アトピー性皮膚炎における長期治療の有効性(Mount Sinai Study Finds Long-Term Eczema Treatment Benefits Patients With Delayed Response)

2025-05-14

2025-05-13 マウントサイナイ医療システム(MSHS)

マウントサイナイ医科大学の研究チームは、中等度から重度のアトピー性皮膚炎(湿疹)患者におけるレブリキズマブ(lebrikizumab)の長期治療効果を検証しました。16週間時点で効果が見られなかった患者の多くが、52週間の継続治療により症状の大幅な改善を示しました。具体的には、52週目には75.5%の患者がEASIスコアで75%以上の改善を達成し、66.4%がかゆみの大幅な軽減を報告しました。この研究は、初期に効果が現れない場合でも治療を継続することの重要性を示しており、個別化された治療戦略の必要性を強調しています。

<関連情報>

2件のランダム化比較臨床試験で16週目にプロトコール定義の奏効基準を満たさなかった中等症から重症のアトピー性皮膚炎患者におけるレブリキズマブ長期投与の有効性 The efficacy of longer-term lebrikizumab treatment in patients with moderate-to-severe atopic dermatitis who did not meet protocol-defined response criteria at week 16 in 2 randomized controlled clinical trials

Emma Guttman-Yassky, MD, PhD ∙ David Rosmarin, MD ∙ Marjolein de Bruin-Weller, MD, PhD ∙ … ∙ Helena Agell, BS ∙ Esther Garcia Gil, MD ∙ Eric Simpson, MD, MCR
Journal of the American Academy of Dermatology Published:December 27, 2024
DOI:https://doi.org/10.1016/j.jaad.2024.12.026

Abstract

Background

Lebrikizumab demonstrated statistically significant improvements in patients with moderate-to-severe atopic dermatitis at week 16 with a durable response up to week 52.

Objective

To investigate the efficacy of lebrikizumab-treated patients at 52 weeks who did not achieve the ADvocate1 and ADvocate2 protocol-defined response criteria (≥75% improvement in the Eczema Area and Severity Index [EASI 75] or Investigator Global Assessment 0/1 with ≥2-point improvement without rescue medication) after 16 weeks.

Methods

This analysis includes observed data for patients who received lebrikizumab every 2 weeks during the induction period, did not achieve the protocol-defined response, and subsequently received open-label lebrikizumab treatment.

Results

At week 16, 38.1% of lebrikizumab-treated patients entered the escape arm due to not achieving the response criteria. However, most of these patients had achieved ≥50% improvement in EASI (58.1%) by week 16. At week 52, 36.1% achieved Investigator Global Assessment 0/1 with ≥2-point improvement, 75.5% achieved EASI 75, 44.2% achieved ≥90% improvement in EASI, and 66.4% reported ≥4-point Pruritus Numeric Rating Scale improvement.