It is important to obtain real-world comparative effectiveness data on oral disease-modifying therapies (DMTs) for persons with highly active relapsing multiple sclerosis (HA-RMS).

Primary objective was to compare relapse rates between HA-RMS patients who received either cladribine tablets (CladT) or fingolimod monotherapy treatment. Secondary objectives reported here include comparing additional relapse outcomes, treatment switching, and discontinuation.

A multicenter, retrospective chart review study was conducted in the UK and Germany to assess CladT versus fingolimod in eligible HA-RMS patients for their first 12 months of treatment. A non-inferiority margin of 1.2 was set for the adjusted annualized relapse rate (ARR) ratio of CladT to fingolimod. Inverse probability of treatment weighting was applied to create balanced treatment groups. Physician-confirmed relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging (MRI) data were also examined.

1,095 patients were included: 610 initiating CladT and 485 initiating fingolimod. During the 12-month period following treatment initiation, 1 (0.2%) patient who initiated CladT switched to another DMT, whereas 10 (2.1%) fingolimod patients switched to another DMT and 7 (1.5%) discontinued treatment. The ARR was 0.10 (95% confidence interval [CI]: 0.07-0.14) for CladT and 0.14 (95% CI: 0.10-0.20) for fingolimod. The adjusted ARR ratio of 0.68 (95% CI: 0.42-1.11) was numerically favorable to CladT and the 95% CI upper bound was under the non-inferiority margin. Time to first relapse and proportion of patients relapse-free were similar between groups.

In the first 12 months of treatment, CladT demonstrated comparable effectiveness on relapse activity to fingolimod in patients with HA-RMS. Treatment switching/discontinuation was more common in the fingolimod group. Future studies should investigate effectiveness and treatment persistence beyond the first 12 months of treatment.