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德国基于表型的多发性硬化症。

Multiple sclerosis by phenotype in Germany.

机构信息

IQVIA, Unterschweinstiege 2-14, 60549, Frankfurt, Germany.

Global Epidemiology, AbbVie, 1 North Waukegan Road, North Chicago, IL 60064, USA.

出版信息

Mult Scler Relat Disord. 2022 Jan;57:103326. doi: 10.1016/j.msard.2021.103326. Epub 2021 Oct 10.

DOI:10.1016/j.msard.2021.103326
PMID:35158442
Abstract

BACKGROUND

A diagnosis of multiple sclerosis (MS) can be categorized based on its disease course into the following phenotypes: relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS). With one exception, studies of MS by phenotype either provide only prevalence data or if describing drug utilization, the emphasis is on patients with RRMS; while drug utilization by phenotype tends to be examined over the course of a year. No recent studies have comprehensively evaluated MS phenotypes by prevalence, drug utilization, and comorbidities over time from a population-based perspective, which is essential for understanding the disease burden and identifying unmet needs in MS. Germany is one of the few countries where specific MS phenotypes are commonly recorded in routine clinical practice. The purpose of this study was to compare MS phenotypes with respect to changes in their population-based prevalence rates and the types of MS treatments prescribed over time, as well as the frequency of clinical conditions associated with MS based on data from a German health insurance database.

METHODS

This retrospective, observational, cohort study used data from a German health insurance database for the period 2010 to 2017. Patients aged 18+ years with a specified phenotype of MS based on ICD-10 diagnosis coding were included in the analysis.

RESULTS

In 2010, RRMS was reported in 73%, PPMS in 8%, and SPMS in 19% of patients with MS with a known phenotype. The mean ages of patients were 41.4, 53.6, and 52.8 years, respectively, and all phenotypes were associated with a female predominance (69%, 63% and 63%, respectively). The prevalence rate of each phenotype markedly increased during the study period (RRMS +113%, PPMS +40%, SPMS +54%; in 2017 the rates were 183, 14, and 34 per 100,000, respectively). The mean age of patients reporting each phenotype also increased (p<0.01), while the female:male proportion remained stable in RRMS and SPMS, the proportion of females significantly declined over time in the PPMS group. The overall percentage of patients prescribed a disease-modifying drug increased across the phenotypes from 51% to 57%. Prescription of interferon-based therapies declined in each phenotype, with the greatest declines observed in RRMS and PPMS. The PPMS and SPMS groups had significantly more prescriptions for symptom management than the RRMS group. Depression was the most prevalent clinical condition associated with each phenotype. There was a significant difference in the percentage of patients with depression across the phenotypes (p = 0.03), with the highest among SPMS (44%) compared with RRMS (35%) or PPMS (37%). Significant differences (p<0.05) across the phenotypes were also observed for the composite prevalence of cardiovascular conditions (highest in PPMS) and cognitive dysfunction (highest in SPMS).

CONCLUSION

The increasing numbers of patients across each MS phenotype, aging population in patients with MS regardless of phenotype, gender differences and variations across the types of treatments prescribed, and clinical conditions associated with each MS phenotype present new insight into the disease burden and treatment strategies of MS. These should be considered when developing healthcare strategies and optimizing care for patients with MS.

摘要

背景

多发性硬化症(MS)的诊断可以根据其疾病过程分为以下表型:复发缓解型 MS(RRMS)、原发性进展型 MS(PPMS)和继发性进展型 MS(SPMS)。除了一个例外,基于表型的 MS 研究要么只提供患病率数据,要么在描述药物使用情况时,重点是 RRMS 患者;而药物使用情况往往在一年的过程中进行检查。最近没有研究从基于人群的角度全面评估 MS 表型的患病率、药物使用情况和随时间变化的合并症,这对于了解疾病负担和确定 MS 的未满足需求至关重要。德国是少数几个在常规临床实践中经常记录特定 MS 表型的国家之一。本研究的目的是比较 MS 表型在患病率、随时间推移的 MS 治疗药物类型和基于德国健康保险数据库的 MS 相关临床疾病的频率方面的变化。

方法

本回顾性、观察性、队列研究使用了 2010 年至 2017 年德国健康保险数据库的数据。根据 ICD-10 诊断编码,纳入了特定 MS 表型的 18 岁以上患者。

结果

2010 年,RRMS 报告率为 73%,PPMS 为 8%,SPMS 为 19%。患者的平均年龄分别为 41.4、53.6 和 52.8 岁,所有表型均与女性为主(分别为 69%、63%和 63%)有关。在研究期间,每种表型的患病率都显著增加(RRMS +113%,PPMS +40%,SPMS +54%;2017 年的患病率分别为 183、14 和 34/10 万)。报告每种表型的患者的平均年龄也有所增加(p<0.01),而 RRMS 和 SPMS 中女性与男性的比例保持稳定,PPMS 组中女性的比例随时间显著下降。总体上,每种表型的疾病修饰药物处方比例从 51%增加到 57%。每种表型的干扰素治疗方案都有所下降,RRMS 和 PPMS 下降幅度最大。PPMS 和 SPMS 组的症状管理药物处方明显多于 RRMS 组。抑郁症是与每种表型最相关的临床疾病。各表型的抑郁症患者比例存在显著差异(p=0.03),SPMS 组(44%)最高,RRMS 组(35%)或 PPMS 组(37%)次之。各表型的心血管疾病(PPMS 最高)和认知功能障碍(SPMS 最高)的综合患病率也存在显著差异(p<0.05)。

结论

每种 MS 表型的患者数量不断增加,MS 患者的人口老龄化与表型无关,性别差异以及处方药物类型的变化,以及与每种 MS 表型相关的临床疾病,为 MS 的疾病负担和治疗策略提供了新的见解。在制定医疗保健策略和优化 MS 患者护理时应考虑这些因素。

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