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Introduction <p>Difamilast is the first selective phosphodiesterase&#xa0;4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase&#xa0;3, 52-week, open-label study was conducted to evaluate efficacy and safety of difamilast ointments in Japanese infants with AD aged 3 to &lt; 24&#xa0;months, because the clinical study in this population has not been conducted.</p> Methods <p>Infants (<i>n</i> = 41) received difamilast 0.3% ointment twice daily in a 4-week primary evaluation period, and subsequently received difamilast 0.3% or 1% ointment on the basis of the existing clinical symptoms in a 48-week, long-term extension period.</p> Results <p>The response rate in Investigator’s Global Assessment score was 56.1% at week&#xa0;4, and it increased to 75.6% at week&#xa0;52. The response rate in Eczema Area and Severity Index&#xa0;75 was 82.9% at week&#xa0;4, and the approximately same response rate was maintained at 80.5% at week&#xa0;52. Adverse events (AEs) were reported in 41 (100.0%) infants, most of which were mild or moderate in severity. The most frequently observed AE was nasopharyngitis (82.9%), followed by gastroenteritis (46.3%). The investigational medicinal product-related AE, folliculitis, was reported in one infant (2.4%). No clinically relevant abnormalities were reported in clinical laboratory tests, physical examinations, and vital signs.</p> Conclusion <p>Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to &lt; 24&#xa0;months for up to 52&#xa0;weeks are effective and well tolerated, indicating a new useful treatment option for this population.</p> Clinical Trial Registration <p>ClinicalTrials.gov identifier NCT05372653.</p>

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A Phase 3, Long-Term, Open-Label Study of Difamilast Ointment to Evaluate Efficacy and Safety in Japanese Infants with Atopic Dermatitis

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  • 发表日期：

    2025年10月31日

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  • Hidehisa Saeki,
  • Yukihiro Ohya,
  • Naoko Baba,
  • Tomomi Imamura,
  • Daisuke Yokota,
  • Hidetsugu Tsubouchi

摘要

Introduction

Difamilast is the first selective phosphodiesterase 4 inhibitor approved for atopic dermatitis (AD) in Japan. A phase 3, 52-week, open-label study was conducted to evaluate efficacy and safety of difamilast ointments in Japanese infants with AD aged 3 to < 24 months, because the clinical study in this population has not been conducted.

Methods

Infants (n = 41) received difamilast 0.3% ointment twice daily in a 4-week primary evaluation period, and subsequently received difamilast 0.3% or 1% ointment on the basis of the existing clinical symptoms in a 48-week, long-term extension period.

Results

The response rate in Investigator’s Global Assessment score was 56.1% at week 4, and it increased to 75.6% at week 52. The response rate in Eczema Area and Severity Index 75 was 82.9% at week 4, and the approximately same response rate was maintained at 80.5% at week 52. Adverse events (AEs) were reported in 41 (100.0%) infants, most of which were mild or moderate in severity. The most frequently observed AE was nasopharyngitis (82.9%), followed by gastroenteritis (46.3%). The investigational medicinal product-related AE, folliculitis, was reported in one infant (2.4%). No clinically relevant abnormalities were reported in clinical laboratory tests, physical examinations, and vital signs.

Conclusion

Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months for up to 52 weeks are effective and well tolerated, indicating a new useful treatment option for this population.

Clinical Trial Registration

ClinicalTrials.gov identifier NCT05372653.