中等症～重症の小児アトピー性皮膚炎の多くは包括的な管理で良好なコントロールが可能～疾患教育・スキンケア指導・適切な外用療法により96.1％が軽症以下へ～

2026-07-02

2026-07-02 国立成育医療研究センター

国立成育医療研究センターは、中等症～重症の小児アトピー性皮膚炎患者77人を対象とした前向きコホート研究（ROAD study）で、疾患教育、スキンケア指導、適切な外用療法を組み合わせた包括的管理の有効性と安全性を1年間評価した。その結果、12か月後には85.7％が皮膚症状75％以上改善（EASI-75）を達成し、67.5％が90％以上改善、33.8％が完全寛解に至った。さらに96.1％が軽症以下まで改善し、かゆみや睡眠障害、患者本人および家族の生活の質（QOL）も大幅に向上した。新たに生物学的製剤などの全身治療を必要とした患者は2.6％にとどまり、重篤な皮膚・眼の副作用も認められず、安全性も確認された。近年は全身治療の選択肢が広がる一方、本研究は適切な疾患教育、スキンケア、外用薬の正しい使用、寛解導入後のプロアクティブ療法を含む包括的な診療体制によって、多くの小児患者が外用療法中心で長期に良好な病勢コントロールを維持できることを示し、早期介入と継続的な管理の重要性を裏付けた。

【図1：今回の研究結果まとめ】

＜関連情報＞

小児の中等度から重度のアトピー性皮膚炎に対する外用療法の長期有効性と安全性（ROAD試験） Long-term efficacy and safety of topical therapy in pediatric moderate to severe atopic dermatitis (ROAD study)

Tomoki Yaguchi, Kenji Toyokuni, Chisato Jimbo, Kouhei Hagino, Daisuke Harama, Marei Omori, Daichi Suzuki, Kotaro Umezawa, Mami Shimada, Hisako Ogasawara, Seiko Hirai, Fumi Ishikawa, Sayaka Hamaguchi, Ai Kishino, Mayako Saito-Abe, Miori Sato, Hideaki Morita, Ichiro Nomura, Tatsuki Fukuie, Yukihiro Ohya…Kiwako Yamamoto-Hanada
Allergology International Available online: 11 December 2025
DOI:https://doi.org/10.1016/j.alit.2025.11.005

Abstract

Background

Data on the long-term efficacy and safety of topical therapy for atopic dermatitis (AD) remain limited.

Methods

This prospective cohort study included all children with AD who had their first visit to the Allergy Center at the National Center for Child Health and Development between December 2020 and September 2022. Participants were evaluated at enrollment, 6, and 12 months, and also monitored via questionnaires. We analyzed those with an Eczema Area and Severity Index (EASI) score ≥7.1 and complete EASI data at both follow-up points. The primary endpoint was the proportion achieving ≥75 % improvement in EASI from baseline (EASI-75) at 12 months. Secondary outcomes included other clinical endpoints, QOL scores, and skin and ocular complications.

Results

Of 763 enrolled children, 107 had EASI ≥7.1, and 77 (72.0 %) had complete follow-up data. Median age at enrollment was 57.0 months [quartile: 13.0–141.0], and 58.4 % were male. Fifty-three had moderate (7.1≤EASI≤21.0) AD, and 24 had severe to very severe (21.1≤EASI) AD. Only two children (2.6 %) required systemic therapy during the study period. Median EASI scores significantly improved from 14.8 at baseline to 0.8 at both 6 and 12 months (P < 0.001). EASI-75 was achieved by 80.5 % at 6 months and 85.7 % at 12 months. Other clinical endpoints, including POEM, pruritus and sleep-disturbance NRS, and QOL scores, were improved. New dermatologic complications were rare, and no ophthalmologic complications occurred.

Conclusions

Most pediatric AD cases with moderate or greater severity can be effectively and safely controlled with topical therapy alone.