NICE Recommends Dupixent (dupilumab) for the Treatment of Severe Asthma

Mon, October 18, 2021, 3:39 AM·7 min read

  • Final Appraisal Determination (FAD) means a novel biologic will be routinely available on the NHS(1)

  • Data shows that, compared to placebo, dupilumab reduces the rate of severe asthma attacks and the number of people needing urgent hospital care(2,3,4)

  • As healthcare services continue to be stretched by COVID-19, effective asthma management that reduces hospital admissions is more important than ever(5)

READING, England, Oct. 18, 2021 /PRNewswire/ -- The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Dupixent® (dupilumab), as an add-on maintenance treatment for severe asthma.1* (Full details below and recommendation here)

We know that every ten seconds someone in the UK has a potentially life-threatening asthma attack,6 with approximately 77,000 people being hospitalised each year7 despite severe asthma being treatable. Now that a new treatment option is available, this is good news for the 200,000 people living with severe asthma in the UK.8

"Living with severe, uncontrolled asthma results is a constant struggle with shortness of breath and wheezing, making it very hard to lead a normal life. It can be life threatening when medications are unable to keep asthma under control and severe asthma attacks are too often a reality," said Professor Ian Pavord, Professor of Respiratory Medicine, Respiratory Medicine Unit and Oxford Respiratory NIHR BRC, Nuffield Department of Medicine, University of Oxford. "Providing patients with new treatment options is particularly important during the ongoing pandemic as people with severe asthma feel especially vulnerable. Biologic treatments, such as dupilumab, which target one of the dominant underlying causes of severe asthma, can transform outcomes for people with severe asthma."

Dupilumab acts on the type 2 immune response which is believed to be a major driver in severe asthma. Dupilumab is different to many existing treatments as it works by dampening down two key drivers of the inflammatory process - interlukin-4 and interlukin-13.2 In severe asthma patients with type 2 inflammation it has been shown, to reduce severe asthma attacks by up to 67% compared to placebo (0.40 exacerbation rate versus 1.24 exacerbation rate), and hospitalisations/A&E visits by nearly 50% compared to placebo (0.035 hospitalisation rate versus 0.065 hospitalisation rate).2

In addition to reducing asthma attacks and hospitalisations/A&E visits, in clinical trials, dupilumab also improved lung function (FEV1) in patients with type 2 inflammation by up to 250mls compared to placebo.2 Furthermore, dupilumab eliminated the need to use oral corticosteroids in 52% (51 patients) of OCS-dependent patients with type 2 inflammation (compared to 29% (27 patients) with placebo).3

The publication date of NICE Final Guidance for the use of dupilumab within NHS England for treating severe asthma is anticipated in early December. Dupilumab will be made available through NHS England within three months from the date of publication.

About the LIBERTY ASTHMA clinical programme and type 2 inflammation
The LIBERTY ASTHMA clinical programme evaluated 2,888 adults and adolescents (12 years of age and older). All trials enrolled eligible asthma patients irrespective of minimum baseline type 2 inflammatory biomarkers, such as eosinophils or fractional exhaled nitric oxide (FeNO) levels.2,3

The NICE FAD is based on a subset of patients taking part in the LIBERTY ASTHMA QUEST clinical trial, with high exacerbation rates and high biomarkers indicating type 2 inflammation.

The type 2 immune response is believed to be a major driver in severe asthma. Uncontrolled severe asthma is mainly driven by type 2 inflammatory cytokines interleukin-4 (IL-4), interleukin-13 (IL-13) and interleukin-5 (IL-5), which contribute to common asthma phenotypes including eosinophilic, allergic and mixed.9,10,11

About Dupilumab
NICE have made a recommendation on the use of dupilumab in severe asthma. Visit the NICE website for more information on the dupilumab recommendation: https://www.nice.org.uk/consultations/874/1/recommendations

The patient population includes a group with type 2 inflammation defined by raised blood eosinophils of 150 cells per microlitre or more and a fractional exhaled nitric oxide (FeNO) of 25 or more that are currently not eligible for other biologics under NICE guidance, and therefore represents a significant unmet need. For patients who have failed to respond adequately to other biologic treatment according to NICE guidance, the reimbursed patient population will allow subsequent treatment with dupilumab.

Those patients who fulfil dupilumab licensed posology for 300 mg dosing are excluded from the reimbursed population.1

Dupilumab is a human monoclonal antibody that inhibits the signalling of IL-4 and IL-13, two key proteins that play a central role in the type 2 inflammation that underlies specific types of asthma, as well as several other allergic diseases. This effect is associated with the reduction of type 2 inflammatory biomarkers (compared to placebo) including FeNO, immunoglobulin E (IgE) and eotaxin-3 (CCL26).12,13

Dupilumab is licensed as an add-on maintenance treatment for people with severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fractional FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.14 For further information please see the latest Dupilumab SmPC here: https://www.medicines.org.uk/emc/product/11321/smpc#gref

About Sanofi

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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

For further information, visit www.sanofi.co.uk.

Adverse events
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Sanofi. Opening office hours: 09.00 – 17.00 (Monday to Thursday) 09.00 – 16.00 (Friday) Tel.: +44 (0) 800 090 2314. Alternatively, send via email to UK-drugsafety@sanofi.com

References

1 NICE, (2021). Final Appraisal Determination. Dupilumab for treating severe asthma with type 2 inflammation. Available at: [insert link]. Last accessed: MONTH 2021.

2 Castro M, Corren J, Pavord ID, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med. 2018;378:2486–96.

3 Rabe KF, Parameswaran N, Brusselle G, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018;378:2475–85.

4 Clinicaltrials.gov. An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma. Available at: https://clinicaltrials.gov/ct2/show/NCT01854047. Last accessed: October 2021.

5 Global Initiative for Asthma. Global strategy for asthma management and prevention. 2020. Available at: https://ginasthma.org/wp-content/uploads/2020/04/GINA-2020-full-report_-final-_wms.pdf Last accessed: October 2021

Asthma UK. Asthma Facts and Statistics. Available at: https://www.asthma.org.uk/about/media/facts-and-statistics/ Last accessed: October 2021.

7 Mukherjee M, Stoddart A, Gupta RP. et al. The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases. BMC Med 14, 113 (2016). https://doi.org/10.1186/s12916-016-0657-8

8 Asthma UK, (2018). Slipping through the net: The reality facing patients with difficult and severe asthma. Available at: https://www.asthma.org.uk/6fc29048/globalassets/get-involved/external-affairs-campaigns/publications/severe-asthma-report/auk-severe-asthma-gh-final.pdf. Last accessed: October 2021.

9 Tran TN, Zeiger RS, Peters SP, et al. Overlap of atopic, eosinophilic, and TH2-high asthma phenotypes in a general population with current asthma. Ann Allergy Asthma Immunol. 2016;116(1):37–42.

10 Seys SF, Scheers H, Van den Brande P, et al. Cluster analysis of sputum cytokine-high profiles reveals diversity in T(h)2-high asthma patients. Respir Res. 2017;18(1):39.

11 Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014;133(2):388–94.

12 Wenzel S, Ford L, Pearlman D, et al. Dupilumab in persistent asthma with elevated eosinophil levels. N Engl J Med. 2013;368(26):2455–66.

13 Gandhi N, Bennett B, Graham N, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov. 2016;15:35–50.

14 Dupixent summary of product characteristics. 20 September 2021.

∇ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. See yellowcard.mhra.gov.uk for how to report side effects.
*In patients aged 12 years and older whose asthma is not adequately controlled by high dose inhaled corticosteroids plus another medicine that prevents asthma attacks (maintenance treatment). Dupilumab can only be prescribed to patients who have an inflammation of their airways called 'type 2 inflammation'

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