Clinical Recommendations For The Use Of Dupilumab In Severe Asthma
Download a pdf version of this document here: Dupilumab Clinical Recommendation [v1 13 May 2022]
About the treatment
Introduction
Dupilumab is an add-on maintenance PBS listed treatment for people with severe uncontrolled eosinophilic asthma or severe allergic asthma (aged 6 years and older). Dupilumab is also indicated and PBS-subsidised as maintenance therapy for people with oral corticosteroid dependent eosinophilic or allergic asthma, or chronic severe atopic dermatitis. It is also indicated for adult patients with chronic rhinosinusitis with nasal polyposis.
Clinical Benefit
Dupilumab has demonstrated efficacy in reducing annualized exacerbation rates and the rate of severe exacerbations leading to hospitalizations and/or emergency department visits (2, 3). Additionally, significant increases in pre-bronchodilator FEV1 have been observed in clinical trials evaluating dupilumab (2, 3). Improvements in FEV1 were similar whether patients were receiving medium dose inhaled corticosteroids, high dose inhaled corticosteroids, or oral corticosteroids. Improvements in asthma control and asthma related quality of life have also been observed (2, 3). In regards to oral corticosteroid reduction, treatment with dupilumab has demonstrated greater reductions in daily maintenance oral corticosteroid dose, while maintaining asthma control, compared to placebo (4).
PBS eligibility for Dupilumab Access
See the PBS criteria for dupilumab here: https://www.servicesaustralia.gov.au/severe-asthma?context=23021
References
1. PBS. Written Authority Required Drugs: Severe Asthma 2022
2. Castro M, Corren J, Pavord ID, Maspero J, Wenzel S, Rabe KF, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med.
2018;378(26):2486-96.
3. Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to- high- dose inhaled corticosteroids plus a long acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose ranging
trial. Lancet. 2016;388(10039):31-44.
4. Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, et al. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. New England Journal of Medicine. 2018;378(26):2475-85.
