3 years ago

Time, PASI and DLQI of psoriasis patients who “drop out” of clinical trials on etanercept due to “lack of efficacy” - a pooled analysis from ten clinical trials

L. Aikman, A. Nast, W. Liyanage, M. Dilleen, C. Dressler, P. Szczypa
Background Patient-reported outcomes in psoriasis studies are assessed at specific study time points. If a treatment has not become effective by a certain time point, it may increase the likelihood of patients being dissatisfied and leaving a clinical study. Objectives Generate evidence concerning the number of patients dropping out of etanercept trials over time including PASI and DLQI data. Methods Data from psoriasis patients in ten trials with etanercept were pooled. Analyses were performed for a) patients who dropped out due to ‘lack of efficacy’ b) patients who continued the trial. Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data were summarized for different time points. Distribution of dropouts over time, PASI and DLQI and the proportion of patients dropping out with given treatment responses, were calculated. Results Of 6119 patients 128 dropped out due to ‘lack of efficacy’(or synonym). The highest increase of patients dropping out happened between Day 75 and 85 (46% to 73%). The lowest PASI of patients dropping out was 6.3 within 120 days. Dropouts who achieved ≥ PASI 75 were rare. Conclusion A critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect appeared to be at around Day 80. Most of the patients dropping out showed little improvement, stable disease or worsening of their psoriasis. This article is protected by copyright. All rights reserved.

Publisher URL: http://onlinelibrary.wiley.com/resolve/doi

DOI: 10.1111/bjd.15864

You might also like
Discover & Discuss Important Research

Keeping up-to-date with research can feel impossible, with papers being published faster than you'll ever be able to read them. That's where Researcher comes in: we're simplifying discovery and making important discussions happen. With over 19,000 sources, including peer-reviewed journals, preprints, blogs, universities, podcasts and Live events across 10 research areas, you'll never miss what's important to you. It's like social media, but better. Oh, and we should mention - it's free.

  • Download from Google Play
  • Download from App Store
  • Download from AppInChina

Researcher displays publicly available abstracts and doesn’t host any full article content. If the content is open access, we will direct clicks from the abstracts to the publisher website and display the PDF copy on our platform. Clicks to view the full text will be directed to the publisher website, where only users with subscriptions or access through their institution are able to view the full article.