Drugs

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
aRandomized patients
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)
aTrial IV studied asthma patients unselected for blood eosinophils

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

Figure summarizes efficacy results by subgroup
FDA Clinical review

Figure 5. Mean Difference in FEV1 for CINQAIR vs. Placebo by Subgroup Figure summarizes efficacy results 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%)
CINQAIR Prescribing Information

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

Pie chart summarizing how many men and women were in the clinical trials of the drug CINQAIR. In total, 664 men (38%) and 1094 women (62%) participated in the clinical trials. 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

Pie chart summarizing the percentage of patients by race in CINQAIR clinical trials. In total, 1278 Whites (72%), 206 Blacks (12%), 136 Asians (8%), and 138 all other races combined (8%) participated in the clinical trials.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 Pie charts summarizing how many individuals of certain age groups were enrolled in the CINQAIR. clinical trials. In total, 1654 were younger than 65 years (94%) and 100 participants were 65 and older(6%). 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 years 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 (<1) 10 (<1) 16 (<1)
Pacific Islander 4(<1) 1(<1) 5(<1)
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)
Clinical Trial Data

 

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.

PRESCRIBING INFORMATION

Back to Drug Trials Snapshots

Page Last Updated: 09/09/2016
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