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Discussing IMPACT with Dr. Anzueto

 
transcript | 10:46

TEXT ONSCREEN:
What were the efficacy and safety results of the IMPACT trial, which compared TRELEGY with 2 dual-maintenance therapies in patients with chronic obstructive pulmonary disease (COPD) who have a history of exacerbations?

TEXT ONSCREEN:
Antonio Anzueto, MD
Pulmonary Medicine/Critical Care Specialist
San Antonio, TX

Dr Anzueto has been compensated by GSK for participation in this program

DR ANZUETO:
Hello, I'm Antonio Anzueto, pulmonary disease specialist, San Antonio, Texas. My areas of interest are chronic lung diseases, COPD treatment, exacerbation prevention, as well as vaccination.

TEXT ONSCREEN:

INDICATION

TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TRELEGY is NOT for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

TRELEGY is contraindicated in the following:

  • Primary treatment of status asthmaticus or other acute episodes of COPD or asthma where intensive measures are required.

  • Patients with severe hypersensitivity to milk proteins or demonstrated hypersensitivity to fluticasone furoate (FF), umeclidinium (UMEC), vilanterol (VI), or any of the excipients.

Please see additional Important Safety Information for TRELEGY at the conclusion of this video.

Please see full Prescribing Information, including Patient Information, for TRELEGY, available on this page.

Profession VO:

TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). TRELEGY is NOT for the relief of acute bronchospasm.

TRELEGY is contraindicated in primary treatment of status asthmaticus or other acute episodes of COPD or asthma and in patients with hypersensitivity to milk proteins, any of the active ingredients, or excipients.

Please see additional Important Safety Information for TRELEGY at the conclusion of this video.

TEXT ONSCREEN:
How would you summarize the key details of the IMPACT study design?

DR ANZUETO :
The IMPACT trial was a randomized, double-blind, parallel group study in more than 10,000 patients with symptomatic COPD and a history of exacerbations. Patients were randomized to one of three treatment arms for 52 weeks. This study evaluated the safety and efficacy of TRELEGY, an ICS/LAMA/LABA, versus BREO, an ICS/LABA and versus ANORO, a LAMA/LABA. The primary endpoint was the annual rate of moderate to severe exacerbations. In the IMPACT study, moderate exacerbations were defined as worsening symptoms of COPD that required oral corticosteroids and/or antibiotics, while severe exacerbations were defined as worsening symptoms of COPD that require inpatient hospitalization.

TEXT ONSCREEN:

The IMPACT Trial Was Designed to Compare TRELEGY With Two Dual Maintenance Therapies in Patients with a History of Exacerbations1,2

Randomized, double-blind, parallel-group, global, multicenter study in patients with a history of COPD exacerbations

Primary efficacy endpoint: annual rate of moderate or severe exacerbations

[data chart with animation]

Moderate exacerbations were defined as worsening symptoms of COPD that required oral corticosteroids and/or antibiotics. Severe exacerbations were defined as worsening symptoms of COPD that required inpatient hospitalizations.

DR ANZUETO:
Let's take a look at the selective inclusion criteria and baseline characteristics. All patients in the IMPACT trial were symptomatic and had a history of exacerbations—70% of patients had at least two moderate or at least one severe exacerbation in the previous 12 months.

TEXT ONSCREEN:

Select Inclusion Criteria

  • Symptomatic patients with COPD

  • Postbronchodilator FEV1

    • <50% predicted and ≥1 moderate to severe exacerbation in the previous 12 months or
    • 50% to <80% predicted and ≥2 moderate exacerbations or ≥1 severe exacerbation in the previous 12 months

Select Baseline Characteristics

  • Postbronchodilator FEV1, % predicted, mean: 46%

  • Exacerbation history

    • <2 moderate and no severe: 30%
    • ≥2 moderate or ≥1 severe : 70%

  • Age, mean: 65 years

  • Smoking history, mean: 47 pack-years

DR ANZUETO:

So how effectively did TRELEGY help prevent COPD exacerbations? Based on the primary endpoint data from the IMPACT trial, triple therapy with TRELEGY significantly reduced the annual rate of moderate to severe exacerbations compared with dual therapies. There was a 15% reduction versus BREO, an ICS/LABA, and a 25% reduction versus ANORO, a LAMA/LABA.

TEXT ONSCREEN:
In Patients With a History of Exacerbations
TRELEGY: HELPS PREVENT EXACERBATIONS
Superior Exacerbation Rate Reduction vs an ICS/LABA and vs a LAMA/LABA1,2

Primary Endpoint: Annual Rate of Moderate to Severe Exacerbations

[data chart with animation]

Moderate exacerbations were defined as worsening symptoms of COPD that required oral corticosteroids and/or antibiotics. Severe exacerbations were defined as worsening symptoms of COPD that required inpatient hospitalizations.

DR ANZUETO:
In a post-hoc descriptive analysis, the number needed to treat with TRELEGY to prevent one moderate to severe exacerbation per year was seven versus BREO and four versus ANORO.

TEXT ONSCREEN:
Post Hoc Analysis Number Needed to Treat for Moderate of Severe Exacerbations1,*

Number Needed to Treat With TRELEGY to Prevent 1 Exacerbation per Year

Vs BREO 7 (95% CI: 5, 10)

Vs ANORO 4 (95% CI: 3, 5)

Data are descriptive only.

*Analysis performed using a generalized linear model assuming a negative binomial distribution and covariates of treatment group, sex, exacerbation history, smoking status at screening, geographical region, and postbronchodilator % predicted FEV1 at screening.

DR ANZUETO:
Now let's review the secondary endpoint of annual rate of severe exacerbations. As shown here, TRELEGY reduced the annual rate of exacerbations requiring hospitalization by 13% versus BREO and 34% versus ANORO, though the comparison versus BREO was not statistically significant.

TEXT ONSCREEN:
In Patients With a History of Exacerbations
TRELEGY: Reduced Hospitalized Exacerbations
Reduced Severe (Hospitalized) Exacerbations vs an ICS/LABA and vs a LAMA/LABA1,2

Secondary Endpoint: Annual Rate of Severe Exacerbations

[data chart with animation]

Severe exacerbations were defined as worsening symptoms of COPD that required inpatient hospitalization.

TEXT ONSCREEN:
Can you review the data that measured lung function improvement with TRELEGY vs an ICS/LABA and vs a LAMA/LABA?

DR ANZUETO:
A secondary and an other endpoint in the IMPACT trial was change from baseline in trough FEV1 at Week 52. In this analysis, patients receiving TRELEGY experienced a mean improvement of 97 milliliters compared with BREO and of 54 milliliters compared with ANORO at Week 52.

TEXT ONSCREEN:
In Patients With a History of Exacerbations
TRELEGY: Superior and Sustained Lung Function Improvement vs an ICS/LABA and vs a LAMA/LABA1,2

Secondary and Other Endpoint: Change From Baseline in Trough FEV1 at Week 52

[data chart with animation]

TEXT ONSCREEN:
As measured by the SGRQ, did the quality of life improve for patients treated with TRELEGY vs an ICS/LABA and vs a LAMA/LABA?

DR ANZUETO:

In the IMPACT trial, TRELEGY also significantly improved quality of life with a 1.41 times higher odds of SGRQ response versus both BREO and ANORO. Response was defined as a decrease in score from baseline of at least four units. The SGRQ is a validated respiratory disease–specific, patient-reported instrument that assesses health status in three domains, including symptoms, activities, and impact on daily life.

TEXT ONSCREEN:

In Patients With a History of Exacerbations
TRELEGY: Significantly Improved Quality of Life as Measured by SGRQ vs an ICS/LABA and vs a LAMA/LABA1,2

SGRQ Responder Rate* at Week 52

[data chart with animation]

*Response defined as a decrease in score from baseline of ≥4 units.

TEXT ONSCREEN:
What were the most common adverse events (AEs) reported in the IMPACT trial?

DR ANZUETO:
The most commonly reported AEs for TRELEGY, with an incidence of at least 5%, included viral upper respiratory tract infection, COPD, upper respiratory tract infection, pneumonia, and headache.

TEXT ONSCREEN:
In Patients With a History of Exacerbations
Adverse Events Reported in the IMPACT Trial

Most Frequently Reported Adverse Events From the 52-Week IMPACT Trial1,2

[data chart]

TEXT ONSCREEN:
In your opinion, why are the results from the IMPACT trial important, and how are these data meaningful to your practice?

DR ANZUETO:
In my practice, I see patients who have been treated with double therapy and continue to be symptomatic and having exacerbations. The IMPACT study showed me that TRELEGY was effective in the reduction in exacerbations in this patient population. What I thought was also very striking is the fact there was a significant reduction of severe exacerbations and also there was a further improvement in patients' lung function that translated, at the end of the day, with a better quality of life.

PROFESSIONAL VO:
LABA without an ICS, for asthma, increases the risk of asthma-related death and in some patients, data suggest increased risk of asthma-related hospitalization. When LABA are used in fixed-dose combination with ICS, data do not show a significant increase in the risk of serious asthma-related events compared with ICS alone.  TRELEGY should NOT be initiated in rapidly deteriorating or potentially life-threatening episodes of COPD or asthma and should NOT be used for the relief of acute symptoms.  TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason due to the risk of clinically significant cardiovascular effects and fatalities.

To help reduce the risk of oropharyngeal candidiasis, advise patients to rinse their mouths with water without swallowing after inhalation.  Patients who use products containing ICS need to be monitored for signs and symptoms of pneumonia, and are at risk for potential worsening of existing infections.  A more serious or fatal course of chickenpox or measles can occur in susceptible patients.  Because deaths due to adrenal insufficiency have occurred in patients during and after transfer, taper patients slowly from systemic corticosteroids if transferring to TRELEGY.  Monitor patients for hypercorticism and adrenal suppression, which may occur with ICS-containing products in susceptible individuals.

Caution should be exercised when considering the coadministration of TRELEGY with strong CYP3A4 inhibitors because increased systemic corticosteroid and cardiovascular adverse effects may occur.  If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.   If hypersensitivity reactions occur, discontinue TRELEGY.  Vilanterol can produce clinically significant cardiovascular effects in some patients. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders.

Decreases in bone mineral density have been observed with long-term administration of products containing ICS. Patients with major risk factors for decreased bone mineral density should be monitored and treated prior to initiating TRELEGY and periodically thereafter.

Glaucoma and cataracts may occur with long-term use of products containing ICS.

Use with caution in patients with narrow-angle glaucoma or urinary retention.

Instruct patients to contact an HCP immediately if any of these signs or symptoms develop.

Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

Be alert to hypokalemia and hyperglycemia.

In subjects with COPD, the most common adverse reactions reported with TRELEGY were headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, gastroenteritis, upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

TRELEGY should be administered with extreme caution to patients treated with MAOIs, TCAs or drugs known to prolong the QTc interval because they may potentiate the effect of vilanterol on the cardiovascular system.

Use beta-blockers with caution, as they block bronchodilatory effects of beta-agonists and may produce severe bronchospasm.

Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia may worsen with concomitant beta-agonists.

Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

Use with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase.

DR ANZUETO:

Thanks for watching. To learn more about TRELEGY, please contact your GSK sales representative.

TEXT ONSCREEN:

IMPORTANT SAFETY INFORMATION (cont’d)

WARNINGS AND PRECAUTIONS

  • Long-acting beta2-adrenergic agonist (LABA) monotherapy for asthma increases the risk of asthma-related death, and in pediatric and adolescent patients, available data also suggest an increased risk of asthma-related hospitalization. These findings are considered a class effect of LABA monotherapy. When LABA are used in fixed-dose combination with inhaled corticosteroids (ICS), data from large clinical trials do not show a significant increase in the risk of serious asthma-related events (hospitalizations, intubations, death) compared with ICS alone.

  • TRELEGY should NOT be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of COPD or asthma.

  • TRELEGY is NOT a rescue medication and should NOT be used for the relief of acute bronchospasm or symptoms. Acute symptoms should be treated with an inhaled, short-acting beta2-agonist.

  • TRELEGY should not be used more often or at higher doses than recommended or with another LABA for any reason, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs, like LABA.

  • Oropharyngeal candidiasis has occurred in patients treated with orally inhaled drug products containing fluticasone furoate. Advise patients to rinse their mouths with water without swallowing after inhalation.

  • Lower respiratory tract infections, including pneumonia, have been reported following use of ICS, like fluticasone furoate. Physicians should remain vigilant for the possible development of pneumonia in patients with COPD, as clinical features of pneumonia and exacerbations frequently overlap.

  • Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients.

  • Particular care is needed for patients transferred from systemic corticosteroids to ICS because deaths due to adrenal insufficiency have occurred in patients during and after transfer. Taper patients slowly from systemic corticosteroids if transferring to TRELEGY.

  • Hypercorticism and adrenal suppression may occur with higher than the recommended dosage or at the regular dosage of ICS in susceptible individuals. If such changes occur, reduce the dose of TRELEGY slowly, and consider other treatments for management of COPD or asthma symptoms.

TEXT ONSCREEN:

IMPORTANT SAFETY INFORMATION (cont’d)

WARNINGS AND PRECAUTIONS (cont’d)

  • Caution should be exercised when considering the coadministration of TRELEGY with ketoconazole and other known strong CYP3A4 inhibitors (including, but not limited to, ritonavir, clarithromycin, conivaptan, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, saquinavir, telithromycin, troleandomycin, voriconazole) because increased systemic corticosteroid and cardiovascular adverse effects may occur.

  • If paradoxical bronchospasm occurs, discontinue TRELEGY and institute alternative therapy.

  • Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.

  • Vilanterol can produce clinically significant cardiovascular effects in some patients as measured by increases in pulse rate, systolic or diastolic blood pressure, and also cardiac arrhythmias, such as supraventricular tachycardia and extrasystoles. If such effects occur, TRELEGY may need to be discontinued. TRELEGY should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

  • Decreases in bone mineral density have been observed with long‐term administration of products containing ICS. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, postmenopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (eg, anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care prior to initiating TRELEGY and periodically thereafter.

  • Glaucoma, increased intraocular pressure, and cataracts have been reported following the long‐term administration of ICS or inhaled anticholinergics. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY long term.

  • Use with caution in patients with narrow-angle glaucoma. Instruct patients to contact a healthcare provider immediately if signs or symptoms of acute narrow-angle glaucoma develop.

  • Use with caution in patients with urinary retention, especially in patients with prostatic hyperplasia or bladder-neck obstruction. Instruct patients to contact a healthcare provider immediately if signs or symptoms of urinary retention develop.

  • Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.

  • Be alert to hypokalemia and hyperglycemia.

TEXT ONSCREEN:

IMPORTANT SAFETY INFORMATION (cont’d)

ADVERSE REACTIONS

  • In subjects with COPD, the most common adverse reactions (≥1% and more common than placebo + FF/VI 100/25) reported in two 12-week clinical trials with UMEC + FF/VI 100/25, the components of TRELEGY 100/62.5/25, (and placebo + FF/VI 100/25) were: headache, 4% (3%); back pain, 4% (2%); dysgeusia, 2% (<1%); diarrhea, 2% (<1%); cough, 1% (<1%); oropharyngeal pain, 1% (0%); and gastroenteritis, 1% (0%).

  • Additional adverse reactions (≥1% incidence) reported in subjects with COPD taking TRELEGY 100/62.5/25 in a 52-week trial included upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

DRUG INTERACTIONS

  • TRELEGY should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval, or within 2 weeks of discontinuation of such agents, because they may potentiate the effect of vilanterol on the cardiovascular system.

  • Use beta‐blockers with caution, as they not only block the pulmonary effect of beta‐agonists, such as vilanterol, but may produce severe bronchospasm in patients with COPD or asthma.

  • Use with caution in patients taking non–potassium-sparing diuretics, as ECG changes and/or hypokalemia associated with these diuretics may worsen with concomitant beta-agonists.

  • Avoid coadministration of TRELEGY with other anticholinergic-containing drugs, as this may lead to an increase in anticholinergic adverse effects.

USE IN SPECIFIC POPULATIONS

  • Use TRELEGY with caution in patients with moderate or severe hepatic impairment, as fluticasone furoate systemic exposure may increase by up to 3-fold. Monitor for corticosteroid-related side effects.

Please see Full Prescribing Information, including Patient Information, for TRELEGY.

The shape of the ELLIPTA inhaler is a trademark of the GSK group of companies.
Trademarks are property of their respective owners

©2024 GSK or licensor
PMUS-FVUVID240002 June 2024
Produced in USA.

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