A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis

Camilla Maersk-Moller; Luigi Pontieri; Morten Leif Munding Stilund; Jeppe Romme Christensen; Lars Kristian Storr; Victoria Hansen; Jakob Schäfer; Arkadiusz Weglewski; Katerina Quinto Romani; Henrik Boye Jensen; Zsolt Illes; Victoria Papp; Tobias Sejbaek; Mai Bang Poulsen; Matthias Kant; Caroline Winther Torring; Finn Sellebjerg; Melinda Magyari; DMSG Group

doi:10.1111/ene.70507

A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis

Camilla Maersk-Moller^*, Luigi Pontieri, Morten Leif Munding Stilund, Jeppe Romme Christensen, Lars Kristian Storr, Victoria Hansen, Jakob Schäfer, Arkadiusz Weglewski, Katerina Quinto Romani, Henrik Boye Jensen, Zsolt Illes, Victoria Papp, Tobias Sejbaek, Mai Bang Poulsen, Matthias Kant, Caroline Winther Torring, Finn Sellebjerg, Melinda Magyari, DMSG Group

^*Corresponding author af dette arbejde

Abstract

BACKGROUND: Ocrelizumab and natalizumab are highly effective disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS). Direct comparison of effectiveness is crucial for optimizing treatment decisions and improving patient outcomes. The aim was to compare any difference in effectiveness of ocrelizumab and natalizumab on disease activity and progression in RRMS.

METHODS: This was a national multicenter comparative effectiveness research study using data from the nationwide population-based registry of MS cases in Denmark. Patients were included from January 2018 to April 2023 with a history of RRMS treated with ocrelizumab or natalizumab. Inverse probability of treatment weighting based on propensity scores was applied. Main outcomes were the comparison of annualized relapse rate (ARR), time to first progression independent of relapse activity (PIRA), and time to first occurrence of new/enlarging T2 or contrast-enhancing lesions on cerebral MRI scans.

RESULTS: We found no statistically significant differences in the ARR between ocrelizumab-treated (n = 542) and natalizumab-treated (n = 384) patients (mean [95% CI] ARR of 0.071 [0.057-0.088] and 0.071 [0.054-0.092], respectively) and in the ARR ratio (0.996, 95% CI [0.687-1.444], p = 0.983). Similarly, we did not find differences between the two groups in terms of time to first PIRA (HR, 1.34; 95% CI, 0.88-2.02; p = 0.17) and time to first inflammatory activity in MRI scans (HR, 1.04; 95% CI, 0.74-1.25; p = 0.78).

CONCLUSIONS: The study could not demonstrate a difference in effectiveness of ocrelizumab and natalizumab treatment in this nationwide population-based registry study in risk of relapses, disability progression, and MRI activity.

Originalsprog	Engelsk
Tidsskrift	European Journal of Neurology
Vol/bind	33
Udgave nummer	2
Sider (fra-til)	e70507
ISSN	1351-5101
DOI	https://doi.org/10.1111/ene.70507
Status	Udgivet - feb. 2026

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10.1111/ene.70507

Citationsformater

Maersk-Moller, C., Pontieri, L., Stilund, M. L. M., Christensen, J. R., Storr, L. K., Hansen, V., Schäfer, J., Weglewski, A., Romani, K. Q., Jensen, H. B., Illes, Z., Papp, V., Sejbaek, T., Poulsen, M. B., Kant, M., Torring, C. W., Sellebjerg, F., Magyari, M., & DMSG Group (2026). A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis. European Journal of Neurology, 33(2), e70507. https://doi.org/10.1111/ene.70507

Maersk-Moller, C, Pontieri, L, Stilund, MLM, Christensen, JR, Storr, LK, Hansen, V, Schäfer, J, Weglewski, A, Romani, KQ, Jensen, HB, Illes, Z, Papp, V, Sejbaek, T, Poulsen, MB, Kant, M, Torring, CW, Sellebjerg, F , Magyari, M & DMSG Group 2026, 'A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis', European Journal of Neurology, bind 33, nr. 2, s. e70507. https://doi.org/10.1111/ene.70507

@article{58830a3443b340e29d0399f89f623a58,

title = "A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis",

abstract = "BACKGROUND: Ocrelizumab and natalizumab are highly effective disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS). Direct comparison of effectiveness is crucial for optimizing treatment decisions and improving patient outcomes. The aim was to compare any difference in effectiveness of ocrelizumab and natalizumab on disease activity and progression in RRMS.METHODS: This was a national multicenter comparative effectiveness research study using data from the nationwide population-based registry of MS cases in Denmark. Patients were included from January 2018 to April 2023 with a history of RRMS treated with ocrelizumab or natalizumab. Inverse probability of treatment weighting based on propensity scores was applied. Main outcomes were the comparison of annualized relapse rate (ARR), time to first progression independent of relapse activity (PIRA), and time to first occurrence of new/enlarging T2 or contrast-enhancing lesions on cerebral MRI scans.RESULTS: We found no statistically significant differences in the ARR between ocrelizumab-treated (n = 542) and natalizumab-treated (n = 384) patients (mean [95% CI] ARR of 0.071 [0.057-0.088] and 0.071 [0.054-0.092], respectively) and in the ARR ratio (0.996, 95% CI [0.687-1.444], p = 0.983). Similarly, we did not find differences between the two groups in terms of time to first PIRA (HR, 1.34; 95% CI, 0.88-2.02; p = 0.17) and time to first inflammatory activity in MRI scans (HR, 1.04; 95% CI, 0.74-1.25; p = 0.78).CONCLUSIONS: The study could not demonstrate a difference in effectiveness of ocrelizumab and natalizumab treatment in this nationwide population-based registry study in risk of relapses, disability progression, and MRI activity.",

keywords = "Humans, Natalizumab/therapeutic use, Denmark, Female, Antibodies, Monoclonal, Humanized/therapeutic use, Male, Adult, Registries, Multiple Sclerosis, Relapsing-Remitting/drug therapy, Immunologic Factors/therapeutic use, Disease Progression, Middle Aged, Comparative Effectiveness Research, Treatment Outcome, Magnetic Resonance Imaging",

author = "Camilla Maersk-Moller and Luigi Pontieri and Stilund, {Morten Leif Munding} and Christensen, {Jeppe Romme} and Storr, {Lars Kristian} and Victoria Hansen and Jakob Sch{\"a}fer and Arkadiusz Weglewski and Romani, {Katerina Quinto} and Jensen, {Henrik Boye} and Zsolt Illes and Victoria Papp and Tobias Sejbaek and Poulsen, {Mai Bang} and Matthias Kant and Torring, {Caroline Winther} and Finn Sellebjerg and Melinda Magyari and {DMSG Group}",

note = "{\textcopyright} 2026 The Author(s). European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.",

year = "2026",

month = feb,

doi = "10.1111/ene.70507",

language = "English",

volume = "33",

pages = "e70507",

journal = "European Journal of Neurology",

issn = "1351-5101",

publisher = "Wiley-Blackwell Publishing Ltd",

number = "2",

}

TY - JOUR

T1 - A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis

AU - Maersk-Moller, Camilla

AU - Pontieri, Luigi

AU - Stilund, Morten Leif Munding

AU - Christensen, Jeppe Romme

AU - Storr, Lars Kristian

AU - Hansen, Victoria

AU - Schäfer, Jakob

AU - Weglewski, Arkadiusz

AU - Romani, Katerina Quinto

AU - Jensen, Henrik Boye

AU - Illes, Zsolt

AU - Papp, Victoria

AU - Sejbaek, Tobias

AU - Poulsen, Mai Bang

AU - Kant, Matthias

AU - Torring, Caroline Winther

AU - Sellebjerg, Finn

AU - Magyari, Melinda

AU - DMSG Group

PY - 2026/2

Y1 - 2026/2

N2 - BACKGROUND: Ocrelizumab and natalizumab are highly effective disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS). Direct comparison of effectiveness is crucial for optimizing treatment decisions and improving patient outcomes. The aim was to compare any difference in effectiveness of ocrelizumab and natalizumab on disease activity and progression in RRMS.METHODS: This was a national multicenter comparative effectiveness research study using data from the nationwide population-based registry of MS cases in Denmark. Patients were included from January 2018 to April 2023 with a history of RRMS treated with ocrelizumab or natalizumab. Inverse probability of treatment weighting based on propensity scores was applied. Main outcomes were the comparison of annualized relapse rate (ARR), time to first progression independent of relapse activity (PIRA), and time to first occurrence of new/enlarging T2 or contrast-enhancing lesions on cerebral MRI scans.RESULTS: We found no statistically significant differences in the ARR between ocrelizumab-treated (n = 542) and natalizumab-treated (n = 384) patients (mean [95% CI] ARR of 0.071 [0.057-0.088] and 0.071 [0.054-0.092], respectively) and in the ARR ratio (0.996, 95% CI [0.687-1.444], p = 0.983). Similarly, we did not find differences between the two groups in terms of time to first PIRA (HR, 1.34; 95% CI, 0.88-2.02; p = 0.17) and time to first inflammatory activity in MRI scans (HR, 1.04; 95% CI, 0.74-1.25; p = 0.78).CONCLUSIONS: The study could not demonstrate a difference in effectiveness of ocrelizumab and natalizumab treatment in this nationwide population-based registry study in risk of relapses, disability progression, and MRI activity.

AB - BACKGROUND: Ocrelizumab and natalizumab are highly effective disease-modifying treatments for relapsing-remitting multiple sclerosis (RRMS). Direct comparison of effectiveness is crucial for optimizing treatment decisions and improving patient outcomes. The aim was to compare any difference in effectiveness of ocrelizumab and natalizumab on disease activity and progression in RRMS.METHODS: This was a national multicenter comparative effectiveness research study using data from the nationwide population-based registry of MS cases in Denmark. Patients were included from January 2018 to April 2023 with a history of RRMS treated with ocrelizumab or natalizumab. Inverse probability of treatment weighting based on propensity scores was applied. Main outcomes were the comparison of annualized relapse rate (ARR), time to first progression independent of relapse activity (PIRA), and time to first occurrence of new/enlarging T2 or contrast-enhancing lesions on cerebral MRI scans.RESULTS: We found no statistically significant differences in the ARR between ocrelizumab-treated (n = 542) and natalizumab-treated (n = 384) patients (mean [95% CI] ARR of 0.071 [0.057-0.088] and 0.071 [0.054-0.092], respectively) and in the ARR ratio (0.996, 95% CI [0.687-1.444], p = 0.983). Similarly, we did not find differences between the two groups in terms of time to first PIRA (HR, 1.34; 95% CI, 0.88-2.02; p = 0.17) and time to first inflammatory activity in MRI scans (HR, 1.04; 95% CI, 0.74-1.25; p = 0.78).CONCLUSIONS: The study could not demonstrate a difference in effectiveness of ocrelizumab and natalizumab treatment in this nationwide population-based registry study in risk of relapses, disability progression, and MRI activity.

KW - Humans

KW - Natalizumab/therapeutic use

KW - Denmark

KW - Female

KW - Antibodies, Monoclonal, Humanized/therapeutic use

KW - Male

KW - Adult

KW - Registries

KW - Multiple Sclerosis, Relapsing-Remitting/drug therapy

KW - Immunologic Factors/therapeutic use

KW - Disease Progression

KW - Middle Aged

KW - Comparative Effectiveness Research

KW - Treatment Outcome

KW - Magnetic Resonance Imaging

U2 - 10.1111/ene.70507

DO - 10.1111/ene.70507

M3 - Journal article

C2 - 41603419

SN - 1351-5101

VL - 33

SP - e70507

JO - European Journal of Neurology

JF - European Journal of Neurology

IS - 2

ER -

A National Danish Effectiveness Study of Ocrelizumab Versus Natalizumab in Multiple Sclerosis

Abstract

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