What is the recommended use and dosing of Dupixent (dupilumab) for various conditions?

Dupixent (Dupilumab): Recommended Use and Dosing

Overview and Mechanism

Dupilumab is a fully human monoclonal antibody targeting the IL-4 receptor α subunit, which blocks both IL-4 and IL-13 signaling—key drivers of type 2 inflammatory diseases. 1 This mechanism makes it effective across multiple allergic and inflammatory conditions by inhibiting IgE synthesis, eosinophil activation, mucus secretion, and airway remodeling. 2

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FDA-Approved Indications and Dosing

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

For adults and adolescents ≥12 years: 300 mg subcutaneously every 2 weeks (Q2W). 1

• Dupilumab is the only monoclonal antibody approved for CRSwNP and should be used in patients fulfilling criteria for biologic therapy. 2
• Demonstrated clinically significant improvements in:
  • SNOT-22 scores (mean difference -19.61) 2
  • Nasal polyp scores (mean difference -1.79) 2
  • Sense of smell via UPSIT (mean difference +10.83) 2
  • Nasal congestion scores (mean difference -0.86) 2
  • CT sinus opacification (Lund-Mackay score) 2, 3
• Benefits observed regardless of comorbid asthma, NSAID-exacerbated respiratory disease, or prior nasal polyp surgery. 4
• In patients with comorbid asthma, also improves FEV1 (mean difference +0.21L) and asthma control. 2

Asthma

Adults and adolescents ≥12 years: 1

• Standard dosing: 400 mg loading dose (two 200 mg injections), then 200 mg Q2W
• OR 600 mg loading dose (two 300 mg injections), then 300 mg Q2W
• For oral corticosteroid-dependent asthma, comorbid moderate-to-severe atopic dermatitis, or comorbid CRSwNP: Use 600 mg loading dose, then 300 mg Q2W 1

Pediatric patients 6-11 years: 1

• 15 to <30 kg: 300 mg Q4W (no loading dose)
• ≥30 kg: 200 mg Q2W (no loading dose)
• If comorbid moderate-to-severe atopic dermatitis: Follow atopic dermatitis dosing with loading dose 1

Real-world effectiveness: Reduces asthma exacerbations by 44% and systemic corticosteroid use by 48%, independent of eosinophil levels or exacerbation history. 5

Atopic Dermatitis

Adults: 600 mg loading dose (two 300 mg injections), then 300 mg Q2W 1

Pediatric patients 6 months to 5 years: 1

• 5 to <15 kg: 200 mg Q4W (no loading dose)
• 15 to <30 kg: 300 mg Q4W (no loading dose)

Pediatric patients ≥6 years: 1

• 15 to <30 kg: 600 mg loading dose, then 300 mg Q4W
• 30 to <60 kg: 400 mg loading dose, then 200 mg Q2W
• ≥60 kg: 600 mg loading dose, then 300 mg Q2W

Eosinophilic Esophagitis

Adults and pediatric patients ≥1 year, weighing ≥15 kg: 1

• 15 to <30 kg: 200 mg Q2W
• 30 to <40 kg: 300 mg Q2W
• ≥40 kg: 300 mg every week (QW)

Prurigo Nodularis

Adults: 600 mg loading dose, then 300 mg Q2W 1

Chronic Obstructive Pulmonary Disease (COPD)

Adults: 300 mg Q2W 1

Chronic Spontaneous Urticaria

Adults: 600 mg loading dose, then 300 mg Q2W 1

Adolescents 12-17 years: 1

• 30 to <60 kg: 400 mg loading dose, then 200 mg Q2W
• ≥60 kg: 600 mg loading dose, then 300 mg Q2W

Bullous Pemphigoid

Adults: 600 mg loading dose, then 300 mg Q2W in combination with a tapering course of oral corticosteroids 1

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Administration Guidelines

• Route: Subcutaneous injection into thigh, abdomen (avoiding 2 inches around navel), or upper arm (if caregiver administers) 1
• Rotate injection sites with each administration 1
• Pre-filled pen: For patients ≥2 years 1
• Pre-filled syringe: For patients ≥6 months 1
• Supervision: Patients ≥12 years may self-inject under adult supervision; patients 6 months to <12 years require caregiver administration 1
• For loading doses: Administer each injection at different sites 1

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Pre-Treatment Considerations

Vaccination

Complete all age-appropriate vaccinations per current immunization guidelines before initiating dupilumab. 1

Ocular Assessment for Atopic Dermatitis Patients

Screen for pre-existing eye disease before starting dupilumab in AD patients: 2

• Refer to ophthalmology (routine pathway): Patients with significant current or chronic corneal/conjunctival disease 2
• Delay dupilumab initiation:
  • History of corneal transplant (until ophthalmology discussion) 2
  • Acute reversible eye conditions like infectious conjunctivitis (until resolution) 2
• Risk factors for dupilumab-related ocular surface disorders (DROSD):
  • Prior ophthalmology attendance for ocular surface disorders, especially dry eye disease and keratitis (OR 6.3) 2
  • Eyelid or facial eczema (OR 8.7) 2
  • AD as indication (versus asthma or other conditions) 2

Note: Prophylactic ocular lubricants are not routinely recommended for patients without pre-existing eye disease, as evidence is insufficient. 2

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Safety Profile and Adverse Effects

Common Adverse Events

• Most common adverse events (nasopharyngitis, headache, epistaxis, injection-site erythema) were more frequent with placebo in CRSwNP trials 2
• Injection site reactions: 40% in dupilumab group vs 7% in placebo 3
• Arthralgias: 5.2% 6
• Rash: 3.2% 6

Conjunctivitis

• Occurs primarily in atopic dermatitis trials, not in asthma or CRSwNP trials 2
• Incidence: 2.8% in respiratory indications 6
• Management in AD patients: 2
  • Children <7 years with mild-moderate symptoms: Start preservative-free ocular lubricants and refer to ophthalmology within 4 weeks 2
  • Red flags requiring emergency referral (<24 hours): Redness with acuity loss, pain, photophobia, or visible corneal damage 2

Eosinophilia

• Transient eosinophilia (≥1.5 × 10³/μL) occurs in 11.3% of patients, with new-onset eosinophilia in 7.7% 6
• Most cases resolve spontaneously while continuing dupilumab (10 of 13 patients) 6
• Eosinophil-related adverse effects are rare 6
• Eosinophilic granulomatous polyangiitis: Extremely rare (1 case with eosinophilia, 1 case with normal eosinophils on systemic corticosteroids) 6
• Treatment benefit maintained despite eosinophilia—continue dupilumab in most cases 6

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Clinical Pearls

• Concomitant therapies: Can be used with or without topical corticosteroids for AD; reserve topical calcineurin inhibitors for problem areas (face, neck, intertriginous, genital areas) 1
• Effectiveness independent of biomarkers: Benefits observed regardless of baseline eosinophil counts in asthma and CRSwNP 4, 5
• Long-term safety: Favorable safety profile demonstrated in long-term clinical trials 7
• Systemic corticosteroid reduction: Significant reduction in need for systemic corticosteroids across indications 4, 5