Abstract
Dupilumab (Dupixent®) is a fully human monoclonal antibody against the interleukin (IL)-4 receptor α subunit of IL-4 and IL-4/IL-13 receptor complexes. IL-4 and IL-13 are key cytokines in driving type 2 inflammation, a dominant and largely eosinophilic inflammatory pathway in asthma. Trials evaluating the efficacy of dupilumab in asthma include three pivotal, placebo-controlled, phase 3 or 2b trials of 24–52 weeks’ treatment duration in patients aged ≥ 12 years with moderate-to-severe asthma (inadequately controlled with medium-to-high dose inhaled corticosteroids) or severe asthma [dependent on oral corticosteroids (OCS) for control]. In these studies, adding subcutaneous dupilumab (200 or 300 mg every 2 weeks) to background therapy was generally well tolerated and reduced the rate of severe asthma exacerbations, improved lung function, as well as asthma control and, where specified, health-related quality of life (HR-QOL), and enabled OCS maintenance doses to be reduced without impacting asthma control. Dupilumab displayed efficacy across various patient subgroups, although those with heightened type 2 immune activity, including elevated eosinophils and fractional exhaled nitric oxide, tended to have a more prominent treatment benefit. Dupilumab is consequently widely indicated (and a valuable treatment option) as an add-on therapy in patients aged ≥ 12 years who have severe/moderate-to-severe asthma with a type 2 inflammation/eosinophilic phenotype despite conventional treatments or have OCS-dependent asthma.
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During the peer review process, the manufacturer of dupilumab was also offered the opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
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The preparation of this review was not supported by any external funding.
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Emma Deeks is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.
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Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.10252718.
The manuscript was reviewed by:C. Incorvaia, Cardiac and Pulmonary Rehabilitation Unit, ASST Pini-CTO, Milan, Italy; I. D. Pavord, NDM Research Building, Oxford Respiratory NIHR BRC, University of Oxford, Oxford, UK.
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Deeks, E.D. Dupilumab: A Review in Moderate to Severe Asthma. Drugs 79, 1885–1895 (2019). https://doi.org/10.1007/s40265-019-01221-x
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DOI: https://doi.org/10.1007/s40265-019-01221-x