The primary objective of the study is to determine the ability of reslizumab administered by subcutaneous injection to produce a corticosteroid-sparing effect in patients with oral corticosteroid (OCS)-dependent asthma and elevated blood eosinophils, without loss of asthma control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
177
Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
Participants continue using their non-OCS background asthma medications without change during the study's treatment period.
Number of Participants With Reduction In Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 As Compared to the Optimized Dose At Baseline
The primary endpoint was the 5-level categorized percent reduction in OCS dose during weeks 20 to 24 compared with the optimized dose at baseline. The primary analysis incorporated data from all randomized patients. Analysis of the primary and secondary variables related to categorical OCS dose reduction incorporated missing data as non-responders. No decrease indicates there was no decrease in OCS, loss of baseline asthma control during weeks 20 to 24, or discontinuation from study drug.
Time frame: Baseline (Day 1), Weeks 20-24
Percentage of Participants Achieving a >=50% Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
Percentage of patients whose OCS dose at weeks 20-24 was reduced \>=50% compared to baseline while maintaining asthma control. Patients listed as "no" did not achieve the 50% reduction in baseline OCS dose goal, or did achieve that goal but lost asthma control during weeks 20 to 24, or discontinued from study drug.
Time frame: Baseline (Day 1), Weeks 20-24
Percentage of Participants Achieving an OCS Dose of <=5 mg at Weeks 20-24 While Maintaining Asthma Control
Percentage of participants whose OCS dose at weeks 20-24 was \<=5 mg and they maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose \> 5 mg, or whose OCS dose was \<=5 mg at weeks 20-24 but did not maintain asthma control, or they discontinued from study drug.
Time frame: Weeks 20-24
Percent Change From Baseline in Daily Oral Corticosteroid (OCS) Dose During Weeks 20-24 Using a Mixed Model for Repeated Measures
The baseline OCS dose is the prescribed optimized OCS dose following the OCS optimization period. Endpoint data are presented using an on-treatment approach. In this context, 'endpoint' was defined as the last observation obtained at a scheduled or qualified early termination visit during the treatment period. Weeks 20-24 data is included between the Week 20 dose and Week 24 for completed patients; last dose of study drug to 4 weeks after the last dose of study drug for patients who discontinued treatment early. Measurements collected outside of these defined timeframes are excluded from the analyses. The mixed model repeated measures (MMRM) included fixed effects for treatment, visit, treatment by visit interaction, age group, and OCS dose group, duration of OCS use and baseline value as covariates, and patient as a random effect. Unstructured covariance was assumed for the repeated measures.
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After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.
Teva Investigational Site 13357
Bakersfield, California, United States
Teva Investigational Site 13365
Long Beach, California, United States
Teva Investigational Site 13371
Clermont, Florida, United States
Teva Investigational Site 13351
Homestead, Florida, United States
Teva Investigational Site 13342
Kissimmee, Florida, United States
Teva Investigational Site 13344
Miami, Florida, United States
Teva Investigational Site 13372
Miami, Florida, United States
Teva Investigational Site 13354
Pembroke Pines, Florida, United States
Teva Investigational Site 13343
Saint Cloud, Florida, United States
Teva Investigational Site 13368
Sebring, Florida, United States
...and 117 more locations
Time frame: Baseline (Day 1), Weeks 20-24
Percentage of Participants Achieving a >=5 mg Reduction in OCS Dose at Weeks 20-24 Compared to Baseline While Maintaining Asthma Control
Percentage of participants whose OCS dose at weeks 20-24 was reduced by at least 5mg from baseline and maintained asthma control. Patients listed as "no" had a week 20-24 OCS dose that did not meet the threshold of a 5mg reduction, or whose OCS dose met the threshold but did not maintain asthma control, or discontinued from study drug.
Time frame: Baseline (Day 1), Weeks 20-24
Annualized Rate of Clinical Asthma Exacerbations (CAEs)
The annual exacerbation rate is based on clinical asthma exacerbations reported by the investigator in the eCRF.
Time frame: Day 1 through Week 24
Percentage of Participants Achieving an OCS Dose of 0 mg at Weeks 20-24 While Maintaining Asthma Control
Percentage of participants who discontinue use of OCS during weeks 20-24 while maintaining asthma control. Patients listed as "no" continued to use OCS during weeks 20-24, or who discontinued use of OCS during weeks 20-24 but lost control of their asthma, or discontinued from study drug.
Time frame: Weeks 20-24
Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Responses
Treatment-emergent responses were defined as a positive sample post-baseline (negative baseline) OR a titer increase of \>=4-fold relative to a positive baseline sample. Two types of antibody assay were performed, an immunogenicity status assay (ADA) and neutralizing assay (NAb). The ADA assay produces a positive or negative result. For samples with a positive result, a neutralizing assay was performed, which also produces a positive or negative result.
Time frame: Weeks 4, 8, 12, 24 or early withdrawal.
Participants With Adverse Events
An adverse event is any untoward medical occurrence in a patient administered a pharmaceutical product, regardless of whether it has a causal relationship with this treatment. In this study, asthma exacerbations (which are efficacy parameters) should not be recorded as adverse events unless assessed by the investigator as more severe than the patient's usual disease course. 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. Treatment-related adverse events or adverse events related to OCS use included events with missing relationship to study drug or OCS use, respectively.
Time frame: Day 1 up to Week 24 (end of treatment visit); Data were included between Day 1 and Week 24 for completed patients, and Day 1 and 4 weeks after the last dose of study drug for patients who discontinued treatment early.