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非戈替尼在65岁及以上和65岁以下类风湿关节炎患者中的疗效和安全性(ENANTIA - 65)。

Efficacy and Safety of Filgotinib in Rheumatoid Arthritis Patients Aged over and under 65 Years (ENANTIA-65).

作者信息

Benucci Maurizio, Bardelli Marco, Cazzato Massimiliano, Bartoli Francesca, Damiani Arianna, Li Gobbi Francesca, Bandinelli Francesca, Panaccione Anna, Di Cato Luca, Niccoli Laura, Frediani Bruno, Mosca Marta, Guiducci Serena, Cantini Fabrizio

机构信息

Rheumatology Unit, S. Giovanni di Dio Hospital, 50143 Florence, Italy.

Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.

出版信息

J Pers Med. 2024 Jul 2;14(7):712. doi: 10.3390/jpm14070712.

DOI:10.3390/jpm14070712
PMID:39063966
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11278154/
Abstract

BACKGROUND

According to recent data, the age of patients could represent an important risk factor for MACE (major cardiovascular events), cancer, and VTE (venous thromboembolism) during treatment with JAK inhibitors in rheumatoid arthritis. We decided to analyze the population involved in the ReLiFiRa study by identifying two groups of patients: 65 years or more and less than 65 years of age, evaluating the efficacy and tolerability of 200 mg of Filgotinib daily.

METHODS

Of the 120 ReLiFiRa patients, 54 were younger than 65 years old and 66 patients were 65 years old or older. The data of efficacy and tolerability of treatment with FIL 200 mg daily for 6 months were evaluated.

RESULTS

After six months of treatment, FIL was effective in both age groups. In both groups, the median values of steroid DAS28, CDAI, ERS, PCR, tender joints, swollen joints, VAS, HAQ, PGA patients, and PGA physicians were reduced with a statistically significant difference comparing these values with the baseline values. The difference in age did not impact the effectiveness of the drug. The lipid profile data also did not demonstrate significant differences between the two age groups; however, the comparison between younger vs. older patients' populations regarding the total cholesterol/HDL ratio and LDL/HDL ratio shows a statistically significant difference: total cholesterol/HDL 3.4 (2.12-3.66) vs. 3.64 (3.36-4.13) = 0.0004, LDL/HDL 1.9 (0.98-2.25) vs. 2.41 (2.04-2.73) = 0.0002. There are no differences regarding the atherogenic index (LDL-C/HDL-C) and coronary risk index (TC/HDL-C) compared to baseline.

CONCLUSIONS

After six months of treatment with FIL, the older population group showed a higher level of LDL and a lower level of HDL compared to younger patients. The atherogenic index and coronary risk index are higher in patients aged ≥ 65 years, but interestingly, there were no differences when comparing the 6-month data to baseline values. This condition highlights the impact of typical risk factors that act independently of treatment with Filgotinib.

摘要

背景

根据最新数据,在类风湿关节炎患者接受JAK抑制剂治疗期间,患者年龄可能是发生主要心血管事件(MACE)、癌症和静脉血栓栓塞(VTE)的重要危险因素。我们决定通过识别两组患者来分析参与ReLiFiRa研究的人群:65岁及以上和65岁以下,评估每日200mg非戈替尼的疗效和耐受性。

方法

在120例ReLiFiRa患者中,54例年龄小于65岁,66例年龄为65岁及以上。评估了每日服用200mg FIL治疗6个月的疗效和耐受性数据。

结果

治疗6个月后,FIL在两个年龄组中均有效。在两组中,与基线值相比,类固醇DAS28、CDAI、ERS、PCR、压痛关节、肿胀关节、VAS、HAQ、患者PGA和医生PGA的中位数均降低,差异具有统计学意义。年龄差异并未影响药物的有效性。血脂谱数据在两个年龄组之间也未显示出显著差异;然而,较年轻与较年长患者群体在总胆固醇/高密度脂蛋白比值和低密度脂蛋白/高密度脂蛋白比值方面的比较显示出统计学显著差异:总胆固醇/高密度脂蛋白 3.4(2.12 - 3.66)对 3.64(3.36 - 4.13)= 0.0004,低密度脂蛋白/高密度脂蛋白 1.9(0.98 - 2.25)对 2.41(2.04 - 2.73)= 0.0002。与基线相比,致动脉粥样硬化指数(低密度脂蛋白胆固醇/高密度脂蛋白胆固醇)和冠心病风险指数(总胆固醇/高密度脂蛋白胆固醇)没有差异。

结论

与年轻患者相比,接受FIL治疗6个月后,老年人群体的低密度脂蛋白水平较高,高密度脂蛋白水平较低。65岁及以上患者的致动脉粥样硬化指数和冠心病风险指数较高,但有趣的是,将6个月数据与基线值进行比较时没有差异。这种情况突出了独立于非戈替尼治疗起作用的典型危险因素的影响。