Wu Eric, Chen Lei, Birnbaum Howard, Yang Elaine, Cifaldi Mary
Analysis Group, Inc., Boston, MA 02199, USA.
Curr Med Res Opin. 2008 Aug;24(8):2229-40. doi: 10.1185/03007990802229548. Epub 2008 Jun 23.
To describe dosing patterns for tumor necrosis factor (TNF) antagonists in patients with rheumatoid arthritis from health care provider and payer point of interest.
Using privately insured US claims data from 31 large employers covering 31 companies across the US, rheumatoid arthritis (RA) patients were identified and three cohorts were defined based on first TNF-antagonist treatment (adalimumab, etanercept, or infliximab) administered after January 1, 2003. Dosage-adjustment patterns were assessed during the following 12-month period. Changes in dosage (both increases and decreases) and maintenance of a stable dosage were evaluated. For the health care provider point of interest, a new algorithm was developed to assess treatment patterns with chronic injectable therapies that incorporated the potential inconsistency between days of supply and prescription-gap data, thus providing the actual use of TNF-antagonist treatment. For the payer, usage data addressed whether the TNF antagonist was used at a greater dosage than recommended. Differences in baseline characteristics and dosage change rates between cohorts were tested using Chi-Square tests for categorical variables and Wilcoxon tests for continuous variables.
From the health care provider point of interest, 83.4% of adalimumab-treated patients (n = 205) initially received the recommended dosage, 10.2% received less, and 6.3% received more; 87.7% of etanercept-treated patients (n = 455) initially received the recommended dosage, 11.2% received less, and 1.1% received more; and 83.8% of infliximab-treated patients (n = 148) started with 2-4 vials (the recommended dosage is based on the weight of the patient, not total milligrams). All treatments had similar dosage decrease and discontinuation rates. Maintenance of stable dosage was lower for infliximab (20.9%) than adalimumab (37.1%) and etanercept (39.1%); both p < 0.01. The infliximab dosage-increase rate (35.1%) was greater than adalimumab (3.9%) and etanercept (0); both p < 0.01. From the payer point of interest, dosage-increase rate was greater for infliximab (28.3%) than adalimumab (8.7%) and etanercept (6.9%), both p < 0.01.
Infliximab had greater dosage-increase rates than adalimumab and etanercept. Adalimumab and etanercept had similar dosage-increase rates. All treatments had similar dosage-decrease and discontinuation rates. Maintenance of stable dosage was lower for infliximab than for adalimumab and etanercept. The study has the usual limitation of claims data analysis in that clinical details might be insufficient to draw causal inference.
从医疗服务提供者和支付方的角度描述类风湿关节炎患者使用肿瘤坏死因子（TNF）拮抗剂的给药模式。
利用来自美国31家大型雇主的私人保险理赔数据，这些雇主涵盖了美国各地的31家公司，识别出类风湿关节炎（RA）患者，并根据2003年1月1日后首次使用的TNF拮抗剂治疗（阿达木单抗、依那西普或英夫利昔单抗）定义了三个队列。在接下来的12个月期间评估剂量调整模式。评估剂量变化（增加和减少）以及稳定剂量的维持情况。对于医疗服务提供者的关注点，开发了一种新算法来评估慢性注射疗法的治疗模式，该算法纳入了供应天数和处方间隔数据之间潜在的不一致性，从而提供TNF拮抗剂治疗的实际使用情况。对于支付方，使用数据涉及TNF拮抗剂的使用剂量是否高于推荐剂量。使用卡方检验对分类变量以及威尔科克森检验对连续变量来测试队列之间基线特征和剂量变化率的差异。
从医疗服务提供者的角度来看，接受阿达木单抗治疗的患者中83.4%（n = 205）最初接受了推荐剂量，10.2%接受的剂量较少，6.3%接受的剂量较多；接受依那西普治疗的患者中87.7%（n = 455）最初接受了推荐剂量，11.2%接受的剂量较少，1.1%接受的剂量较多；接受英夫利昔单抗治疗的患者中83.8%（n = 148）开始时使用2 - 4瓶（推荐剂量基于患者体重，而非总毫克数）。所有治疗的剂量降低和停药率相似。英夫利昔单抗稳定剂量的维持率（20.9%）低于阿达木单抗（37.1%）和依那西普（39.1%）；两者p < 0.01。英夫利昔单抗的剂量增加率（35.1%）高于阿达木单抗（3.9%）和依那西普（0）；两者p < 0.01。从支付方的角度来看，英夫利昔单抗的剂量增加率（28.3%）高于阿达木单抗（8.7%）和依那西普（6.9%），两者p < 0.01。
英夫利昔单抗的剂量增加率高于阿达木单抗和依那西普。阿达木单抗和依那西普的剂量增加率相似。所有治疗的剂量降低和停药率相似。英夫利昔单抗稳定剂量的维持率低于阿达木单抗和依那西普。本研究具有理赔数据分析的常见局限性，即临床细节可能不足以得出因果推断。
