Efficacy vs BREO (an ICS/LABA) and vs ANORO (a LAMA/LABA)

Help patients with COPD breathe better today and reduce exacerbations tomorrow

TRELEGY was evaluated in 2 replicate studies vs BREO—and in IMPACT, a 52-week landmark study vs BREO and vs ANORO in 10,000+ patients with a history of COPD exacerbations1,2

Designed to help patients with COPD breathe better today

TRELEGY delivers rapid and lasting improvement in lung function1

RAPID

As early as 15 minutes1

TRELEGY is not a rescue inhaler and should not be used for the relief of acute symptoms.

TRELEGY provided improvement in FEV1 vs BREO, as measured by LS mean change from baseline in FEV1, beginning at 15 minutes on Day 1.1

LASTING

Maintained for 24 hours1

Improvement persisted for 24 hours on Day 1 and Day 84.1

In these 2 replicate studies, the primary efficacy endpoint was trough FEV1 at Day 85. The LS mean change from baseline in trough FEV1 at Day 85 for TRELEGY 100/62.5/25 (n=206 in each trial) vs placebo + BREO 100/25 (n=206 in each trial) was 124 mL for trial 1 and 122 mL for trial 2.1

  • Trials 1 & 2 study description1,3

    Design: Two 12-week, randomized, double-blind, parallel-group, multicenter studies were conducted to evaluate the efficacy and safety of INCRUSE 62.5 mcg or placebo added to BREO 100/25 mcg. Treatment with TRELEGY 100/62.5/25 mcg refers to patients who received INCRUSE 62.5 mcg added to BREO 100/25 mcg. Eligible patients entered a 4-week open-label run-in period following screening where they received BREO 100/25 mcg. Patients were then randomized to receive INCRUSE 62.5 mcg (n=206 in each trial) or placebo (n=206 in each trial) added to open-label BREO 100/25 mcg.

    Patients: At screening, patients with COPD (mean age: 64 years) had a mean postbronchodilator percent predicted FEV1 of 46%, a mean postbronchodilator FEV1/FVC ratio: 0.48, and a mean mMRC score of 2.4. 

TRELEGY helps prevent exacerbations

In patients with a history of COPD exacerbations:

Superior exacerbation rate reduction vs ANORO (a LABA/LAMA) & vs BREO (an ICS/LABA)2


Primary endpoint: annual rate of moderate to severe exacerbations2

Primary Endpoint
production

Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

  • IMPACT study description2,3

    Design: A 12-month, randomized, double-blind, parallel-group study comparing the rate of moderate to severe exacerbations between TRELEGY 100/62.5/25 and BREO 100/25, an ICS/LABA, and between TRELEGY 100/62.5/25 and ANORO 62.5/25, a LAMA/LABA. Patients were eligible if they were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate exacerbations or 1 severe exacerbation in the previous year.

    Patients: At screening, patients with COPD (N=10,355, mean age: 65 years) had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47. Patients were randomized (2:2:1) to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).

    Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

 
 
 

Improved lung function with TRELEGY

In patients with a history of COPD exacerbations:

Superior and sustained lung function improvement vs BREO (an ICS/LABA) & vs ANORO (a LABA/LAMA)2


Secondary and other endpoint:

change from baseline in trough FEV1 at Week 522,3

Improved lung function with TRELEGY
Improved lung function with TRELEGY
  • IMPACT study description2,3

    Design: A 12-month, randomized, double-blind, parallel-group study comparing the rate of moderate to severe exacerbations between TRELEGY 100/62.5/25 and BREO 100/25, an ICS/LABA, and between TRELEGY 100/62.5/25 and ANORO 62.5/25, a LAMA/LABA. Patients were eligible if they were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate exacerbations or 1 severe exacerbation in the previous year.

    Patients: At screening, patients with COPD (N=10,355, mean age: 65 years) had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47. Patients were randomized (2:2:1) to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).

    Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

 
 
 

Superior improvement in quality of life with TRELEGY

Patients with a history of COPD exacerbations taking TRELEGY were more likely to show an improvement in quality of life at 1 year vs BREO and vs ANORO as measured by the SGRQ. 2
  • SGRQ is a validated, respiratory disease-specific, patient-reported instrument that assesses symptoms, activities, and impact on daily life domains4
  • Responder rate is the percentage of patients with a response, defined as a decrease from baseline of 4 or more in SGRQ total score2

TRELEGY demonstrated superior improvement in quality of life vs BREO (an ICS/LABA) & vs ANORO (a LABA/LAMA)2

Responder rate was statistically significantly greater for TRELEGY2,3

percentages
  • IMPACT study description2,3

    Design: A 12-month, randomized, double-blind, parallel-group study comparing the rate of moderate to severe exacerbations between TRELEGY 100/62.5/25 and BREO 100/25, an ICS/LABA, and between TRELEGY 100/62.5/25 and ANORO 62.5/25, a LAMA/LABA. Patients were eligible if they were symptomatic with a postbronchodilator percent predicted FEV1 <50% and a history of 1 or more moderate or severe exacerbations within the previous year, or with a postbronchodilator percent predicted FEV1 of 50% to 80% and a history of 2 or more moderate exacerbations or 1 severe exacerbation in the previous year.

    Patients: At screening, patients with COPD (N=10,355, mean age: 65 years) had a mean postbronchodilator percent predicted FEV1 of 45.5% and a mean postbronchodilator FEV1/FVC ratio: 0.47. Patients were randomized (2:2:1) to treatment following a 2-week run-in period on their current COPD treatment. Current medications included ICS + LABA + LAMA (34%), ICS + LABA (26%), LAMA + LABA (8%), LAMA (7%), and other (25%).

    Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.

Adverse events and additional safety information from the IMPACT trial (COPD)

The most commonly reported adverse events with ≥5% incidence from the 52‑week IMPACT trial2,3

 

TRELEGY 100/62.5/25
(n=4151)
%

BREO
100/25
(n=4134)
%

ANORO

 62.5/25

(n=2070)

%

Viral URTI

13

12

11

COPD*

11

11

13

URTI

7

7

6

Pneumonia

7

6

4

Headache

6

5

5

*Signs, symptoms, or progression of COPD are more severe than expected for the subject's condition.

Pneumonia incidence as reported from adverse events of special interest from the 52-week IMPACT trial2

TRELEGY
100/62.5/25

(n=4151)

%

BREO
100/25

(n=4134)

%

ANORO

62.5/25

(n=2070)

%

8

7

5

Fatal pneumonia occurred in 12 of 4151 patients (0.35 per 100 patient-years) receiving TRELEGY 100/62.5/25; 5 of 4134 patients (0.17 per 100 patient-years) receiving BREO 100/25; and 5 of 2070 patients (0.29 per 100 patient-years) receiving ANORO.  

 

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