Disease-modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)
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
Authors
- Sarah M. Planchon (ORCID: https://orcid.org/0000-0002-5093-0754)
- Katharine Harding (ORCID: https://orcid.org/0000-0001-6299-5582)
- Daniel Ontaneda (ORCID: https://orcid.org/0000-0002-2838-9148)
- Clare Bale
- Owen Pearson (ORCID: https://orcid.org/0000-0002-2712-0200)
- John Mays
- OH Kantarci
- Meredith Dever (ORCID: https://orcid.org/0000-0003-4343-7299)
- Aram Zabeti (ORCID: https://orcid.org/0000-0002-0424-7460)
- Alasdair Coles (ORCID: https://orcid.org/0000-0003-4738-0760)
- Harriet Howard
- Tarunya Arun (ORCID: https://orcid.org/0000-0001-5024-3615)
- Nadia Frowd
- JC Hobart
- Wallace Brownlee (ORCID: https://orcid.org/0000-0003-0481-8902)
- Myla D. Goldman (ORCID: https://orcid.org/0000-0002-5675-945X)
- Emma H. Gray
- Carrie M. Hersh (ORCID: https://orcid.org/0000-0002-5716-5645)
- STEPHEN GERRY
- Douglas Gunzler (ORCID: https://orcid.org/0000-0003-3786-8578)
- Megan Hyland
- William F. Schmalstieg
- Kunio Nakamura (ORCID: https://orcid.org/0000-0002-7833-8138)
- Rajesh Kumar Gupta (ORCID: https://orcid.org/0000-0002-4959-5477)
- Oliver Lily
- Nicholas G. LaRocca
- Meena Kannan
- N Frost
- N Evangelou
- M Singh
- L Freeman
- E Zune The
- D Mahad
- Y Liu
- S Kalra
- J Nicholas
- R Nicholas
- David Paling
- Deborah M Miller (ORCID: https://orcid.org/0000-0002-8026-1854)
- Bianca Weinstock-Guttman (ORCID: https://orcid.org/0000-0001-6732-151X)
- Thomas E Love
- Daniel Lashley
- Emma C Tallantyre (ORCID: https://orcid.org/0000-0002-3760-6634)
- Claire M Rice (ORCID: https://orcid.org/0000-0002-9851-4426)
- Gwen Covey-Crump
- Rohini Samudralwar
- Enrique Alvarez
- George J Hutton
- Matt Craner
- Jeffrey A Cohen (ORCID: https://orcid.org/0000-0001-9245-9772)
Institutions
- Swansea Bay University Health Board (GB)
- University of Minnesota (US)
- North Bristol NHS Trust (GB)
- Cleveland Clinic (US)
- Mayo Clinic (US)
- Nottingham University Hospitals NHS Trust (GB)
- National Multiple Sclerosis Society (US)
- University of Wisconsin–Madison (US)
- University of Nottingham (GB)
- Imperial College Healthcare NHS Trust (GB)
- Baylor College of Medicine (US)
- Virginia Commonwealth University (US)
- University of Cambridge (GB)
- Leeds Teaching Hospitals NHS Trust (GB)
- Riverside Methodist Hospital (US)
- University Hospitals of North Midlands NHS Trust (GB)
- Lou Ruvo Brain Institute (US)
- University Hospital of Wales (GB)
- Royal Hallamshire Hospital (GB)
- Nuffield Orthopaedic Centre (GB)
- Multiple Sclerosis Society (GB)
- Aneurin Bevan University Health Board (GB)
- University Hospitals of Leicester NHS Trust (GB)
- Frimley Health NHS Foundation Trust (GB)
- University of Bristol (GB)
- University of Warwick (GB)
- University of Oxford (GB)
- Institute of Mental Health (GB)
- AID Atlanta (US)
- UCL Biomedical Research Centre (GB)
- Jacobs Institute (US)
- Rocky Mountain MS Center (US)
- MetroHealth Medical Center (US)
- University College London (GB)
- University of Virginia (US)
- University of Colorado Anschutz Medical Campus (US)
- University of Rochester (US)
- Keele University (GB)
- University of Cincinnati (US)
- Cardiff University (GB)
- University of Pennsylvania (US)
- The University of Texas at Austin (US)
- The University of Texas Health Science Center at Houston (US)
- University of Edinburgh (GB)
Publication Details
- Journal
- Multiple Sclerosis Journal
- Published
- 2026-05-31
- DOI
- https://doi.org/10.1177/13524585261449988
- Primary Topic
- Multiple Sclerosis Research Studies
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Patient-Centered Outcomes Research Institute