Kallmann Boris A, Ries Stefan, Kullmann Jennifer S, Quint Laura M, Engelmann Ulrich, Chan Andrew
Multiple-Sclerosis-Center Bamberg, Bamberg, Germany.
Neuro Centrum Odenwald, Erbach, Germany.
Ther Adv Neurol Disord. 2021 May 18;14:17562864211005588. doi: 10.1177/17562864211005588. eCollection 2021.
To investigate effectiveness and safety of teriflunomide (14 mg once daily) in association with age and pre-treatment in unselected MS patients.
Prespecified analysis of a non-interventional, prospective, real-world study in Germany.
A total of 558 (49.5%) patients were above 45 years old, and 593 patients (52.6%) had been pre-treated within 6 months prior to teriflunomide. Baseline Expanded Disability Status Scale (EDSS) was higher with older age, with lower number of relapses. Relapse rate decreased in all age groups, and in both treatment-naïve (0.82 ± 0.73 at baseline; 0.25 ± 0.55 under teriflunomide) and pre-treated (from 0.48 ± 0.76; 0.22 ± 0.50) patients after 12 months compared with the year before teriflunomide initiation. EDSS remained stable in patients of all age groups as well as in therapy-naïve and pre-treated patients over 24 months. The percentage of patients with adverse events (AEs) ranged between 29.2% (age group >25-35) and 38.9% (age group >55-65), with an increased discontinuation rate (most commonly due to diarrhoea, alopecia and nausea) in the higher age groups. AE rates were lower in pre-treated compared with treatment-naïve patients.
Overall, patients of all age groups including older patients, and irrespective of pre-treatment, benefit from teriflunomide treatment in routine clinical practice.
BfArM public study database number 2075.
研究在未经挑选的多发性硬化症(MS)患者中,年龄及预处理因素与每日一次服用14毫克特立氟胺的有效性和安全性之间的关系。
对德国一项非干预性、前瞻性、真实世界研究进行预设分析。
共有558名(49.5%)患者年龄超过45岁,593名(52.6%)患者在服用特立氟胺前6个月内接受过预处理。随着年龄增长,基线扩展残疾状态量表(EDSS)评分更高,复发次数更少。所有年龄组的复发率均下降,在未经治疗的患者(基线时为0.82±0.73;服用特立氟胺后为0.25±0.55)和接受过预处理的患者(从0.48±0.76降至0.22±0.50)中,与开始服用特立氟胺前一年相比,12个月后的复发率均有所下降。在24个月内,所有年龄组的患者以及未经治疗和接受过预处理的患者的EDSS评分均保持稳定。不良事件(AE)患者的百分比在29.2%(年龄组>25 - 35岁)至38.9%(年龄组>55 - 65岁)之间,年龄较大的组停药率增加(最常见原因是腹泻、脱发和恶心)。与未经治疗的患者相比,接受过预处理的患者AE发生率更低。
总体而言,在常规临床实践中,包括老年患者在内的所有年龄组患者,无论是否接受过预处理,均可从特立氟胺治疗中获益。
德国联邦药品与医疗器械研究所(BfArM)公共研究数据库编号2075 。