Caon C, Din M, Ching W, Tselis A, Lisak R, Khan O
Multiple Sclerosis Center, Department of Neurology, Wayne State University School of Medicine, Detroit, MI, USA.
Eur J Neurol. 2006 May;13(5):471-4. doi: 10.1111/j.1468-1331.2006.01273.x.
We examined the clinical course after switching disease-modifying therapy (DMT) in patients with relapsing-remitting multiple sclerosis (RRMS). Eighty-five consecutive RRMS patients who received weekly interferon beta-1a (IFN beta-1a) 6 MU i.m. for at least 18 months were enrolled. Baseline annualized relapse rate (ARR) for the 2 years prior to initiating therapy with IFN beta-1a was obtained from charts. All 85 patients received treatment with IFN beta-1a at 6 MU i.m. weekly for 18-24 months (mean 19.7 months). Treatment with IFN beta-1a reduced the mean ARR from 1.41 to 1.23 (P=0.005). All 85 patients were then switched to glatiramer acetate (GA) 20 mg s.c. daily and prospectively followed up for 36-42 months (mean 37.5 months). Patients were switched because of persistent clinical disease activity (n=62) or persistently unacceptable toxicity (n=23) as determined by the treating neurologist. Treatment with GA reduced the mean ARR from 1.23 to 0.53 (P=0.0001). Subgroup analysis showed that in patients who were switched because of lack of efficacy (n=62), the mean ARR was reduced from 1.32 on IFN beta-1a to 0.52 on GA (P=0.0001). In contrast, in patients who switched because of persistent toxicity (n=23), the mean ARR was reduced from 0.61 on IFN beta-1a to 0.47 on GA (P, non-significant). Our observations suggest that clinical observations such as relapse rate and tolerability may be used as criteria for switching DMT in clinical practice. More definitive consensus criteria incorporating magnetic resonance imaging and clinical observations for defining optimal response and tolerability need to be developed for the routine clinical management of RRMS patients receiving DMT.
我们研究了复发缓解型多发性硬化症（RRMS）患者更换疾病修饰治疗（DMT）后的临床病程。连续纳入85例接受每周一次皮下注射6百万单位（MU）干扰素β-1a（IFNβ-1a）至少18个月的RRMS患者。从病历中获取开始使用IFNβ-1a治疗前2年的基线年化复发率（ARR）。所有85例患者每周一次皮下注射6 MU的IFNβ-1a治疗18 - 24个月（平均19.7个月）。IFNβ-1a治疗使平均ARR从1.41降至1.23（P = 0.005）。然后所有85例患者更换为每日皮下注射20 mg醋酸格拉替雷（GA），并进行前瞻性随访36 - 42个月（平均37.5个月）。更换治疗是因为经主治神经科医生判定存在持续的临床疾病活动（n = 62）或持续无法接受的毒性（n = 23）。GA治疗使平均ARR从1.23降至0.53（P = 0.0001）。亚组分析显示，因疗效不佳而更换治疗的患者（n = 62），平均ARR从IFNβ-1a治疗时的1.32降至GA治疗时的0.52（P = 0.0001）。相比之下，因持续毒性而更换治疗的患者（n = 23），平均ARR从IFNβ-1a治疗时的0.61降至GA治疗时的0.47（P，无统计学意义）。我们的观察结果表明，诸如复发率和耐受性等临床观察指标可作为临床实践中更换DMT的标准。需要制定更明确的共识标准，纳入磁共振成像和临床观察指标，以确定接受DMT的RRMS患者的最佳反应和耐受性，用于常规临床管理。
