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Phase II-III Studies of Mepoluzimab in eosinophilic asthma

Key features

• All three studies ran from 2010-2013

• More than 1,000 patients recruited to all studies

• Over 15 NIHR funded sites contributed to recruitment in the UK

• Glaxo Smith Kline (GSK) funded all three studies

• NIHR recruited all UK patients onto the studies

• Chief Investigator: Professor Ian Pavord

• Mepolizumab drug adopted into the NICE guidelines December 2016 to treat severe eosinophilic asthma

Severe eosinophilic asthma is a distressing and socially isolating condition for patients. It affects up to 100,000 adults and children in the UK and this type cannot be controlled by their regular medicines. There remains an unmet treatment need in asthma, which results in more than 1,000 deaths per year. But recent clinical trials using the drug Mepolizumab has proved to be an effect treatment for patients with severe eosinophilic asthma. For people with severe eosinophilic asthma, attacks can happen suddenly, so this group of people often live in fear, afraid to go out.

If an attack does happen, it may lead to hospitalisation and in the worst cases, death. People with severe eosinophilic asthma are often unable to work and may need help with day-to-day activities because of the symptoms, such as constant breathlessness. The standard treatment for severe eosinophilic asthma is oral steroids and although asthma can respond rapidly to these, they have long-term complications such as diabetes, high blood pressure and mood swings. The MENSA, DREAM AND SIRIUS studies tested if Mepolizumab could reduce asthama attacks for this group of patients, reduce oral steroid doses and provide cost-effective data for the NHS.

Outcomes and findings

Mepolizumab has been previously tested for general asthma and found to be ineffective. The MENSA, DREAM AND SIRIUS studies were set up after a proof-of-concept study, carried out in Leicester, suggested important benefits in a sub-group of patients with severe asthma and evidence of eosinophilic airway inflammation. The studies found that Mepolizumab stops the activity of a molecule called IL-5 which attracts asthma-causing eosinophils to airways and helps them survive. Recruitment for all three studies was supported by the NIHR from more than 15 different secondary care sites. The NIHR supported these sites through staff funding and training.

Patients on the studies were injected with Mepolizumab every four weeks for the time they were on the trial, in addition to their regular medicine. Patients had a notable reduction in the number of asthma attacks and it improved their lung function and quality of life. The studies confirmed the “first in class” novel strategy of targeting this inflammatory pathway in asthma and has led to adoption by NICE, making this the first entirely new treatment in asthma for 20 years.

“This is the first new treatment for asthma of this type in 20 years so we are delighted that it has shown to be so effective for patients in this group. Now that it’s approved by NICE, many patients across the UK will be able to access the treatment which will reduce the burden on the NHS.“

Professor Ian Pavord, Respiratory Medicine at the University of Oxford Chief Investigator on all three Studies for the NIHR

Value to the NHS

The MENSA, DREAM and SIRIUS studies were all used by NICE to decide on the usefulness and cost effectiveness of Mepoluzimab. These rigorously conducted studies with UK patient level data convinced NICE to embed this treatment into national treatment pathways. Notably the drug has become available and is used within the NHS within three years of the pivotal study completing. 

Key publications:

• Haldar P, Brightling CE, Hargadon B, Gupta S, Monteiro W, Sousa A, Marshall RP, Bradding P, Green RH, Wardlaw AJ, Pavord ID. Mepolizumab (anti-IL 5) and exacerbations of refractory eosinophilic asthma. N Engl J Med 2009;360:973-84

• Pavord ID, Korn S, Howarth P, Bleeker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo controlled trial. Lancet 2012;380:651-9

• Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, Humbert M, Katz LE, Keene ON, Yancey SW, Chanez P. Mepolizumab Treatment in Patients with Severe Eosinophilic Asthma. N Engl J Med. 2014; 371:1198-207

• Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID. Oral Glucocorticoid-Sparing Effect of Mepolizumab in Eosinophilic Asthma. N Engl J Med. 2014;371:1189-97.