420例在现实环境中服用抗肿瘤坏死因子药物的银屑病关节炎患者的长期临床结局
Longterm Clinical Outcomes in 420 Patients with Psoriatic Arthritis Taking Anti-tumor Necrosis Factor Drugs in Real-world Settings.
作者信息
Iannone Florenzo, Lopriore Simona, Bucci Romano, Lopalco Giuseppe, Chialà Angela, Cantarini Luca, Lapadula Giovanni
机构信息
From the Rheumatology Unit, Medical School, University of Bari, Bari; the Rheumatology Unit, Ospedali Riuniti di Foggia, Foggia; and the Department of Rheumatology, Policlinico Le Scotte, University of Siena, Siena, Italy.F. Iannone, MD, PhD, Associate Professor of Rheumatology, Rheumatology Unit, Medical School, University of Bari; S. Lopriore, MD, Research Assistant of Rheumatology, Rheumatology Unit, Medical School, University of Bari; R. Bucci, MD, Consultant of Rheumatology, Rheumatology Unit, Ospedali Riuniti di Foggia; G. Lopalco, MD, Consultant of Rheumatology, Rheumatology Unit, Medical School, University of Bari; A. Chialà, MD, Consultant of Rheumatology, Rheumatology Unit, Medical School, University of Bari; L. Cantarini, MD, Senior Lecturer of Rheumatology, Policlinico Le Scotte, University of Siena; G. Lapadula, MD, Rheumatology Unit, Medical School, University of Bari.
出版信息
J Rheumatol. 2016 May;43(5):911-7. doi: 10.3899/jrheum.151042. Epub 2016 Mar 15.
OBJECTIVE
An observational study to evaluate the longterm clinical outcomes of adalimumab (ADA), etanercept (ETN), and infliximab (IFX) in patients with psoriatic arthritis (PsA), in real-world settings.
METHODS
From a prospective cohort we studied 420 biologic-naive patients with PsA who had peripheral arthritis and were beginning a treatment with ADA, ETN, or IFX. Drug survival was evaluated by Kaplan-Meier life analysis, and baseline predictors of drug discontinuation were assessed by Cox regression analysis. The frequency of concomitant glucocorticoids and the daily mean dosage were compared by chi-square test and ANOVA repeated measures across 4 years.
RESULTS
After 4 years the overall survival of the first anti-tumor necrosis factor-α (anti-TNF) was 51.0%, but significantly higher for ETN (58.9%) than ADA (43.9%) or IFX (44.0%; p = 0.003). Patients taking ETN also had the lowest HR of drug discontinuation (HR 0.57, 95% CI 0.34-0.93, p = 0.02). The strongest predictor of drug interruption was female sex (HR 2.02, 95% CI 1.28-3.20, p = 0.002). The disease duration was inversely correlated with drug discontinuation (HR 0.96, 95% CI 0.93-0.99, p = 0.02). The average daily dose of prednisone significantly decreased from baseline: 5.6 ± 2.5 to 4.7 ± 1.9 at 1 year (p = 0.01) to 4.0 ± 1.8 at 4 years (p = 0.001). Additionally, compared to baseline (49.6%), a significant reduction of patients taking glucocorticoids was detected at 2 years (36.5%, p < 0.05), 3 years (29.9%, p < 0.01), and 4 years (22.6%, p < 0.01).
CONCLUSION
In real-world settings, TNF inhibitors showed a high rate of drug survival at 4 years. Further, the need for glucocorticoids for controlling active PsA was lowered with time.
目的
一项观察性研究，旨在评估在实际临床环境中，阿达木单抗（ADA）、依那西普（ETN）和英夫利昔单抗（IFX）治疗银屑病关节炎（PsA）患者的长期临床疗效。
方法
我们从一个前瞻性队列中研究了420例初治的PsA患者，这些患者患有外周关节炎，且开始接受ADA、ETN或IFX治疗。通过Kaplan-Meier生存分析评估药物生存率，并通过Cox回归分析评估药物停用的基线预测因素。通过卡方检验和4年的重复测量方差分析比较了糖皮质激素的使用频率和每日平均剂量。
结果
4年后，首个抗肿瘤坏死因子-α（anti-TNF）药物的总体生存率为51.0%，但ETN的生存率（58.9%）显著高于ADA（43.9%）或IFX（44.0%；p = 0.003）。接受ETN治疗的患者药物停用的风险比（HR）也最低（HR 0.57，95%可信区间0.34 -0.93，p = 0.02）。药物中断的最强预测因素是女性（HR 2.02，95%可信区间1.28 - 3.20，p = 0.002）。疾病持续时间与药物停用呈负相关（HR 0.96，95%可信区间0.93 - 0.99，p = 0.02）。泼尼松的平均每日剂量从基线显著下降：1年时从5.6±2.5降至4.7±1.9（p = 0.01），4年时降至4.0±1.8（p = 0.001）。此外，与基线（49.6%）相比，2年时服用糖皮质激素的患者显著减少（36.5%，p < 0.05），3年时（29.9%，p < 0.01）和4年时（22.6%，p < 0.01）。
结论
在实际临床环境中，TNF抑制剂在4年时显示出较高的药物生存率。此外，随着时间的推移，控制活动性PsA所需的糖皮质激素减少。
Zotero 插件