Scholarlink

Introduction <p>Roflumilast cream 0.3% contains a selective, highly potent phosphodiesterase&#xa0;4 inhibitor approved to treat plaque psoriasis. The Psoriasis Area and Severity Index (PASI)-High Discrimination (PASI-HD) is more precise than PASI when psoriasis involves &lt; 10% of the area of an anatomic region. Clinical trials of roflumilast utilized PASI and its modified version, PASI-HD, to assess disease improvement. The objective of this analysis was to demonstrate the effect of topical roflumilast in patients with psoriasis and to compare PASI-HD with PASI.</p> Methods <p>DERMIS-1 and DERMIS-2 were phase&#xa0;III, 8-week, randomized, vehicle-controlled trials of once-daily roflumilast cream 0.3% in patients aged ≥ 2&#xa0;years with psoriasis involving 2–20% body surface area. PASI and PASI-HD were clinical endpoint measures.</p> Results <p>At week&#xa0;8, statistically significantly more roflumilast- than vehicle-treated patients achieved ≥ 75% reduction in PASI (40.3% vs 6.5%; <i>P</i> &lt; 0.0001) and PASI-HD (59.9% vs 17.9%; <i>P</i> &lt; 0.0001). Evaluations using PASI-HD resulted in larger effect sizes compared with PASI at higher levels of response.</p> Conclusions <p>Roflumilast-treated patients experienced greater improvements in disease severity than vehicle-treated patients. The PASI-HD can more accurately assess disease changes compared with PASI.</p> Trial Registration <p>ClinicalTrials.gov Identifiers: DERMIS-1, NCT04211363; DERMIS-2, NCT04211389.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Roflumilast Cream 0.3% in Patients with Chronic Plaque Psoriasis: Pooled PASI and PASI-HD Results from the DERMIS Phase III Trials

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月24日

查看全文
  • Kim A. Papp,
  • James Q. Del Rosso,
  • Mark G. Lebwohl,
  • Melinda J. Gooderham,
  • Adelaide A. Hebert,
  • H. Chih-ho Hong,
  • Leon H. Kircik,
  • David M. Pariser,
  • Linda Stein Gold,
  • Bruce Strober,
  • Melissa S. Seal,
  • David Krupa,
  • David H. Chu,
  • Patrick Burnett,
  • David R. Berk,
  • Robert C. Higham

摘要

Introduction

Roflumilast cream 0.3% contains a selective, highly potent phosphodiesterase 4 inhibitor approved to treat plaque psoriasis. The Psoriasis Area and Severity Index (PASI)-High Discrimination (PASI-HD) is more precise than PASI when psoriasis involves < 10% of the area of an anatomic region. Clinical trials of roflumilast utilized PASI and its modified version, PASI-HD, to assess disease improvement. The objective of this analysis was to demonstrate the effect of topical roflumilast in patients with psoriasis and to compare PASI-HD with PASI.

Methods

DERMIS-1 and DERMIS-2 were phase III, 8-week, randomized, vehicle-controlled trials of once-daily roflumilast cream 0.3% in patients aged ≥ 2 years with psoriasis involving 2–20% body surface area. PASI and PASI-HD were clinical endpoint measures.

Results

At week 8, statistically significantly more roflumilast- than vehicle-treated patients achieved ≥ 75% reduction in PASI (40.3% vs 6.5%; P < 0.0001) and PASI-HD (59.9% vs 17.9%; P < 0.0001). Evaluations using PASI-HD resulted in larger effect sizes compared with PASI at higher levels of response.

Conclusions

Roflumilast-treated patients experienced greater improvements in disease severity than vehicle-treated patients. The PASI-HD can more accurately assess disease changes compared with PASI.

Trial Registration

ClinicalTrials.gov Identifiers: DERMIS-1, NCT04211363; DERMIS-2, NCT04211389.