.639 liters/second Standard Deviation 0.9079	1.741 liters/second Standard Deviation 0.9854
Forced Expiratory Flow at 25% to 75% Forced Vital Capacity (FEF 25%-75%) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=468, 563, 1031)	1.546 liters/second Standard Deviation 0.9041	1.629 liters/second Standard Deviation 0.9300	1.592 liters/second Standard Deviation 0.9188

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

SABA are used for quick relief of asthma symptoms. To measure SABA use, at each clinical visit participants were asked to recall their usage of SABA therapy within the last 3 days of the scheduled visit. If usage was confirmed, the number of puffs used was recorded. For the purpose of summaries, an average daily usage was evaluated by dividing the total number of puffs recorded over 3 days by 3.

.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=276, 323, 599)	2.5 # puffs/day Standard Deviation 2.42	2.4 # puffs/day Standard Deviation 2.45	2.5 # puffs/day Standard Deviation 2.43
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=258, 302, 560)	2.4 # puffs/day Standard Deviation 2.28	2.4 # puffs/day Standard Deviation 2.62	2.4 # puffs/day Standard Deviation 2.46
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=251, 278, 529)	2.6 # puffs/day Standard Deviation 2.07	2.4 # puffs/day Standard Deviation 2.50	2.5 # puffs/day Standard Deviation 2.30
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=244, 261, 505)	2.5 # puffs/day Standard Deviation 2.30	2.2 # puffs/day Standard Deviation 2.29	2.4 # puffs/day Standard Deviation 2.30
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=211, 243, 454)	2.6 # puffs/day Standard Deviation 2.55	2.3 # puffs/day Standard Deviation 2.46	2.4 # puffs/day Standard Deviation 2.51
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=160, 174, 334)	2.4 # puffs/day Standard Deviation 2.27	2.3 # puffs/day Standard Deviation 2.64	2.3 # puffs/day Standard Deviation 2.47
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=111, 121, 232)	2.2 # puffs/day Standard Deviation 2.28	2.4 # puffs/day Standard Deviation 2.54	2.3 # puffs/day Standard Deviation 2.42
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=50, 64, 114)	2.1 # puffs/day Standard Deviation 2.19	2.5 # puffs/day Standard Deviation 3.30	2.3 # puffs/day Standard Deviation 2.86
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=29, 47, 76)	2.1 # puffs/day Standard Deviation 2.19	1.8 # puffs/day Standard Deviation 1.88	1.9 # puffs/day Standard Deviation 1.99
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=19, 35, 54)	2.0 # puffs/day Standard Deviation 1.57	2.4 # puffs/day Standard Deviation 2.38	2.2 # puffs/day Standard Deviation 2.12
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=14, 26, 40)	1.8 # puffs/day Standard Deviation 1.41	1.7 # puffs/day Standard Deviation 1.57	1.8 # puffs/day Standard Deviation 1.50
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=16, 23, 39)	2.1 # puffs/day Standard Deviation 1.76	2.7 # puffs/day Standard Deviation 1.99	2.4 # puffs/day Standard Deviation 1.90
Average Daily Use of Short-Acting Beta-Agonist (SABA)Therapy at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=390, 453, 843)	2.2 # puffs/day Standard Deviation 2.20	2.2 # puffs/day Standard Deviation 4.09	2.2 # puffs/day Standard Deviation 3.35

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The ASUI is an 11-item instrument designed to assess the frequency and severity of asthma symptoms and side effects, weighted by patient preferences (Revicki et al 1998). ASUI is a utility score that ranges from 0 to 1, with higher values indicating better asthma control.

.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=456, 552, 1008)	0.831 units on a scale Standard Deviation 0.1829	0.844 units on a scale Standard Deviation 0.1631	0.838 units on a scale Standard Deviation 0.1724
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=436, 514, 950)	0.843 units on a scale Standard Deviation 0.1663	0.851 units on a scale Standard Deviation 0.1596	0.847 units on a scale Standard Deviation 0.1626
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=426, 500, 926)	0.839 units on a scale Standard Deviation 0.1752	0.854 units on a scale Standard Deviation 0.1578	0.847 units on a scale Standard Deviation 0.1661
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=416, 486, 902)	0.845 units on a scale Standard Deviation 0.1690	0.856 units on a scale Standard Deviation 0.1659	0.851 units on a scale Standard Deviation 0.1673
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=386, 458, 844)	0.844 units on a scale Standard Deviation 0.1720	0.859 units on a scale Standard Deviation 0.1602	0.852 units on a scale Standard Deviation 0.1658
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=291, 354, 645)	0.844 units on a scale Standard Deviation 0.1821	0.867 units on a scale Standard Deviation 0.1536	0.857 units on a scale Standard Deviation 0.1673
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=198, 251, 449)	0.851 units on a scale Standard Deviation 0.1699	0.856 units on a scale Standard Deviation 0.1705	0.854 units on a scale Standard Deviation 0.1701
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=100, 146, 246)	0.869 units on a scale Standard Deviation 0.1573	0.865 units on a scale Standard Deviation 0.1513	0.866 units on a scale Standard Deviation 0.1534
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	0.876 units on a scale Standard Deviation 0.1346	0.858 units on a scale Standard Deviation 0.1509	0.865 units on a scale Standard Deviation 0.1453
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 87, 132)	0.884 units on a scale Standard Deviation 0.1460	0.868 units on a scale Standard Deviation 0.1541	0.873 units on a scale Standard Deviation 0.1510
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	0.822 units on a scale Standard Deviation 0.2036	0.836 units on a scale Standard Deviation 0.1729	0.832 units on a scale Standard Deviation 0.1823
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 55, 83)	0.877 units on a scale Standard Deviation 0.0979	0.840 units on a scale Standard Deviation 0.2053	0.853 units on a scale Standard Deviation 0.1767
Asthma Symptom Utility Index (ASUI) Score at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=478, 569, 1047)	0.843 units on a scale Standard Deviation 0.1679	0.850 units on a scale Standard Deviation 0.1661	0.847 units on a scale Standard Deviation 0.1669

SECONDARY outcome

Timeframe: Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, end of study and endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The ACQ is a 7-item instrument that measures asthma control (Juniper et al 1999). Six questions are self-assessments; the seventh item, completed by a member of the study staff, is the result of the patient's FEV1 measurement. Each item has 7 possible answers on a scale of 0 to 6, and the total score is the mean of all responses (the total scale is therefore 0-6). A higher score is an indication of poorer asthma control.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 4 (n=456, 552, 1008)	1.546 units on a scale Standard Deviation 1.0154	1.429 units on a scale Standard Deviation 0.9573	1.482 units on a scale Standard Deviation 0.9852
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 8 (n=437, 517, 954)	1.446 units on a scale Standard Deviation 0.9805	1.392 units on a scale Standard Deviation 0.9729	1.417 units on a scale Standard Deviation 0.9762
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 12 (n=426, 500, 926)	1.459 units on a scale Standard Deviation 1.0004	1.360 units on a scale Standard Deviation 0.9320	1.405 units on a scale Standard Deviation 0.9648
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 16 (n=416, 487, 903)	1.444 units on a scale Standard Deviation 1.0016	1.305 units on a scale Standard Deviation 0.9299	1.369 units on a scale Standard Deviation 0.9655
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 24 (n=386, 458, 844)	1.436 units on a scale Standard Deviation 1.0135	1.299 units on a scale Standard Deviation 0.9497	1.362 units on a scale Standard Deviation 0.9812
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 36 (n=291, 353, 644)	1.425 units on a scale Standard Deviation 1.0189	1.282 units on a scale Standard Deviation 0.9331	1.347 units on a scale Standard Deviation 0.9746
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 48 (n=198, 250, 448)	1.408 units on a scale Standard Deviation 0.9699	1.297 units on a scale Standard Deviation 0.9810	1.346 units on a scale Standard Deviation 0.9766
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 60 (n=100, 143, 243)	1.284 units on a scale Standard Deviation 0.9739	1.297 units on a scale Standard Deviation 0.9432	1.292 units on a scale Standard Deviation 0.9540
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 72 (n=56, 105, 161)	1.283 units on a scale Standard Deviation 0.9176	1.231 units on a scale Standard Deviation 0.8295	1.249 units on a scale Standard Deviation 0.8587
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 84 (n=45, 87, 132)	1.143 units on a scale Standard Deviation 0.9020	1.209 units on a scale Standard Deviation 0.9186	1.186 units on a scale Standard Deviation 0.9100
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	1.323 units on a scale Standard Deviation 0.9862	1.391 units on a scale Standard Deviation 0.9559	1.369 units on a scale Standard Deviation 0.9594
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint End of study (n=28, 54, 82)	1.061 units on a scale Standard Deviation 0.7653	1.437 units on a scale Standard Deviation 0.9750	1.308 units on a scale Standard Deviation 0.9216
Asthma Control Questionnaire (ACQ) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint Endpoint (n=478, 569, 1047)	1.450 units on a scale Standard Deviation 0.9901	1.389 units on a scale Standard Deviation 0.9637	1.417 units on a scale Standard Deviation 0.9759

SECONDARY outcome

Timeframe: Weeks 24, 48, 72, 96, End of Study and Endpoint

Population: Safety analysis set of participants with assessments at stated timeframes

The AQLQ is a 32-item instrument administered as a self-assessment (Juniper et al 1992). The questionnaire is divided into 4 domains: activity limitation, symptoms, emotional function, and environmental stimuli. Patients were asked to recall their experiences during the last 2 weeks and to respond to each question on a 7-point scale (1=severe impairment, 7=no impairment). The overall AQLQ score is the mean of all 32 responses. Five of the activity questions were "patient-specific," which means that each patient identified and scored 5 activities in which the patient was limited by asthma; these 5 activities were identified at the first visit and retained for all subsequent follow-up visits.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg n=1051 Participants Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint Endpoint (n=472, 558, 1030)	5.535 units on a scale Standard Deviation 1.1690	5.631 units on a scale Standard Deviation 1.1334	5.587 units on a scale Standard Deviation 1.1503
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint Week 24 (n=382, 452, 834)	5.551 units on a scale Standard Deviation 1.1558	5.691 units on a scale Standard Deviation 1.0651	5.627 units on a scale Standard Deviation 1.1091
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint Week 48 (n=193, 249, 442)	5.602 units on a scale Standard Deviation 1.1180	5.725 units on a scale Standard Deviation 1.0818	5.672 units on a scale Standard Deviation 1.0982
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint Week 72 (n=56, 106, 162)	5.808 units on a scale Standard Deviation 1.0002	5.809 units on a scale Standard Deviation 1.0235	5.809 units on a scale Standard Deviation 1.0124
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint Week 96 (n=23, 46, 69)	5.585 units on a scale Standard Deviation 1.1422	5.809 units on a scale Standard Deviation 1.1340	5.734 units on a scale Standard Deviation 1.1333
Asthma Quality of Life Questionnaire (AQLQ) Total Score at Weeks 24, 48, 72, 96, End of Study and Endpoint End of study (n=28, 55, 83)	5.956 units on a scale Standard Deviation 0.9431	5.765 units on a scale Standard Deviation 1.2361	5.829 units on a scale Standard Deviation 1.1434

SECONDARY outcome

Timeframe: Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall

Population: Safety analysis set of participants with assessments at stated timeframes

Blood samples were collected for the determination of anti-drug antibody (ADAs) before study drug infusion at baseline and every 24 weeks until end of treatment visit or early withdrawal. Serum samples were analyzed by Teva (Teva Biopharmaceuticals USA, Rockville, Maryland, USA) using a validated homogeneous solution based bridging enzyme linked immune sorbent assay (Mikulsis et al 2011, Qui et al 2010). The analysis of anti-reslizumab antibody in patient serum consists of 3 tiers of assays for screening, confirmation, and titer analysis. If a participant had a treatment-emergent ADA response (ie, ADA positive at any of the postdose time points but negative at the predose time point) or if there was a treatment-boosted ADA response (defined as a greater than 4-fold increase from a positive baseline ADA response (Shankar et at 2014), the participant was classified as overall ADA positive.

Predose samples for the reslizumab-experienced participants came from the previous studies.

Outcome measures

Measure	Previous Placebo-Treated Subpopulation n=480 Participants The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Previous Reslizumab-Treated Subpopulation n=571 Participants The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.	Reslizumab 3.0 mg/kg Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Overall (n=466, 548)	24 participants	25 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Baseline (n=442, 541)	16 participants	24 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Week 24 (n=382, 445)	12 participants	13 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Week 48 (n=187, 247)	9 participants	7 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Week 72 (n=56, 104)	4 participants	4 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Week 96 (n=24, 48)	3 participants	1 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall End of study (n=142, 52)	4 participants	1 participants	—
Participants With a Positive Anti-Reslizumab Antibody Status at Baseline, Weeks 24, 48, 72, 96, End of Study, Endpoint and Overall Endpoint (n=466, 545)	12 participants	17 participants	—

Adverse Events

Reslizumab 3.0 mg/kg

Serious events: 78 serious events

Other events: 519 other events

Deaths: 0 deaths

Serious adverse events

Measure	Reslizumab 3.0 mg/kg n=1051 participants at risk Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Cardiac disorders Acute myocardial infarction	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Cardiac arrest	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Cardiac failure	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Cardio-respiratory arrest	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Coronary artery occlusion	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Coronary artery stenosis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Myocardial infarction	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Tachycardia	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Cardiac disorders Ventricular extrasystoles	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Eye disorders Amaurosis fugax	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Gastrointestinal disorders Megacolon	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Gastrointestinal disorders Pancreatitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Gastrointestinal disorders Pneumoperitoneum	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Gastrointestinal disorders Small intestinal obstruction	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Gastrointestinal disorders Umbilical hernia	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
General disorders Adverse drug reaction	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
General disorders Chest pain	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
General disorders Hernia	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
General disorders Suprapubic pain	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Hepatobiliary disorders Cholangitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Hepatobiliary disorders Cholecystitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Hepatobiliary disorders Cholelithiasis	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Appendicitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Bronchitis pneumococcal	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Cellulitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Diverticulitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Infectious pleural effusion	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Infective exacerbation of bronchiectasis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Lower respiratory tract infection	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Mastoiditis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Otitis media acute	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Peritonitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Pneumonia	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Sinusitis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Upper respiratory tract infection	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Urinary tract infection	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Wound infection	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Contusion	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Hand fracture	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Hip fracture	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Lower limb fracture	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Skull fractured base	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Spinal compression fracture	0.10% 1/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Injury, poisoning and procedural complications Tibia fracture	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Investigations Liver function test abnormal	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Metabolism and nutrition disorders Diabetes mellitus	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Metabolism and nutrition disorders Gout	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.10% 1/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Borderline ovarian tumour	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.29% 3/1051 • Number of events 3 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.19% 2/1051 • Number of events 3 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Nervous system disorders Carpal tunnel syndrome	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Nervous system disorders Nervous system disorder	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Nervous system disorders Transient ischaemic attack	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Psychiatric disorders Aggression	0.10% 1/1051 • Number of events 4 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Psychiatric disorders Suicide attempt	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Renal and urinary disorders Stress urinary incontinence	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Renal and urinary disorders Urethral stenosis	0.10% 1/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Reproductive system and breast disorders Endometrial hyperplasia	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Asthma	1.7% 18/1051 • Number of events 24 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 1/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Skin and subcutaneous tissue disorders Actinic keratosis	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Skin and subcutaneous tissue disorders Drug eruption	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Vascular disorders Hypovolaemic shock	0.19% 2/1051 • Number of events 2 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Vascular disorders Shock haemorrhagic	0.10% 1/1051 • Number of events 1 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

Other adverse events

Measure	Reslizumab 3.0 mg/kg n=1051 participants at risk Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
Infections and infestations Bronchitis	5.9% 62/1051 • Number of events 77 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Nasopharyngitis	14.3% 150/1051 • Number of events 226 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Sinusitis	7.3% 77/1051 • Number of events 114 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Infections and infestations Upper respiratory tract infection	10.2% 107/1051 • Number of events 141 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Nervous system disorders Headache	6.9% 73/1051 • Number of events 106 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Asthma	28.6% 301/1051 • Number of events 563 • Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

Additional Information

Director, Clinical Research

Teva Branded Pharmaceutical Products, R&D Inc.

Phone: 215-591-3000

Email: ustevatrials@tevapharm.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
• Publication restrictions are in place

Restriction type: OTHER