Summary of Research: Cognition and Employment Status of People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-Year CLARIFY-MS Study.

INTRODUCTION

Cognitive impairment is a common issue for people with multiple sclerosis (MS), affecting their daily lives and work. This study aimed to report the cognition and employment status of participants with highly active relapsing MS (RMS) treated with cladribine tablets (CladT) during the 2-year, open-label, single-arm, Phase 4 CLARIFY-MS study.

METHODS

In this post hoc analyses, 482 participants with highly active RMS received at least one dose of CladT. Cognitive function was assessed using the Brief International Cognitive Assessment for MS (BICAMS) at the start of the study (baseline [BL]), and at 12 and 24 months (M) after initiating treatment with CladT (n = 399). Symbol Digit Modalities Test (SDMT) scores were further analysed to check for clinically meaningful changes (4- and 8-point) from BL to M24. Employment status was also evaluated.

RESULTS

Cognitive function: BICAMS parameter scores remained stable over 24 months. Most participants showed stable or improved cognitive processing speed, as measured by clinically meaningful 4- and 8-point changes in the SDMT scores  from BL to M24. Employment status: No major differences in the employment status of participants were observed over 2 years, with > 40% of participants being in full-time employment during the study.

CONCLUSIONS

Most CLARIFY-MS participants with highly active RMS treated with CladT showed clinically meaningful improvements and stability in SDMT scores at M24 compared to BL, with overall cognitive function (BICAMS scores) remaining stable over 2 years. Despite the challenges posed by the COVID-19 pandemic, most participants maintained stable employment over 24 months, supporting the positive quality-of-life outcomes associated with CladT and supporting its overall efficacy in treating RMS.