Treatment with Methotrexate in Infants and Toddlers with Atopic Dermatitis: A Retrospective Multi-Center Study

Jen A. Barak Levitt, Sima Alemi, Ayelet Ollech, Shiran Reiss-Huss, Mohammad Sah, Yael Renert-Yuval, Rivka Friedland, Shoshana Greenberger, Eran Cohen Barak*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


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.

Original languageEnglish
Article number5409
JournalJournal of Clinical Medicine
Issue number16
StatePublished - Aug 2023


FundersFunder number
National Eczema AssociationLF-OC-20-000585, NEA20-CRG134


    • atopic dermatitis (AD)
    • infants
    • methotrexate
    • pediatric patients
    • toddlers


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