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从多发性硬化症患者的达标治疗转向早期高效治疗方法——来自德国的真实世界证据。

Shifting from the treat-to-target to the early highly effective treatment approach in patients with multiple sclerosis - real-world evidence from Germany.

作者信息

Papukchieva Steffeni, Stratil Ann-Sophie, Kahn Maria, Neß Nils-Henning, Hollnagel-Schmitz Maike, Gerencser Vivien, Rustemeier Julia, Eberl Markus, Friedrich Benjamin, Ziemssen Tjalf

机构信息

Temedica GmbH, Munich, Germany.

Hexal AG, Holzkirchen, Germany.

出版信息

Ther Adv Neurol Disord. 2024 Mar 23;17:17562864241237857. doi: 10.1177/17562864241237857. eCollection 2024.

Abstract

BACKGROUND

While evidence highlights the effectiveness of initiating disease-modifying therapy with a high-efficacy medication for multiple sclerosis (MS) patients with poor prognostic factors, it remains unclear whether this approach has been adopted by a broad range of MS providers in Germany yet.

OBJECTIVE

To assess the adoption of the early highly effective treatment (EHT) compared to the treat-to-target treatment approach with the option of escalating treatment efficacy over time in Germany based on real-world evidence data.

DESIGN

Patient-level pharmacy dispensing data from the Permea platform were analysed from 2020 to 2022.

METHODS

In total, 29,529 therapy beginners (>18 years) were included to analyse shifts in treatment approaches over time and switching behaviour. Medication classification adhered to the German Society of Neurology guidelines and designated fumarates, glatiramer acetate, teriflunomide and interferons as low-efficacy category 1 medications; cladribine and S1P-modulators as medium-efficacy category 2 medications; and alemtuzumab, natalizumab, ocrelizumab, ofatumumab and rituximab (off-label) as high-efficacy category 3 medications.

RESULTS

Our results show that 70.0% of patients redeemed their first prescription for category 1 medication, 16.3% for category 2 and 13.7% for category 3 medications. The proportion of prescriptions filled shifted from 2020 to 2022 with a decrease of 14.7% for category 1 drugs and an increase of 12.5% for category 3 drugs. 93.2% of patients stayed on their initially prescribed medication category. 3.2% of category 1 and 3.7% of category 2 therapy beginners escalated to category 3 medication. 3.4% of category 3 medication users de-escalated their treatment to category 1 or category 2.

CONCLUSION

While most individuals started their treatment according to the treat-to-target approach and remained on their initially prescribed medication category, there has been a steadily increasing shift towards the EHT approach since 2020. These insights demonstrate that, while not officially recommended by German guidelines, MS providers increasingly adopt the EHT approach.

摘要

背景

虽然有证据表明,对于具有不良预后因素的多发性硬化症(MS)患者,使用高效药物启动疾病修正治疗是有效的,但目前尚不清楚德国广大MS医疗服务提供者是否已采用这种方法。

目的

根据真实世界证据数据,评估在德国与随时间推移提高治疗效果的达标治疗方法相比,早期高效治疗(EHT)的采用情况。

设计

分析了2020年至2022年Permea平台的患者级药房配药数据。

方法

总共纳入了29529名治疗初学者(>18岁),以分析治疗方法随时间的变化以及换药行为。药物分类遵循德国神经病学学会指南,将富马酸盐、醋酸格拉替雷、特立氟胺和干扰素指定为低效1类药物;克拉屈滨和S1P调节剂为中效2类药物;阿仑单抗、那他珠单抗、奥瑞珠单抗、奥法木单抗和利妥昔单抗(未按标签用药)为高效3类药物。

结果

我们的结果显示,70.0%的患者首次领取1类药物处方,16.3%领取2类药物处方,13.7%领取3类药物处方。从2020年到2022年,已配药处方的比例发生了变化,1类药物减少了14.7%,3类药物增加了12.5%。93.2%的患者继续使用最初开具的药物类别。3.2%的1类治疗初学者和3.7%的2类治疗初学者升级为3类药物。3.4%的3类药物使用者将治疗降级为1类或2类。

结论

虽然大多数人开始治疗时遵循达标治疗方法,并继续使用最初开具的药物类别,但自2020年以来,向EHT方法的转变一直在稳步增加。这些见解表明,虽然德国指南未正式推荐,但MS医疗服务提供者越来越多地采用EHT方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2836/10960977/6970338ee2a5/10.1177_17562864241237857-fig1.jpg

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