Lanzillo R, Carotenuto A, Moccia M, Saccà F, Russo C V, Massarelli M, De Rosa A, Brescia Morra V
Department of Neurosciences, Reproductive and Odontostomatological Sciences, Multiple Sclerosis Clinical Care and Research Centre, Federico II University, Naples, Italy.
Acta Neurol Scand. 2017 Sep;136(3):217-222. doi: 10.1111/ane.12718. Epub 2016 Dec 15.
Different retrospective studies compared natalizumab and fingolimod in relapsing-remitting multiple sclerosis (RRMS), with conflicting results. We aimed to explore the prescriptive attitude and the clinical outcome of the two therapies.
We retrospectively included all RRMS patients treated with natalizumab (n=101) or fingolimod (n=78) as their first second-line therapy with at least 24-month follow-up. Demographic and clinical features were recorded to calculate the propensity score (PS). Outcomes of interest were annualized relapse rate (ARR), risk of relapse, and change in the EDSS RESULTS: At baseline, natalizumab patients were younger and had a shorter disease duration, a higher number of relapse in 1 year (1yR) and 2 years (2yR) and overall (ARR-PT) pretherapy, compared to fingolimod patients. On therapy, the proportion of relapsing patients and the mean RR were similar in the two groups. However, the change in the ARR was higher in natalizumab than in fingolimod group (P<.002), but, using PS as a covariate, it was comparable (P=.960). Similarly, the change in EDSS was significantly different for the two groups (P<.004), but not after adjusting for the PS (P=.321).
We observed a comparable efficacy on ARR reduction and on EDSS progression with natalizumab and fingolimod correcting through PS, suggesting that the efficacy difference observed before correction might derive from the clinical attitude in prescribing natalizumab in more active MS patients in real life.
不同的回顾性研究比较了那他珠单抗和芬戈莫德治疗复发缓解型多发性硬化症(RRMS)的效果,结果相互矛盾。我们旨在探讨这两种疗法的处方态度和临床结局。
我们回顾性纳入了所有接受那他珠单抗(n = 101)或芬戈莫德(n = 78)作为首次二线治疗且随访至少24个月的RRMS患者。记录人口统计学和临床特征以计算倾向评分(PS)。感兴趣的结局指标为年化复发率(ARR)、复发风险和扩展残疾状态量表(EDSS)的变化。结果:在基线时,与芬戈莫德组患者相比,那他珠单抗组患者更年轻,病程更短,治疗前1年(1yR)、2年(2yR)及总体(ARR-PT)的复发次数更多。在治疗过程中,两组复发患者的比例和平均复发率相似。然而,那他珠单抗组的ARR变化高于芬戈莫德组(P <.002),但将PS作为协变量时,二者具有可比性(P =.960)。同样,两组的EDSS变化有显著差异(P <.004),但校正PS后差异无统计学意义(P =.321)。
我们观察到那他珠单抗和芬戈莫德在通过PS校正后,对降低ARR和EDSS进展具有相似的疗效,这表明校正前观察到的疗效差异可能源于现实生活中对病情更活跃的MS患者处方那他珠单抗的临床态度。