Bergvall Niklas, Lahoz Raquel, Reynolds Tracy, Korn Jonathan R
Novartis Pharma AG , Basel , Switzerland.
Curr Med Res Opin. 2014 Aug;30(8):1461-71. doi: 10.1185/03007995.2014.915802. Epub 2014 May 2.
Healthcare resource utilization in patients with multiple sclerosis (MS) is linked to relapses and disease progression. This retrospective cohort database analysis compared healthcare resource use and proxy measures of relapse outcomes in patients with active disease who switched to fingolimod or natalizumab.
Using administrative claims data from the US PharMetrics Plus database, we identified patients with an MS diagnosis and a claim for fingolimod or natalizumab between 1 October 2010 and 30 June 2012 (index period) who had experienced a relapse (identified using a claims-based algorithm) and used other disease-modifying therapies (DMTs) in the previous year. Patients in the fingolimod and natalizumab cohorts were propensity score matched (1:1). MS-related inpatient stays, corticosteroid use and the proportion of patients experiencing claims-based relapses were assessed in the pre-index and post-index persistence periods. Time to first claims-based relapse in the post-index persistence period was assessed using a Kaplan-Meier curve.
The study included 623 unmatched patients (299 and 324 patients in the fingolimod and natalizumab cohorts, respectively) and 370 matched patients (185 in each cohort). In the matched analysis, MS-related inpatient stays and corticosteroid use were similar in the fingolimod and natalizumab cohorts during the post-index persistence period, and were significantly reduced versus the pre-index period (p < 0.01). A similar proportion of patients in the fingolimod and natalizumab cohorts were free from claims-based relapses in the persistence period (68.1% and 68.6%, respectively). There was no significant difference in the likelihood of experiencing a claims-based relapse (p = 0.8696).
Identification of relapses is based on database claims rather than on clinical assessment.
In analyses of patients with MS with a history of relapse and DMT use, fingolimod and natalizumab reduce healthcare resource utilization and have similar effectiveness in a real-world setting.
多发性硬化症（MS）患者的医疗资源利用与疾病复发及病情进展相关。本回顾性队列数据库分析比较了换用芬戈莫德或那他珠单抗的活动性疾病患者的医疗资源使用情况及复发结局的替代指标。
利用美国PharMetrics Plus数据库中的管理索赔数据，我们确定了在2010年10月1日至2012年6月30日（索引期）期间被诊断为MS且有芬戈莫德或那他珠单抗索赔记录、经历过复发（使用基于索赔的算法确定）且在前一年使用过其他疾病修饰疗法（DMTs）的患者。芬戈莫德组和那他珠单抗组的患者进行倾向得分匹配（1:1）。在索引前和索引后持续期评估与MS相关的住院时间、皮质类固醇的使用情况以及经历基于索赔复发的患者比例。使用Kaplan-Meier曲线评估索引后持续期首次基于索赔复发的时间。
该研究纳入了623例未匹配患者（芬戈莫德组和那他珠单抗组分别为299例和324例）以及370例匹配患者（每组185例）。在匹配分析中，索引后持续期芬戈莫德组和那他珠单抗组与MS相关的住院时间和皮质类固醇的使用情况相似，且与索引前期相比显著减少（p < 0.01）。芬戈莫德组和那他珠单抗组在持续期无基于索赔复发的患者比例相似（分别为68.1%和68.6%）。经历基于索赔复发的可能性无显著差异（p = 0.8696）。
复发的识别基于数据库索赔而非临床评估。
在对有复发史和使用DMTs的MS患者的分析中，芬戈莫德和那他珠单抗可降低医疗资源利用，且在实际应用中效果相似。
