TRELEGY demonstrated superior efficacy vs BREO* and vs ANORO1†

TRELEGY demonstrated superior
efficacy vs BREO* and vs ANORO1†

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Better breathing for patients with COPD at risk of exacerbation

TRELEGY was evaluated extensively against other COPD medicines in IMPACT, a 52-week landmark study vs BREO and vs ANORO in 10,000+ patients with a history of COPD exacerbations1

*BREO is an ICS/LABA.

ANORO is a LAMA/LABA.

In patients with a history of COPD exacerbations

TRELEGY is proven to help prevent exacerbations vs an ICS/LABA and vs a LAMA/LABA1


Primary endpoint: annual rate of moderate to severe exacerbations1

Primary endpoint bar chart
Primary endpoint bar chart

TRELEGY significantly reduced the annual rate of moderate to severe exacerbations by 15% vs BREO (P<0.001) and by 25% vs ANORO (P<0.001).1

Exacerbation severity criteria: Moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required.1

  • IMPACT study description1

    The IMPACT trial was a 52-week, randomized, double-blind, parallel-group study that evaluated the efficacy and safety of TRELEGY 100 vs BREO 100, an ICS/LABA, and vs ANORO, a LAMA/LABA, in symptomatic patients with a history of 1 or more moderate or severe COPD exacerbations in the previous year. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required. 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 of 0.47.

 

 

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In patients with a history of COPD exacerbations

TRELEGY reduced hospitalized exacerbations vs an ICS/LABA and vs a LAMA/LABA1


Secondary endpoint: annual rate of severe exacerbations1

Secondary endpoint bar chart
Secondary endpoint bar chart

TRELEGY demonstrated a reduction of 13% in annual rate of severe exacerbations vs BREO (P=NS) and a significant 34% reduction vs ANORO (P<0.001).1

  • IMPACT study description1

    The IMPACT trial was a 52-week, randomized, double-blind, parallel-group study that evaluated the efficacy and safety of TRELEGY 100 vs BREO 100, an ICS/LABA, and vs ANORO, a LAMA/LABA, in symptomatic patients with a history of 1 or more moderate or severe COPD exacerbations in the previous year. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required. 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 of 0.47.

 

 

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In patients with a history of COPD exacerbations

TRELEGY showed superior and sustained lung function improvement vs an ICS/LABA and vs a LAMA/LABA1


Secondary and other endpoints: change from baseline in trough FEV1 at Month 121,2

Secondary and other endpoints line graph
Secondary and other endpoints line graph

TRELEGY demonstrated a significant 97 mL improvement vs BREO (P<0.001) and a significant 54 mL improvement vs ANORO (P<0.001).1

  • IMPACT study description1

    The IMPACT trial was a 52-week, randomized, double-blind, parallel-group study that evaluated the efficacy and safety of TRELEGY 100 vs BREO 100, an ICS/LABA, and vs ANORO, a LAMA/LABA, in symptomatic patients with a history of 1 or more moderate or severe COPD exacerbations in the previous year. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required. 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 of 0.47.

 

 

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TRELEGY demonstrated superior improvement in quality of life vs an ICS/LABA and vs a LAMA/LABA1

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.1

  • SGRQ is a validated, respiratory disease-specific, patient-reported instrument that assesses symptoms, activities, and impact on daily life domains3
Responder rate was statistically significantly greater for TRELEGY1,2
TRELEGY 100
42%
(1723/4108)
vs
BREO 100
34%
(1390/4092)

(OR: 1.41; 95% CI: 1.29, 1.55; P<0.001)

 
TRELEGY 100
42%
(1723/4108)
vs
ANORO
34%
(696/2050)

(OR: 1.41; 95% CI: 1.26, 1.57; P<0.001)

42% of patients receiving TRELEGY had a decrease from baseline of 4 or more in SGRQ total score vs 34% of patients receiving BREO (P<0.001) and 34% of patients receiving ANORO (P<0.001).1

Responder rate is the percentage of patients with a response, defined as a decrease from baseline of 4 or more in SGRQ total score.1

  • IMPACT study description1

    The IMPACT trial was a 52-week, randomized, double-blind, parallel-group study that evaluated the efficacy and safety of TRELEGY 100 vs BREO 100, an ICS/LABA, and vs ANORO, a LAMA/LABA, in symptomatic patients with a history of 1 or more moderate or severe COPD exacerbations in the previous year. Exacerbations were moderate if treatment with systemic corticosteroids and/or antibiotics was required and severe if hospitalization was required. 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 of 0.47.

Adverse events reported in the IMPACT trial

From the 52-week IMPACT trial, the most commonly reported adverse events with ≥5% incidence were1:

Adverse Events

TRELEGY 100
(n=4151)
%

BREO 100
(n=4134)
%

ANORO
(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 patient's condition.

 

In the 52-week IMPACT trial, the incidence of pneumonia (Adverse Events of Special Interest) was1

Adverse Events of Special Interest

TRELEGY 100
(n=4151)
%

BREO 100
(n=4134)
%

ANORO
(n=2070)
%

Pneumonia

8

7

5

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

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Explore results of a non-US, head-to-head study: FULFIL.

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