在一大群类风湿性关节炎患者的真实世界数据中分析巴瑞替尼的生存率和持续性预测因素。
Analysis of survival rate and persistence predictors of baricitinib in real-world data from a large cohort of rheumatoid arthritis patients.
作者信息
Parisi Simone, Andrea Becciolini, Chiara Ditto Maria, Lo Gullo Alberto, Maddalena Larosa, Palma Scolieri, Olga Addimanda, Massimo Reta, Paroli Marino, Rosalba Caccavale, Elisa Visalli, Rosario Foti, Giorgio Amato, Francesco De Lucia, Ylenia Dal Bosco, Roberta Foti, Antonella Farina, Francesco Girelli, Simone Bernardi, Dario Camellino, Gerolamo Bianchi, Matteo Colina, Romina Andracco, Natalia Mansueto, Giulio Ferrero, Patrizia Del Medico, Aldo Molica Colella, Veronica Franchina, Francesco Molica Colella, Federica Lumetti, Gilda Sandri, Carlo Salvarani, Marta Priora, Aurora Ianniello, Valeria Nucera, Daniele Santilli, Gianluca Lucchini, Adorni Giuditta, Eleonora Di Donato, Elena Bravi, Ilaria Platè, Eugenio Arrigoni, Alessandra Bezzi, Cristina Focherini Maria, Fabio Mascella, Vincenzo Bruzzese, Viviana Ravagnani, Alessia Fiorenza, Guido Rovera, Rosetta Vitetta, Antonio Marchetta, Alessandro Volpe, Francesca Ometto, Alarico Ariani, Enrico Fusaro
机构信息
Azienda Ospedaliero Universitaria Città della Salute e della Scienza di Torino, Rheumatology Unit, Turin, Italy.
Azienda Ospedaliero-Universitaria di Parma, Department of Medicine, Internal Medicine and Rheumatology Unit, Parma, Italy.
出版信息
Curr Res Pharmacol Drug Discov. 2024 Feb 16;6:100178. doi: 10.1016/j.crphar.2024.100178. eCollection 2024.
OBJECTIVES
The persistence in therapy of rheumatoid arthritis drugs and particularly bDMARD is a limiting factor for their long-term use. The randomized controlled trials (RCTs) may not reflect real-world contexts due to strict inclusion and exclusion criteria. Baricitinib, which targets both JAK1 and JAK2, has been used in Italy for several years. The aim of this multi-center study is to assess the real world persistence on therapy of baricitinib in RA patients and to identify predictive factors of baricitinib's survival rate.
METHODS
This is a retrospective, multicentric, Italian, longitudinal study. All patients were enrolled according to the following criteria: a) age ≥ 18 years old; b) diagnosed with RA according 2010 ACR/EULAR classification criteria; c) treated with baricitinib. In order to describe baricitinib clinical efficacy, the survival rate was evaluated by The Kaplan-Meier curve. Then, predictive factors of drug retention rate were assessed by performing the Cox analysis, identifying which risk factors influenced treatment persistence.
RESULTS
Overall, we included 478 patients treated with baricitinib. Among them, 380 (79.5%) were females. Baricitinib's survival rate was 94.6% at 6 months, 87.9% at 12 months, 81.7% at 24 months and 53.4% at 48 months. The Cox analysis regression showed that a higher bDMARDs/tsDMARD line of therapy seems to be a negative prognostic factor for the drug retention rate (HR 1.26 CI 95% 1.07-1.49, p = 0.006.
CONCLUSION
Real-life study confirms baricitinib effectiveness up to 4 years, but previous treatment with bDMARDs was a negative prognostic factor for its survival rate.
目的
类风湿关节炎药物尤其是生物改善病情抗风湿药（bDMARD）治疗的持续性是其长期使用的一个限制因素。由于严格的纳入和排除标准，随机对照试验（RCT）可能无法反映真实世界的情况。巴瑞替尼可同时作用于JAK1和JAK2，已在意大利使用数年。这项多中心研究的目的是评估巴瑞替尼在类风湿关节炎患者治疗中的真实世界持续性，并确定巴瑞替尼生存率的预测因素。
方法
这是一项回顾性、多中心、意大利的纵向研究。所有患者均根据以下标准纳入：a）年龄≥18岁；b）根据2010年美国风湿病学会（ACR）/欧洲抗风湿病联盟（EULAR）分类标准诊断为类风湿关节炎；c）接受巴瑞替尼治疗。为描述巴瑞替尼的临床疗效，采用Kaplan-Meier曲线评估生存率。然后，通过进行Cox分析评估药物保留率的预测因素，确定哪些危险因素影响治疗持续性。
结果
总体而言，我们纳入了478例接受巴瑞替尼治疗的患者。其中，380例（79.5%）为女性。巴瑞替尼在6个月时的生存率为94.6%，12个月时为87.9%，24个月时为81.7%，48个月时为53.4%。Cox分析回归显示，更高线的bDMARDs/传统合成改善病情抗风湿药（tsDMARD）治疗似乎是药物保留率的不良预后因素（风险比1.26，95%置信区间1.07 - 1.49，p = 0.006）。
结论
真实世界研究证实巴瑞替尼在4年内有效，但先前使用bDMARDs治疗是其生存率的不良预后因素。
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