What are the adverse effects of Dupixent (dupilumab)?

Adverse Effects of Dupilumab (Dupixent)

Dupilumab commonly causes ocular surface disorders, with conjunctivitis occurring in up to 26.1% of patients in real-world studies, along with injection site reactions, head and neck dermatitis, and other less common side effects. 1

Common Adverse Effects

• Ocular Surface Disorders (DROSD - Dupilumab-Related Ocular Surface Disorders):

  • Conjunctivitis: Occurs in 6-15% of patients in clinical trials and up to 26.1% in real-world studies 1
  • Dry eyes: Reported in 13% of all treated patients and 36% of those with ocular complications 1
  • Keratitis: Observed in 11% of all patients and 38% of those with ocular issues 1
  • Blepharitis: Affects 8% of all patients and 29% of those with ocular complications 1
  • Typically presents with bilateral conjunctival and limbal injection, watery or mucous discharge, and follicular, papillary, or cicatrizing conjunctival changes 1

• Injection Site Reactions: One of the most commonly reported adverse events 2

  • Includes redness, swelling, or pain at the injection site 3

• Head and Neck Dermatitis: Reported in approximately 19.5% of patients in real-world studies 4

• Skin-Related Issues:

  • Erythema, pruritus, and peeling of skin (10.9% of patients) 4
  • Onset of psoriatic lesions in some patients 2

Less Common Adverse Effects

• Serious Allergic Reactions: Though rare, can include 3:

  • Breathing problems or wheezing
  • Swelling of the face, lips, mouth, tongue, or throat
  • Hives, itching, skin rash
  • Fainting, dizziness, feeling lightheaded

• Hematologic Effects:

  • Eosinophilia (high count of certain white blood cells) 3, 2

• Infectious Complications:

  • Upper respiratory tract infections 3
  • Herpes virus infections (cold sores) 3, 5
  • Increased risk of skin infections with discontinuation 6

• Musculoskeletal Issues:

  • Joint aches and pain, sometimes severe enough to require hospitalization 3
  • Arthritis has been reported in some cases 2

• Other Reported Effects:

  • Inflammation of blood vessels (rare, primarily in asthma patients) 3
  • Headache and dizziness 3
  • Gastrointestinal symptoms including diarrhea and stomach problems 3

Ocular Complications Management

• Most ocular complications are mild to moderate in severity and present within weeks to months of starting treatment 1

• Many cases are manageable with treatment while continuing dupilumab 1

• Risk factors for ocular complications include:

  • Severe atopic dermatitis
  • History of atopic conjunctivitis
  • Low serum levels of dupilumab 1

• Management approach:

  • Preservative-free ocular lubricants and topical antihistamine eyedrops are first-line treatments 7
  • Urgent ophthalmological referral (within 24 hours) is needed for:
    • Worsening visual acuity
    • Ocular pain
    • Sensitivity to light
    • Visible corneal damage 1
  • Non-urgent ophthalmology referral for persistent but non-severe symptoms 1

Important Clinical Considerations

• Despite these adverse effects, dupilumab has an excellent overall safety profile with over 10 years of follow-up data 1, 7
• Only 4.2% of patients discontinue dupilumab due to ocular complications 1
• Unilateral eye symptoms are very unlikely to be dupilumab-related and should be managed through existing pathways 1
• Patients should be advised to avoid environments with ocular irritants (smoke, pollution, cooling fans) 1
• An ophthalmological examination for potential predictive indicators of ophthalmic adverse events is recommended before initiating dupilumab therapy 2