Epidemiology, characteristics and treatment of patients with relapsing remitting multiple sclerosis and incidence of high disease activity: Real world evidence based on German claims data

Abstract

Background Multiple Sclerosis (MS) is a chronic inflammatory, immune mediated disease of the central nervous system, with Relapsing Remitting MS (RRMS) being the most common type. Within the last years, the status of high disease activity (HDA) has become increasingly important for clinical decisions. Nevertheless, little is known about the incidence, the characteristics, and the current treatment of patients with RRMS and HDA in Germany. Therefore, this study aims to estimate the incidence of HDA in a German RRMS patient population, to characterize this population and to describe current drug treatment routines and further healthcare utilization of these patients. Methods A claims data analyses has been conducted, using a sample of the InGef Research Database that comprises data of approximately four million insured persons from around 70 German statutory health insurances (SHI). The study was conducted in a retrospective cohort design, including the years 2012-2016. Identification of RRMS population based on ICD-10 code (ICD-10-GM: G35.1). For identification of HDA, criteria from other studies as well as expert opinions have been used. Information on incidence, characteristics and current treatment of patients with RRMS and HDA was considered.

Digital Twins for Multiple Sclerosis

“…Increasing number of potential therapeutic interventions. The number of treatment options that intervene in the immune system on different levels can modify disease is increasing (19,(21)(22)(23)(24)(25). This growing availability of DMTs is broadening the treatment options towards a more individualized therapy (24).…”

Efficacy of cladribine tablets in high disease activity patients with relapsing multiple sclerosis: post hoc analysis of subgroups with and without prior disease-modifying drug treatment

“…Relapsing-remitting multiple sclerosis (RRMS) patients with high disease activity (HDA) experience a more severe disease course marked by rapidly developing lesion load, more frequent relapses, and significant increases in physical disability [1][2][3]. A recent real-world study from Germany suggests that the incidence of HDA is quite high overall (8.5% of all RRMS patients), particularly in the youngest individuals who will have to live with the disease the longest (e.g., 30.3% of those patients aged 19 years or younger) [4]. While there are a number of currently-licensed disease-modifying drugs (DMDs) available that have been shown to help control RRMS and delay disability progression, there are fewer DMDs for patients with HDA-RRMS [2,[5][6][7].…”

Recommendations for switching patients with highly active multiple sclerosis from other disease modifying drugs for multiple sclerosis to cladribine tablets

“…В ходе подготовки рекомендаций по переключению пациентов с других ПИТРС на кладрибин в таблетках использовался многоступенчатый консенсусный подход. На основании данных литературы [3][4][5]15], результатов клинических исследований и реальной клинической практики применения кладрибина в таблетках [8][9][10][11][12]16, 17], а также очного обсуждения был подготовлен проект рекомендаций по переключению пациентов с ПИТРС первой и второй линии, таких как интерферон β (ИФНβ), глатирамера ацетат (ГА), диметилфумарат, терифлуномид, финголимод, натализумаб, алемтузумаб, окрелизумаб и митоксантрон, на кладрибин в таблетках.…”

“…Самой частой формой заболевания (более 80% случаев) является ремиттирующий РС (РРС) с чередованием клинических обострений и ремиссий [4]. Внутри этой группы выделяют прогностически более неблагоприятный высокоактивный РС (ВАРС), доля которого составляет при первичной постановке диагноза от 4 до 15% [2].…”

“…Внутри этой группы выделяют прогностически более неблагоприятный высокоактивный РС (ВАРС), доля которого составляет при первичной постановке диагноза от 4 до 15% [2]. Для ВАРС характерны высокая частота обострений и ускоренное накопление неврологического и когнитивного дефицита, приводящее к быстрой инвалидизации [2,4].…”