What conditions is Dupixent (dupilumab) used to treat?

Dupilumab (Dupixent) FDA-Approved Indications

Dupilumab (Dupixent) is FDA-approved for multiple conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, chronic spontaneous urticaria, and bullous pemphigoid. 1

Specific FDA-Approved Indications

Atopic Dermatitis

• For adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable 1
• Can be used with or without topical corticosteroids

Asthma

• Add-on maintenance treatment for adult and pediatric patients aged 6 years and older with:
  • Moderate-to-severe asthma characterized by an eosinophilic phenotype
  • Oral corticosteroid-dependent asthma 1
• Not indicated for relief of acute bronchospasm or status asthmaticus

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

• Add-on maintenance treatment for adult and pediatric patients aged 12 years and older with inadequately controlled CRSwNP 1
• Significantly improves:
  • Nasal polyp score (reduction of MD -1.79) 2
  • Quality of life (SNOT-22 improvement of MD -19.61) 2
  • Rhinosinusitis disease severity (VAS reduction of MD -2.54) 2
  • Nasal congestion/obstruction (improvement of MD -0.86) 2
  • Sense of smell (UPSIT score improvement of MD 10.83) 2
  • Sinus opacification on CT (Lund-Mackay score) 2

Eosinophilic Esophagitis

• For adult and pediatric patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis 1

Prurigo Nodularis

• For treatment of adult patients with prurigo nodularis 1

Chronic Obstructive Pulmonary Disease

• Add-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype 1
• Not indicated for relief of acute bronchospasm

Chronic Spontaneous Urticaria

• For treatment of adult and pediatric patients aged 12 years and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment 1
• Not indicated for treatment of other forms of urticaria

Bullous Pemphigoid

• For treatment of adult patients with bullous pemphigoid 1

Mechanism of Action

Dupilumab is a fully human monoclonal antibody that:

• Binds to the interleukin-4 receptor α (IL-4Rα) subunit 3
• Inhibits both IL-4 and IL-13 signaling pathways 4
• Blocks key drivers of type 2 inflammation involved in multiple inflammatory conditions 3

Administration

• Administered by subcutaneous injection 1
• Standard dosing is 300 mg subcutaneously every 2 weeks for most indications 3
• For initial doses:
  • 600 mg loading dose (two 300 mg injections) for some indications 1
  • 400 mg loading dose (two 200 mg injections) for other indications 1
• Injection sites include thigh, abdomen (except 2 inches around navel), or upper arm 1
• Sites should be rotated with each injection 1

Safety Profile

Common adverse effects include:

• Injection site reactions 3
• Nasopharyngitis 3
• Headache 3
• Conjunctivitis and keratitis (particularly in atopic dermatitis patients) 3

Treatment-related adverse events are generally mild to moderate, although monitoring is recommended for:

• Hypersensitivity reactions 3
• Eosinophilic conditions, especially when reducing oral corticosteroids 3
• Eye symptoms 3

Clinical Significance

Dupilumab represents a significant advancement in treating multiple type 2 inflammatory conditions, particularly for patients with inadequate response to conventional therapies. Its ability to simultaneously address multiple related conditions (such as asthma and nasal polyps) makes it particularly valuable for patients with comorbid type 2 inflammatory diseases.