Drug Trials Snapshot: Cinqair
HOW TO USE THIS SNAPSHOT:
The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.
LIMITATIONS OF THIS SNAPSHOT:
Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to CINQAIR Prescribing Information for complete information.
CINQAIR (reslizumab)
sink-ayr’
Teva Pharmaceuticals
Approval date: March 23, 2016
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
CINQAIR is a drug for the treatment of specific type of severe asthma (called eosinophilic phenotype asthma) in adults whose asthma is not well controlled with current medications. CINQUAR is to be used in addition to asthma maintenance medications.
How is this drug used?
CINQAIR is given by a healthcare provider using a needle placed in a vein (known as intravenous infusion) one time every 4 weeks. It takes about 20 to 50 minutes to receive the full dose of CINQAIR.
What are the benefits of this drug?
Patients taking CINQAIR had fewer episodes of asthma attacks and an improved air flow through the lungs.
What are the benefits of this drug (results of trials used to assess efficacy)?
The tables below summarize efficacy results for the clinical trials.
Table 2. Frequency of Asthma Exacerbations during the 52-Week Treatment Period in Patients with Severe Asthma with an Eosinophilic Phenotype (Trials I and II)a
Treatment Arm | Asthma Exacerbation Rate | Rate Ratio (95% CI) |
|
---|---|---|---|
All exacerbations | |||
Trial I | CINQAIR 3 mg/kg (n=245) | 0.90 | 0.5 (0.37, 0.67) |
Placebo (n=244) | 1.80 | ||
Trial II | CINQAIR 3 mg/kg (n=232) | 0.86 | 0.41 (0.28, 0.59) |
Placebo (n=232) | 2.11 | ||
Exacerbations requiring systemic corticosteroid use | |||
Trial I | CINQAIR 3 mg/kg (n=245) | 0.72 | 0.45 (0.33, 0.62) |
Placebo (n=244) | 1.60 | ||
Trial II | CINQAIR 3 mg/kg (n=232) | 0.65 | 0.39 (0.27, 0.58) |
Placebo(n=232) | 1.66 | ||
Exacerbations resulting in a hospitalization AND/OR emergency room visit | |||
Trial I | CINQAIR 3 mg/kg (n=245) | 0.14 | 0.66 (0.32, 1.36) |
Placebo(n=244) | 0.21 | ||
Trial II | CINQAIR 3 mg/kg (n=232) | 0.03 | 0.69 (0.29, 1.65) |
Placebo (n=232) | 0.05 |
CINQAIR Prescribing Information
Table 3: Mean Change (95% CI) from Baseline in FEV1 in mL over 16 Weeks (Difference from CINQAIR and Placebo) in Patients with Severe Asthma with an Eosinophilic Phenotype
Trial | FEV1 Change in mL |
---|---|
Trial I | 137 (76, 198) |
Trial II | 93 (30, 155) |
Trial III | 160 (60, 259) |
Trial IVa | 76 (-6,158) |
CINQAIR Prescribing Information
Were there any differences in how well the drug worked in clinical trials among sex, race, and age?
- Sex: CINQAIR worked similarly in men and women.
- Race: CINQAIR worked similarly among races studied.
- Age: CINQAIR worked similarly in patients below and above 65 years of age.
Were there any differences in how well the drug worked in clinical trials among sex, race, and age groups?
The figures below summarize efficacy results by subgroup.
Figure 4. Clinical Asthma Exacerbation Rate for CINQAIR vs. Placebo by Subgroup
FDA Clinical review
Figure 5. Mean Difference in FEV1 for CINQAIR vs. Placebo by Subgroup FDA Clinical review
What are the possible side effects?
The most common side effect of CINQAIR is throat pain.
CINQAIR may cause serious side effects, including cancer and a life threatening allergic reaction called anaphylaxis.
What are the possible side effects (results of trials used to assess safety)?
The table below summarizes adverse reactions that occurred in at least 2% of patients and more frequently for CINQAIR in pooled placebo-controlled trials in patients with severe asthma.
Table 4. Adverse Reactions in Patients with Severe Asthma
Adverse Reactions | Placebo (N=730) n (%) |
CINQAIR (N=1028) n (%) |
---|---|---|
Oropharyngeal pain | 16 (2.2%) | 27 (2.6%) |
Were there any differences in side effects among sex, race, and age?
The total number of patients who had side effects was low and differences by age, sex, and race could not be determined.
Were there any differences in side effects of the clinical trials among sex, race, and age groups?
Due to overall low frequency of side effects in the trials, differences by age, sex, race could not be assessed.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved CINQAIR based mainly on the evidence from four clinical trials of 1758 patients with severe asthma. The trials were conducted in the USA, Canada, Europe, Russia, Israel, Mexico, Argentina, Brazil, Peru, Chile, Columbia, Philippines, South Africa, Korea, Taiwan, and Australia.
The figure below summarizes how many men and women were in the clinical trials.
Figure 1. Baseline Demographics by Sex
Clinical trial data
Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.
Figure 2. Baseline Demographics by Race
Clinical trial data
Table 1. Baseline Demographics by Race
Race | Number of Patients | Percentage |
---|---|---|
White | 1278 | 73 |
Black or African American | 206 | 12 |
Asian | 136 | 8 |
American Indian or Alaskan Native | 16 | less than 1 |
Pacific Islander | 5 | less than 1 |
Other | 117 | 7 |
Clinical trial data
Figure 3 summarizes the percentage of patients by age in the clinical trials.
Figure 3. Baseline Demographics by Age Clinical trial data
Who participated in the trials?
The table below summarizes demographics of patients in the clinical trials.
Table 5. Baseline Demographics of Patients in the Clinical Trials (safety population)
Placebo (N=730) n (%) |
CINQAIR (N=1028) n (%) |
Total (N=1758) n (%) |
|
---|---|---|---|
Age group | |||
65> | 674 (92) | 984(96) | 1658(94) |
≥65 years | 56 (8) | 44 (4) | 100 (6) |
Sex | |||
Male | 276 (38) | 388 (38) | 664 (38) |
Female | 454 (62) | 640 (62) | 1094(62) |
Race Group | |||
White | 549 (75) | 729 (71) | 1278 (73) |
Black or African American | 61 (8) | 145 (14) | 206(12) |
Asian | 57 (8) | 79 (8) | 136 (8) |
American Indian or Alaskan Native | 6 (> | 10 (> | 16 (> |
Pacific Islander | 4(> | 1(> | 5(> |
Other | 53 (7) | 64 (6) | 117 (7) |
Geographic Region | |||
U.S. | 224 (31) | 517 (50) | 741(42) |
Europe | 260 (36) | 237 (23) | 497 (28) |
Other | 246 (34) | 274(27) | 520 (30) |
How were the trials designed?
The benefit and side effects of CINQAIR were evaluated in four clinical trials of patients with severe asthma and increased eosinophilic white cells in blood. All patients were taking their usual treatments for asthma. In addition, patients received new treatment with either CINQAIR or placebo for 16-52 weeks. Neither the patients nor the health care providers knew which new treatment was being given until after the trial was completed.
The benefit of CINQAIR was evaluated by measuring the frequency of asthma attacks (exacerbations) and improvement in lung function called FEV1 (forced expiratory volume in one second).
How were the trials designed?
The safety and efficacy of CINQAIR were established in 4 randomized, double-blind, placebo-controlled trials 16 to 52 weeks in duration. All patients had elevated blood eosinophil count and continued their background asthma therapy throughout the duration of the trials.
The efficacy outcome measure in Trials 1 and 2 was the frequency of asthma exacerbations for each patient during the 52-week treatment period. The primary outcome for Trials 3 and 4 was the FEV1 over 16 weeks.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.