Comparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study
Abstract
BACKGROUND: Ocrelizumab, a monoclonal antibody targeting CD20+ B cells, is a high-efficacy therapy for multiple sclerosis (MS). METHODS: Patients with relapse-onset MS treated with ocrelizumab, fingolimod, natalizumab or alemtuzumab for ≥6 months were identified from three registries: MSBase, OFSEP and Danish MS Registry. Pairwise comparisons were performed in the overall cohort and 14 predefined clinicodemographic subgroups based on sex, disease activity, MS duration, Expanded Disability Status Scale, prior therapy and reason for prior treatment cessation. Relapses, progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) were compared in pairwise-censored groups. RESULTS: Fingolimod was associated with a higher annualised relapse rate (ARR) (0.14 vs 0.06, p<0.001), relapse risk (HR 2.26, 95% CI 1.98 to 2.58), RAW (1.62, 1.08 to 2.43) and lower risk of disability improvement (0.78, 0.63 to 0.96) than ocrelizumab. Superiority of ocrelizumab over fingolimod on relapses was maintained in all subgroups. Natalizumab was associated with marginally higher ARR (0.10 vs 0.07, p<0.001), relapse risk (1.35, 1.16 to 1.57) and RAW (1.77, 1.07 to 2.94) than ocrelizumab. Alemtuzumab was associated with higher ARR (0.18 vs 0.12, p<0.001) and relapse risk (1.48, 1.25 to 1.76) than ocrelizumab, but there was no evidence for a difference in risk of RAW. There was no evidence for a difference on PIRA in any comparisons. Ocrelizumab was superior to natalizumab and alemtuzumab on relapses in patients who were not treatment-naïve, experienced disease activity on the prior therapy or stopped prior therapy due to lack of efficacy. CONCLUSIONS: Ocrelizumab provides superior control of relapses and RAW, especially among patients with prior on-treatment disease activity. Treatment of PIRA remains an unmet need.
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BibTeX
@article{roos2026comparative,
title = {{Comparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study}},
author = {Izanne Roos and Sifat Sharmin and Dana Horakova and Eva Kubala Havrdova and Jana Libertinova and Marta Vachova and Raed Alroughani and Cavit Boz and Zuzana Rous and Katherine Buzzard and Olga Skibina and Marek Peterka and Pavel Hradilek and Miroslav Mares and Alasdair Coles and J William L Brown and Sara Eichau Madueño and Matteo Foschi and Julie Prevost and Murat Terzi and Alexandre Prat and Marc Girard and Jose Meca-Lallana and Nevin John and Yolanda Blanco and Anneke van der Walt and Helmut Butzkueven and Eva Recmanova and Guy Laureys and Radek Ampapa and Richard Macdonell and Zbysek Pavelek and Samia Joseph Khoury and Emanuele d'Amico and Oliver Gerlach and Vincent van Pesch and Davide Maimone and Beatriz Romero-Ferrando and Pamela Mccombe and Saloua Mrabet and Barbara Willekens and Simón Cárdenas-Robledo and Cristina Ramo-Tello and Pavel Stourac and Jana Houskova and Vahid Shaygannejad and Suzanne Hodgkinson and Elisabetta Cartechini and Allan Kermode and Marzena Fabis-Pedrini and William Carroll and Mark Slee and José Luis Sánchez-Menoyo and Abdullah Al-Asmi and Guillaume Mathey and Claire Giannesini and Laure Michel and Jonathan Ciron and Jérôme de Sèze and Aurelie Ruet},
journal = {Journal of Neurology, Neurosurgery and Psychiatry},
year = {2026},
month = sep,
doi = {10.1136/jnnp-2026-338424},
url = {https://univ-rennes.hal.science/hal-05837258v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparative effectiveness of ocrelizumab in subgroups of patients with multiple sclerosis: a multi-registry observational cohort study
AU - Izanne Roos
AU - Sifat Sharmin
AU - Dana Horakova
AU - Eva Kubala Havrdova
AU - Jana Libertinova
AU - Marta Vachova
AU - Raed Alroughani
AU - Cavit Boz
AU - Zuzana Rous
AU - Katherine Buzzard
AU - Olga Skibina
AU - Marek Peterka
AU - Pavel Hradilek
AU - Miroslav Mares
AU - Alasdair Coles
AU - J William L Brown
AU - Sara Eichau Madueño
AU - Matteo Foschi
AU - Julie Prevost
AU - Murat Terzi
AU - Alexandre Prat
AU - Marc Girard
AU - Jose Meca-Lallana
AU - Nevin John
AU - Yolanda Blanco
AU - Anneke van der Walt
AU - Helmut Butzkueven
AU - Eva Recmanova
AU - Guy Laureys
AU - Radek Ampapa
AU - Richard Macdonell
AU - Zbysek Pavelek
AU - Samia Joseph Khoury
AU - Emanuele d'Amico
AU - Oliver Gerlach
AU - Vincent van Pesch
AU - Davide Maimone
AU - Beatriz Romero-Ferrando
AU - Pamela Mccombe
AU - Saloua Mrabet
AU - Barbara Willekens
AU - Simón Cárdenas-Robledo
AU - Cristina Ramo-Tello
AU - Pavel Stourac
AU - Jana Houskova
AU - Vahid Shaygannejad
AU - Suzanne Hodgkinson
AU - Elisabetta Cartechini
AU - Allan Kermode
AU - Marzena Fabis-Pedrini
AU - William Carroll
AU - Mark Slee
AU - José Luis Sánchez-Menoyo
AU - Abdullah Al-Asmi
AU - Guillaume Mathey
AU - Claire Giannesini
AU - Laure Michel
AU - Jonathan Ciron
AU - Jérôme de Sèze
AU - Aurelie Ruet
PY - 2026
DA - 2026/09/20
JO - Journal of Neurology, Neurosurgery and Psychiatry
DO - 10.1136/jnnp-2026-338424
UR - https://univ-rennes.hal.science/hal-05837258v1
AB - BACKGROUND: Ocrelizumab, a monoclonal antibody targeting CD20+ B cells, is a high-efficacy therapy for multiple sclerosis (MS). METHODS: Patients with relapse-onset MS treated with ocrelizumab, fingolimod, natalizumab or alemtuzumab for ≥6 months were identified from three registries: MSBase, OFSEP and Danish MS Registry. Pairwise comparisons were performed in the overall cohort and 14 predefined clinicodemographic subgroups based on sex, disease activity, MS duration, Expanded Disability Status Scale, prior therapy and reason for prior treatment cessation. Relapses, progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) were compared in pairwise-censored groups. RESULTS: Fingolimod was associated with a higher annualised relapse rate (ARR) (0.14 vs 0.06, p<0.001), relapse risk (HR 2.26, 95% CI 1.98 to 2.58), RAW (1.62, 1.08 to 2.43) and lower risk of disability improvement (0.78, 0.63 to 0.96) than ocrelizumab. Superiority of ocrelizumab over fingolimod on relapses was maintained in all subgroups. Natalizumab was associated with marginally higher ARR (0.10 vs 0.07, p<0.001), relapse risk (1.35, 1.16 to 1.57) and RAW (1.77, 1.07 to 2.94) than ocrelizumab. Alemtuzumab was associated with higher ARR (0.18 vs 0.12, p<0.001) and relapse risk (1.48, 1.25 to 1.76) than ocrelizumab, but there was no evidence for a difference in risk of RAW. There was no evidence for a difference on PIRA in any comparisons. Ocrelizumab was superior to natalizumab and alemtuzumab on relapses in patients who were not treatment-naïve, experienced disease activity on the prior therapy or stopped prior therapy due to lack of efficacy. CONCLUSIONS: Ocrelizumab provides superior control of relapses and RAW, especially among patients with prior on-treatment disease activity. Treatment of PIRA remains an unmet need.
SN - 0022-3050
SN - 1468-330X
ER -