Dupilumab

• Atopic Dermatitis (Eczema)
• Asthma
• Chronic Rhinosinusitis with Nasal Polyps
• Eosinophilic Esophagitis

Dupilumab is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, used for the treatment of moderate to severe atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, and prurigo nodularis. This biologic targets key drivers of type 2 inflammation.

Mechanism of Action

Dupilumab is a human IgG4 monoclonal antibody that binds to the shared IL-4Rα subunit of the IL-4 and IL-13 receptor complexes. IL-4 and IL-13 are key cytokines in type 2 (Th2) inflammation, driving IgE production, eosinophil recruitment, mucus production, and tissue remodeling. By blocking IL-4Rα, dupilumab inhibits signaling from both IL-4 and IL-13, reducing type 2 inflammatory responses. In atopic dermatitis, this reduces skin inflammation and pruritus. In asthma, it reduces airway inflammation and hyperreactivity. The medication provides sustained suppression of type 2 inflammation while preserving other immune functions.

Available Formulations

Dupilumab is available as a solution for subcutaneous injection in prefilled syringes and prefilled pens containing 200 mg/1.14 mL or 300 mg/2 mL. Prefilled syringes containing 100 mg/0.67 mL are available for pediatric patients. The medication requires refrigeration but can be kept at room temperature for up to 14 days before use. Patients can self-inject after proper training.

Medical Uses

Dupilumab is FDA-approved for moderate to severe atopic dermatitis in patients 6 months and older inadequately controlled with topical therapies, moderate to severe asthma aged 6 years and older with an eosinophilic phenotype or oral corticosteroid-dependent asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) in adults inadequately controlled with intranasal corticosteroids, eosinophilic esophagitis in patients 12 years and older weighing at least 40 kg, and prurigo nodularis in adults. It is the first biologic approved for atopic dermatitis.

Dosing Guidelines

For adults with atopic dermatitis or prurigo nodularis, the dose is 600 mg (two 300 mg injections) initially, followed by 300 mg every other week. For asthma (without oral corticosteroid dependence), the dose is 400 mg initially, then 200 mg every other week, or 600 mg initially then 300 mg every other week for severe disease. For CRSwNP and eosinophilic esophagitis, 300 mg every other week is used. Pediatric dosing is weight-based. Injections can be given in the thigh, abdomen (except 2 inches around navel), or upper arm.

Important Safety Information

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported. The medication should be discontinued if severe reactions occur. Conjunctivitis and keratitis are common, particularly in atopic dermatitis patients; new or worsening eye symptoms should be evaluated. Helminth infections should be treated before initiating therapy. Patients should not discontinue systemic or inhaled corticosteroids abruptly when starting dupilumab for asthma. Live vaccines should be avoided during treatment.

Drug Interactions

No formal drug interaction studies have been conducted. Dupilumab is not expected to undergo hepatic metabolism or interact with cytochrome P450 enzymes. However, the formation of CYP450 enzymes can be altered by cytokines; as dupilumab modulates IL-4 and IL-13 signaling, it could theoretically affect CYP450 substrates with narrow therapeutic indices (warfarin). Vaccines may be administered during treatment, but live vaccines should be avoided.

Special Populations

There are limited data on dupilumab use during pregnancy. Animal studies showed no evidence of harm. The medication should be used during pregnancy only if the potential benefit justifies the potential risk. It is unknown whether dupilumab is excreted in human breast milk. Safety and efficacy have been established in pediatric patients: atopic dermatitis (6 months and older), asthma (6 years and older), and eosinophilic esophagitis (12 years and older). Elderly patients do not require dose adjustment. No dose adjustment is needed for renal or hepatic impairment.