Reply to Kiran Javaid and Cassidy Andruszka: Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance (‘clinical super response’): Week 28 results from the ongoing phase IIIb randomized, double‐blind, parallel‐group, GUIDE study: An analysis with considerations for future studies

医学 银屑病 皮肤病科 大学医院 干预(咨询) 家庭医学 精神科
作者
Knut Schäkel
出处
期刊:Journal of The European Academy of Dermatology and Venereology [Wiley]
卷期号:38 (4): e304-e305
标识
DOI:10.1111/jdv.19534
摘要

Early disease intervention with guselkumab in psoriasis leads to a higher rate of stable complete skin clearance ('clinical super response'): Week 28 results from the ongoing phase IIIb randomized, double-blind, parallel-group, GUIDE study: An analysis with considerations for future studiesDear Editor, Javaid and Andruszka emphasized in their letter to the editor the role of psychological stress, history of anxiety, weather conditions, and tobacco consumption as possible confounders in the GUIDE study.1,2 We thank the authors for sharing their thoughts and opinions.Psoriasis is associated with a number of concomitant diseases.3 These conditions may contribute to the manifestation of psoriasis, may develop in response to the burden of psoriasis, and may well hinder treatment responses to biologic therapy.Therefore, the points brought up by Javaid and Andruszka are well received.Prior to designing the GUIDE study, 4 we specifically addressed this matter and performed an analysis of pooled data from the VOYAGE 1 and VOYAGE 2 studies.This allowed us to determine baseline demographic factors, and disease and pharmacokinetic characteristics that could impact the likelihood of a patient becoming a super responder (SRe; Psoriasis Area and Severity Index [PASI] = 0 at Weeks 20 and 28). 5 A stepwise logistic regression analysis was performed, with a significance level of 0.1.Patient age at study entry, baseline body weight (≤90 kg vs. >90 kg), and baseline PASI and Investigator's Global Assessment scores were significant predictors of SRe status, with odds ratios (95% confidence intervals) of 0.98 (0.967-0.993; p = 0.003), 1.42 (1.026-1.977;p = 0.034), 0.97 (0.955-0.993; p = 0.007) and 0.66 (0.433-0.997; p = 0.048), respectively.This analysis concluded that guselkumab treatment was more likely to result in early clinical responses in younger patients, those with lower body weight, and patients with less severe psoriasis.Tobacco consumption was also assessed, though was not found to be a predictor of response in this analysis.Other parameters brought up by Javaid and Andruszka were weather conditions and geographic location.These factors are less likely to have impacted our results, as patients in the GUIDE study were all enrolled continuously from 2019 to 2022 across all seasons and the study was largely

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