醋酸格拉替雷与皮下注射用干扰素β-1a治疗多发性硬化症患者的疗效比较

Castelli-Haley Jane, Oleen-Burkey MerriKay, Lage Maureen J, Johnson Kenneth P

Teva Neuroscience, Kansas City, Missouri, USA.

Adv Ther. 2008 Jul;25(7):658-73. doi: 10.1007/s12325-008-0077-z.

INTRODUCTION

We compared the outcomes of multiple sclerosis (MS) patients treated with either glatiramer acetate (GA) (Copaxone, Teva Pharmaceutical Industries, Israel) or interferon beta-1a for subcutaneous administration (IFN beta-1a-SC) (Rebif, Merck Serono, Switzerland).

METHODS

Data were obtained from i3's Lab Rx Database from July 2001 to June 2006. We established an 'intent-to-treat' (ITT) cohort (n=845) of patients diagnosed with MS who began therapy on either GA (n=542) or IFN beta-1a-SC (n=303) and had continuous insurance coverage from 6 months before to 24 months after the date they began taking the medication. We also created a 'continuous use' (CU) cohort (n=410) of individuals who, in addition to the criteria listed above, used either GA or IFN beta-1a-SC within 28 days of the end of the 2-year-post period. Using multivariate regressions, we examined both the 2-year total direct medical costs and the likelihood of relapse associated with the use of these two MS medications. We defined relapse as either being hospitalised with a diagnosis of MS, or being diagnosed with MS during an outpatient visit and then prescribed steroids within a 7-day period. All regressions controlled a wide range of factors that have potentially affected outcomes.

RESULTS

In the ITT cohort, patients who started therapy on GA had a significantly lower 2-year risk of relapse (5.92% versus 10.89%; P=0.0305), as well as significantly lower 2-year total medical costs (US$41,786 versus US$49,030; P=0.0002). In the CU cohort, patients who used GA also had a significantly lower 2-year risk of relapse (1.94% versus 9.09%; P=0.0049) and significantly lower total medical costs (US$45,213 versus US$57,311; P<0.0001).

CONCLUSIONS

Results indicate that, compared with the use of IFN beta-1a-SC, use of GA is associated with significantly lower probability of relapse as well as significantly lower 2-year total direct medical costs. In addition, these results are more pronounced among patients defined as continuous users.

引言

我们比较了接受醋酸格拉替雷（GA）（考帕松，梯瓦制药工业公司，以色列）或皮下注射用干扰素β-1a（IFNβ-1a-SC）（利比，默克雪兰诺公司，瑞士）治疗的多发性硬化症（MS）患者的治疗结果。

方法

数据来自i3公司的实验室处方数据库，时间跨度为2001年7月至2006年6月。我们建立了一个“意向性治疗”（ITT）队列（n = 845），该队列中的MS患者开始接受GA治疗（n = 542）或IFNβ-1a-SC治疗（n = 303），并且在开始服药日期前6个月至服药后24个月期间拥有持续的保险覆盖。我们还创建了一个“持续使用”（CU）队列（n = 410），这些个体除了满足上述标准外，在2年后期结束后的28天内使用了GA或IFNβ-1a-SC。使用多变量回归分析，我们研究了这两种MS药物使用相关的2年总直接医疗费用和复发可能性。我们将复发定义为因MS诊断住院，或在门诊就诊时被诊断为MS并在7天内开具类固醇药物。所有回归分析都控制了一系列可能影响治疗结果的因素。

结果

在ITT队列中，开始接受GA治疗的患者2年复发风险显著更低（5.92%对10.89%；P = 0.0305），2年总医疗费用也显著更低（41,786美元对49,030美元；P = 0.0002）。在CU队列中，使用GA的患者2年复发风险同样显著更低（1.94%对9.09%；P = 0.0049），总医疗费用也显著更低（45,213美元对57,311美元；P < 0.0001）。