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古塞库单抗治疗慢性斑块状银屑病患者的超级反应者特征:一项长期真实世界经验

Characterization of Super-Responder Profile in Chronic Plaque Psoriatic Patients under Guselkumab Treatment: A Long-Term Real-Life Experience.

作者信息

Marcelli Lorenzo, Belcastro Alfredo, Talamonti Marina, Paganini Claudia, Fico Angela, Savastano Lorenzo, Di Raimondo Cosimo, Vellucci Laura, Bianchi Luca, Galluzzo Marco

机构信息

Department of Systems Medicine, University of Rome "Tor Vergata", Via Montpellier 1, 00133 Rome, Italy.

Dermatology Unit, Fondazione Policlinico "Tor Vergata", 00133 Rome, Italy.

出版信息

J Clin Med. 2024 Aug 31;13(17):5175. doi: 10.3390/jcm13175175.

DOI:10.3390/jcm13175175
PMID:39274388
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11396162/
Abstract

The term "super responder" identifies a group of patients who exhibit a rapid and optimal response to biological treatment compared to the overall treated population. The primary objective of our study is to characterize this subgroup of patients to enable the early identification of those who will respond most effectively to the proposed treatment while also evaluating clinical efficacy. This retrospective study evaluated 232 patients treated with guselkumab in monotherapy for at least 20 weeks between November 2018 and November 2023. Patients were divided into two groups: those who achieved complete clear skin (PASI = 0) during the first 20 weeks of treatment were defined as super responders (SRe) and non-super responders (nSRe) were the remaining patients. PASI was assessed at weeks 0, 4, and subsequently every eight weeks. Predictors of the SRe status were evaluated by univariate and multivariate logistic regression analyses. The univariate analyses showed that patients with psoriatic arthritis at the baseline, bio-naïve patients, or those who had not received an interleukin (IL) 17 inhibitor as their last therapy before guselkumab administration were more likely to be super responders to the proposed treatment. Multivariate logistic analysis models suggested that the combination of psoriatic arthritis at the baseline and the bio-naïve condition was the strongest predictive model for the SRe status. At week 204, the main difference between the two groups concerned the achievement of PASI100, maintained by 86.8 of SRe compared to 62.8% of nSRe. The efficacy and safety of guselkumab are confirmed in our real-life experience. Identifying the SRe status will undoubtedly play a role in clinical practice and the therapeutic decision-making algorithm.

摘要

“超级应答者”一词指的是与总体治疗人群相比,对生物治疗表现出快速且最佳反应的一组患者。我们研究的主要目的是对这一亚组患者进行特征描述,以便能够早期识别出那些对拟议治疗反应最有效的患者,同时评估临床疗效。这项回顾性研究评估了2018年11月至2023年11月期间接受古塞库单抗单药治疗至少20周的232例患者。患者被分为两组:在治疗的前20周内实现皮肤完全清除(银屑病面积和严重程度指数[PASI]=0)的患者被定义为超级应答者(SRe),其余患者为非超级应答者(nSRe)。在第0、4周进行PASI评估,随后每八周评估一次。通过单因素和多因素逻辑回归分析评估SRe状态的预测因素。单因素分析表明,基线时患有银屑病关节炎的患者、未接受过生物制剂治疗的患者,或在使用古塞库单抗之前最后一次治疗未接受过白细胞介素(IL)-17抑制剂的患者更有可能对拟议治疗产生超级应答。多因素逻辑分析模型表明,基线时银屑病关节炎与未接受过生物制剂治疗的情况相结合是SRe状态最强的预测模型。在第20周时,两组之间的主要差异在于达到PASI100,SRe组为86.8%,而nSRe组为62.8%。在我们的实际经验中,古塞库单抗的疗效和安全性得到了证实。确定SRe状态无疑将在临床实践和治疗决策算法中发挥作用。

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