Characteristics Associated with Biologic Monotherapy Use in Biologic-Naive Patients with Rheumatoid Arthritis in a US Registry Population.
Characteristics Associated with Biologic Monotherapy Use in Biologic-Naive Patients with Rheumatoid Arthritis in a US Registry Population.
复制标题
DOI：
10.1007/s40744-015-0008-9
复制
发表时间：
2015-06
影响因子：
3.8
通讯作者：
Kremer JM
中科院分区：
文献类型：
--
作者：
Pappas DA;Reed GW;Saunders K;John A;Shewade A;Greenberg JD;Kremer JM
本研究的目的是描述在Corrona登记研究中入组的类风湿关节炎（RA）生物制剂初治患者中启动生物制剂单药治疗与联合常规疾病缓解抗风湿药物（DMARD）治疗的相关因素。首次生物治疗分为单药治疗（Bio MT）或联合治疗（Bio CMB）。评价基线人口统计学和临床特征。基于混合效应回归模型的比值比（OR）估计协变量与单药治疗的相关性。中位比值比（莫尔）基于估计的医生随机效应，量化了个体医生使用单药治疗的变化。2001年10月至2012年4月期间，3，923例既往未接受过生物制剂治疗的患者开始接受生物制剂治疗，其中19.1%的患者开始接受单药治疗。开始Bio MT和Bio CMB治疗的患者在年龄、性别、RA病程和临床疾病活动指数方面的基线特征相似。与Bio MT启动者相比，Bio CMB启动者既往使用过传统DMARD（97.23 vs 85.60%; P < 0.01）和甲氨蝶呤（MTX）（91.68 vs 71.87%; P < 0.01）的比例显著更高。个体医生使用单药治疗的差异[莫尔1.89; 95%置信区间（CI），1.66-2.23]和使用美国食品和药物管理局批准的生物制剂进行单药治疗（OR 1.47; 95% CI，1.20-1.81）显著影响启动Bio MT的几率。肝病、中性粒细胞减少症和恶性肿瘤患者病史与Bio MT处方的可能性增加相关。除了单药治疗和特定既存合并症的监管批准外，医生使用单药治疗的显著差异与启动Bio MT的可能性增加相关，与患者因素无关。本文的在线版本（doi：10.1007/s40744-015-0008-9）包含补充材料，可供授权用户使用。
The aim of this study was to describe factors associated with initiating a biologic as monotherapy vs in combination with a conventional disease-modifying antirheumatic drug (DMARD) in biologic-naive patients with rheumatoid arthritis (RA) enrolled in the Corrona registry. First biologic initiations were classified as monotherapy (Bio MT) or combination therapy (Bio CMB). Baseline demographic and clinical characteristics were evaluated. Odds ratios (OR) based on mixed effects regression models estimated the association of covariates and use of monotherapy. Median odds ratios (MOR) based on estimated physician random effects quantified variation in individual physician use of monotherapy. Between October 2001 and April 2012, 3,923 previously biologic-naive patients initiated biologic therapy, of which 19.1 % initiated as monotherapy. Baseline characteristics of patients initiating Bio MT and Bio CMB were similar for age, sex, duration of RA, and clinical disease activity index. Significantly higher proportions of Bio CMB initiators had prior conventional DMARD (97.23 vs 85.60 %; P < 0.01) and methotrexate (MTX) use (91.68 vs 71.87 %; P < 0.01) compared with Bio MT initiators. Variation in individual physician use of monotherapy [MOR 1.89; 95 % confidence interval (CI), 1.66–2.23] and use of biologics approved by the United States Food and Drug Administration for monotherapy (OR 1.47; 95 % CI, 1.20–1.81) significantly influenced the odds of initiating Bio MT. Patient history of hepatic disease, neutropenia, and malignancy were associated with increased odds of being prescribed Bio MT. In addition to regulatory approval for monotherapy and specific pre-existing comorbidities, significant variation in physician use of monotherapy was associated with increased likelihood of initiating Bio MT, independent of patient factors. The online version of this article (doi:10.1007/s40744-015-0008-9) contains supplementary material, which is available to authorized users.