Multicenter observational study on the efficacy of selective Janus Kinase-1 inhibitor upatacitinib in rheumatoid arthritis.

Minerva medica Pub Date : 2024-08-01 DOI:10.23736/S0026-4806.24.09409-6

Alberto Lo Gullo, Simone Parisi, Andrea Becciolini, Marino Paroli, Elena Bravi, Romina Andracco, Valeria Nucera, Francesca Ometto, Federica Lumetti, Antonella Farina, Patrizia Del Medico, Matteo Colina, Viviana Ravagnani, Palma Scolieri, Maddalena Larosa, Marta Priora, Elisa Visalli, Olga Addimanda, Rosetta Vitetta, Alessandro Volpe, Alessandra Bezzi, Francesco Girelli, Aldo Biagio Molica Colella, Rosalba Caccavale, Eleonora DI Donato, Giuditta Adorni, Daniele Santilli, Gianluca Lucchini, Eugenio Arrigoni, Ilaria Platè, Natalia Mansueto, Aurora Ianniello, Enrico Fusaro, Maria Chiara Ditto, Vincenzo Bruzzese, Dario Camellino, Gerolamo Bianchi, Francesca Serale, Rosario Foti, Giorgio Amato, Francesco DE Lucia, Ylenia Dal Bosco, Roberta Foti, Massimo Reta, Alessia Fiorenza, Guido Rovera, Antonio Marchetta, Maria C Focherini, Fabio Mascella, Simone Bernardi, Gilda Sandri, Dilia Giuggioli, Carlo Salvarani, Maria Ilenia DE Andres, Veronica Franchina, Francesco Molica Colella, Giulio Ferrero, Alarico Ariani

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Abstract

Background: Upadacitinib (UPA) is a selective, reversible Janus kinase inhibitor (JAKi) approved for the treatment of RA. However, there is still no solid evidence on the long-term efficacy of UPA in treated patients. The purpose of this study was to determine the efficacy of UPA to obtain remission or low disease activity (LDA) in a series of UPA patients in patients with RA after 6 and 12 months of treatment in a real-world setting.

Methods: A series of 111 consecutive patients treated with UPA in 23 rheumatology centers were enrolled. Personal history, treatment history and disease activity at baseline, after 6 and 12 months were recorded. Intention-to-treat (ITT) and per-protocol (PP) analyses assessed achievement of remission or LDA or defined as DAS28 <2.6 and ≤3.2, respectively. Logistic regression analysis examined the role of several independent factors on the reduction of disease activity after 6 months of treatment.

Results: Of the initial group of 111 subjects at baseline, 86 and 29 participants completed clinical assessments at 6 and 12 months. According to ITT analysis, the rates of remission and LDA were 18% and 18% at 6 months and 31.5% and 12.5% at 12 months, respectively. PP analysis showed higher rates of remission and LDA at 6 (23.3% and 19.8%) and 12 months (55.2% and 20.7%). Results of multivariate logistic regression analysis indicated that a low DAS28 score (P=0.045) was the only predictor of achieving remission at 6 months. None of the baseline factors predicted remission/LDA at 6 months.

Conclusions: RA patients treated with UPA achieved a significant rate of disease remission or LDA in a real-world setting. The 6-month response was found to depend only on the baseline value of DAS28, while it was not influenced by other factors such as disease duration, line of treatment or concomitant therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or corticosteroids.

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选择性 Janus 激酶-1 抑制剂 upatacitinib 对类风湿性关节炎疗效的多中心观察性研究。

背景：乌达替尼（UPA）是一种选择性、可逆性 Janus 激酶抑制剂（JAKi），已被批准用于治疗 RA。然而，目前仍无确凿证据表明 UPA 对接受治疗的患者具有长期疗效。本研究的目的是在现实世界中确定一系列UPA患者在治疗6个月和12个月后获得缓解或低疾病活动性（LDA）的疗效：方法：在23个风湿病中心连续收治了111名接受UPA治疗的患者。记录了个人病史、治疗史以及基线、6个月和12个月后的疾病活动情况。意向治疗（ITT）和按方案（PP）分析评估了缓解或LDA（定义为DAS28）的实现情况：在最初的 111 名基线受试者中，分别有 86 人和 29 人完成了 6 个月和 12 个月的临床评估。根据 ITT 分析，6 个月时的缓解率和 LDA 率分别为 18% 和 18%，12 个月时分别为 31.5% 和 12.5%。PP分析显示，6个月和12个月的缓解率和LDA率较高（分别为23.3%和19.8%），分别为55.2%和20.7%。多变量逻辑回归分析结果表明，DAS28得分低（P=0.045）是预测6个月缓解率的唯一因素。没有一个基线因素能预测6个月后的缓解/LDA：结论：在真实世界环境中，接受UPA治疗的RA患者获得了显著的疾病缓解率或LDA。结论：在真实世界环境中，接受UPA治疗的RA患者的疾病缓解率或LDA显著提高，6个月的反应仅取决于DAS28的基线值，而不受其他因素的影响，如病程、治疗方案或同时接受传统合成改善病情抗风湿药（csDMARDs）或皮质类固醇的治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Minerva medica

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