评估一项真实世界药物警戒研究（OPTIMISE:MS）的可行性。

Evaluating the feasibility of a real world pharmacovigilance study (OPTIMISE:MS).

机构信息

Preventive Neurology Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, UK; Department of Neurology, Royal London Hospital, Barts Health NHS Trust, London, UK.

Department of Neurology, John Radcliffe Hospital NHS Trust, Oxford, UK; Department of Neurology, Frimley Park Health Foundation NHS Trust, Frimley, UK.

出版信息

Mult Scler Relat Disord. 2022 Jul;63:103894. doi: 10.1016/j.msard.2022.103894. Epub 2022 May 20.

DOI:10.1016/j.msard.2022.103894

PMID:35636271

Abstract

BACKGROUND

Clinical trial populations do not fully reflect routine practice. The power of routinely collected data to inform clinical practice is increasingly recognised.

METHODS

The OPTIMISE:MS pharmacovigilance study is a prospective, pragmatic observational study, conducted across 13 UK MS centres. Data were collected at the time of routine clinical visits. The first participant was recruited on 24th May 2019; data were extracted on 11th November 2021.

RESULTS

2112 participants were included (median age 44.0 years; 1570 (72%) female; 1981 (94%) relapsing-remitting MS). 639 (30%) were untreated at study entry, 205 (10%) taking interferon beta/copaxone, 1004 (47%) second/third generation DMT first line and 264 (13%) had escalated from a platform DMT. 342 clinical events were reported, of which 108 infections. There was an increased risk of adverse events in people taking second/third generation DMT (RR 3.45, 95%CI 1.57-7.60, p<0.01 vs no DMT). Unadjusted Poisson regression demonstrated increased incident adverse events in people taking natalizumab (IRR 5.28, 95%CI 1.41-19.74, p<0.05), ocrelizumab (IRR 3.24, 95%CI 1.22-8.62, p<0.05), and GA biosimilar (Brabio) (IRR 4.89, 95%CI 1.31-18.21, p<0.05) vs no DMT.

CONCLUSIONS

Routinely collected healthcare data can be used to evaluate DMT safety in people with MS. These data highlight the potential of pragmatic studies to guide understanding of risks and benefits associated with DMT.

摘要

背景

临床试验人群不能完全反映常规实践。常规收集的数据对指导临床实践的作用越来越受到认可。

方法

OPTIMISE:MS 药物警戒研究是一项前瞻性、实用观察性研究，在英国 13 个 MS 中心进行。数据在常规临床就诊时收集。第一位参与者于 2019 年 5 月 24 日招募；数据于 2021 年 11 月 11 日提取。

结果

共纳入 2112 名参与者（中位年龄 44.0 岁；1570 名（72%）为女性；1981 名（94%）为复发缓解型 MS）。639 名（30%）在研究入组时未接受治疗，205 名（10%）接受干扰素 β/考帕松治疗，1004 名（47%）一线使用第二代/第三代 DMT，264 名（13%）从平台 DMT 升级。报告了 342 例临床事件，其中 108 例为感染。接受第二代/第三代 DMT 的患者发生不良事件的风险增加（RR 3.45，95%CI 1.57-7.60，p<0.01 与无 DMT 相比）。未调整的泊松回归显示，接受那他珠单抗（IRR 5.28，95%CI 1.41-19.74，p<0.05）、奥瑞珠单抗（IRR 3.24，95%CI 1.22-8.62，p<0.05）和 GA 生物类似药（Brabio）（IRR 4.89，95%CI 1.31-18.21，p<0.05）治疗的患者发生不良事件的风险增加，与无 DMT 相比。