- The FDA has approved the IL-4 receptor α-inhibitor dupilumab (Dupixent) for inadequately controlled chronic rhinosinusitis with nasal polyps in adults.
Why this matters
- This is the first treatment indicated for chronic rhinosinusitis with nasal polyps.
- Nasal polyps can lead to loss of smell and frequently require polyp removal surgery.
- Prescribing information is found here.
- FDA-recommended dose: 300 mg given every other week by subcutaneous injection with prefilled syringe.
- Efficacy was established in 2 phase 3 trials involving 724 adults who were symptomatic despite receiving intranasal corticosteroids. Four important outcomes were found:
- Reductions in nasal polyp size vs placebo.
- Reductions in nasal congestion vs placebo.
- Patient-reported increased ability to smell.
- Less nasal polyp surgery and oral steroids.
- FDA warnings and precautions include serious allergic reactions and eosinophilic conditions such as vasculitic rash, worsening pulmonary symptoms, and/or neuropathy.
- Most frequent adverse events include:
- Injection site reactions.
- Eye and eyelid inflammation.
- Patients should be encouraged to contact their provider if they have new or worsening eye symptoms, such as redness, itching, pain, or visual changes.
- Dupilumab was first approved by the FDA in 2017 for atopic dermatitis not adequately controlled by topical therapies, and in 2018 for moderate to severe eosinophilic asthma or oral corticosteroid-dependent asthma.