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