Disease-modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)
Year: 2026
Type: article
Abstract: Background: There is growing support for high-efficacy disease-modifying therapy (DMT) in multiple sclerosis (MS), but escalation (ESC) approaches remain common. Objective: To describe decision-making in a pragmatic trial of early high-efficacy treatment (EHT) versus ESC. Methods: DELIVER-MS is a multi-center, pragmatic, randomized controlled trial (RCT) with a parallel observational study (OBS), which enrolled treatment-naïve people with RRMS in 31 UK/US sites. Primary outcome was as follows: 36-month brain volume loss according to initial treatment approach (EHT vs. ESC). Stepwise multivariable logistic regression was used to predict participation in RCT versus OBS and choice of EHT versus ESC within the OBS cohort. Results: In total, 816 people with MS were enrolled. Participants declined randomization due to preference for a particular DMT (85%), efficacy concerns (20%), and safety concerns (9%). RCT versus OBS participation was associated with lower relapse rate ( p = 0.043) and greater brain parenchymal fraction ( p = 0.002). Among 374 in the OBS cohort, 125 (33%) chose ESC and 249 (67%) chose EHT. People commencing EHT had higher education attainment ( p < 0.001) and relapse rate ( p = 0.025). Conclusion: Baseline DELIVER-MS data demonstrate that participants with milder disease are more likely to participate in RCT. The choice of EHT versus ESC was associated with demographic factors and disease activity. Clinical trial registration: NCT03535298
Source: Multiple Sclerosis Journal
Authors: Emma C Tallantyre, Sarah M Planchon, Harriet Howard, John Mays, Nadia Frowd, Jeffrey A Cohen, Alasdair Coles, Carrie M Hersh, Deborah M Miller, Meredith Dever, Emma H Gray, Nicholas G LaRocca, Kunio Nakamura, Clare Bale, Gwen Covey-Crump, Enrique Alvarez, Tarunya Arun, Wallace J Brownlee, Matt Craner, Leorah Freeman, Natasha Frost, Myla D Goldman, Rajesh K Gupta, Katharine E Harding, Jeremy Hobart, George J Hutton, Megan H Hyland, Seema Kalra, Meena Kannan, Orhun Kantarci, Daniel Lashley, Oliver Lily, Don Mahad, Jacqueline A Nicholas, Richard Nicholas, David Paling, Owen R Pearson, Claire M Rice, Rohini Samudralwar, William F Schmalstieg, Mini Singh, Ei Zune The, Bianca Weinstock-Guttman, Aram Zabeti, Thomas E Love, Douglas D Gunzler, Yi Liu, Stephen Gerry, Nikos Evangelou, Daniel Ontaneda
Institutions: University Hospital of Wales, Cardiff University, Nottingham University Hospitals NHS Trust, University of Cambridge, Cleveland Clinic, Lou Ruvo Brain Institute, Multiple Sclerosis Society, National Multiple Sclerosis Society, University of Bristol, University of Warwick, UCL Biomedical Research Centre, UCL Queen Square Institute of Neurology, University College London, Frimley Health NHS Foundation Trust, University of Oxford, The University of Texas at Austin, University of Wisconsin–Madison, Virginia Commonwealth University, The University of Texas Health Science Center at Houston, Royal Gwent Hospital, Aneurin Bevan University Health Board, Peninsula College of Medicine and Dentistry, University of Plymouth, Baylor College of Medicine, University of Rochester Medicine, University of Rochester, University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital, Keele University, Mayo Clinic, Leeds Teaching Hospitals NHS Trust, University of Edinburgh, OhioHealth, Riverside Methodist Hospital, Imperial College Healthcare NHS Trust, Royal Hallamshire Hospital, Swansea Bay University Health Board, North Bristol NHS Trust, Southmead Hospital, University of Pennsylvania, University of Minnesota, University of Virginia, University Hospitals of Leicester NHS Trust, University of Cincinnati, MetroHealth, MetroHealth Medical Center, Case Western Reserve University, University of Nottingham
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: U.S. Department of Defense, National Multiple Sclerosis Society, Bristol-Myers Squibb, Sanofi, Biogen, Patient-Centered Outcomes Research Institute, Alexion Pharmaceuticals, TG Therapeutics, Celltrion, Horizon Therapeutics, National Institute for Health and Care Research, Multiple Sclerosis Society, Neuraxpharm, National Institutes of Health, Genentech, NIHR Cambridge Biomedical Research Centre, National Institute of Neurological Disorders and Stroke, National Institute of Arthritis and Musculoskeletal and Skin Diseases, Congressionally Directed Medical Research Programs
Award: G802878776
OpenAlex ID: W7162935216