학술논문

Addressing high placebo response rates in randomized clinical trials for hidradenitis suppurativa.
Document Type
Article
Source
British Journal of Dermatology. Mar2024, Vol. 190 Issue 3, p427-429. 3p.
Subject
*HIDRADENITIS suppurativa
*CLINICAL trials
*RANDOMIZED response
*PLACEBOS
*PSYCHOMETRICS
Language
ISSN
0007-0963
Abstract
The article explores the issue of high placebo response rates in clinical trials for hidradenitis suppurativa (HS), a skin condition. It highlights the challenge this poses for drug development programs in distinguishing the effects of active treatments from placebos. The article provides data from 11 phase II/III trials, revealing a median placebo response rate of 31% using a specific measurement tool. This information is valuable for researchers and those interested in understanding the difficulties of developing effective treatments for HS. The text also discusses the challenges in accurately assessing disease activity and measuring treatment response in HS patients, due to the complex nature of the disease and the difficulty in identifying and counting specific lesion types. Efforts are being made to develop alternative measures that are more reliable and do not require lesion counting, such as the HS Investigator Global Assessment and a measure that assesses various aspects of the condition. Standardization of morphological terms and study assessments is also being pursued. Overcoming these challenges will be crucial for improving care for HS patients. [Extracted from the article]