GSK and Innoviva Report Positive Headline Results from IMPACT Study Showing Single Inhaler Triple Therapy Trelegy Ellipta Reduced COPD Exacerbations
Trelegy Ellipta met study primary endpoint demonstrating reduction in exacerbations compared with the dual therapies Anoro Ellipta and Relvar/Breo Ellipta in patients with COPD
Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI) is approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo (fluticasone furoate/vilanterol, FF/ VI) and require additional bronchodilation or who are receiving Breo and Incruse (umeclidinium, UMEC).
The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK's existing portfolio. The study showed a:
-
15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta
(FF/VI,100/25mcg);
0.91 vs 1.07 per year; p < 0.001 -
25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI,
62.5/25mcg);
0.91 vs 1.21 per year; p < 0.001
In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and associated treatment comparisons:
- Change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL; p < 0.001 and for FF/UMEC/VI compared with UMEC/VI was 54mL; p < 0.001
- Change from baseline St George's Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units; p < 0.001 and for FF/UMEC/VI compared with UMEC/VI was -1.8 units; p < 0.001
- Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI compared with FF/VI; p < 0.001, and a 16.0% reduction in risk for FF/UMEC/VI compared with UMEC/VI; p < 0.001
Based on review of the headline data, the safety profile of once-daily FF/UMEC/VI was consistent with the known profile of the individual medicines and their dual combinations. The most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache. The incidences of common serious adverse events were worsening of COPD 11%, 11% and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; for pneumonia was 4%, 4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.
Full results will be presented at upcoming scientific meetings and in peer-reviewed publications.
On
On
Global regulatory filings with the IMPACT study are expected to commence in the second quarter of 2018 for consideration of expansion of the indicated patient population.
About IMPACT
The InforMing the PAthway of COPD Treatment (IMPACT)
study was a randomised, double-blind, 3-arm parallel group, multicentre
study evaluating FF/UMEC/VI (100mcg/62.5mcg/25mcg) versus UMEC/VI
(62.5mcg/25mcg) and FF/VI (100mcg/25mcg), all given once daily via the
ELLIPTA dry powder inhaler. The total duration of the study was
approximately 55 weeks consisting of a 2-week run-in period, 52-week
treatment period and a 1-week safety follow-up period. Patients had
moderate to very severe symptomatic COPD with a history of exacerbation
in the prior 12 months. In the study, 10,355 patients were treated in
over 1,035 study centres globally.
The primary efficacy endpoint was the annual rate of on-treatment moderate and severe exacerbations. This was compared for FF/UMEC/VI versus UMEC/VI and, FF/UMEC/VI versus FF/VI. Other endpoints included lung function and patient reported outcomes, including health related quality of life measures.
About COPD
COPD is a disease of the lungs that includes
chronic bronchitis, emphysema or both and limits airflow to the lungs,
interfering with normal breathing. It is thought to affect 384 million
people worldwide. 1
For people living with COPD the inability to breathe normally and worsening of their symptoms can consume their daily life and make simple activities, like walking upstairs, an everyday struggle.
Long-term exposure to lung irritants that damage the lungs and the airways are usually the cause of COPD. Cigarette smoke, breathing in second hand smoke, air pollution, chemical fumes or dust from the environment or workplace can all contribute to COPD. Most people who have COPD are at least 40 years old when symptoms begin. 2
Every person with COPD is different, with different needs, different challenges and different goals. Understanding this, and providing support to help meet these needs is the foundation of our work.
About Trelegy Ellipta
Trelegy Ellipta is the first
once-daily single inhaler triple therapy approved in the US for the
long-term, once-daily, maintenance treatment of patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis
and/or emphysema, who are on a fixed-dose combination of fluticasone
furoate and vilanterol for airflow obstruction and reducing
exacerbations in whom additional treatment of airflow obstruction is
desired or for patients who are already receiving umeclidinium and a
fixed-dose combination of fluticasone furoate and vilanterol. Trelegy
Ellipta is not indicated for relief of acute bronchospasm or the
treatment of asthma.
Trelegy contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, in a single inhaler, the Ellipta.
Full US Prescribing Information, including BOXED WARNING and Medication Guide is available at: us.gsk.com.
Important Safety Information (ISI) for Trelegy Ellipta
The
following ISI is based on the Highlights section of the US Prescribing
Information for Trelegy Ellipta. Please consult the full Prescribing
Information for all the labelled safety information for Trelegy Ellipta.
Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths. This finding with salmeterol is considered a class effect of all LABA. The safety and efficacy of Trelegy Ellipta in patients with asthma have not been established. Trelegy Ellipta is not indicated for the treatment of asthma.
Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or any of the ingredients.
Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating COPD. Do not use Trelegy Ellipta to treat acute symptoms.
Trelegy Ellipta should not be used in combination with other medicines containing LABA because of risk of overdose.
Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
There is an increased risk of pneumonia in patients with COPD taking Trelegy Ellipta. Monitor patients for signs and symptoms of pneumonia.
Patients who use corticosteroids are at risk for potential worsening of infections (e.g. existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex). Use Trelegy Ellipta with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
There is a risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Trelegy Ellipta.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of Trelegy Ellipta in susceptible individuals. If such changes occur, consider appropriate therapy.
If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and institute alternative therapy.
Use Trelegy Ellipta with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
Assess patents for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.
Close monitoring for glaucoma and cataracts is warranted in patients taking Trelegy Ellipta. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.
Worsening of urinary retention may occur in patients taking Trelegy Ellipta. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.
Use Trelegy Ellipta with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be alert to hypokalemia and hyperglycemia in patients taking Trelegy Ellipta.
The most common adverse reactions reported for Trelegy Ellipta (incidence ≥1%) are headache, back pain, dysgeusia, diarrhea, cough, oropharyngeal pain, and gastroenteritis.
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
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are trademarks of the
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materially from those projected. Such factors include, but are not
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This press release
contains certain "forward-looking" statements as that term is defined in
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closed triple combination therapy and the potential benefits and
mechanisms of action of closed triple combination therapy.
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References
- Global Initiative for Chronic Obstructive Lung Disease Global Initiative for Chronic Obstructive Lung Disease. 2017. Pocket guide to COPD diagnosis, management, and prevention. Available at: http://goldcopd.org/wp-content/uploads/2016/12/wms-GOLD-2017-Pocket-Guide.pdf
-
Diagnosis of COPD.
World Health Organisation . Available at: http://www.who.int/respiratory/copd/diagnosis/en/]
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