What is the recommended dosing regimen for Dupixent (dupilumab) in the treatment of Eosinophilic Esophagitis (EOE)?

Dupixent (Dupilumab) Dosing for Eosinophilic Esophagitis

For patients with eosinophilic esophagitis weighing 40 kg or more, administer dupilumab 300 mg subcutaneously every week; for those weighing 15 to less than 40 kg, use weight-based dosing every other week as specified in the FDA-approved regimen. 1

FDA-Approved Dosing Regimen

The official dosing for eosinophilic esophagitis varies by body weight 1:

Adults and Adolescents ≥40 kg

• 300 mg subcutaneously every week (QW) 1
• This is the only regimen that demonstrated consistent symptomatic improvement in phase 3 trials 2, 3

Pediatric Patients (≥1 year old) and Adolescents 15 to <40 kg

• 15 to <30 kg: 200 mg subcutaneously every other week (Q2W) 1
• 30 to <40 kg: 300 mg subcutaneously every other week (Q2W) 1

Critical Dosing Distinction: Weekly vs Every 2 Weeks

Weekly dosing is superior to every-2-week dosing for symptom control in EOE. 2, 3 In the phase 3 LIBERTY EoE TREET trial, weekly dupilumab 300 mg significantly reduced dysphagia scores (mean DSQ reduction of -9.92 points, P<0.001), while the every-2-week regimen failed to meet the primary symptomatic endpoint despite achieving similar histologic remission rates 2. At 52 weeks, the weekly regimen maintained superior symptomatic improvement with mean DSQ reductions of -30.3 points compared to -20.9 points with every-2-week dosing 3.

Evidence Supporting Weekly Dosing

Histologic Efficacy

• Histologic remission (≤6 eosinophils/hpf) occurred in 59-60% of patients on weekly dupilumab versus 5-6% on placebo at week 24 2, 3
• Peak eosinophil counts decreased by 86.8-107.1% with weekly dosing 2, 4
• At week 52,85% of patients continuing weekly dupilumab maintained histologic remission 3

Symptomatic Efficacy

• Mean dysphagia score (DSQ) improved by 12.32 points more than placebo in part A and 9.92 points in part B at week 24 2
• Symptomatic improvements continued through week 52 with mean DSQ reductions of -30.3 points from baseline 3

Endoscopic and Functional Improvements

• Endoscopic reference scores improved by 1.6 points versus placebo (P=0.0006) 4
• Esophageal distensibility increased by 18% compared to placebo (P<0.0001) 4
• At week 52, endoscopic scores improved by -5.4 to -6.1 points from baseline 3

Administration Details

Preparation and Injection

• Remove from refrigerator and allow 45 minutes to reach room temperature for 300 mg formulation, 30 minutes for 200 mg formulation 1
• Must be used within 14 days after removal from refrigerator 1
• Administer subcutaneously; can be self-administered after proper training 1
• Inspect for particulate matter; solution should be clear to slightly opalescent, colorless to pale yellow 1

Missed Dose Management

• For weekly dosing: Administer as soon as possible and start new weekly schedule from that date 1
• For every-other-week dosing: If within 7 days of missed dose, give immediately and resume original schedule; if beyond 7 days, wait until next scheduled dose 1

Special Populations and Clinical Scenarios

Adolescents with Fibrostenotic Disease

Real-world data demonstrates 100% histologic response in adolescents with fibrostenotic EOE after mean 16.8 weeks of weekly 300 mg dupilumab 5. This is particularly important as fibrostenotic disease represents advanced EOE with structural complications.

Rapid Steroid Discontinuation

In clinical practice, 94% of patients successfully discontinued topical corticosteroids 2-4 weeks after initiating dupilumab 5. This allows for monotherapy with dupilumab rather than combination treatment.

Non-EOE Eosinophilic Gastrointestinal Disease

For patients with eosinophilic gastrointestinal disease extending beyond the esophagus, dupilumab showed 60% esophageal histologic response, though requiring longer treatment duration (mean 40.1 weeks) 5.

Safety Profile

Common Adverse Events

• Injection-site erythema: 35% versus 8% with placebo 4
• Nasopharyngitis: 17% versus 4% with placebo 4
• Injection-site reactions: 14% in long-term weekly treatment 3

Serious Adverse Events

Serious adverse events occurred in 7 patients on weekly dupilumab during the 24-week treatment period, with generally good tolerability through 52 weeks 2, 3.

Contraindications

Dupilumab is contraindicated in patients with known hypersensitivity to dupilumab or any excipients 1. Hypersensitivity reactions including anaphylaxis, serum sickness, angioedema, and generalized urticaria have been reported; discontinue immediately if clinically significant hypersensitivity occurs 1.

Guideline Context

While the 2022 British Society of Gastroenterology guidelines acknowledge dupilumab shows promise for EOE treatment, they note the evidence level as "low" with "weak" recommendation strength, as the guidelines were published before FDA approval 6. The phase 2 trial data available at guideline publication showed weekly dupilumab 300 mg for 12 weeks significantly reduced dysphagia and eosinophil counts with good tolerability 6.

Common Pitfalls to Avoid

• Do not use every-2-week dosing for patients ≥40 kg expecting full symptomatic benefit—the FDA label specifies weekly dosing for this weight category based on superior symptomatic outcomes 1, 2
• Do not delay treatment awaiting steroid failure—dupilumab is FDA-approved for EOE and can be used as primary therapy 1
• Do not underdose pediatric patients—weight-based dosing is critical, with specific thresholds at 15,30, and 40 kg 1
• Do not expect immediate response—histologic assessment should occur after 10-24 weeks of treatment 2, 4