31 Oct FDA Approves Dupixent: Only Self-Administered Biologic for Moderate-to-Severe Asthma

MedicalResearch.com Interview with:
Neil Graham,  M.B.B.S., M.D., M.P.H
VP of Immunology & Inflammation
Regeneron

MedicalResearch.com: What is the background for this announcement? 

Response: Patients with moderate-to-severe asthma often have uncontrolled, persistent symptoms despite standard-of-care therapy that may make them suitable for treatment with a biologic therapy. They live with coughing, wheezing and difficulty breathing, and are at risk of severe asthma attacks that may require emergency room visits or hospitalizations. ^[i],[ii] Oral corticosteroids can provide relief for severe, short-term symptoms. However, their chronic use is limited to the most severe patients due to the potential for serious side effects. ^[iii],[iv]

A particular type of inflammation contributes to the cause of uncontrolled symptoms in multiple inflammatory diseases such as asthma and atopic dermatitis.[v] Dupixent is a medicine that inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to this type of inflammation. This inhibits cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE; however, the mechanism of action of Dupixent in asthma has not been definitively established.

MedicalResearch.com: What are the main findings of Dupixent asthma pivotal clinical trial program?

Response: FDA approval was based on efficacy and safety data from the LIBERTY ASTHMA clinical trial program. The pivotal trial program evaluated 2,888 adult and adolescent patients with moderate-to-severe asthma in three randomized, placebo-controlled, multicenter trials for six months to one year (24 to 52 weeks).  All trials enrolled patients irrespective of minimum baseline eosinophil levels. In the trials, Dupixent reduced severe exacerbations, improved lung function, reduced oral corticosteroid use and improved measures of health-related quality of life.  The adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood. 

MedicalResearch.com: How does Dupixent differ from other medications for moderate to severe asthma?

Response: Despite available treatments, there are significant unmet needs for patients with moderate-to-severe asthma. Dupixent is the only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype and the only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype. Dupixent is also the only asthma biologic that offers patient self-administration at home. Additionally, Dupixent is the only asthma biologic also approved for adult patients with uncontrolled moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway. 

MedicalResearch.com: What should readers take away from your report? 

Response: Last week’s approval of Dupixent marks a significant development for people with asthma aged 12 years and older who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma. For people with asthma, Dupixent comes in two doses (200 mg and 300 mg) for subcutaneous injection every other week at different injection sites after an initial loading dose. It can be given in a clinic or, for convenience, at home by self-administration after training by a healthcare professional. Both doses are now available. 

MedicalResearch.com: Is there anything else you would like to add?

Response: Patients who are taking other biologics for asthma should not change or stop their asthma medicine without talking to their healthcare provider.

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Citations:

[1] Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2018. Available at: http://ginasthma.org/download/832/. Last accessed July 2018.

[1] Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014;24:14009.

[1] Daugherty J et al. The impact of long-term systemic glucocorticoid use in severe asthma: A UK retrospective cohort analysis. J Asthma. 2017 Sep 19:1-8.

[1] Lefebvre et al. Burden of systemic glucocorticoid-related complications in severe asthma. Curr Med Res Opin. 2017 Jan;33(1):57-65.

[1] Gandhi NA, BL Bennett, NM Graham, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov 2016;15(1):35-50.

[i] Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2018. Available at: http://ginasthma.org/download/832/. Last accessed July 2018.

[ii] Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med 2014;24:14009.

[iii] Daugherty J et al. The impact of long-term systemic glucocorticoid use in severe asthma: A UK retrospective cohort analysis. J Asthma. 2017 Sep 19:1-8.

[iv] Lefebvre et al. Burden of systemic glucocorticoid-related complications in severe asthma. Curr Med Res Opin. 2017 Jan;33(1):57-65.

[v] Gandhi NA, BL Bennett, NM Graham, et al. Targeting key proximal drivers of type 2 inflammation in disease. Nat Rev Drug Discov 2016;15(1):35-50.

FDA APPROVES ASTHMA INDICATION FOR DUPIXENT® (DUPILUMAB)

Last Updated on October 31, 2018 by Marie Benz MD FAAD