019  Autologous stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis (StarMS). Issue 6 (27th May 2022)

• Record Type: Journal Article
• Authors: Sharrack, Basil; Snowden, John; Muraro, Paolo
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 93:Issue 6(2022)
• Page Start: A19
• Page End: A19
• Publication Date: 2022-05-27
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2022-ABN.58
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : In recent years, autologous haematopoietic stem cell transplantation (aHSCT) has been increasingly used to treat patients with highly-active relapsing remitting multiple sclerosis (RRMS). Observational and limited clinical trial data suggest that aHSCT reduces relapse rates, improves disability and enhances quality of life to a greater degree than most disease modifying therapies (DMTs). There is now a need to compare aHSCT with the two most efficacious DMTs: Alemtuzumab and Ocrelizumab. StarMS aims to determine whether aHSCT has superior clinical efficacy to Alemtuzumab and Ocreli- zumab with an acceptable safety profile. Mechanistic studies will assess immune re-constitution which will enhance understanding of the biological mechanisms of these treatments. Other sub-studies will assess their effect on cognitive recovery, neurofilament light and retinal nerve fibre layer measurements as markers of neuronal damage, and the safety of re-vaccination post-aHSCT. This EME funded parallel-group rater-blinded RCT will randomise 198 patients (1:1) to aHSCT versus DMT (Alemtuzumab or Ocrelizumab) from 19 centres across the UK. The primary endpoint, NEDA rate, will be assessed throughout the 2-year follow-up period. The StarMS trial has the potential to provide definitive data on the comparative efficacy of aHSCT vs highly efficacious DMTs, help improve patient outcomes, and impact national and international guidelines. [e-mail]