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Treatment with Methotrexate in Infants and Toddlers with Atopic Dermatitis: A Retrospective Multi-Center Study
Jen A Barak Levitt1, Sima Alemi1, Ayelet Ollech2,3
1Department of Dermatology, Emek Medical Center, Afula 1834111, Israel.
Insights
Methotrexate (MTX) shows a good safety profile for treating young children with atopic dermatitis (AD). While efficacy was moderate, concerns about this immunomodulatory drug led to early cessation in some cases.
Area of Science:
- Pediatric Dermatology
- Immunomodulatory Therapies
- Systemic Treatment for Atopic Dermatitis
Background:
- Atopic dermatitis (AD) is a prevalent chronic inflammatory skin condition in children.
- Methotrexate (MTX) is an off-label systemic option for severe AD unresponsive to topical treatments.
- Limited data exist on MTX safety and efficacy in pediatric AD, particularly in children under 4 years old.
Purpose of the Study:
- To evaluate the safety and efficacy of methotrexate (MTX) in infants and toddlers (< 4 years old) with atopic dermatitis (AD).
- To assess treatment response rates and adverse events in this young patient population.
Main Methods:
- Retrospective chart review of 28 patients under 4 years old with AD treated with MTX across three referral centers (2016-2022).
- Data collected included patient demographics, Investigator Global Assessment (IGA) scores, treatment duration, response rates, and adverse events.
- Analysis focused on MTX initiation age, IGA scores, treatment outcomes at 12 and 24 weeks, and reasons for treatment cessation.
Main Results:
- The mean age at MTX initiation was 2.7 years, with a median treatment duration of five months.
- At 12 and 24 weeks, response rates were 50% and 21.4% achieved IGA 0/1, respectively.
- Adverse events occurred in 57.1% of patients, but only 7.1% discontinued MTX due to adverse events; lack of efficacy or parental concern were primary reasons for cessation.
Conclusions:
- Methotrexate (MTX) demonstrates a favorable safety profile in infants and toddlers with atopic dermatitis (AD).
- The efficacy of MTX in this young population was moderate, potentially underestimated due to parental concerns leading to premature treatment discontinuation.
- Further research is warranted to optimize MTX use and address parental concerns regarding immunomodulatory therapies in pediatric AD.
Abstract:
Atopic dermatitis (AD) is a chronic inflammatory skin disease affecting up to 20% of children. Methotrexate (MTX) is used off-label as a systemic treatment for AD patients unresponsive to topical therapies, but limited data exist regarding its safety and efficacy in children, especially in those < 4 years old. To further investigate MTX in younger patients, we screened the medical records of three referral centers between 2016 and 2022 and identified 28 infants and toddlers < 4 years old with AD treated with MTX. Mean age upon MTX initiation was 2.7 ± 1.2 years and mean investigator global assessment (IGA) score was 3.78 ± 0.4. Median duration of MTX treatment was five months. Following 12 and 24 weeks of MTX treatment, the response rate was 50% and IGA 0/1 was achieved in 14.2% and 21.4% of patients, respectively. Most treatment cessations were attributed to a lack of efficacy or parental concern. Although adverse events were reported in 57.1% of patients, MTX was discontinued due to such adverse events only in two patients (7.1%). Taken together, MTX demonstrated a high safety profile in AD patients <4 years old. MTX efficacy was moderate and presumably underestimated by parents who opted for premature treatment cessation due to concerns associated with an immunomodulatory drug.
