Division of Neurology and Brain Research Centre, Department of Medicine and Vancouver Coastal Health Research Institute, University of British Columbia, Vancouver, Canada.
JAMA. 2012 Jul 18;308(3):247-56. doi: 10.1001/jama.2012.7625.
Interferon beta is widely prescribed to treat multiple sclerosis (MS); however, its relationship with disability progression has yet to be established.
To investigate the association between interferon beta exposure and disability progression in patients with relapsing-remitting MS.
DESIGN, SETTING, AND PATIENTS: Retrospective cohort study based on prospectively collected data (1985-2008) from British Columbia, Canada. Patients with relapsing-remitting MS treated with interferon beta (n = 868) were compared with untreated contemporary (n = 829) and historical (n = 959) cohorts.
The main outcome measure was time from interferon beta treatment eligibility (baseline) to a confirmed and sustained score of 6 (requiring a cane to walk 100 m; confirmed at >150 days with no measurable improvement) on the Expanded Disability Status Scale (EDSS) (range, 0-10, with higher scores indicating higher disability). A multivariable Cox regression model with interferon beta treatment included as a time-varying covariate was used to assess the hazard of disease progression associated with interferon beta treatment. Analyses also included propensity score adjustment to address confounding by indication.
The median active follow-up times (first to last EDSS measurement) were as follows: for the interferon beta-treated cohort, 5.1 years (interquartile range [IQR], 3.0-7.0 years); for the contemporary control cohort, 4.0 years (IQR, 2.1-6.4 years); and for the historical control cohort, 10.8 years (IQR, 6.3-14.7 years). The observed outcome rates for reaching a sustained EDSS score of 6 were 10.8%, 5.3%, and 23.1% in the 3 cohorts, respectively. After adjustment for potential baseline confounders (sex, age, disease duration, and EDSS score), exposure to interferon beta was not associated with a statistically significant difference in the hazard of reaching an EDSS score of 6 when either the contemporary control cohort (hazard ratio, 1.30; 95% CI, 0.92-1.83; P = .14) or the historical control cohort (hazard ratio, 0.77; 95% CI, 0.58-1.02; P = .07) were considered. Further adjustment for comorbidities and socioeconomic status, where possible, did not change interpretations, and propensity score adjustment did not substantially change the results.
Among patients with relapsing-remitting MS, administration of interferon beta was not associated with a reduction in progression of disability.
干扰素 β 被广泛用于治疗多发性硬化症（MS）；然而，其与残疾进展的关系尚未确定。
研究干扰素 β 暴露与复发性缓解型 MS 患者残疾进展之间的关系。
设计、地点和患者：基于加拿大不列颠哥伦比亚省前瞻性收集的数据（1985-2008 年）进行的回顾性队列研究。接受干扰素 β 治疗的复发性缓解型 MS 患者（n=868）与未接受治疗的同期（n=829）和历史（n=959）队列进行比较。
主要观察指标是从干扰素 β 治疗资格（基线）到扩展残疾状况量表（EDSS）上确认和持续评分 6 分的时间（需要拐杖行走 100 米；在 >150 天内确认，没有可衡量的改善）（范围，0-10，分数越高表示残疾程度越高）。使用包含干扰素 β 治疗作为时变协变量的多变量 Cox 回归模型评估与干扰素 β 治疗相关的疾病进展风险。分析还包括倾向评分调整以解决指示性混杂。
中位活跃随访时间（从第一次到最后一次 EDSS 测量）如下：干扰素 β 治疗队列为 5.1 年（四分位距 [IQR]，3.0-7.0 年）；同期对照组为 4.0 年（IQR，2.1-6.4 年）；历史对照组为 10.8 年（IQR，6.3-14.7 年）。3 个队列中达到持续 EDSS 评分 6 分的观察结果发生率分别为 10.8%、5.3%和 23.1%。在调整潜在基线混杂因素（性别、年龄、疾病持续时间和 EDSS 评分）后，与同期对照组（风险比，1.30；95%CI，0.92-1.83；P=0.14）或历史对照组（风险比，0.77；95%CI，0.58-1.02；P=0.07）相比，干扰素 β 暴露与 EDSS 评分达到 6 分的风险无统计学显著差异。在可能的情况下进一步调整合并症和社会经济状况并未改变结论，倾向评分调整也未显著改变结果。
在复发性缓解型 MS 患者中，给予干扰素 β 治疗与残疾进展的减少无关。
