Impact case study database

Through highly original reverse translational research and innovative laboratory methodologies, LILH were integral to the development of mepolizumab – a new class of highly effective treatment therapies for severe asthma. First licensed in 2015, the drug is prescribed worldwide, providing substantial economic benefits and significant patient outcome improvements.

Using novel targeting of distinct pathophysiological traits identified through innovative laboratory approaches by the team, with a classical precision medicine approach, LILH have trail-blazed therapy development for asthma and related diseases, achieving global impact in three main areas.

Economic Impact

Prior to LILH intervention, GSK intended to cease mepolizumab development. Leicester research prevented this and opened new markets enabling global release of mepolizumab (Nucala™), now a key pillar of GSK’s continued success. Nucala™ was first licensed in 2015 [E1] and has grown exponentially, with sales revenue rising from GBP1,000,000 in 2015 to GBP768,000,000 in 2019. To date, Nucala™ has generated GSK revenue of ~GBP1,800,000,000 [E2].

Significantly, Nucala™ is the fastest growing respiratory product within the GSK portfolio and, despite its relatively recent market introduction, has compensated for the general decline of sales within the GSK pharmaceuticals area. The 2019 Annual Report states that “respiratory sales were up 18% AER, 15% CER to [GBP]3,081 million, on growth of Trelegy, Elipta and Nucala”. Of the drugs listed as continuing successes, Nucala™ is the highest selling drug class [E2].

Beyond GSK, mepolizumab’s benefits are widespread within the healthcare sector. Of the GBP1,100,000,000 annual NHS cost of asthma treatment, GBP137,000,000 results from patient hospitalisation [E11]. Studies into mepolizumab’s efficacy demonstrate that its use provides a 73% reduction in hospitalisation, thereby saving the NHS an estimated ~GBP19,000,000 annually [E8].

Changing Clinical Practice

In 2016, a joint committee of the British Thoracic Society and the Scottish Intercollegiate Guideline Network, on which Brightling provided expert advice, produced their ‘British Guideline on the Management of Asthma’. This guideline, for the first time, recommended the use of mepolizumab as a treatment option for severe asthma based on LILH research. The guideline also extensively utilised LILH research to inform and underpin best-practice recommendations for eosinophilic disease detection. These recommendations were adopted and included in guidelines issued the same year by the British Society for Haematology, European Academy of Allergy and Clinical Immunology, and American Academy of Allergy, Asthma and Immunology [E4].

National clinical standards in the UK are defined by NICE whose recommendations are implemented as standard procedure within all NHS hospitals and represent the gold standard globally. Following the BTS-SIGN guideline, NICE began consultation on the use of mepolizumab as a treatment for severe asthma, resulting in the 2017 guideline ‘Mepolizumab for treating severe refractory eosinophilic asthma’. This codified the drug as a treatment option in the NHS for the first time, noting that prior to its creation “there was a need for alternative treatments for people with severe refractory eosinophilic asthma” [E3].

Since 2016, as a result of ground-breaking LILH research, mepolizumab is recommended for use in treatment of severe eosinophilic asthma in clinical practice guidelines worldwide including Japan, the EU, Canada, Australia, New Zealand, and Saudi Arabia [E4].

The Global Initiative for Asthma (GINA) is the leading international medical guidelines organisation covering asthma prevalence, morbidity, and mortality. Each year, GINA publish evidence-based guidelines titled ‘Global Strategy for Asthma Management and Prevention’, used by clinicians worldwide. In each iteration since 2017, mepolizumab is a recommended treatment option. This demonstrates the paradigm shift driven and enabled by LILH [E5].

Improving Patient Health Outcomes

Following NICE approval, a statement was released by the Director of the NICE Centre for Health Technology Evaluation, Professor Carole Longson, in which the novelty and efficacy of Mepolizumab was foregrounded. Longson stated that the 100,000 adults in England and Wales with severe, uncontrolled asthma previously “had limited treatment options” with many using inhaled corticosteroids for prolonged periods causing further complications such as diabetes and high blood pressure; “as the first biologic treatment to target immune cells called eosinophils. These cells are responsible for symptoms in thousands of asthma patients”. Mepolizumab would enable significant treatment and quality of life improvements for sufferers [E6].

By 2019, there were an estimated 17,507 UK patients eligible for mepolizumab, with 3,258 receiving the treatment [E11]. Global adoption of mepolizumab immediately provided significant patient health improvements. The French mepolizumab early-access programme demonstrated 86% reduction in severe exacerbations with 65% of patients stopping continuous corticosteroid treatment [E7], while the Australian Mepolizumab Registry showed 60% reduction in severe exacerbations. Follow-up studies demonstrated a 73% reduction in hospitalisations in patients receiving the drug between 2015 and 2017 [E8].

The real-world benefits of mepolizumab were confirmed by the US Institute for Clinical and Economic Review which concluded that use of the drug was associated with a 53% reduction in asthma exacerbations with similar reductions demonstrated in the annual per-patient rates of emergency department visits (61% reduction) and hospitalisations generally (69% reduction) [E9]. To date, an estimated 150,000 people worldwide have been treated with mepolizumab since 2015 [E10].

Without the expert intervention of LILH, mepolizumab would have been abandoned, falsely regarded as ineffective based on an incorrect understanding of asthma pathophysiology. Instead, thousands of patients globally now benefit from new treatment options and drastically improved life quality. Drug discovery methods have been revolutionised and avenues for novel, effective treatments have been opened, ensuring continued progress in the global battle against asthma.