Department of Neurology, University Hospital, Rennes, France.
Department of Epidemiology and Public Health, University Hospital, Rennes, France.
Eur J Neurol. 2017 Feb;24(2):237-244. doi: 10.1111/ene.13181. Epub 2016 Oct 18.
The benefits of immunomodulatory treatments in secondary progressive multiple sclerosis (SPMS) are unclear, calling into question their continuation. In the present observational study, we investigated the effect of treatment withdrawal on the clinical course of SPMS.
We included 100 consecutive patients with SPMS who regularly attended our multiple sclerosis clinic. Inclusion criteria were (i) secondary progressive phenotype for at least 2 years, (ii) immunomodulatory treatment for at least 6 months and (iii) treatment stopped with no plans to switch to another. Clinical and magnetic resonance imaging (MRI) data before and after treatment discontinuation were assessed. Factors associated with relapses and/or MRI activity were identified.
Mean treatment duration was 60.4 ± 39.3 months, and mean follow-up duration after treatment withdrawal was 62.4 ± 38.4 months. The annualized relapse rate remained stable at 1 and 3 years after treatment withdrawal [0.09, 95% confidence interval (CI), 0.05-0.17 and 0.07, 95% CI, 0.05-0.11, respectively], relative to the 3 years prior to treatment withdrawal (0.12, 95% CI, 0.09-0.16). Sixteen patients experienced a relapse and 19 had a gadolinium-positive MRI scan without relapse during follow-up. A gadolinium-positive MRI scan within the previous 3 years before treatment withdrawal and Expanded Disability Status Scale score of <6 were positively associated with relapse and/or MRI activity after discontinuation (P = 0.0004 and P = 0.03, respectively).
In this retrospective study, including a limited number of patients with SPMS, the annualized relapse rate remained stable after treatment withdrawal, relative to before treatment withdrawal. Further prospective studies are needed to confirm this result and provide evidence-based guidelines for daily practice.
免疫调节治疗在继发进展型多发性硬化症(SPMS)中的获益尚不清楚,这使其继续治疗的必要性受到质疑。在本观察性研究中,我们研究了治疗停药对 SPMS 临床病程的影响。
我们纳入了 100 例连续就诊于我们多发性硬化症门诊的 SPMS 患者。纳入标准为:(i)至少 2 年的继发进展型病程,(ii)免疫调节治疗至少 6 个月,(iii)停药且无计划更换另一种治疗。评估治疗停止前后的临床和磁共振成像(MRI)数据。确定与复发和/或 MRI 活动相关的因素。
平均治疗持续时间为 60.4 ± 39.3 个月,停药后平均随访时间为 62.4 ± 38.4 个月。停药后 1 年和 3 年时的年复发率保持稳定[0.09,95%置信区间(CI),0.05-0.17 和 0.07,95%CI,0.05-0.11],与治疗前 3 年相比(0.12,95%CI,0.09-0.16)。16 例患者在随访期间发生复发,19 例患者在无复发的情况下 MRI 扫描增强。停药前 3 年内有增强 MRI 扫描和扩展残疾状况量表评分<6 与停药后复发和/或 MRI 活动相关(P=0.0004 和 P=0.03)。
在这项回顾性研究中,纳入了数量有限的 SPMS 患者,停药后年复发率与停药前相比保持稳定。需要进一步的前瞻性研究来证实这一结果,并为临床实践提供循证指南。