首页> 外文期刊>Journal of Clinical Medicine >Background Glucocorticoid Therapy Has No Impact on Efficacy and Safety of Abatacept or Adalimumab in Patients with Rheumatoid Arthritis
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Background Glucocorticoid Therapy Has No Impact on Efficacy and Safety of Abatacept or Adalimumab in Patients with Rheumatoid Arthritis

机译:背景技术糖皮质激素治疗对类风湿性关节炎患者的ABATACEPT或Adalimalab的疗效和安全性没有影响

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To date, the impact of background glucocorticoids (GC) on the efficacy and safety of abatacept or adalimumab in patients with active rheumatoid arthritis (RA) is not clearly established. This post hoc analysis of (AMPLE) trial (NCT00929864) compared efficacy and safety outcomes over 2 years in patients treated with abatacept or adalimumab plus background methotrexate (MTX), who continued GC (≤10 mg/day) versus those who were not receiving GC (no-GC). Of 646 randomized patients, 317 received abatacept + MTX (161 GC, 156 no-GC) and 326 received adalimumab + MTX (162 GC, 164 no-GC). At Year 2, the adjusted mean changes from baseline in Disease Activity Score (DAS28 C-reactive protein (CRP)) and Health Assessment Questionnaire-Disability Index (HAQ-DI) were not significantly different in the GC versus no-GC subgroups receiving abatacept or adalimumab. A similar proportion of patients achieved remission, HAQ-DI score improvement ≥0.3 and radiographic progression rates. No clinically meaningful safety differences were observed between GC versus no-GC subgroups either with abatacept or adalimumab. In patients with active RA of similar baseline disease activity treated with abatacept or adalimumab plus background MTX, there was no additional value of background GC on clinical, functional or radiographic outcomes over two years.
机译:迄今为止,没有明确建立迄今为止,背景糖皮质激素(GC)对有活性类风湿性关节炎(RA)患者的Abatacept或Adalimalab的疗效和安全性。 (充足)审判(NCT00929864)的后HOC分析(NCT00929864)与Abatacept或Adalimalab加上背景甲氨蝶呤(MTX)治疗的患者有超过2年的疗效和安全结果,甲氨蝶呤(MTX),他持续的GC(≤10毫克/天)与那些没有收到的人GC(No-GC)。在646例随机患者中,317名接受ABATACEPT + MTX(161GC,156号NO-GC)和326个接受Adalimalab + MTX(162 GC,164 No-GC)。在2年,在疾病活动评分(DAS28 C反应蛋白(CRP))和健康评估问卷 - 残疾指数(HAQ-DI)的调整后的平均变化在接受ABATACEPT的GC与NO-GC子组中没有显着差异或atabalimumab。类似比例的患者取得了缓解,HAQ-DI分数提高≥0.3和放射线进展率。在GC与No-GC子组之间没有观察到临床上有意义的安全差异,无论是Abatacept还是Ad-GC子组。在用AbataCept或Adalimalab加上背景MTX处理的​​类似基线疾病活性的患者中,在两年内临床,功能或射线照相结果没有额外的背景GC。

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