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Bone and Cancer

Clinical Trials

Dupixent (dupilumab)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved June 2019

Specific Treatments:

chronic rhinosinusitis with nasal polyposis in adults

General Information

Dupixent (dupilumab) is a fully-human monoclonal antibody which inhibits the overactive signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that contribute to inflammation. 

Dupixent is specifically indicated for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled. 

Dupixent is supplied as an injection for subcutaneous administration.  The recommended dose of Dupixent for adult patients is 300 mg given every other week.

Clinical Results

FDA Approval

The FDA approval of Dupixent for chronic rhinosinusitis with nasal polyposis in adults was based on two pivotal trials (the 24-week SINUS-24 and 52-week SINUS-52) that are part of the Phase 3 LIBERTY clinical trial program. These trials evaluated Dupixent 300 mg every two weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared to placebo injection plus MFNS. In these trials, Dupixent significantly improved key disease measures and met all primary and secondary endpoints. At 24 weeks, patients treated with Dupixent achieved statistically significant improvements in all primary and secondary endpoints, including:

  • Co-primary endpoints:
    • 57% and 51% improvement in their nasal congestion/obstruction severity compared to a 19% and 15% improvement with placebo in SINUS-24 and SINUS-52, respectively (least squares [LS] mean change from baseline of -1.34 and -1.25 for Dupixent compared to -0.45 and -0.38 for placebo; difference between Dupixent and placebo: -0.89 and -0.87).
    • 33% and 27% reduction in their nasal polyps score compared to a 7% and 4% increase with placebo in SINUS-24 and SINUS-52, respectively (LS mean change from baseline of -1.89 and -1.71 for Dupixent compared to 0.17 and 0.10 for placebo; difference between Dupixent and placebo: -2.06 and -1.80).

Side Effects

Adverse effects associated with the use of Dupixent in adults with chronic rhinosinusitis with nasal polyposis may include, but are not limited to, the following:

injection site reactions

eosinophilia

insomnia

toothache

gastritis

arthralgia

conjunctivitis

 

Mechanism of Action

Dupixent (dupilumab) is a human monoclonal IgG4 antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling by specifically binding to the IL-4Rα subunit shared by the IL-4 and IL-13 receptor complexes. Dupilumab inhibits IL-4 signaling via the Type I receptor and both IL-4 and IL-13 signaling through the Type II receptor. Multiple cell types that express IL-4Rα (e.g., mast cells, eosinophils, macrophages, lymphocytes, epithelial cells, goblet cells) and inflammatory mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines, chemokines) are involved in inflammation. Blocking IL-4Rα with dupilumab inhibits IL-4 and IL-13 cytokine-induced inflammatory responses, including the release of proinflammatory cytokines, chemokines, nitric oxide, and IgE.

Additional Information

For additional information regarding Dupixent or chronic rhinosinusitis with nasal polyposis in adults, please visit https://www.dupixent.com/crswnp

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