Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universitätsklinikum Würzburg, Würzburg, Germany.
Universitätsklinik und Poliklinik für Dermatologie und Venerologie, Ernst-Grube-Str. 40, 06120 Halle (Saale) und Abteilung für translationale Dermatoinfektiologie, Röntgenstraße 21, 48149, Muenster, Germany.
BMC Neurol. 2019 Jun 15;19(1):130. doi: 10.1186/s12883-019-1354-y.
Interferon (IFN) beta drugs have been approved for the treatment of relapsing forms of multiple sclerosis (RMS) for more than 20 years and are considered to offer a favourable benefit-risk profile. In July 2014, subcutaneous (SC) peginterferon beta-1a 125 μg dosed every 2 weeks, a pegylated form of interferon beta-1a, was approved by the EMA for the treatment of adult patients with RRMS and in August 2014 by the FDA for RMS. Peginterferon beta-1a shows a prolonged half-life and increased systemic drug exposure resulting in a reduced dosing frequency compared to other available interferon-based products in MS. In the Phase 3 ADVANCE trial peginterferon beta-1a demonstrated significant positive effects on clinical and MRI outcome measures versus placebo after one year. Furthermore, in the ATTAIN extension study, sustained efficacy with long-term treatment for nearly 6 years was shown.
In July 2016, an interdisciplinary panel of German and Austrian experts convened to discuss the management of side effects associated with peginterferon beta-1a and other interferon beta-based treatments in MS in daily practice. The panel was composed of experts from university hospitals and private clinics comprised of neurologists, dermatologists, and an MS nurse. In this paper we report recommendations regarding best practices for adverse event management, focussing on peginterferon beta-1a. Injection site reactions (ISRs) and influenza-like illness are the most common adverse effects of interferon beta therapies and can present a burden for MS patients leading to non-adherence and discontinuation of therapy. Peginterferon beta-1a shows improved pharmacological properties. In clinical trials, the adverse event (AE) profile of peginterferon beta-1a was similar to other interferon beta formulations. The most common AEs were mild to moderate ISRs, influenza-like illness, pyrexia, and headache. Current information on the underlying cause of skin reactions associated with SC interferon treatment, and the management strategies for these AEs are limited. In pivotal trials, ISRs were mainly characterized and classified by neurologists, while dermatologists were only rarely consulted.
This report addresses expert recommendations on the management of most relevant adverse effects related to peginterferon beta-1a and other interferon betas, based on literature and interdisciplinary experience.
干扰素（IFN）β药物已获批用于治疗复发缓解型多发性硬化症（RRMS）超过 20 年，被认为具有良好的获益风险比。2014 年 7 月，皮下（SC）聚乙二醇干扰素β-1a 125μg，每 2 周 1 次给药，这是一种聚乙二醇化的干扰素β-1a，被欧洲药品管理局（EMA）批准用于治疗成人 RRMS，2014 年 8 月被美国食品药品监督管理局（FDA）批准用于 RMS。聚乙二醇干扰素β-1a 半衰期延长，全身药物暴露增加，与其他可用的 MS 中基于干扰素的产品相比，给药频率降低。在 3 期 ADVANCE 试验中，聚乙二醇干扰素β-1a 在一年后与安慰剂相比，在临床和 MRI 结果测量方面显示出显著的积极效果。此外，在 ATTAIN 扩展研究中，近 6 年的长期治疗显示出持续的疗效。
2016 年 7 月，一个由德国和奥地利专家组成的跨学科小组召开会议，讨论在日常实践中管理聚乙二醇干扰素β-1a 和其他基于干扰素β的 MS 治疗相关的副作用。该小组由来自大学医院和私人诊所的专家组成，包括神经病学家、皮肤科医生和一名多发性硬化症护士。在本文中，我们报告了关于不良事件管理的最佳实践建议，重点是聚乙二醇干扰素β-1a。注射部位反应（ISR）和流感样疾病是干扰素β治疗最常见的不良反应，会给 MS 患者带来负担，导致不依从和治疗中断。聚乙二醇干扰素β-1a 具有改善的药理学特性。在临床试验中，聚乙二醇干扰素β-1a 的不良事件（AE）谱与其他干扰素β制剂相似。最常见的 AE 是轻度至中度 ISR、流感样疾病、发热和头痛。目前关于与 SC 干扰素治疗相关的皮肤反应的潜在原因以及这些 AE 的管理策略的信息有限。在关键试验中，ISR 主要由神经病学家进行特征描述和分类，而皮肤科医生很少参与。
本报告根据文献和跨学科经验，针对与聚乙二醇干扰素β-1a 和其他干扰素β相关的最相关不良事件，提出了专家管理建议。
