EMD Serono, Inc.

Author Of 2 Presentations

Observational Studies Poster Presentation

P0846 - Characteristics of relapsing multiple sclerosis patients treated with cladribine tablets in five European countries: multi-year chart review (ID 375)

Speakers
Presentation Number
P0846
Presentation Topic
Observational Studies

Abstract

Background

In 2017, cladribine tablets 10mg (given as 3.5 mg/kg over 2 years) (CT) were approved for highly active relapsing multiple sclerosis (RMS) in the European Union. Clinical care delivery in RMS can be informed by understanding the profile of RMS patients treated with CT in real-world settings.

Objectives

To describe characteristics of patients with RMS treated with CT in the largest Europe Union Five countries (EU5) since market authorization.

Methods

The Ipsos Healthcare Multiple Sclerosis Monitor collects data from 300 neurologists across France, Germany, Italy, Spain, and the United Kingdom (UK) on their MS practices and patient information. Descriptive statistics were used to summarize patient age and sex, country, Expanded Disability Status Scale (EDSS) score as of CT initiation, disease modifying drugs (DMD) history, and physician reason for prescribing CT.

Results

A total of 182 patients who initiated CT were identified in UK (n=42, 23.1%), Germany (n=82, 45.1%), Italy (n=26, 14.3%), Spain (n=26, 14.3%) and France (n=6, 3.3%) from October 2017 to June 2019. 65.4% were female, 46.7% and 30.8% were between the ages of 18-34 and 35-44 years old, respectively. Only 98 (53.8%) patients had EDSS data at CT initiation, with median EDSS (25 percentile, 75 percentile) equal to 3 (1.5, 4.5). The majority of patients (94.5%) had a relapsing-remitting multiple sclerosis (RRMS) diagnosis. At CT initiation, 34.6% of patients were naïve to DMDs. The most common DMDs before CT initiation were dimethyl fumarate (18.5%), fingolimod (13.4%), and natalizumab (12.6%). Efficacy for active/highly active disease was the primary reason cited by physicians for prescribing CT (31.3%), followed by efficacy in stabilizing or preventing new lesions (15.9%).

Conclusions

In this real-world analysis of patients treated with CT in the EU5, more than one third of patients were naïve to DMDs. The most frequently cited reason for physicians to prescribe CT was efficacy for active/highly active disease.

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Observational Studies Poster Presentation

P0847 - Characterization of relapsing multiple sclerosis patients treated with cladribine tablets in Germany since marketing authorization (ID 376)

Speakers
Presentation Number
P0847
Presentation Topic
Observational Studies

Abstract

Background

In 2017, cladribine tablets (CT) were approved for highly active relapsing multiple sclerosis (RMS) in the European Union. Data on real-world utilization of this novel disease modifying drug (DMD) can inform evidence-based treatment selection.

Objectives

To describe treatment and disease characteristics of RMS patients treated with CT in Germany since market authorization.

Methods

The German MS Registry (GMSR) captures data from more than 180 neurological centres. This study included all adult RMS patients newly treated with CT from August 2017 to September 18, 2019. We used descriptive statistics to summarize patient characteristics: age and sex, DMD history; and disease characteristics: relapse in the 12 months prior to CT initiation and Expanded Disability Status Scale (EDSS) score within the 90-days prior to or following CT initiation.

Results

A total of 141 patients who initiated CT were identified across 46 neurological centers. The median (25 percentile, 75 percentile) age was 39 (32, 49) years with most patients being female (71%). The majority (91%) had a relapsing-remitting multiple sclerosis (RRMS) diagnosis at CT initiation, with a median disease duration of 9.5 (5.0, 16.3) years. Among persons (68.8%) with a documented EDSS score within 90-days of CT initiation, median EDSS was 2.5 (1.5, 4). 15% of persons were naïve to DMDs. Dimethyl fumarate (16%), daclizumab (16%), and fingolimod (13%) were the most common DMDs prior to CT initiation. In the 12 months prior to CT initiation, 25% of patients experienced 1 relapse, and 9% of patients experienced ≥2 relapses.

Conclusions

In this German real-world neurological care setting, both DMD-naïve and DMD-experienced patients initiated CT. Median disability level indicated mild disability in one functional system or minimal disability in two functional systems. One third of patients had at least one relapse in the 12 months prior to CT initiation.

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