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 data shows 44% reduction in asthma exacerbations (IRR 0.56) and 48% reduction in systemic corticosteroid use. 5

• Effectiveness independent of baseline 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

• Can be used with or without topical corticosteroids. 1

• Reserve topical calcineurin inhibitors for problem areas (face, neck, intertriginous, genital areas). 1

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 1

• Must use in combination with a tapering course of oral corticosteroids. 1
• Once disease control achieved, gradually taper corticosteroids and continue dupilumab as monotherapy. 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
• For loading doses requiring two injections: Administer at different injection sites. 1
• Pre-filled pen: For patients ≥2 years 1
• Pre-filled syringe: For patients ≥6 months 1
• Supervision: Patients ≥12 years or caregivers may self-inject; patients 6 months to <12 years require caregiver administration. 1

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Pre-Treatment Considerations

Vaccination

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

Ocular Assessment (Atopic Dermatitis Patients)

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

• Refer to ophthalmology (routine pathway) if significant current or chronic corneal/conjunctival disease present. 2
• Delay dupilumab initiation for:
  • History of corneal transplant (until ophthalmology discussion) 2
  • Reversible acute eye conditions (e.g., infectious conjunctivitis) until resolution 2

Risk factors for dupilumab-related ocular surface disorders (DROSD): 2

• Prior ophthalmology attendance for ocular surface disorder (especially dry eye disease with keratitis: OR 6.3)
• Eyelid or facial eczema (OR 8.7)
• Atopic dermatitis indication (vs. asthma/CRSwNP)
• Prior ophthalmic medication use (OR 5.16)

Insufficient evidence to recommend prophylactic ocular lubricants for patients without pre-existing eye disease. 2

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Safety Profile

Common Adverse Events

• In CRSwNP trials, most common adverse events (nasopharyngitis, worsening nasal polyps/asthma, headache, epistaxis, injection-site erythema) were more frequent with placebo. 2
• Conjunctivitis occurs in atopic dermatitis trials but not in asthma/CRSwNP trials. 2
• Real-world data: arthralgias (5.2%), rash (3.2%), conjunctivitis (2.8%). 6

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; persistent eosinophilia or eosinophil-related adverse effects are rare. 6
• Eosinophilic granulomatous polyangiitis is extremely rare. 6
• Treatment benefit typically maintained despite eosinophilia; continued use supported. 6

Ocular Monitoring (Atopic Dermatitis)

For children <7 years with mild-to-moderate ocular symptoms: 2

• Commence preservative-free ocular lubricants
• Refer to ophthalmology for assessment within 4 weeks

Red flags requiring emergency ophthalmology referral (<24 hours): 2

• RAPID acronym: Redness, Acuity loss, Pain (moderate-to-severe), Intolerance to light, Damage to cornea
• Any bilateral or unilateral redness with another red flag warrants immediate discussion with ophthalmology

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Clinical Pearls

• Dupilumab demonstrates consistent efficacy across multiple type 2 inflammatory conditions due to its dual IL-4/IL-13 blockade. 2, 7
• In CRSwNP, benefits extend to comorbid asthma regardless of eosinophil count. 4
• Real-world effectiveness mirrors clinical trial data, with sustained benefit in routine practice. 5
• Favorable long-term safety profile established across multiple indications. 7
• For atopic dermatitis patients, pre-existing dry eye disease with keratitis is the strongest predictor of DROSD, not disease severity. 2