Menge Til, Rehberg-Weber Karin, Taipale Kirsi, Nastos Ilias, Jauß Marek
Centre for Neurology and Neuropsychiatry, LVR-Klinikum Düsseldorf, Medical Faculty, Heinrich-Heine-University Düsseldorf, Bergische Landstr. 2, Düsseldorf, 40629, Germany.
Biogen GmbH, München, Germany.
Ther Adv Neurol Disord. 2021 Mar 19;14:17562864211000461. doi: 10.1177/17562864211000461. eCollection 2021.
Peginterferon beta-1a was developed for treatment of relapsing-remitting multiple sclerosis (RRMS) to provide an interferon with increased exposure to facilitate adherence by reducing frequency of application. This non-interventional observational study investigated the adherence to peginterferon beta-1a in real-world clinical practice settings.
This prospective study was conducted from 1/2015 to 1/2018 at 77 German MS sites. Adult patients with RRMS (previously treated or treatment-naïve) receiving peginterferon beta-1a (125 µg SC every 2 weeks) were eligible for participation. Data were documented every 3 months over 2 years (nine visits). The primary endpoint was the percentage of patients with overall adherence defined as ⩽10% of injections not administered throughout the 24-month observation period. Secondary endpoints included persistence, patient satisfaction, efficacy (relapse activity, disability progression), and tolerability. Patients were invited to participate in an individualised patient support programme.
Out of 250 enrolled patients, 190 (aged 18-74 years, 75.3% female) were included in the efficacy analysis. Of those, 74 patients completed the study; 33.2% were treatment-naïve. The proportion of patients with an overall adherence of >90% was 75.7% (95% CI 67.9-81.6). The annualised relapse rate was 0.17. Compared with previous therapies, the scores for treatment satisfaction and convenience were markedly higher with peginterferon beta-1a. Overall, 87.4% participated in the patient support programme, and 47.8% of patients reported adverse events.
Adherence to the bi-weekly treatment with peginterferon beta-1a was very high. Although adherence could have been positively influenced by the well-accepted patient support programme, the extent could not be unequivocally evaluated. Clinical disease activity remained low. Peginterferon beta-1a was well tolerated, and there were no new relevant safety findings.
聚乙二醇化干扰素β-1a被开发用于治疗复发缓解型多发性硬化症(RRMS),以提供一种能增加药物暴露量的干扰素,通过减少给药频率来提高依从性。这项非干预性观察研究在真实世界临床实践环境中调查了聚乙二醇化干扰素β-1a的依从性。
这项前瞻性研究于2015年1月至2018年1月在德国77个多发性硬化症治疗点进行。接受聚乙二醇化干扰素β-1a(每2周皮下注射125μg)的RRMS成年患者(既往接受过治疗或未接受过治疗)符合参与条件。在2年时间里(9次访视),每3个月记录一次数据。主要终点是在24个月观察期内未注射次数≤10%的总体依从性患者的百分比。次要终点包括持续治疗率、患者满意度、疗效(复发活动、残疾进展)和耐受性。邀请患者参加个性化患者支持计划。
在250名入组患者中,190名(年龄18 - 74岁,75.3%为女性)纳入疗效分析。其中,74名患者完成了研究;33.2%为未接受过治疗的患者。总体依从性>90%的患者比例为75.7%(95%置信区间67.9 - 81.6)。年化复发率为0.17。与先前的治疗方法相比,聚乙二醇化干扰素β-1a的治疗满意度和便利性评分明显更高。总体而言,87.4%的患者参加了患者支持计划,47.8%的患者报告了不良事件。
每两周一次的聚乙二醇化干扰素β-1a治疗依从性非常高。尽管患者支持计划被广泛接受可能对依从性有积极影响,但影响程度无法明确评估。临床疾病活动度仍然较低。聚乙二醇化干扰素β-1a耐受性良好,没有新的相关安全性发现。