What are the indications, dosing regimen, and safety considerations for Adbry (tralokinumab‑ldrm) in patients aged 12 years or older with moderate-to-severe atopic dermatitis?

Adbry (Tralokinumab-ldrm) for Moderate-to-Severe Atopic Dermatitis

Adbry is FDA-approved for patients aged 12 years and older with moderate-to-severe atopic dermatitis whose disease is inadequately controlled with topical therapies or when topical therapies are not advisable, and can be used with or without topical corticosteroids 1.

Indications

Adbry targets patients with:

• Moderate-to-severe atopic dermatitis (IGA score ≥3, EASI ≥16, BSA involvement ≥10%)
• Inadequate response to topical prescription therapies or when topical therapies are not advisable
• Age ≥12 years (adults and adolescents) 1

The 2024 American Academy of Dermatology guidelines position tralokinumab as the second biologic approved for AD after dupilumab, with a conditional recommendation for its use 2. While all guideline workgroup members favored dupilumab as first-line systemic therapy, tralokinumab represents a valuable alternative, particularly when dupilumab is not suitable 2.

Dosing Regimen

Initial Treatment (Weeks 0-16)

Adults:

• Loading dose: 600 mg subcutaneously at Week 0
• Maintenance: 300 mg every 2 weeks 1

Adolescents (12-17 years):

• Loading dose: 300 mg subcutaneously at Week 0
• Maintenance: 150 mg every 2 weeks 1

Maintenance Treatment (After Week 16)

For patients achieving clinical response (IGA 0/1 or EASI-75):

• Continue every 2 weeks dosing, OR
• Consider extending to every 4 weeks for responders to minimize treatment burden 1

In real-world practice, dose interval extension was feasible in approximately 33% of patients who achieved sustained control 3.

Practical Administration Points

• Subcutaneous injection via prefilled syringe (150 mg/1 mL) or autoinjector (300 mg/2 mL)
• First injection should be supervised by healthcare provider for proper technique training 1
• Can be used as monotherapy or combined with topical corticosteroids 1

Efficacy Outcomes

Adults

Clinical trials demonstrated at Week 16 4:

• IGA 0/1: 15.8-22.2% vs. 7.1-10.9% placebo
• EASI-75: 25.0-33.2% vs. 11.4-12.7% placebo
• Early improvements in pruritus and sleep seen as early as Week 1

Adolescents (12-17 years)

At Week 16 1:

• IGA 0/1: 21% vs. 4% placebo (18% difference)
• EASI-75: 29% vs. 6% placebo (23% difference)
• Pruritus reduction (≥4 points): 23% vs. 3% placebo

Long-term Maintenance

• 92% of Week 16 responders maintained EASI-75 response at Week 32 with every-other-week dosing 1
• Real-world data showed 79.1% composite responders at 12 months (IGA 0/1, EASI-75, or SCORAD <10) 5
• Sustained effectiveness through 48 weeks across all age groups (15-17,18-64, ≥65 years) 6

Comparative Effectiveness

Tralokinumab is somewhat less effective than dupilumab at 16 weeks based on network meta-analysis, though no head-to-head trials exist 2. This positions it as a second-line biologic option when dupilumab fails, is not tolerated, or is contraindicated.

Safety Considerations

Common Adverse Events

Most frequent treatment-emergent adverse events over 52 weeks 7:

• Worsening of AD: 8.9%
• Conjunctivitis: 8.2%
• Nasopharyngitis: 8.2%
• Allergic conjunctivitis: 6.0%
• Herpesvirus infection: 5.0%

Less common:

• Injection site reactions: 2.4%
• Eosinophilia: 1.5%
• Anaphylaxis: 0% 7

Key Safety Monitoring

Conjunctivitis and Keratitis:

• Advise patients to report new or worsening eye symptoms immediately 1
• Real-world incidence: 4.4% 5
• Most cases are mild-to-moderate severity 8

Hypersensitivity:

• Discontinue immediately if systemic hypersensitivity reactions occur 1
• Seek immediate medical attention for anaphylaxis symptoms

Laboratory Monitoring:

• No routine laboratory monitoring required 9
• Eosinophil levels may transiently increase but rarely clinically significant (3.4% shifted to moderate eosinophilia by Week 16 in adolescents) 9
• IgE levels decrease with treatment (median -186 to -105 IU/mL at Week 16) 9

Special Populations

Real-world evidence demonstrates favorable safety in clinically complex patients including those with 3:

• Active or prior malignancies
• Advanced cardiovascular disease
• Chronic kidney disease
• Latent tuberculosis or HIV
• Neurologic disorders

No tumor progression, infection reactivation, major cardiovascular events, or severe adverse events were observed in these high-risk populations over mean follow-up of 24.6 months 3.

Clinical Positioning

Use tralokinumab when:

1. Topical therapies have failed or are not advisable
2. Dupilumab is contraindicated, not tolerated, or has failed
3. JAK inhibitors are not preferred due to safety concerns or patient preference
4. Patient has significant comorbidities where IL-13-specific blockade is preferred over broader immunosuppression

Advantages over other systemics:

• Excellent long-term safety profile with no major safety concerns identified 2
• No required laboratory monitoring 9
• Flexible dosing (every 2 or 4 weeks) after achieving response 1
• Safe in multimorbid and elderly populations 6, 3

Common Pitfalls to Avoid

1. Don't discontinue prematurely: Early response rates appear modest (15-33% at Week 16), but responders maintain excellent long-term control (>90% at Week 32) 1, 4

2. Don't overlook adolescent dosing differences: Adolescents require 150 mg maintenance (not 300 mg) after 300 mg loading dose 1

3. Don't forget storage requirements: Refrigerate at 2-8°C; if removed, must use within 14 days at room temperature ≤30°C 1

4. Don't assume all biologics are equal: Tralokinumab is less effective than dupilumab based on indirect comparisons, making it a second-line biologic choice 2