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 exacerbations^1,2

Rapid & Lasting Data: Trials 1 & 2 Exacerbation Rate: IMPACT Lung Function: IMPACT Health-Related Quality of Life: IMPACT Adverse Events: IMPACT

Rapid & Lasting Data: Trials 1 & 2
Exacerbation Rate: IMPACT
Lung Function: IMPACT
Health-Related Quality of Life: IMPACT
Adverse Events: IMPACT

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

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 52^2,3

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 TRELEGY^2,3

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 trial^2,3

	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)

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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INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: TRELEGY is NOT for the relief of acute bronchospasm.

INDICATIONS

COPD: TRELEGY 100/62.5/25 is for maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
Asthma: TRELEGY is for maintenance treatment of adults with asthma.

Limitations of Use: 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.

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 is not indicated for use in pediatric patients aged 17 years and younger.
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.
A more serious or even fatal course of chickenpox or measles may occur in susceptible patients using corticosteroids. ICS should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
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.
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.
Orally inhaled corticosteroids may reduce growth velocity in children and adolescents.

ADVERSE REACTIONS: TRELEGY 100/62.5/25 MCG FOR COPD

In subjects with COPD, the most common adverse reactions (≥1% and more common than placebo + FF/VI) reported in two 12-week clinical trials with UMEC + FF/VI, the components of TRELEGY, (and placebo + FF/VI) 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 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.

ADVERSE REACTIONS: TRELEGY FOR ASTHMA

In subjects with asthma, the most common adverse reactions (≥2% incidence with TRELEGY) reported in a 24-week to 52-week clinical trial with:
- TRELEGY 100/62.5/25 mcg (or FF/VI 100/25 mcg) were: pharyngitis/nasopharyngitis, 17% (16%); headache, 9% (7%); upper respiratory tract infection/viral upper respiratory tract infection, 5% (7%); respiratory tract infection/viral respiratory tract infection, 4% (4%); bronchitis, 4% (3%); influenza, 4% (3%); back pain, 3% (4%); sinusitis/acute sinusitis, 2% (3%); rhinitis, 2% (3%).
- TRELEGY 200/62.5/25 mcg (or FF/VI 200/25 mcg) were: pharyngitis/nasopharyngitis, 15% (16%); upper respiratory tract infection/viral upper respiratory tract infection, 7% (6%); headache, 5% (6%); bronchitis, 5% (5%); sinusitis/acute sinusitis, 3% (2%); respiratory tract infection/viral respiratory tract infection, 3% (2%); back pain, 2% (1%); urinary tract infection, 2% (<1%).

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

TRELEGY is not indicated for use in children and adolescents. The safety and efficacy in pediatric patients (aged 17 years and younger) have not been established.
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.

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.

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.

IMPORTANT SAFETY INFORMATION

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Definitions

CI=confidence interval; COPD=chronic obstructive pulmonary disease; FVC=forced vital capacity; FEV₁=forced expiratory volume in 1 second; ICS=inhaled corticosteroid; IMPACT=InforMing the PAthway of COPD Treatment; LABA=long-acting beta₂-adrenergic agonist; LAMA=long-acting muscarinic antagonist; LS=least squares; mMRC=modified Medical Research Council dyspnea scale; OR=odds ratio; SGRQ=St. George's Respiratory Questionnaire; URTI=upper respiratory tract infection.

References

Siler TM, Kerwin E, Sousa A, et al. Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: results of two randomized studies. Respir Med. 2015;109(9):1155-1163.
Lipson DA, Barnhart F, Brealey N, et al; for the IMPACT Investigators. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378(18):1671‑1680, Supplementary Appendix.
Data on file, GSK.
Jones PW, Quirk FW, Baveystock CM. The St. George’s Respiratory Questionnaire. Respir Med. 1991;85(suppl B):25-31.

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Help patients with COPD breathe better today and reduce exacerbations tomorrow

Designed to help patients with COPD breathe better today

TRELEGY delivers rapid and lasting improvement in lung function1

TRELEGY helps prevent exacerbations

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

Improved lung function with TRELEGY

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

Superior improvement in quality of life with TRELEGY

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

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

TRELEGY delivers rapid and lasting improvement in lung function¹

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

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

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