Clinical trials in multiple sclerosis: past, present, and future

Abstract

For the past four decades, multiple sclerosis (MS) has been a focus for clinical trial development and execution. Advances in translational neuroimmunology have led to the development of effective disease-modifying therapies (DMTs) that greatly benefit patients with MS and mitigate their burden of disease. These achievements also stem from continued progress made in the definition and discovery of sensitive disease diagnostic criteria, objective disability assessment scales, precise imaging techniques, and disease-specific biomarkers. As a result, our knowledge of MS pathophysiology is more mature; the established clinical practice for the diagnosis and management of MS could serve as a roadmap to guide the development of more disease-specific interventions. In this article we briefly review the main achievements in the evolution of clinical trials for MS, and discuss opportunities for improvements.

Cladribine tablets for highly active relapsing-remitting multiple sclerosis in Poland: a real-world, multi-centre, retrospective, cohort study during the COVID-19 pandemic

“…Cladribine is a potent anti-inflammatory agent to treat relapsing-remitting MS (RRMS). The drug selectively targets lymphocytes, depleting primarily CD19+ B cells, with a small reduction in CD4+ or CD8+ T-cells and CD16+/CD56+ natural killer cells [3][4][5]. Cladribine depletes lymphocytes via apoptosis rather than cell lysis, which is associated with a favourable safety profile during dosing.…”

Multiple sclerosis and related disorders: where do we stand in 2022?

“…Such progress has mainly been applicable to the relapsing forms of MS, and much less so to the progressive phenotypes [28] Carefully planned clinical trials and sophisticated statistical analysis tools shape and guide the therapeutic landscape in MS, which has become extensive and diverse. In our leading topic issue on MS and related disorders, Manouchehri et al discuss milestones in the evolution of clinical trials in MS [29]. They point out how the evolution of MS diagnostic criteria and definitions alongside the latest achievements in imaging techniques has translated into the improvement of pharmacotherapy trial design.…”