To describe treatment patterns and characteristics of patients with highly active relapsing-remitting multiple sclerosis (RRMS) in Germany who reached year (Y)5 after initiating treatment with cladribine tablets (CladT).

Currently, there are few reports on the clinical management of patients in the fifth year after starting CladT treatment. Real-world insights on characteristics of patients who continue/discontinue therapy can help inform clinical decision making.

Descriptive analysis of retrospective, longitudinal, prescription data from IQVIA LRx database in Germany was performed using datasets available in two time frames: long-term panel (previous disease-modifying therapy [DMT] use) and trust panel (Y5 patient population sizing and profiling), with CladT treatment (3.5 mg/kg cumulative dose over 2 years) initiated between Sep 2017–Jun 2018. Observation period: from 1^st CladT prescription until end of Y5 with ≥6 months follow up after end of Y5. Three cohorts were analyzed: initiating new CladT course in Y5, no new CladT course in Y5, switching to another DMT (within 4 years or in Y5 or beyond after CladT initiation).

In total, 847 patients initiated CladT: 84% completed two CladT courses (completers), 16% switched to another DMT (switchers, 12% before end of Y4, 4% in Y5 or beyond). Only 10% of completers initiated new CladT course in Y5 or beyond.

More female patients initiated a new CladT course in Y5 or beyond (80%) vs. completers or switchers (~67%). There were more CladT non-completers in 18–30 years old group vs. other analyzed age groups. CladT was predominantly used in 1^st or 2^nd line of treatment (each ~40%). Median number of CladT used by completers was 14 tablets/treatment year.

In real-world clinical settings, CladT are used early in the therapy pathway and patients in most cases, complete the full 4-year CladT treatment without needing a new course in Y5.