Baldi Caterina, Parisi Simone, Falsetti Paolo, Sota Jurgen, Ditto Maria Chiara, Capassoni Marco, D'alessandro Miriana, Conticini Edoardo, Nacci Francesca, Peroni Clara Lisa, Cometi Laura, Fusaro Enrico, Frediani Bruno, Guiducci Serena
Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.
Rheumatology Unit, Azienda Ospedaliera Universitaria Città Della Salute e Della Scienza di Torino, 10126 Torino, Italy.
J Clin Med. 2024 Jan 11;13(2):401. doi: 10.3390/jcm13020401.
We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data.
RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy.
Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved ( = 0.029, = 0.001, = 0.001, = 0.001, respectively). Regression analysis revealed a significant association between the concomitant csDMARDs therapy at baseline and the lack of improvement in synovial hypertrophy [OR -4.824, = 0.010] as well as with DAS28-CRP [OR -0.690, = 0.045], whereas the presence of increased ESR or CRP at baseline was able to predict a significant improvement in SDAI [OR 8.481, = 0.003]. No adverse events, such as deep venous thrombosis, pulmonary embolism, or herpes zoster virus infection, were reported during this study observation.
Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.
我们提供了在现实生活环境中关于乌帕替尼治疗类风湿关节炎（RA）的疗效和安全性的首个前瞻性纵向多中心经验，重点关注临床测量和超声（US）数据。
根据美国风湿病学会（ACR）/欧洲抗风湿病联盟（EULAR）分类标准，纳入在三个意大利三级中心开始使用乌帕替尼的RA患者，并进行前瞻性评估。本研究的主要目的是评估随时间推移（治疗开始时的基线、治疗1个月后、3个月后和6个月后）临床测量和超声评分的变化。次要目的是：（i）评估生物治疗线和联合治疗对治疗反应的影响；（ii）探索实验室参数的变化；（iii）找出与治疗反应相关的潜在预测因素。
纳入71例患者（49例女性和22例男性）。临床测量评分，包括疾病活动评分（DAS28-CRP）和简化临床疾病活动指数（SDAI），以及超声检查结果（滑膜增生和能量多普勒）均有显著改善（分别为P = 0.029、P = 0.001、P = 0.001、P = 0.001）。回归分析显示，基线时联合使用传统合成改善病情抗风湿药（csDMARDs）治疗与滑膜增生改善不足[比值比（OR）-4.824，P = 0.010]以及与DAS28-CRP[OR -0.690，P = 0.045]之间存在显著关联，而基线时红细胞沉降率（ESR）或C反应蛋白（CRP）升高能够预测SDAI有显著改善[OR 8.481，P = 0.003]。在本研究观察期间，未报告深静脉血栓形成、肺栓塞或带状疱疹病毒感染等不良事件。
我们的现实生活经验证实了乌帕替尼在临床和超声改善方面的疗效，以及良好的安全性。
