University of Ottawa, Department of Medicine and the Ottawa Hospital Research Institute, Ottawa, ON, Canada.
Merck Serono Ltd, Feltham, UK (an affiliate of Merck KGaA).
Mult Scler Relat Disord. 2021 Nov;56:103283. doi: 10.1016/j.msard.2021.103283. Epub 2021 Sep 28.
In accordance with expert guidance, patients have typically continued to receive treatment with subcutaneous interferon beta-1a (sc IFN β-1a) for relapsing multiple sclerosis (MS) during the COVID-19 pandemic.
We provide a summary of outcomes among sc IFN β-1a-treated patients with adverse events related to confirmed or suspected COVID-19, as reported to the Merck Global Patient Safety Database (as of 2 February 2021). Serious COVID-19-related adverse events (as classified by the reporting clinician) included those leading to hospitalization, admission to intensive care, or death. Outcomes were classified per usual pharmacovigilance practice.
The evaluable cohort comprised 603 patients of median age 43 (range, 13-84) years and 75.1% were female. COVID-19 was experienced at a median of 33.0 (range, 0-321.8) months after start of treatment with sc IFN β-1a. A total of 136 (22.6%) patients experienced serious COVID-19 events, including 59 hospitalizations (4 patients admitted to intensive care) and 5 deaths (fatality rate, 0.8%). Regarding non-fatal outcomes, 47.8% of patients (289/603) with COVID-19 adverse events were recovered or recovering at time of analysis; similar findings were apparent for the serious and hospitalized cohorts.
Findings of this analysis from the Merck Global Patient Safety Database suggest that, compared with available statistics for the general population and those with MS, patients receiving sc IFN β-1a for treatment of relapsing MS have relatively low rates of serious disease and/or severe outcomes with COVID-19.
根据专家指导,COVID-19 大流行期间,多发性硬化(MS)复发患者通常继续接受皮下注射干扰素β-1a(sc IFNβ-1a)治疗。
我们总结了 Merck 全球患者安全数据库中报告的 sc IFNβ-1a 治疗患者因确诊或疑似 COVID-19 而发生不良事件的结局(截至 2021 年 2 月 2 日)。严重的 COVID-19 相关不良事件(由报告医生分类)包括导致住院、入住重症监护病房或死亡的不良事件。结局按常规药物警戒实践进行分类。
可评估队列包括 603 名中位年龄 43 岁(范围,13-84 岁)的患者,其中 75.1%为女性。sc IFNβ-1a 治疗开始后中位 33.0 个月(范围,0-321.8 个月)时发生 COVID-19。共有 136 名(22.6%)患者发生严重 COVID-19 事件,包括 59 例住院(4 例患者入住重症监护病房)和 5 例死亡(病死率 0.8%)。对于非致命结局,603 名 COVID-19 不良事件患者中有 47.8%(289/603)在分析时已康复或正在康复;严重和住院患者队列也出现了类似的结果。
这项来自 Merck 全球患者安全数据库的分析结果表明,与普通人群和 MS 患者的可用统计数据相比,接受 sc IFNβ-1a 治疗复发性 MS 的患者 COVID-19 的严重疾病和/或严重结局发生率相对较低。