What is the recommended use and dosage of Dupilumab (dupilumab) for patients with atopic dermatitis or asthma?

From the Guidelines

Dupilumab is recommended for moderate-to-severe atopic dermatitis and moderate-to-severe asthma with type 2 inflammation, with a standard dosage of an initial 600 mg dose, followed by 300 mg every other week for adults with atopic dermatitis, as supported by the most recent evidence from 2024 studies 1. The medication works by inhibiting interleukin-4 and interleukin-13 signaling, key drivers of type 2 inflammation in both conditions. Some key points to consider when prescribing dupilumab include:

• For adults with atopic dermatitis, the standard dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as a subcutaneous injection.
• For adolescents (12-17 years) weighing ≥60 kg, the same adult dosing applies; for those weighing 30-60 kg, the initial dose is 400 mg followed by 200 mg every other week.
• For asthma in adults and adolescents (12+ years), the recommended dose is an initial 400 mg or 600 mg (based on eosinophil count and/or oral corticosteroid dependence), followed by 200 mg or 300 mg every other week.
• Patients should be trained on proper subcutaneous injection technique if self-administering.
• The medication should be stored in the refrigerator, allowed to reach room temperature before injection, and administered in the thigh or abdomen (except within 2 inches of the navel) or upper arm.
• Common side effects include injection site reactions, conjunctivitis (particularly in dermatitis patients), and rarely, hypersensitivity reactions, as noted in studies such as 1 and 1.
• Management of dupilumab-related ocular surface disorders is an important aspect of dupilumab prescribing, with recommendations including the use of topical antihistamines, warm compresses, and tacrolimus ointment, as outlined in 1 and 1. It is essential to weigh the benefits of dupilumab against the potential risks, including ocular surface disorders, and to consider alternative therapies, such as Janus kinase inhibitors, which may carry different risks, as discussed in 1.

From the FDA Drug Label

DOSAGE AND ADMINISTRATION Atopic Dermatitis Dosage in Adults (2.3): Recommended dosage is an initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W). Dosage in Pediatric Patients 6 Months to 5 Years of Age (2. 3): Body WeightInitial and Subsequent Dosage 5 to less than 15 kg200 mg (one 200 mg injection) every 4 weeks (Q4W) 15 to less than 30 kg300 mg (one 300 mg injection) every 4 weeks (Q4W) Dosage in Pediatric Patients 6 Years to 17 Years of Age (2. 3): Body WeightInitial Loading DoseSubsequent Dosage*

• Q2W – every other week; Q4W – every 4 weeks 15 to less than 30 kg600 mg (two 300 mg injections)300 mg Q4W 30 to less than 60 kg400 mg (two 200 mg injections)200 mg Q2W 60 kg or more600 mg (two 300 mg injections)300 mg Q2W Asthma Dosage in Adult and Pediatric Patients 12 Years and Older (2. 4): Initial Loading DoseSubsequent Dosage 400 mg (two 200 mg injections)200 mg every 2 weeks (Q2W) Or 600 mg (two 300 mg injections)300 mg every 2 weeks (Q2W) Dosage for patients with oral corticosteroid-dependent asthma or with co-morbid moderate-to-severe atopic dermatitis or adults with co-morbid chronic rhinosinusitis with nasal polyps 600 mg (two 300 mg injections)300 mg every 2 weeks (Q2W) Dosage in Pediatric Patients 6 to 11 Years of Age (2.4): Body WeightInitial Dose and Subsequent Dosage 15 to less than 30 kg300 mg every four weeks (Q4W) ≥30 kg200 mg every other week (Q2W)

The recommended use and dosage of Dupilumab for patients with atopic dermatitis or asthma are as follows:

• For atopic dermatitis:
  • Adults: initial dose of 600 mg (two 300 mg injections), followed by 300 mg given every other week (Q2W) 2
  • Pediatric patients 6 months to 5 years:
    • 5 to less than 15 kg: 200 mg (one 200 mg injection) every 4 weeks (Q4W)
    • 15 to less than 30 kg: 300 mg (one 300 mg injection) every 4 weeks (Q4W)
  • Pediatric patients 6 years to 17 years:
    • 15 to less than 30 kg: 600 mg (two 300 mg injections) initial loading dose, followed by 300 mg Q4W
    • 30 to less than 60 kg: 400 mg (two 200 mg injections) initial loading dose, followed by 200 mg Q2W
    • 60 kg or more: 600 mg (two 300 mg injections) initial loading dose, followed by 300 mg Q2W
• For asthma:
  • Adult and pediatric patients 12 years and older:
    • 400 mg (two 200 mg injections) initial loading dose, followed by 200 mg every 2 weeks (Q2W)
    • Or 600 mg (two 300 mg injections) initial loading dose, followed by 300 mg every 2 weeks (Q2W)
  • Pediatric patients 6 to 11 years:
    • 15 to less than 30 kg: 300 mg every four weeks (Q4W)
    • ≥30 kg: 200 mg every other week (Q2W)
    • For patients with co-morbid moderate-to-severe atopic dermatitis, follow the recommended dosage as per the atopic dermatitis section 2

From the Research

Dupilumab for Atopic Dermatitis and Asthma

• Dupilumab is a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, key drivers of type 2 helper T-cell (Th2)-mediated inflammation 3, 4, 5, 6.
• The recommended dosage of dupilumab for patients with atopic dermatitis is 300 mg once weekly or 300 mg every 2 weeks, administered subcutaneously 3, 4, 7.
• Concomitant use of topical corticosteroids along with dupilumab results in a greater improvement in signs and symptoms of atopic dermatitis than with use of dupilumab alone 4, 5, 6.
• Clinical trials have shown that adults with moderate-to-severe atopic dermatitis who receive weekly or biweekly dupilumab injections have significantly improved clinical and patient-reported outcomes, including Eczema Area Severity Index, SCORing Atopic Dermatitis, Dermatology Life Quality Index, and itch Numeric Rating Scale scores 3, 4, 5, 6.

Efficacy and Safety

• Dupilumab has been shown to improve clinical responses in adults with moderate-to-severe atopic dermatitis in a dose-dependent manner, without significant safety concerns 3, 4, 7, 5, 6.
• Common adverse events reported in clinical trials were nasopharyngitis, upper respiratory tract infection, injection site reactions, skin infections, and conjunctivitis, which were mild-to-moderate in nature 3, 4, 5, 6.
• Long-term safety and efficacy data for dupilumab treatment have been established, with sustained safety and efficacy of continuous long-term dupilumab treatment for adults with moderate to severe atopic dermatitis 7.

Dosage and Administration

• The dosage of dupilumab for asthma has not been explicitly stated in the provided studies, but the dosage for atopic dermatitis is 300 mg once weekly or 300 mg every 2 weeks, administered subcutaneously 3, 4, 7.
• Dupilumab can be administered with or without topical corticosteroids, and the concomitant use of topical corticosteroids may result in a greater improvement in signs and symptoms of atopic dermatitis 4, 5, 6.