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GSK to share evidence supporting a personalised approach to asthma treatment at ATS 2020 Virtual

For media and investors only

Issued: London UK

GlaxoSmithKline plc (LSE/NYSE: GSK) will share new evidence from the pivotal CAPTAIN study exploring the potential for a biomarker-directed approach to determine appropriate inhaled therapy for patients with uncontrolled asthma. The new sub-analyses will be amongst a range of abstracts GSK is presenting at the American Thoracic Society (ATS) Virtual Conference, 5-10 August 2020, advancing its increasingly personalised approach towards asthma management.

Scientific understanding of the heterogenous nature of asthma is growing, and evidence now suggests that identifying specific ‘treatable traits’ in patients could help predict their response to different types of inhaled therapy, helping healthcare professionals select the right treatment for the right patient.

The CAPTAIN study was designed to evaluate once-daily single inhaler triple therapy as a treatment for adults whose asthma is inadequately controlled despite treatment with maintenance asthma medication. The analyses being presented at ATS provide new insights on triple therapy and the movement towards personalised treatment.

Christopher Corsico, Senior Vice President Development, GSK commented, “The need for a more targeted, personalised and proactive approach in asthma management is clear. Many patients continue to suffer with avoidable symptoms of their disease. The data we are sharing at ATS explore the specific characteristics that may help determine treatment options for these patients, such as increasing bronchodilation or further reducing inflammation. Progressing towards an increasingly personalised approach has the potential to reshape the asthma treatment paradigm and ultimately improve patient outcomes.”

GSK has been a leader in establishing a targeted approach to the management of patients suffering with severe asthma through the use of biomarkers such as eosinophil counts. In line with efforts to further advance eosinophil science, GSK will also share new data on its targeted biologic therapy, Nucala (mepolizumab). Results from the COMET study, which explored outcomes in patients with severe eosinophilic asthma after continuing or stopping Nucala following long-term treatment, will be shared for the first time, as will data from the pivotal phase 3 trial in hypereosinophilic syndrome (HES), a rare but severe eosinophil-driven disease. Nucala is not yet approved for use in HES anywhere in the world.

Reinforcing the need for further research and new treatment options, data will also be presented on the burden of asthma looking at the proportion of patients with sub-optimal levels of asthma control.

The full list of GSK ATS abstracts from across its broad respiratory portfolio and pipeline includes:

Abstract Name

Study Author

*Lead Presenter, where relevant

The Severe Asthma Patient Experience: In-Clinic and Self-Administration of Mepolizumab

Bernstein D*, Prazma C, Brightling CE, Follows R, Bentley J, Bradford ES

Asthma Control Among the Treated U.S. Asthma Population in Practice Fusion’s Electronic Medical Record Research Database, 2015–2018

Davitte J, DeBarmore B, Hinds D, Zhang S, Sansbury L

Prevalence of Asthma and Severe Asthma in Patients Affiliated to the Hospital Italiano Medical Care Program in Buenos Aires, Argentina

Moraes dos Santos F, Abreu G, Thiago N, Lijavetzky AM, Espinosa J, Raimondi A, Felice R, Jotimliansky L, Levy G, Di Boscio V, Beruto V, Scibona P, Belloso W, Blugerman GA, Svetliza GN, Wainstein E, Talamoni H, Pisapia N, Soares C

 

Assessment of Asthma Control in Respiratory Specialist Offices in the US

Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D,

McSorley D, Molfino NA, Slade DJ

 

Characterization of Severe Asthma Patients Affiliated to the

Hospital Italiano Medical Care Program in Buenos Aires, Argentina

Moraes dos Santos F, Abreu G, Nogueira T, Lijavetzky AM, Espinosa J, Raimondi A,

Felice R, Jotimliansky L, Levy G, Di Boscio V, Beruto V, Scibona P, Belloso W, Blugerman GA, Svetliza GN, Wainstein E, Talamoni H, Pisapia N, Soares C

 

Treatment Sequencing Among Asthma Patients who were Newly Treated with Long-Acting Antimuscarinic Antagonist (LAMA) in the United States

Sansbury L, Hinds D, Chao J, Semus S, Zhang S

 

Rescue Medication Use as an Indicator of Symptom Burden in Patients with COPD: A Post Hoc Analysis of the EMAX Trial

Kerwin EM, Bjermer L, Maltais F, Boucot I, Naya I, Tombs L,

Jones P, Compton C, Lipson DA, Vogelmeier C

 

Improvements in COPD Symptoms with Umeclidinium/Vilanterol Analyzed by Baseline CAT Score: A Post Hoc Analysis of the EMAX Trial

 

Vogelmeier C, Boucot I, Kerwin EM, Bjermer L, Jones P, Naya I, Tombs L, Compton C, Lipson DA, Maltais F

 

Efficacy of Umeclidinium/Vilanterol Versus Umeclidinium or Salmeterol: A Number-Needed to Treat Analysis of the EMAX Trial

Bjermer LH, Maltais F, Vogelmeier C, Naya I, Jones P, Tombs L, Boucot I, Compton C, Lipson DA, Keeley T, Kerwin EM

 

Neutrophil Extracellular Traps and CXCR2 Antagonism in Chronic Obstructive Pulmonary Disease: A Pilot Randomized Control Study

Keir H*, Richardson HJI, Mayhew D, Waite S, Fillmore C, Lazaar AL, Miller BE, Tal-Singer R, Chalmers JD, Mohan D

 

CAPTAIN Study: Simultaneous Step-Up to High Dose Fluticasone Furoate and Addition of Umeclidinium for the Treatment of Inadequately Controlled Asthma

Kerstjens H*, Pavord ID, Peachey G, Kerwin E, Nathan R, Hanania NA, Pascoe S, Fowler A, Bailes Z, Edwards D, Papi A, Barnes N, Boulet L, Tabberer M, Oppenheimer J, Lee L

 

Outcomes Following Continuation or Stopping Long-Term Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma: The Randomized COMET Trial

Moore W*, Kornmann O, Humbert M, Poirier C, Bel EH, Kaneko N, Smith SG, Martin N, Gilson MJ, Price RG, Bradford ES, Liu MC

 

Efficacy and Safety of Mepolizumab in Hypereosinophilic Syndrome: A Phase III, Randomized, Placebo-Controlled Trial

Roufosse F*, Steinfeld J, Kahn J, Gleich G, Rothenberg M, Wardlaw A, Yun Kirby S, Gilson M, Bentley J, Bradford ES, Yancey S

 

Asthma Control in Patients With Severe Eosinophilic Asthma Treated With Mepolizumab in Real-Life Settings: The Prospective, REALITI-A Study

Chaudhuri R, Canonica GW, Bals R, Lougheed MD, Pilette C,

Ramos-Barbón D, Pollard S, Maxwell A, Worsley S, Van Dyke MK, Joksaite S, Howarth P, Alfonso Cristancho R

 

Single-Inhaler Triple Therapy Fluticasone Furoate/Umeclidinium/Vilanterol Improves Lung Function and Symptoms Compared with Tiotropium Monotherapy in Patients With Symptomatic Chronic Obstructive Pulmonary Disease at Risk of Exacerbations

Obeid D*, Bansal S, Brown N, Compton C, Corbridge TC, Dorais K, Erb D, Harvey C, Kaisermann MC, Kaye M, Lipson DA, Martin N, Zhu CQ, Papi A

 

Once-Daily Single-Inhaler Versus Twice-Daily Multiple-Inhaler Triple Therapy: Two Replicate Trials in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Ferguson G*, Brown N, Compton C, Corbridge TC, Dorais K, Fogarty CM, Harvey C, Kaisermann MC, Lipson DA, Martin N, Sciurba FC, Stiegler MA

 

Symptom Burden in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone

Propionate/Salmeterol Therapy

Moretz C, Hahn B, White J, Goolsby Hunter A, Essoi B, Elliott C, Ray R

 

Assessment of Peak Inspiratory Flow Rate in Patients with Chronic Obstructive Pulmonary Disease: Impact on Dose Delivery and Relationship with Response to Fluticasone Furoate/Umeclidinium/Vilanterol Triple Therapy

Anderson M*, Drummond M, Jain R, Corbridge TC, Zhu C, Collison K, Hamilton M, Prime D, Martin N

 

 

Evaluation of Medication Adherence and Rescue Medication Use in Non-Exacerbating COPD Patients Receiving Umeclidinium/Vilanterol or Budesonide/Formoterol as Initial

Maintenance Therapy Within a Large US Health Insurer Database

 

Cole A, Moretz C, Mu G, Wu B, Guisinger A, Liu Y, Baylis L

 

INTREPID: Clinical Effectiveness of Once-Daily Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol Versus Multiple-Inhaler Triple Therapy in Usual Clinical Practice

Halpin D*, Worsley S, Ismaila AS, Astrom J, Beeh KM, Brintziki D, Di Boscio V, Kocks J, Marin JM, Tabberer M, Snowise NG, Compton C

 

Analysis of a Composite Endpoint of Exacerbation and Early Study Treatment Withdrawal in Symptomatic Patients with COPD Free of Inhaled Corticosteroids: A Post Hoc Analysis of the EMAX Trial

Kerwin EM, Maltais F, Boucot I, Naya I, Bjermer L, Jones P,

Tombs L, Lipson DA, Compton C, Vogelmeier C

 

Use of Mepolizumab Among Individuals with Asthma in the U.S.

Wu AC, McMahon P, Mendelsohn A, Welch E, Gokhale M, McMahill-Walraven C, Zhang J, Jamal-Allial A, Gallagher M, Draper C, Kline A, Koerner L, Brown J, Van Dyke M

 

Continuity of Care Assessment Within a Vertically

Integrated Care Management Organization Before and

After COPD-Related Exacerbations

Mularski RA, Wu B, Fuoco M, Moretz C, McBurnie M, Stanford R, Crawford P, Gratie D, Salas B

 

Utility of Self-Administered Questionnaires for Identifying

Individuals At-Risk for COPD in Japan: The OCEAN

(Okinawa COPD Case Finding Assessment) Study

Tamaki K, Sakihara E, Miyata H, Hirahara N, Kirichek O, Tawata R, Akiyama S, Katsumata M, Haruya M, Ishii T, Tal-Singer R, Simard E, Kaise T

 

Comparison of Peak Inspiratory Flow Rate Between Clinical Trial and Real-World Populations

Corbridge T*, Mularski RA, Drummond MB, Jain R, Moretz C, Zhu CQ, Collison K, Hamilton M, Prime D, Martin N

 

Predicting Improvements in COPD with Clinically Important Improvements in Patient Reported Outcomes: A Post Hoc Analysis of the EMAX Trial

Vogelmeier C*, Kerwin EM, Naya I, Tombs L, Bjermer L, Maltais F, Jones P, Lipson DA, Compton C, Boucot I

 

Prevalence and Characteristics of Individuals with

Impaired Lung Function in the General Population in Japan: The Okinawa COPD Case Finding Assessment (OCEAN) Study

Kaise T, Tamaki K, Sakihara E, Miyata H, Hirahara N, Kirichek O, Tawara R, Akiyama S, Katsumata M, Haruya M, Ishii T, Tal-Singer R, Simard E

 

Exploring the Patient Experience of Chronic Cough and Mucus in COPD Using Qualitative Methods

Keeley T*, Kaur S, Tal-Singer R, Stott-Miller M, Morgan L, Miller BE, Gater A, Lazaar AL, Hall R

 

Evaluation of the Psychometric Properties,

Scoring Algorithm, and Score Interpretation of the E-RS®: Asthma in Two Clinical Trials of Moderate to Severe Asthma

Tabberer M, von Maltzahn R, Bacci E, Karn H, Hsieh R,

Bailes Z, Fowler A, Lee L, Murray L

 

CAPTAIN Study: Daily Digital Spirometry and Symptom Data for Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) in Asthma

Lee L, Boulet L, Fowler A, Tabberer M, Bailes Z, Pascoe S, Kerwin EM

 

CAPTAIN Study: Evaluating the Efficacy of Once-Daily, Single-Inhaler Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI in Inadequately Controlled Asthma Using Change in Asthma Control Questionnaire and the Relationship with Trough FEV1

Fowler A, Kerstjens H, Bailes Z, Tabberer M, Barnes N,

Peachey G, Oppenheimer J, Lee L

 

Differences in Patient Characteristics Between Asthma Patients with and without Blood Eosinophil Measurements

Verhamme KM, de Ridder M, Webb D, Prieto-Alhambra D, Rijnbeek P, Pedersen L, Van Dyke M, Brusselle GG

 

CAPTAIN Study: Treatable Traits and the Outcome of Treatment with Inhaled Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Versus FF/VI Therapies in Patients with Uncontrolled Asthma,

a Pre-Specified Subgroup Analysis

Pavord I*, Fowler A, Kerstjens H, Papi A, Hartley B, Goldfrad C, Barnes N, Oppenheimer J, Pizzichini E, Lee LA

 

 

Real World Evidence in Asthma: Pulmonary Function and Asthma Control in Respiratory Specialty Clinics in the US

Molfino NA, Averell CM, Hahn B, Zografos L, Gilsenan A, Richardson D, McSorley D, Slade DJ

 

Prescription Patterns Among Newly Diagnosed Patients

with Eosinophilic Granulomatosis with Polyangiitis

(EGPA, formerly Churg-Strauss Syndrome): Evidence from a Managed Care Database in the United States

Bell C, Blauer-Peterson C

 

Patients with Uncontrolled Asthma Eligible for a Biologic

Molfino NA, Averell CM, Hahn BA, Zografos L, Gilsenan A,

Richardson D, McSorley D, Slade DJ

 

Changes in Oral Corticosteroid (OCS) Use Following Initiation of Mepolizumab Therapy in Patients with Asthma

Hahn B, Bogart M, Silver J, Moore-Schiltz L, Wu J, Packnett E

 

Treatment Patterns and Disease Burden of Triple Therapy in Asthma

Bogart M, Chastek B, White J, Sundquist K, Averell CM

 

Altered Levels of Exhaled Volatile Organic Compounds are Associated with Early Signs of Lung Function Abnormality in Young Smokers

Bikov A

 

Feasibility of an Observational, Digitally-Enabled Study Using Sensors and Electronic Health Record-Derived Outcomes

Locantore N

 

About asthma and severe eosinophilic asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily lives.

The causes of asthma are not completely understood but likely involve an interaction between a person’s genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

Severe asthma is defined as asthma which requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy.

Severe asthma patients are also often categorised by long-term use of oral corticosteroids (OCS). In a sub-set of severe asthma patients, the over-production of eosinophils (a type of white blood cell) is known to cause inflammation in the lungs. Interleukin-5 (IL-5) is the main promoter of eosinophil growth, activation and survival and provides an essential signal for the movement of eosinophils from the bone marrow into the lung. Studies suggest that approximately half of patients with severe asthma have eosinophilic airway inflammation.

About the CAPTAIN Study

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to adults aged 18 and older whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication. In the study 2,436 patients were treated across 15 countries.

About Trelegy Ellipta (FF/UMEC/VI) in the US

FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK’s Ellipta dry powder inhaler.

FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm or for the treatment of asthma. US Prescribing Information for Trelegy Ellipta. An sNDA for FF/UMEC/VI for the treatment of asthma in adults was submitted to FDA in October 2019.

Important Safety Information for Trelegy Ellipta

The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta for the maintenance treatment of patients with COPD. Please consult the full Prescribing Information for all the labelled safety information.

Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm or for the treatment of asthma.

Trelegy Ellipta is contraindicated in patients with severe hypersensitivity to milk proteins or any of the ingredients.

LABA monotherapy increases the risk of serious asthma-related events.

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 patients for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.

Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Trelegy Ellipta long term. 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 upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

About Nucala

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils reducing blood eosinophils to normal levels. The mechanism of action of mepolizumab in asthma has not been definitely established. At normal levels eosinophils may play a role in maintaining health.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 21 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use from ages six to 17 in Europe and the US and several other markets in SEA. In the US, Japan and Canada and a number of other markets, it is approved for use in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Regulatory submissions for Hypereosinophilic Syndrome and chronic rhinosinusitis with nasal polyps are expected to progress in 2020. Mepolizumab is also being investigated for COPD. Mepolizumab is not yet approved for use in HES, chronic rhinosinusitis with nasal polyps or COPD anywhere in the world.

Mepolizumab is not approved for the relief of acute bronchospasm or status asthmaticus. Full US Prescribing Information is available at US Prescribing Information Nucala.

Important safety information for Nucala

The following information is based on the US Prescribing Information for Nucala in licensed indications only. 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 (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of Nucala. Discontinue Nucala in the event of a hypersensitivity reaction.
  • Do not use to treat acute bronchospasm or status asthmaticus.
  • Herpes zoster infections have occurred in patients receiving Nucala. Consider vaccination if medically appropriate.
  • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Nucala. Decrease corticosteroids gradually, if appropriate.
  • Treat patients with pre-existing helminth infections before therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue Nucala until parasitic infection resolves.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) in severe asthma clinical trials included headache, injection site reaction, back pain, and fatigue. Injection site reactions (eg, pain, erythema, swelling, itching, burning sensation) occurred in 8% of subjects treated with 100 mg of Nucala versus 3% treated with placebo.

In a clinical trial in patients with EGPA receiving 300 mg of Nucala, no additional adverse reactions were identified to those reported in severe asthma clinical trials. Injection site reactions (eg, pain, erythema, swelling) occurred in 15% of subjects treated with 300 mg of Nucala versus 13% treated with placebo.

GSK’s commitment to respiratory disease

For over 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world’s first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today’s industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won’t stand still until the simple act of breathing is made easier for everyone.  

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us

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