What are the monitoring requirements for Dupixent (dupilumab)?

Monitoring Requirements for Dupixent (Dupilumab)

No routine laboratory monitoring is required before initiation or during treatment with dupilumab. 1, 2

Pre-Treatment Assessment

Ocular Evaluation

• Refer patients with significant current or chronic corneal or conjunctival eye disease to ophthalmology (standard/routine referral pathway) before starting dupilumab 1
• Delay dupilumab initiation in patients with:
  • History of corneal transplant (until discussion with ophthalmology) 1
  • Reversible acute eye conditions (e.g., infectious conjunctivitis) until resolution 1

Baseline Considerations

• No baseline laboratory tests are mandated by FDA labeling 2
• Consider documenting baseline eosinophil count, though not required, as transient eosinophilia can occur (11.3% develop post-treatment eosinophilia) 3

During Treatment Monitoring

Ocular Surveillance (Most Important)

Conjunctivitis is the most common adverse event requiring active monitoring, occurring in 6-15% of patients in clinical trials and up to 26.1% in real-world practice 1, 4.

For Adults and Children ≥7 Years:

• Mild-to-moderate symptoms (intermittent foreign body sensation, mild conjunctival injection):

  • Start preservative-free ocular lubricants 1
  • Refer to ophthalmology if symptoms persist or worsen 1

• Red flag symptoms requiring emergency referral (<24 hours) using the RAPID acronym 1:

  • Redness (bilateral or unilateral)
  • Acuity loss or worsening
  • Pain (moderate-to-severe ocular pain, not just irritation)
  • Intolerance to light (photophobia)
  • Damage to cornea (visible opacity, ulceration, or purulent discharge)

For Children <7 Years:

• Refer to ophthalmology within 4 weeks for any mild-to-moderate ocular symptoms (intermittent symptoms, foreign body sensation, eye rubbing) or mild conjunctival injection/eyelid swelling 1

Eosinophilia Monitoring

• No routine eosinophil monitoring is required 2
• If eosinophilia develops (≥1.5 × 10³/μL), most cases are transient and resolve spontaneously (10 of 13 patients in one study) 3
• Continue dupilumab despite eosinophilia in most cases, as treatment benefit typically persists 3
• Monitor for eosinophil-related complications only if clinically indicated (e.g., symptoms suggesting eosinophilic granulomatosis with polyangiitis) 3, 5

Clinical Response Assessment

For chronic rhinosinusitis with nasal polyps, assess at regular intervals (typically 16-24 weeks) 1, 6:

• Nasal polyp score 6
• Nasal congestion/obstruction severity 6
• Sino-Nasal Outcome Test-22 (SNOT-22) 1
• For comorbid asthma: FEV1 and asthma control questionnaire 1

Key Safety Considerations

No Laboratory Monitoring Required

Unlike traditional immunosuppressants (cyclosporine, azathioprine, methotrexate), dupilumab does not require 1, 2:

• Complete blood counts
• Liver function tests
• Renal function tests
• Blood pressure monitoring
• Lipid panels

Rare Adverse Events to Recognize

• Serum sickness or serum sickness-like reactions: Occurred in 2 adult AD patients with high-titer antibodies 2
• Eosinophilic granulomatosis with polyangiitis (EGPA): Rare cases reported, including in patients without baseline eosinophilia on systemic corticosteroids 3, 5
• Arthralgias (5.2%), rash (3.2%) in real-world use 3

Common Pitfalls to Avoid

1. Do not discontinue dupilumab for mild conjunctivitis alone - most cases are self-limited and manageable with artificial tears 1
2. Do not routinely check eosinophil counts - this is not required and transient elevations do not necessitate drug discontinuation 2, 3
3. Do not delay treatment for patients without pre-existing eye disease - prophylactic ocular lubricants are not recommended 1
4. Do not apply traditional immunosuppressant monitoring protocols - dupilumab's safety profile is distinct and does not require laboratory surveillance 1, 2