|Target||IL4 receptor alpha|
|Chemical and physical data|
|Molar mass||146898.98 g·mol−1|
Dupilumab, sold under the brand name Dupixent, is a monoclonal antibody used for allergic diseases such as eczema (atopic dermatitis), asthma and nasal polyps which result in chronic sinusitis.
Side effects include allergic reactions, cold sores, and inflammation of the cornea. It was developed by Regeneron Pharmaceuticals and Sanofi Genzyme. It received approval from the United States Food and Drug Administration (FDA) for moderate-to-severe atopic dermatitis in 2017 and for asthma in late 2018. The FDA considers it to be a first-in-class medication.
Dupilumab appears to be useful for moderate-to-severe atopic dermatitis for which it is approved in the United States. It is also being evaluated for treatment of persistent asthma in adults and adolescents. In October 2019, the European Commission (EC) approved Dupixent in chronic rhinosinusitis with nasal polyposis (CRSwNP).
There is one reported case of dupilumab triggering hair growth in a patient with complete hair loss. This is being investigated as an unintended, but positive, side effect.
One other case reports a possibility of chronic eosinophilic pneumonia associated with dupilumab.
Some concern of potential worsened COVID-19 disease with patients taking dupilumab have been expressed, but according to one study all patients had mild course of disease.
Mechanism of action
Dupilumab binds to the alpha subunit of the interleukin-4 receptor (IL-4Rα), making it a receptor antagonist. Through blockade of IL-4Rα, dupilumab modulates signaling of both the interleukin 4 and interleukin 13 pathways. In clinical trials, specimens from people receiving dupilumab showed decreased levels of Th2 bio-markers.
Development of dupilumab was a joint effort by Regeneron Pharmaceuticals and Sanofi, the latter of which provided 130 million dollars to Regeneron for research and development towards monoclonal antibodies.
The United States Food and Drug Administration granted it priority review status. On March 28, 2017, the U.S. Food and Drug Administration approved dupilumab injection to treat adults with moderate-to-severe eczema.
In October 2016, Regeneron completed a phase III trial comparing dupilumab with topical corticosteroids, in which subjects had a larger decrease in symptoms with both duplimab and topical steroids than with steroids alone.
Phase III studies were also performed to evaluate the efficacy of dupilumab in combination with topical corticosteroids. In these trials 38% and 36% of patients respectively, met the primary efficacy goal of the trial, compared to 8% and 10% under placebo.
Phase II trials for asthma treatment showed increased lung function for patients, showing increased forced expiratory volume.
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