Pigmented Spots in Children on Dupilumab
Pigmented spots can occur in children receiving dupilumab, though this is a rare adverse effect. The most commonly reported pigmentary changes include café-au-lait macules and post-inflammatory hyperpigmentation following other cutaneous reactions.
Evidence for Pigmentary Changes
The FDA label for dupilumab does not specifically list pigmented spots as a common adverse effect in pediatric populations 1. However, case reports document pigmentary changes:
Café-au-lait macules (CALMs) have been reported as a rare adverse effect in patients receiving dupilumab for atopic dermatitis 2. These benign pigmented lesions appeared during therapy and were directly linked to dupilumab treatment.
Post-inflammatory hyperpigmentation has been documented in pediatric patients. In a 5-year-old child who developed a dupilumab-associated erythema multiforme-like eruption, mild residual post-inflammatory skin hyperpigmentation persisted after resolution of the primary reaction 3.
Pediatric Safety Profile
The established safety profile in children focuses primarily on:
- Ocular surface disorders (most common adverse effect, though less frequent in children than adults) 4
- Injection site reactions (14-18% in clinical trials) 1
- Hand-foot-and-mouth disease (5% in children 6 months to 5 years) 1
- Skin papilloma (2% in children 6 months to 5 years) 1
Clinical Implications
If pigmented spots develop in a child on dupilumab:
- Document the lesions - photograph and measure the pigmented areas
- Differentiate the type - CALMs appear as distinct tan-brown macules, while post-inflammatory changes follow inflammatory skin reactions
- Assess for associated symptoms - determine if pigmentation is isolated or part of another cutaneous reaction
- Monitor for progression - pigmented lesions may persist even after drug discontinuation 2
- Consider continuation vs. discontinuation based on:
- Severity of the pigmentary change
- Therapeutic benefit from dupilumab for the underlying condition
- Impact on quality of life
- Availability of alternative treatments
Important Caveats
- Pigmentary changes are not listed as red flag symptoms requiring immediate dupilumab discontinuation 4
- Unlike ocular complications, pigmented spots do not typically affect morbidity or mortality
- The mechanism appears related to immune pathway alterations rather than direct drug toxicity
- Depigmentation (vitiligo) has also been rarely reported with dupilumab, though primarily in adults 5
The decision to continue dupilumab should prioritize the control of the underlying atopic dermatitis against the cosmetic concern of pigmentation, as the pigmentary changes are benign and do not pose health risks, while uncontrolled atopic dermatitis significantly impacts quality of life and can lead to complications including infection and sleep disturbance.