Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)

DELIVER-MS co-investigators; EC Tallantyre; SM Planchon; H Howard; J Mays; N Frowd; JA Cohen; A Coles; CM Hersh; DM Miller; M Dever; EH Gray; NG La Rocca; Nakamura K; Bale C; Gwen L Covey-Crump; E Alvarez; T Arun; WJ Brownlee; M Craner; L Freeman; N Frost; M Goldman; R Gupta; K  Harding; J Hobart; GJ Hutton; M Hyland; S Kalra; M Kannan; O Kantarci; D Lashley; O Lily; D Mahad; J Nicholas; R Nicholas; D Paling; OR Pearson; Claire M Rice; RD Samudralwar; W Schmalsteig; M Singh; E Zune The; B Weinstock-Guttman; A Zabeti; TE Love; D Gunzler; Y Liu; S Gerry; N Evangelou; D Ontaneda

doi:10.1177/13524585261449988

Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)

DELIVER-MS co-investigators, EC Tallantyre, SM Planchon, H Howard, J Mays, N Frowd, JA Cohen, A Coles, CM Hersh, DM Miller, M Dever, EH Gray, NG La Rocca, Nakamura K, Bale C, Gwen L Covey-Crump, E Alvarez, T Arun, WJ Brownlee, M CranerL Freeman, N Frost, M Goldman, R Gupta, K Harding, J Hobart, GJ Hutton, M Hyland, S Kalra, M Kannan, O Kantarci, D Lashley, O Lily, D Mahad, J Nicholas, R Nicholas, D Paling, OR Pearson, Claire M Rice, RD Samudralwar, W Schmalsteig, M Singh, E Zune The, B Weinstock-Guttman, A Zabeti, TE Love, D Gunzler, Y Liu, S Gerry, N Evangelou, D Ontaneda^*

^*Corresponding author for this work

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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: 36-month brain volume loss by initial treatment approach (EHT versus ESC). Stepwise multivariable logistic regression was used to predict participation in RCT vs. OBS, and choice of EHT vs. ESC within the OBS cohort.

Results:

816 people with MS were enrolled. Participants declined randomization due to preference for a particular DMT (85%), efficacy concerns (20%), safety concerns (9%). RCT vs. 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 vs. ESC was associated with demographic factors and disease activity.

Clinical trial registration: NCT03535298

Original language	English
Number of pages	15
Journal	Multiple Sclerosis Journal
Early online date	31 May 2026
DOIs	https://doi.org/10.1177/13524585261449988
Publication status	E-pub ahead of print - 31 May 2026

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Publisher Copyright:
© The Author(s), 2026.

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DELIVER-MS co-investigators, Tallantyre, EC., Planchon, SM., Howard, H., Mays, J., Frowd, N., Cohen, JA., Coles, A., Hersh, CM., Miller, DM., Dever, M., Gray, EH., La Rocca, NG., K, N., C, B., Covey-Crump, G. L., Alvarez, E., Arun, T., Brownlee, WJ., ... Ontaneda, D. (2026). Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS). Multiple Sclerosis Journal. Advance online publication. https://doi.org/10.1177/13524585261449988

@article{eaa4d66d2e9f458a86a7138ee6a83feb,

title = "Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)",

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-na{\"i}ve people with RRMS in 31 UK/US sites. Primary outcome: 36-month brain volume loss by initial treatment approach (EHT versus ESC). Stepwise multivariable logistic regression was used to predict participation in RCT vs. OBS, and choice of EHT vs. ESC within the OBS cohort. Results: 816 people with MS were enrolled. Participants declined randomization due to preference for a particular DMT (85\%), efficacy concerns (20\%), safety concerns (9\%). RCT vs. 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 vs. ESC was associated with demographic factors and disease activity. Clinical trial registration: NCT03535298",

author = "\{DELIVER-MS co-investigators\} and EC Tallantyre and SM Planchon and H Howard and J Mays and N Frowd and JA Cohen and A Coles and CM Hersh and DM Miller and M Dever and EH Gray and \{La Rocca\}, NG and Nakamura K and Bale C and Covey-Crump, \{Gwen L\} and E Alvarez and T Arun and WJ Brownlee and M Craner and L Freeman and N Frost and M Goldman and R Gupta and K Harding and J Hobart and GJ Hutton and M Hyland and S Kalra and M Kannan and O Kantarci and D Lashley and O Lily and D Mahad and J Nicholas and R Nicholas and D Paling and OR Pearson and Rice, \{Claire M\} and RD Samudralwar and W Schmalsteig and M Singh and \{Zune The\}, E and B Weinstock-Guttman and A Zabeti and TE Love and D Gunzler and Y Liu and S Gerry and N Evangelou and D Ontaneda",

note = "Publisher Copyright: {\textcopyright} The Author(s), 2026. ",

year = "2026",

month = may,

day = "31",

doi = "10.1177/13524585261449988",

language = "English",

journal = "Multiple Sclerosis Journal",

issn = "1352-4585",

publisher = "SAGE Publications Ltd",

}

DELIVER-MS co-investigators, Tallantyre, EC, Planchon, SM, Howard, H, Mays, J, Frowd, N, Cohen, JA, Coles, A, Hersh, CM, Miller, DM, Dever, M, Gray, EH, La Rocca, NG, K, N, C, B, Covey-Crump, GL, Alvarez, E, Arun, T, Brownlee, WJ, Craner, M, Freeman, L, Frost, N, Goldman, M, Gupta, R, Harding, K, Hobart, J, Hutton, GJ, Hyland, M, Kalra, S, Kannan, M, Kantarci, O, Lashley, D, Lily, O, Mahad, D, Nicholas, J, Nicholas, R, Paling, D, Pearson, OR, Rice, CM, Samudralwar, RD, Schmalsteig, W, Singh, M, Zune The, E, Weinstock-Guttman, B, Zabeti, A, Love, TE, Gunzler, D, Liu, Y, Gerry, S, Evangelou, N & Ontaneda, D 2026, 'Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)', Multiple Sclerosis Journal. https://doi.org/10.1177/13524585261449988

TY - JOUR

T1 - Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)

AU - DELIVER-MS co-investigators

AU - Tallantyre, EC

AU - Planchon, SM

AU - Howard, H

AU - Mays, J

AU - Frowd, N

AU - Cohen, JA

AU - Coles, A

AU - Hersh, CM

AU - Miller, DM

AU - Dever, M

AU - Gray, EH

AU - La Rocca, NG

AU - K, Nakamura

AU - C, Bale

AU - Covey-Crump, Gwen L

AU - Alvarez, E

AU - Arun, T

AU - Brownlee, WJ

AU - Craner, M

AU - Freeman, L

AU - Frost, N

AU - Goldman, M

AU - Gupta, R

AU - Harding, K

AU - Hobart, J

AU - Hutton, GJ

AU - Hyland, M

AU - Kalra, S

AU - Kannan, M

AU - Kantarci, O

AU - Lashley, D

AU - Lily, O

AU - Mahad, D

AU - Nicholas, J

AU - Nicholas, R

AU - Paling, D

AU - Pearson, OR

AU - Rice, Claire M

AU - Samudralwar, RD

AU - Schmalsteig, W

AU - Singh, M

AU - Zune The, E

AU - Weinstock-Guttman, B

AU - Zabeti, A

AU - Love, TE

AU - Gunzler, D

AU - Liu, Y

AU - Gerry, S

AU - Evangelou, N

AU - Ontaneda, D

PY - 2026/5/31

Y1 - 2026/5/31

N2 - 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: 36-month brain volume loss by initial treatment approach (EHT versus ESC). Stepwise multivariable logistic regression was used to predict participation in RCT vs. OBS, and choice of EHT vs. ESC within the OBS cohort. Results: 816 people with MS were enrolled. Participants declined randomization due to preference for a particular DMT (85%), efficacy concerns (20%), safety concerns (9%). RCT vs. 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 vs. ESC was associated with demographic factors and disease activity. Clinical trial registration: NCT03535298

AB - 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: 36-month brain volume loss by initial treatment approach (EHT versus ESC). Stepwise multivariable logistic regression was used to predict participation in RCT vs. OBS, and choice of EHT vs. ESC within the OBS cohort. Results: 816 people with MS were enrolled. Participants declined randomization due to preference for a particular DMT (85%), efficacy concerns (20%), safety concerns (9%). RCT vs. 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 vs. ESC was associated with demographic factors and disease activity. Clinical trial registration: NCT03535298

U2 - 10.1177/13524585261449988

DO - 10.1177/13524585261449988

M3 - Article (Academic Journal)

C2 - 42218617

SN - 1352-4585

JO - Multiple Sclerosis Journal

JF - Multiple Sclerosis Journal

ER -

Disease modifying treatment preferences and decision-making in a multiple sclerosis randomized and observational clinical trial (DELIVER-MS)

Abstract

Bibliographical note

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