What is the role of biologics, such as dupilumab (dupilumab), in the treatment of moderate to severe atopic dermatitis?

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Last updated: November 9, 2025View editorial policy

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Biologics in Atopic Dermatitis

Primary Recommendation

For adults with moderate-to-severe atopic dermatitis inadequately controlled by topical therapies, dupilumab is the first-line systemic therapy with a strong recommendation based on moderate-certainty evidence. 1


Treatment Algorithm for Systemic Therapy Selection

First-Line Biologic Therapy

Dupilumab receives the strongest endorsement from the American Academy of Dermatology, with all guideline workgroup members favoring it over other systemic agents for moderate-to-severe atopic dermatitis. 2, 3

  • Dosing: 600 mg subcutaneous loading dose, then 300 mg every 2 weeks 2
  • Expected efficacy: 63-64% achieve EASI 75 at 16 weeks when combined with topical corticosteroids 2
  • Mechanism: Fully human IgG4 monoclonal antibody blocking IL-4 receptor α subunit, inhibiting both IL-4 and IL-13 signaling 2

Alternative Biologic Options (Strong Recommendations)

Tralokinumab is an alternative first-line biologic with a strong recommendation for adults with moderate-to-severe atopic dermatitis. 1

  • Approved for patients ≥18 years old 4
  • Targets IL-13 specifically 5
  • Comparable efficacy and safety profile to dupilumab 4

Patient Selection Criteria

Candidates for Biologic Therapy

Initiate biologics when patients meet these criteria:

  • Disease severity: Moderate-to-severe atopic dermatitis affecting multiple body areas 2, 3
  • Treatment failure: Inadequate response to optimized topical prescription therapies 1, 6
  • Sensitive area involvement: Face, ears, or other high-impact locations 2, 3
  • Quality of life impairment: Substantial impact despite topical management 2, 3

FDA Approval Considerations

  • Dupilumab: Approved for patients as young as 6 months old 6, 4
  • Tralokinumab: Approved for patients ≥18 years old 4

Safety Profile and Adverse Event Management

Overall Safety

Dupilumab demonstrates an excellent safety track record with few major emergent safety concerns after more than 5 years in clinical practice. 2, 3

Ocular Adverse Events (Most Common)

Conjunctivitis is the most prevalent adverse event, occurring in 6-15% of patients in clinical trials and up to 26.1% in real-world data. 2, 7

Management algorithm for ocular complications:

  • Mild symptoms: Preservative-free ocular lubricants and topical antihistamine eyedrops 2, 3
  • Moderate symptoms: Continue dupilumab while treating ocular symptoms 2
  • Severe symptoms: Refer to ophthalmology 2
  • Only 4.2% discontinue dupilumab due to ocular complications 2

Indications for dupilumab withdrawal:

  • Progressive loss of visual acuity 2
  • Progressive conjunctival cicatrization 2
  • Significant quality of life loss from ocular symptoms 2
  • Requirement for prolonged ocular topical corticosteroid therapy 2

Other Notable Adverse Events

New-onset psoriasis has been reported with dupilumab use—advise patients to report new psoriatic symptoms. 6, 8

Eosinophilic conditions (eosinophilic pneumonia, eosinophilic granulomatosis with polyangiitis) require patient notification to healthcare provider if clinical features develop. 6

Previously unreported adverse events in real-world data include blood eosinophilia, rosacea-like skin lesions, and weight gain, though mechanistic association requires clarification. 7


Critical Clinical Pearls

Concomitant Therapy

Always use dupilumab with topical agents for maintenance, rescue, or flare treatment—do not use as monotherapy without topical support. 2, 3

Pre-Treatment Counseling

Counsel all patients about ocular adverse events before initiating dupilumab and establish an ophthalmology referral pathway for management. 2, 3

Monitoring Requirements

Regular follow-up is essential to assess treatment response and monitor for adverse effects, particularly ocular symptoms. 3, 6

Vaccination Considerations

Live vaccines are not recommended immediately prior to or during dupilumab therapy—patients must inform healthcare providers about dupilumab use before vaccination. 6


Alternative Systemic Therapies

JAK Inhibitors (Strong Recommendations)

The following JAK inhibitors also receive strong recommendations for moderate-to-severe atopic dermatitis:

  • Upadacitinib 1
  • Abrocitinib 1
  • Baricitinib 1

FDA approval caveat: These JAK inhibitors are approved for patients who have failed other systemic therapies (pills or injections, including biologics) or when use of those therapies is inadvisable. 1

Conditional Recommendations

Phototherapy, cyclosporine, methotrexate, azathioprine, and mycophenolate receive conditional recommendations for use in atopic dermatitis. 1

Strong Recommendation Against

Systemic corticosteroids are conditionally recommended against for atopic dermatitis due to substantial risk of serious adverse events and rebound flares upon discontinuation. 1


Management of Inadequate Response

When Dupilumab Fails

If inadequate response to dupilumab occurs:

  • Rule out confounding dermatoses before declaring treatment failure 9
  • Consider individual goals and quality of life, not just body surface area 9
  • Adjust dosing frequency in some circumstances 9
  • Add adjuvant therapies: methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, or phototherapy (though safety and efficacy of combinations are not established) 9
  • Switch to JAK inhibitor such as upadacitinib if psoriasiform switch occurs 8

Patients Requiring Alternative Therapies

Consider alternatives to dupilumab for:

  • Pre-existing severe ocular surface disease 2
  • Patients requiring faster onset of action 2
  • DROSD (dupilumab-related ocular surface disease) refractory to ophthalmologic management 2

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Dupilumab in Atopic Dermatitis

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Atopic Dermatitis Treatment with Dupilumab

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Systemic Biologic Management of Atopic Dermatitis.

Advances in experimental medicine and biology, 2024

Research

Management of inadequate response and adverse effects to dupilumab in atopic dermatitis.

Journal of the American Academy of Dermatology, 2022

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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