TNFi Cycling Versus Changing Mechanism of Action in TNFi-Experienced Patients: Result of the Corrona CERTAIN Comparative Effectiveness Study.

TNFi Cycling Versus Changing Mechanism of Action in TNFi-Experienced Patients: Result of the Corrona CERTAIN Comparative Effectiveness Study.
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DOI:
10.1002/acr2.11337
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发表时间:
2022-01
影响因子:
3.4
通讯作者:
Pappas DA
Pappas DA
中科院分区:
其他
文献类型:
--
作者:
Curtis JR;Kremer JM;Reed G;John AK;Pappas DA

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比较有效性研究可以为类风湿关节炎(RA)生物制剂的选择提供治疗决策。本研究的目的是比较肿瘤坏死因子抑制剂(TNFis)和非TNFis(nTNFis)在真实的RA患者和既往TNFi经验中的疗效。研究关节炎和炎症性疾病治疗的比较有效性登记研究(CERTAIN)嵌套在美国Corrona登记研究中。招募了具有中度至高度疾病活动性(临床疾病活动性指数[CDAI] >10)的患有RA的成人患者,其暴露于一种或多种先前的TNF i,并转换为新的TNFi或nTNFi(根据医生选择的治疗选择)。主要结局是在12个月时达到低疾病活动度(LDA)(CDAI ≤10;基于C反应蛋白[DAS 28-CRP]的28个关节疾病活动度评分<2.67)。倾向评分建模nTNFi与TNFi治疗概率,针对不平衡因素进行调整。使用混合效应logistic回归模型对缓解率进行建模,调整先验和不平衡的基线因素,并考虑实践相关的治疗模式。在应用纳入标准后,分析了939例生物学启动,505例(53.7%)nTNF和434例(46.3%)TNF。开始使用nTNFis的患者更有可能有更长的疾病持续时间,更早的TNFi使用,更高的患者疲劳评分,更有可能有政府保险。在12个月时,28%的nTNFi和24%的TNFi启动者通过CDAI处于LDA中,22%的nTNFi和19%的TNFi启动者通过DAS 28 ‐CRP处于LDA中。在多变量调整和控制研究中心相关混杂因素的影响后,通过CDAI(调整后比值比[aOR] = 1.12; 95%置信区间[CI],0.78 - 1.62)或DAS 28-CRP(aOR = 1.16; 95% CI,0.77 - 1.75)达到LDA的可能性无显著差异。在这项大型、真实的世界研究中,入组了既往暴露于TNFi的RA患者,转换为nTNFi生物制剂与转换为另一种TNFi的临床有效性相当。
Comparative effectiveness research can inform treatment decisions regarding the choice of biologics for rheumatoid arthritis (RA). The objective of this study is to compare the efficacy of tumor necrosis factor inhibitors (TNFis) and non‐TNFis (nTNFis) in real‐world patients with RA and past TNFi experience. Comparative Effectiveness Registry to study Therapies for Arthritis and Inflammatory Conditions (CERTAIN) was nested within the United States Corrona registry. Adult patients with RA with moderate to high disease activity (Clinical Disease Activity Index [CDAI] >10) with exposure to one or more prior TNFis who were switching to a new TNFi or nTNFi (choice of therapy per physician choice) were enrolled. The primary outcome was the achievement of low disease activity (LDA) at 12 months (CDAI ≤10; disease activity score in 28 joints based on C‐reactive protein [DAS28‐CRP] <2.67). Propensity score modeling probability of treatment with nTNFi versus TNFi adjusted for imbalanced factors. The response rate was modeled using mixed‐effect logistic regression models, adjusting for a priori and imbalanced baseline factors and accounting for the practice‐related treatment patterns. After applying inclusion criteria, 939 biologic initiations were analyzed, 505 (53.7%) nTNFis and 434 (46.3%) TNFis. Patients who started nTNFis were significantly more likely to have longer disease duration, more prior TNFi use, and higher patient fatigue scores and were more likely to have government insurance. At 12 months, 28% of nTNFi and 24% of TNFi initiators were in LDA by CDAI, and 22% of nTNFi and 19% of TNFi initiators were in LDA by DAS28‐CRP. After multivariable adjustment and controlling for the influence of site‐related confounding, there were no significant differences in the likelihood to reach LDA by CDAI (adjusted odds ratio [aOR] = 1.12; 95% confidence interval [CI], 0.78‐1.62) or DAS28‐CRP (aOR = 1.16; 95% CI, 0.77‐1.75). In this large, real‐world study enrolling patients with RA with prior TNFi exposure, switching to an nTNFi biologic was comparable in its clinical effectiveness with switching to another TNFi.
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