GSK demonstrates leadership in respiratory medicine at ATS 2017 with over 50 abstracts from across comprehensive portfolio

London UK

GSK will present 59 abstracts at the American Thoracic Society (ATS) conference 19-24 May, Washington DC, US, from across its comprehensive respiratory portfolio. These will include key studies that, alongside clinical efficacy data, will address the impact of GSK medicines on endpoints relevant to patients’ everyday lives.

Data will be presented from randomised controlled trials where, in addition to the endpoints evaluating product efficacy via clinical outcomes, such as lung function or reduction in exacerbations, other key endpoints will be shared such as patient-reported outcomes, quality of life measures and inhaler preference, which reflect patients’ response to medicine in everyday clinical practice.

Professor Neil Barnes, Global Franchise Medical Head, GSK Respiratory, said: “We will have a strong presence at ATS this year with data from across our portfolio, the broadest in respiratory medicine. We have included endpoints across a number of our studies which have increased relevance to patients and clinicians, reflecting patient preference and evaluating patient-reported outcomes. This underscores our commitment to understanding how patients are impacted by our medicines when they are used as part of their normal daily life.”

Amongst the studies being presented are:

• Clinical effectiveness, patient reported outcomes and population comparison results from the Salford Lung Study in COPD, a pioneering study to compare the effectiveness and safety profile of fixed dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist, vilanterol (FF/VI) 100/25mcg to existing COPD usual care in a broad population of patients in everyday clinical practice. [Abstracts A5476, A1705 and A5482]
• Results will be presented from the Nucala (mepolizumab) MUSCA (Mepolizumab adjUnctive therapy in subjects with Severe eosinophiliC Asthma) study, which look at response rates to treatment and the effect of mepolizumab on lung function as well as health-related quality of life and asthma control, in patients with severe asthma with an eosinophilic phenotype, assessing the role that this first in class targeted biologic plays in the treatment of appropriate severe asthma patients. [Abstracts A3197 and A3185]
• Further results will be presented from the FULFIL trial, comparing investigational once-daily single inhaler triple therapy fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) 100μg/62.5μg/25μg with twice-daily budesonide/formoterol (B/F) 400μg/12μg, including patient reported symptom and inhaler preference results, as well as health-related quality of life and activity outcomes. [Abstracts A5484 and A6742]
• GSK will present data on the ease of use and usage errors of GSK’s Ellipta and other commonly-used inhaler devices. The Ellipta is used across the GSK portfolio of asthma and COPD inhaled products. [Abstracts A1415 and A6316]

GSK abstracts to be presented at ATS 2017 include:

Fluticasone furoate/vilanterol trifenatate (GSK2285997)
Device errors in COPD and asthma: systematic literature review and meta-analysis	P1118 (A1415)	Henry Chrystyn Job van der Palen Raj Sharma Mike Thomas Bruno Delafont Anadi Mahajan Neil Barnes	A37 - THE SPECTRUM OF COPD: EPIDEMIOLOGY TO OUTCOMES Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Evaluating the Burden of Asthma-Related Exacerbations: Findings from Patient & Physician Online Focus Groups	P1050 (A3315)	Averell CM Johnson PT Essoi B Bell CF	B38 - ASTHMA: A PANORAMIC VIEW Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area K, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Fluticasone furoate (FF)/Vilanterol (VI) once daily improves night-time awakenings in asthma patients with night-time symptoms	P193 (A1299)	Barnes N Gibbs MR Forth R	A32 - ASTHMA AND ALLERGY CLINICAL STUDIES Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area C, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center Viewing Time: 11:15 - 13:00 Discussion Time: 13:00 - 16:15
Acute exacerbations of chronic obstructive pulmonary disease increase subsequent cardiovascular event risk: a secondary analysis of adjudicated SUMMIT study data	A1014	Ken M Kunisaki Mark T. Dransfield Julie A. Anderson Robert D Brook Peter MA Calverley, Bartolome R Celli, Courtney Crim,  Benjamin F. Hartley, Fernando Martinez, David E Newby, Alexa A. Pragman, Jørgen Vestbo, Julie Yates, Dennis Niewoehner	A14 - COPD: SYSTEMS BIOLOGY AND COMORBIDITY Mini symposium Session date: Monday 22nd May 2017 Session time: 09:15-11:15 Presentation time: 10:45-11:00 Location: Room 202 A (South Building, Level 2), Walter E. Washington Convention Center
A Comparison of the Patient Population in the Salford Lung Study (SLS COPD) of Clinical Effectiveness versus Six Typical Large Efficacy/Safety Studies in COPD	P362 (A3595)	Dave Leather, Jorgen Vestbo, Nawar Bakerly, Isabelle Boucot, Sue Collier, Ashley Woodcock, Sue Blaikie, John New, Steven Hargreaves	B47-LONG ACTING BRONCHODILATOR THERAPY IN COPD I Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area D, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Clinical Effectiveness of Fluticasone Furoate/Vilanterol (FF/VI): The impact on Exacerbations in COPD Patient Subgroups of the Salford Lung Study (SLS COPD)	P1098 (A5482)	Nawar Diar Bakerly, Ashley Woodcock, Sue Collier, Dave Leather, John New, Jodie Crawford, Jorgen Vestbo	C41 - LONG ACTING BRONCHODILATOR THERAPY IN COPD II Thematic poster session Session date: Tuesday 23rd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Serious Adverse Events of Pneumonia in patient subgroups of the Salford Lung Study chronic obstructive pulmonary disease (SLS COPD) population	P1151 (A1703)	Sue Collier, Nawar Bakerly, Cath Harvey, Jodie Crawford, John New, Hanaa Elkhenini, Glen Cardwell, Claire Williams, Jorgen Vestbo, Ashley Woodcock, Dave Leather	A47 - NEW CONCEPTS IN COPD EXACERBATIONS Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
The clinical effectiveness of fluticasone furoate/vilanterol (FF/VI) in everyday clinical practice: patient reported outcomes in the Salford Lung Study (SLS COPD)	P1092 (A5476)	Ashley Woodcock, Isabelle Boucot, Dominy Browning, Sue Collier, James Sedgley, Julie Millar, James Lay-Flurrie, Sheila McCorkindale, Jorgen Vestbo	C41-LONG ACTING BRONCHODILATOR THERAPY IN COPD II Thematic poster session Session date: Tuesday 23rd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Interpretation of safety findings in clinical effectiveness trials: insights from the Salford Lung Study (SLS COPD)	P373 (A3606)	Sue Collier, Cath Harvey, Nawar Bakerly, John New, Ashley Woodcock, Jorgen Vestbo, Martin Gibson, Glen Cardwell, Hanaa Elkhenini, Claire Williams, Dave Leather, J. Gibson	B47 - LONG ACTING BRONCHODILATOR THERAPY IN COPD I Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area D, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Health Care Resource Utilisation Data from SLS COPD	P1154 (A1705)	Jorgen Vestbo, Hanaa Elkhenini, Dominy Browning, Isabelle Boucot, Janet Flemming, Rich Boladz, Jodie Crawford, Sheila McCorkindale,  John New	A48 - COPD: ISSUES IN HEALTH CARE DELIVERY Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Relationships between ease of use, preference and inhaler usage errors in COPD and asthma	P1231 (A6316)	Job Van der Palen, Henrik Svedsater, Mike Thomas, Henry Chrystyn, Raj Sharma, Chang-Qing Zhu, Neil Barnes	C74-  ADVANCES IN TRANSLATIONAL COPD Thematic poster session Session date: Tuesday 23rd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Fluticasone furoate/vilanterol trifenatate/Umeclidinium (GSK2834425)
Improved Lung Function by 24-Hour Serial Spirometric Assessment with Single Inhaler Triple Therapy Versus Dual Therapy in Advanced Chronic Obstructive Pulmonary Disease (COPD): Sub-analysis of the Global, Randomized, Phase III FULFIL Study	P372 (A3605)	David Lipson, Helen Barnacle, Ruby Birk, Noushin Brealey, Chang-Qing Zhu, Steven Pascoe	B47 - LONG ACTING BRONCHODILATOR THERAPY IN COPD I Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area D, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Single Inhaler Triple Therapy (ICS/LAMA/LABA) in Patients with Advanced COPD: Patient Reported Symptom and Inhaler Preference Results from the FULFIL Trial	P1100 (A5484)	Maggie Tabberer, David Lomas, Helen Barnacle, Ruby Birk, Noushin Brealey, Chang-Qing Zhu, Steve Pascoe, Nick Locantore, David Lipson	C41-LONG ACTING BRONCHODILATOR THERAPY IN COPD II Thematic poster session Session date: Tuesday 23rd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Single inhaler, once-daily, triple therapy (ICS/LAMA/LABA) in patients with advanced COPD: health-related quality of life (HRQoL) and activity outcome results from the FULFIL trial	A6742	Maggie Tabberer, David Lomas, Helen Barnacle, Ruby Birk, Noushin Brealey, Chang-Qing Zhu Steve Pascoe, Nick Locantore, David Lipson	C95 - COPD ADVANCES IN THERAPY Mini symposium Session date: Tuesday 23rd May 2017 Session time: 14:15-16:15 Presentation time: 15:15-15:30 Location: Ballroom B (South Building, Level 3), Walter E. Washington Convention Center
Mepolizumab (SB240563)
Oral corticosteroid dose modulation in severe asthma: impact on peripheral blood eosinophil count	P246 (A1363)	Prazma C, Bel E, Price R, Bradford E, Albers F, Yancey S	A35 - SEVERE ASTHMA Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area C, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Asthma Control in Patients with Severe Eosinophilic Asthma with Mepolizumab	P1009 (A3192)	Llanos JP, Price R, Liu M, Yancey S, Forshag M	B32 - THERAPEUTIC TRIALS IN ASTHMA Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area K, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Impact of Asthma Exacerbations on Health Related Quality of Life in Patients with Severe Asthma	719 (A3000)	Nelsen L, Gunsoy N, Cockle S, Albers F, Jones P	B23 - NOVEL EPIDEMIOLOGY, MANAGEMENT, AND OUTCOMES IN ASTHMA Poster discussion session Session date: Monday 22nd May 2017 Session time: 09:15-11:15 Viewing time: 09:15-10:00 Discussion time: 10:00-11:15 Location: Room 209 A-C (South Building, Level 2), Walter E. Washington Convention Center
Treatment response of mepolizumab on health status and asthma control in patients with severe eosinophilic asthma	P1014 (A3197)	Chupp G, Albers F, Nelsen L, Bratton D, Wang J, Bradford E, Jones P	B32 - THERAPEUTIC TRIALS IN ASTHMA Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area K, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Effect of Mepolizumab on Health Status, Lung Function and Asthma Control According to Baseline Blood Eosinophil Count in Patients with Severe Eosinophilic Asthma	P1002 (A3185)	Trevor J, Albers F, Nelsen L, Bratton D, Wang J, Bradford E	B32 - THERAPEUTIC TRIALS IN ASTHMA Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area K, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Effect of Exacerbation on Health Related Quality of life in Patients with Severe Asthma	720 (A3001)	Nelsen L, Gunsoy N, Albers F, Mullerova H, Bradford E, Cockle S, Shin J-Y	B23 - NOVEL EPIDEMIOLOGY, MANAGEMENT, AND OUTCOMES IN ASTHMA Poster discussion session Session date: Monday 22nd May 2017 Session time: 09:15-11:15 Viewing time: 09:15-10:00 Discussion time: 10:00-11:15 Location: Room 209 A-C (South Building, Level 2), Walter E. Washington Convention Center
The Effects of Systemic Corticosteroids on Blood Eosinophil Counts in Patients with Asthma	P1038 (A3219)	Bell C, Lafeuille M-H, Duh M, Germain G, Lejeune D, Hahn B	B33 - TH2 ENDOTYPE IN ASTHMA Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area K, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Mepolizumab for the Treatment of Patients with Eosinophilic Granulomatosis with Polyangiitis: A Phase III Randomized, Placebo-controlled Trial	A7602	Wechsler M, Akuthota P, Jayne D, Khoury P, Klion A, Langford C, Merkel P, Moosig F, Specks U, Cid M, Luqmani R, Brown J, Mallett S, Philipson R, Yancey S, Steinfeld J, Weller P, Gleich G	JAMA-NEJM session presentation A2 - JAMA AND THE NEW ENGLAND JOURNAL OF MEDICINE. DISCUSSION ON THE EDGE: REPORTS OF RECENTLY PUBLISHED PULMONARY RESEARCH Clinical Topics in Pulmonary Medicine Sunday, May 21, 2017 Session time: 9:15 AM-11:15 AM Presentation time: 10:15-10:33 Location: Room 207 A-B (South Building, Level 2), Walter E. Washington Convention Center Normal presentation B14 - CLINICAL TRIALS ACROSS PULMONARY DISEASE Mini symposium Session date: Monday 22nd May 2017 Session time: 09:15-11:15 Presentation time: 09:30-09:45 Location: Liberty Ballroom I-L (Level M4), Marriott Marquis Washington
Umeclidinium/vilanterol trifenatate (GSK2592356)
Integrated Safety Analysis Comparing Umeclidinium/Vilanterol with Tiotropium	P1096 (A5480)	Long D, Ray R, Naya I, Lipson D	C41 - LONG ACTING BRONCHODILATOR THERAPY IN COPD II Thematic poster session Session date: Tuesday 23rd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Use of Triple COPD Therapy Among Incident Users of Tiotropium or Umeclidinium/Vilanterol	P1112 (A1409)	Hahn B, Hull M, Blauer-Peterson C, Buikema A, Stanford R	A37 - THE SPECTRUM OF COPD: EPIDEMIOLOGY TO OUTCOMES Thematic poster session Session date: Sunday 21st May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area L, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Umeclidinium bromide (GSK573719)
Prevention of Early Worsening of COPD with Umeclidinium Open Triple Therapy Compared with Inhaled Corticosteroid/Long-acting β2-agonist Alone: A Pooled Post Hoc Analysis	P375 (A3608)	Naya I, Lipson D, Compton C	B47-LONG ACTING BRONCHODILATOR THERAPY IN COPD I Thematic poster session Session date: Monday 22nd May 2017 Session time: 09:15-16:15 Viewing time: 11:15-13:00 Location: Area D, Hall B-C (Middle Building, Lower Level), Walter E. Washington Convention Center
Idiopathic Pulmonary Fibrosis
The TOPICAL Study of Inhaled Drug (Salbutamol) Delivery in Idiopathic Pulmonary Fibrosis	P1282 (A5382)	T. Maher, M. Biddiscombe, W. Fahy, P. Lukey, R. Marshall, S. Meah, E. Oballa, J. Simpson, S. Yang, O. Usmani	C38-UNDERSTANDING THERAPEUTICS IN IPF Thematic Poster Session TUESDAY, MAY 23, 2017 9:15 AM-4:15 PM Location: Walter E. Washington Convention Center, Area M, Hall B-C (Middle Building, Lower Level)
Randomised, Placebo-Controlled, Double-Blind, Repeat Dose Escalation Study with Omipalisib (GSK2126458) in Patients with Idiopathic Pulmonary Fibrosis (IPF)	A7010	T. Maher, P. Bareille, M. Costa, W. Fahy, S. Harrison, B. Holman, P. Lukey, Y. Man, P. Saunders, J. Simpson, R. Toshner, H. Woodcock, S. Yang, R. Marshall	D14-IPF: MOVING FORWARD Mini Symposium WEDNESDAY, MAY 24, 2017 9:15 AM-11:15 AM Location: Walter E. Washington Convention Center, Room 143 A-C (Middle Building, Street Level)

 

Commitment to respiratory disease

GSK has been a leader in respiratory for over 45 years, developing new and first-in-class medicines, approaches and insights which have helped to influence and support the management of asthma and COPD. The company is relentless in striving to expand knowledge and the understanding of respiratory disease to help transform the way that medicines are developed and is focused on identifying new scientific insights, applying our expertise and developing innovative new medicines that enable clinicians to tailor treatment to the individual needs of patients, to help patients to live every breath.

About COPD

COPD is a disease of the lungs that includes chronic bronchitis, emphysema or both. COPD is characterised by obstruction to airflow that interferes with normal breathing. COPD is thought to affect 329 million people worldwide.

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.

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide.

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment

About Relvar Ellipta (fluticasone furoate + vilanterol)

Relvar Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting beta2-agonist, in a single inhaler, the Ellipta.

Relvar Ellipta is indicated in Europe in the regular treatment of patients aged 12 and over with asthma, where use of a combination product (long-acting ß2–agonist, LABA, and inhaled corticosteroid, ICS) is appropriate: Patients not adequately controlled on both ICS and 'as-needed' short-acting ß2-agonist (SABA).

Full EU prescribing information is available at: EU Prescribing Information for Relvar Ellipta.

Important safety information for Relvar Ellipta in Europe

FF/VI is contraindicated in patients with hypersensitivity to either fluticasone furoate, vilanterol, or any of the excipients.

FF/VI should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.

Patients should not stop therapy with FF/VI in asthma or COPD, without physician supervision since symptoms may recur after discontinuation.

Asthma-related adverse events and exacerbations may occur during treatment with FF/VI. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of treatment with FF/VI.

Paradoxical bronchospasm may occur with an immediate increase in wheezing after dosing. This should be treated immediately with a short-acting inhaled bronchodilator. FF/VI should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary.

Cardiovascular effects, such as cardiac arrhythmias e.g. supraventricular tachycardia and extrasystoles may be seen with sympathomimetic medicinal products including FF/VI. Therefore fluticasone furoate/vilanterol should be used with caution in patients with severe cardiovascular disease.

For patients with moderate to severe hepatic impairment, the 92/22 mcg dose should be used and patients should be monitored for systemic corticosteroid-related adverse reactions. FF/VI 184/22 mcg is not indicated for patients with COPD. There is no additional benefit of the 184/22 mcg dose compared to the 92/22 mcg dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions.

An increase in the incidence of pneumonia has been observed in patients with COPD receiving FF/VI. There was also an increased incidence of pneumonias resulting in hospitalisation. In some instances these pneumonia events were fatal.

The incidence of pneumonia in patients with asthma was common at the higher dose. In a previous study of FF/VI in asthma the incidence of pneumonia in patients with asthma taking FF/VI 184/22 mcg was numerically higher compared with those receiving FF/VI 92/22 mcg or placebo.

Hyperglycaemia: There have been reports of increases in blood glucose levels in diabetic patients and this should be considered when prescribing to patients with a history of diabetes mellitus.

Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur than with oral corticosteroids. Possible systemic effects include Cushing’s syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).

FF/VI should be administered with caution in patients with pulmonary tuberculosis or in patients with chronic or untreated infections. Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with FF/VI.

Very common adverse reactions (occurring in >1/10 patients) with FF/VI were headache and nasopharyngitis. Common adverse reactions (occurring in >1/100 to <1/10 patients) were pneumonia, upper respiratory tract infection, bronchitis, influenza, candidiasis of mouth and throat, oropharyngeal pain, sinusitis, pharyngitis, rhinitis, cough, dysphonia, abdominal pain, arthralgia, back pain, fractures, and pyrexia and muscle spasms..Extrasystoles were observed as an uncommon adverse reaction (occurring in >1/1,000 to <1/100 patients). Rare adverse reactions (occurring in >1/10,000 to < 1/1,000) were hypersensitivity reactions (including anaphylaxis, angioedema, rash and urticaria), anxiety, tremor, palpitations, tachycardia and paradoxical bronchospasm. With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD. During clinical studies, pneumonia and fractures were more frequently observed in patients with COPD.

Relvar Ellipta is known as Breo Ellipta in the United States. Breo Ellipta is licensed in the US for:

• The once-daily treatment of asthma in patients aged 18 years and older.
  
  Long-acting beta2-adrenergic agonists (LABA), such as vilanterol, one of the active ingredients in Breo Ellipta, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe Breo Ellipta for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Breo Ellipta) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use BREO ELLIPTA for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids.

• Breo Ellipta is NOT indicated for the relief of acute bronchospasm. Full US prescribing information, including BOXED WARNING and Medication Guide is available at us.gsk.com or US Prescribing Information for Breo Ellipta.

About Nucala

Nucala is a monoclonal antibody that binds to IL-5, preventing it from binding to its receptor on the surface of eosinophils. Inhibiting IL-5 binding in this way reduces blood, tissue and sputum eosinophil levels.Error! Bookmark not defined.

Nucala has been approved in the US, EU, Canada, Australia and Japan. Further regulatory applications have been submitted and are under review in other countries.

In the EU, Nucala is licensed as an add-on treatment for severe refractory eosinophilic asthma in adult patients. For the EU Summary of Product Characteristics for Nucala, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003860/WC500198037.pdf

Nucala® is a registered trade mark of the GSK group of companies.

Important Safety Information for Nucala

The following information is based on the US Prescribing Information for Nucala. Please consult the full Prescribing Information for all the labelled safety information for Nucala.

CONTRAINDICATIONS

Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions (e.g. anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred following administration of Nucala. These reactions generally occur within hours of administration but in some instances can have a delayed onset (i.e. days). In the event of a hypersensitivity reaction, Nucala should be discontinued.

Acute Asthma Symptoms or Deteriorating Disease
Nucala should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
In controlled clinical trials, 2 serious adverse reactions of herpes zoster occurred in subjects treated with Nucala compared to none in placebo. Consider varicella vaccination if medically appropriate prior to starting therapy with Nucala.

Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids (ICS) abruptly upon initiation of therapy with Nucala. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
It is unknown if Nucala will influence a patient’s response against parasites. Treat patients with pre-existing helminth infections before initiating therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue treatment with Nucala until infection resolves.

ADVERSE REACTIONS

The most common adverse reactions (≥3% and more common than placebo) reported in the first 24 weeks of two clinical trials with Nucala (and placebo) were: headache, 19% (18%); injection site reaction, 8% (3%); back pain, 5% (4%); fatigue, 5% (4%); influenza, 3% (2%); urinary tract infection 3% (2%); abdominal pain upper, 3% (2%); pruritus, 3% (2%); eczema, 3% (<1%); and muscle spasm, 3% (<1%).

Systemic Reactions, including Hypersensitivity Reactions: In 3 clinical trials, 3% of subjects who received Nucala experienced systemic (allergic and nonallergic) reactions compared to 5% in the placebo group. Systemic allergic/hypersensitivity reactions were reported by 1% of subjects who received Nucala compared to 2% of subjects in the placebo group. Manifestations included rash, pruritus, headache, and myalgia. Systemic nonallergic reactions were reported by 2% of subjects who received Nucala and 3% of subjects in the placebo group. Manifestations included rash, flushing, and myalgia. A majority of the systemic reactions were experienced on the day of dosing. Reports of anaphylaxis have been received postmarketing.

Injection site reactions (e.g. pain, erythema, swelling, itching, burning sensation) occurred at a rate of 8% in subjects treated with Nucala compared with 3% in subjects treated with placebo.

USE IN SPECIFIC POPULATIONS

The data on pregnancy exposures from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are progressively transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a foetus are likely to be greater during the second and third trimesters of pregnancy.

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.

ANORO, BREO, RELVAR and ELLIPTA are trademarks of the GlaxoSmithKline group of companies.

GSK enquiries:

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D Principal risks and uncertainties in the company's Annual Report on Form 20-F for 2016.

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