What is the recommended use of Dupixent (dupilumab) for patients with moderate to severe atopic dermatitis, asthma, or chronic rhinosinusitis with nasal polyposis?

Dupixent (Dupilumab) Use

Dupixent is FDA-approved and strongly recommended as add-on therapy for adults and pediatric patients with moderate-to-severe atopic dermatitis (≥6 months old), moderate-to-severe asthma (≥6 years old), chronic rhinosinusitis with nasal polyps (≥12 years old), eosinophilic esophagitis (≥1 year old, ≥15 kg), prurigo nodularis (adults), and COPD with eosinophilic phenotype (adults). 1

Mechanism of Action

Dupilumab is a fully human monoclonal antibody targeting the IL-4 receptor α subunit, which blocks both IL-4 and IL-13 signaling pathways. 2 These cytokines drive type 2 immune responses by:

• Promoting IgE synthesis through B cell isotype class switching 2
• Activating eosinophils and inducing mucus secretion 2
• Driving airway and tissue remodeling 3
• Inducing production of IL-5, IL-9, IL-13, TARC, and eotaxin 3

FDA-Approved Indications and Dosing

Atopic Dermatitis

Adults: 600 mg loading dose (two 300 mg injections), then 300 mg every 2 weeks 1

Pediatric patients 6-17 years:

• 15 to <30 kg: 600 mg loading dose, then 300 mg every 4 weeks 1
• 30 to <60 kg: 400 mg loading dose, then 200 mg every 2 weeks 1
• ≥60 kg: 600 mg loading dose, then 300 mg every 2 weeks 1

Pediatric patients 6 months-5 years:

• 5 to <15 kg: 200 mg every 4 weeks (no loading dose) 1
• 15 to <30 kg: 300 mg every 4 weeks (no loading dose) 1

Asthma

Adults and pediatric patients ≥12 years:

• Standard dosing: 400 mg loading dose, then 200 mg every 2 weeks OR 600 mg loading dose, then 300 mg every 2 weeks 1
• For oral corticosteroid-dependent asthma, comorbid moderate-to-severe atopic dermatitis, or comorbid chronic rhinosinusitis with nasal polyps: 600 mg loading dose, then 300 mg every 2 weeks 1

Pediatric patients 6-11 years:

• 15 to <30 kg: 300 mg every 4 weeks (no loading dose) 1
• ≥30 kg: 200 mg every 2 weeks (no loading dose) 1
• For comorbid moderate-to-severe atopic dermatitis, use the atopic dermatitis dosing with loading dose 1

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Adults and pediatric patients ≥12 years: 300 mg every 2 weeks (no loading dose specified) 1

Dupilumab demonstrates superior efficacy compared to other biologics for CRSwNP, with the largest improvements in disease-specific quality of life (SNOT-22 mean difference: -19.61 points), nasal symptom scores (mean difference: -3.25 points), nasal polyp score reduction (mean difference: -1.79 points), and smell identification (UPSIT mean difference: 10.83 points). 2, 4

Eosinophilic Esophagitis

Patients ≥1 year old, ≥15 kg:

• 15 to <30 kg: 200 mg every 2 weeks 1
• 30 to <40 kg: 300 mg every 2 weeks 1
• ≥40 kg: 300 mg every week 1

Prurigo Nodularis

Adults: 600 mg loading dose, then 300 mg every 2 weeks 1

Chronic Obstructive Pulmonary Disease

Adults with eosinophilic phenotype: 300 mg every 2 weeks 1

Clinical Efficacy Evidence

CRSwNP Outcomes

In phase 3 trials (LIBERTY NP SINUS-24 and SINUS-52), dupilumab added to standard-of-care demonstrated:

• SNOT-22 improvement: Mean difference -19.61 (95% CI -22.53 to -16.69), exceeding the minimally important difference by more than twofold 2, 4
• Rhinosinusitis severity (VAS): Mean difference -2.54 (95% CI -2.84 to -2.23) 2
• Nasal congestion: Mean difference -0.86 (95% CI -0.98 to -0.75) 2
• Smell improvement (UPSIT): Mean difference 10.83 (95% CI 9.59 to 12.08) 2
• Lund-Mackay CT score: Standardized mean difference -1.50 (95% CI -1.84 to -1.16) 2, 4
• Asthma outcomes: Improvements in FEV1 and asthma control regardless of baseline eosinophil count 2, 5

Benefits were consistent regardless of comorbid asthma, NSAID-exacerbated respiratory disease, or previous nasal polyp surgery history. 5

Treatment Selection Algorithm for CRSwNP

First-line biologic selection:

• High disease burden + comorbid atopic dermatitis: Dupilumab (dual indication benefit) 4
• High disease burden + elevated IgE + allergic asthma: Omalizumab 4
• High disease burden without above comorbidities: Dupilumab (superior efficacy across outcomes) 4

Critical prerequisite: Patients must have failed intranasal corticosteroids for at least 4 weeks before initiating biologics 4

Safety Profile and Monitoring

Common Adverse Effects

• Injection site reactions: Most common across all indications 1, 6
• Conjunctivitis: 2.8% in real-world respiratory disease cohorts 7; notably observed in atopic dermatitis trials but not in CRSwNP or asthma trials 4
• Arthralgias: 5.2% 7
• Rash: 3.2% 7
• Nasopharyngitis and headache 6

Dupilumab-Associated Ocular Surface Disease

Bilateral conjunctival and limbal injection with watery or mucous discharge can occur, typically presenting within weeks to months of initiation. 2 Most cases are mild-to-moderate, manageable with treatment, and resolve while continuing dupilumab. 2

Ocular monitoring protocol:

• Pre-treatment ophthalmology referral for patients with significant corneal/conjunctival disease 3
• Start preservative-free ocular lubricants for mild-to-moderate conjunctivitis 3
• Emergency referral for RAPID symptoms: Redness, Acuity loss, Pain, Intolerance to light, or Damage to cornea 3

Eosinophilia

Transient eosinophilia (≥1.5 × 10³/μL) occurs in approximately 11% of patients, with new-onset eosinophilia in 7.7%. 7 Most cases resolve spontaneously while continuing treatment (10 of 13 patients in one cohort). 7

• Eosinophil-related adverse effects are rare 7
• Eosinophilic granulomatous polyangiitis cases are extremely rare 7
• Treatment benefit typically outweighs eosinophilia concerns; continued use is supported even with persistent eosinophilia 7

Monitoring Requirements

No routine laboratory monitoring is required before or during treatment. 3 However:

• Monitor for new or worsening joint symptoms (consider rheumatological evaluation if persistent) 1
• Ophthalmological examination as appropriate for eye symptoms 1
• Treat pre-existing helminth infections before initiating; discontinue if helminth infection occurs and doesn't respond to anti-helminth treatment 1

Important Clinical Considerations

Corticosteroid Management

Do not discontinue systemic, topical, or inhaled corticosteroids abruptly upon dupilumab initiation. 1 Decrease steroids gradually if appropriate. 1

Vaccinations

Complete all age-appropriate vaccinations per current immunization guidelines before initiating dupilumab. 1 Avoid live vaccines during treatment. 1

Administration

• Subcutaneous injection into thigh or abdomen (avoid 2 inches around navel); upper arm acceptable if caregiver administers 1
• Rotate injection sites with each injection 1
• Remove from refrigerator 45 minutes (300 mg) or 30 minutes (200 mg) before injection to reach room temperature 1
• Use within 14 days after removal from refrigerator 1

Concomitant Therapy Benefits

For patients with both atopic dermatitis and CRSwNP, dupilumab provides dual-indication treatment with a single medication, improving compliance and reducing healthcare costs while achieving near-remission of both conditions. 8

Common Pitfalls to Avoid

• Do not initiate biologics without adequate intranasal corticosteroid trial (minimum 4 weeks) 4
• Do not assume equivalent evidence for all biologics in CRSwNP—dupilumab has the strongest efficacy data 4
• Do not discontinue for transient eosinophilia alone—most cases resolve spontaneously and treatment benefit typically continues 7
• Do not overlook ocular symptoms—early intervention with lubricants prevents progression 3