Comparative effectiveness of ofatumumab and ocrelizumab in relapsing multiple sclerosis: a target trial emulation using multinational registry data

BACKGROUND: Ofatumumab and ocrelizumab are widely used high-efficacy anti-CD20 therapies for relapsing-remitting multiple sclerosis (RRMS), but direct comparative evidence remains limited. We aimed to compare their effectiveness in routine clinical practice. METHODS: We conducted an observational cohort study emulating a target trial using data from the MSBase and Observatoire Français de la Sclérose en Plaques registries (January 2021 to December 2024). Adults with RRMS initiating ofatumumab or ocrelizumab were included. Patients were matched 1:1 using propensity scores. Primary outcomes were annualised relapse rate (ARR) and time to first relapse. Secondary outcomes included time to confirmed disability progression (CDP), progression independent of relapse activity (PIRA), confirmed disability improvement (CDI), MRI activity and treatment discontinuation. Negative binomial and Cox regression models were applied. RESULTS: A total of 5288 patients were matched with a median follow-up of 1.2 years for ofatumumab and 1.4 years for ocrelizumab. ARR was 0.07 (95% CI 0.05 to 0.08) with ofatumumab and 0.04 (0.03 to 0.05) with ocrelizumab, corresponding to an ARR ratio of 1.75 (1.43 to 2.13). Ofatumumab was associated with a lower risk of CDP (HR 0.66; 0.49 to 0.87) and PIRA (0.53; 0.39 to 0.73), but a lower probability of CDI (0.76; 0.60 to 0.96). No significant differences were observed in MRI activity or treatment discontinuation. CONCLUSIONS: Both therapies were highly effective in a large cohort of patients with RRMS, with very low relapse or CDP rates. Ofatumumab was associated with slightly greater disability control, while ocrelizumab more effectively suppressed relapses. These differences were modest, and their clinical relevance requires further evidence and should be interpreted with caution.

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Publication Details

Journal
Journal of Neurology Neurosurgery & Psychiatry
Published
2026-08-14
DOI
https://doi.org/10.1136/jnnp-2026-339059
Primary Topic
Multiple Sclerosis Research Studies
Type
article
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article

Comparative effectiveness of ofatumumab and ocrelizumab in relapsing multiple sclerosis: a target trial emulation using multinational registry data

Jean‐Philippe Camdessanché, Gregor Brecl Jakob, Jonathan Ciron, Corinne Pottier et al.
Journal of Neurology Neurosurgery & Psychiatry
Multiple Sclerosis Research Studies
article

Comparative effectiveness of ofatumumab and ocrelizumab in relapsing multiple sclerosis: a target trial emulation using multinational registry data

Jean‐Philippe Camdessanché, Gregor Brecl Jakob, Jonathan Ciron, Corinne Pottier, Abdullatif Al Khedr, Emmanuelle Lapointe, Guy Laureys, Nevin John, Allan G. Kermode, Yi Chao Foong, Radek Ampapa, Tomáš Kalinčík, Bertrand Bourre, Élisabeth Maillart, Mastura Monif, Aurélie Ruet, Anneke van der Walt, D. Laplaud, Izanne Roos, Guillaume Mathey, Emanuele D’Amico, Ivana Štětkářová, Hélène Zéphir, Matteo Foschi, Seyed Mohammad Baghbanian, Mario Habek, Alain Créange, Éric Thouvenot, Christine Lebrun‐Frénay, Chantal Nifle, Solène Moulin, Vilija Jokubaitis, Jennifer Aboab, Karolina Hankiewicz, Serkan Özakbaş, Zhou Zhen, Chao Zhu, Olivier Heinzlef, Jean Pelletier, Arnaud Kwiatkowski, Mariana Sarov Riviere, Emanuelle Le Page, G. Defer, Suzanne Hodgkinson, Marzena Fabis-Pedrini, Oliver Gerlach, Eva Kubala Havrdova, Olga Skibina, Caroline Papeix, Dana Horakova, Mehmet Fatih Yetkin, Raed Alroughani, William M Carroll, Gabriel Valero López, Pierre Clavelou, Thomas David, Laurent Magy, Thibault Moreau, Sandra Vukusic, Pavel Stourac, Olivier Casez, Daniel Merlo, Eric Berger, Maia Tchikviladze, Eric Manchon, Jose E Meca-Lallana, Helmut Butzkueven, Jeannette Lechner-Scott, Jérôme De Sèze, Alexandre Prat, Ines Doghri, Pierre Labauge
article en

Abstract

BACKGROUND: Ofatumumab and ocrelizumab are widely used high-efficacy anti-CD20 therapies for relapsing-remitting multiple sclerosis (RRMS), but direct comparative evidence remains limited. We aimed to compare their effectiveness in routine clinical practice. METHODS: We conducted an observational cohort study emulating a target trial using data from the MSBase and Observatoire Français de la Sclérose en Plaques registries (January 2021 to December 2024). Adults with RRMS initiating ofatumumab or ocrelizumab were included. Patients were matched 1:1 using propensity scores. Primary outcomes were annualised relapse rate (ARR) and time to first relapse. Secondary outcomes included time to confirmed disability progression (CDP), progression independent of relapse activity (PIRA), confirmed disability improvement (CDI), MRI activity and treatment discontinuation. Negative binomial and Cox regression models were applied. RESULTS: A total of 5288 patients were matched with a median follow-up of 1.2 years for ofatumumab and 1.4 years for ocrelizumab. ARR was 0.07 (95% CI 0.05 to 0.08) with ofatumumab and 0.04 (0.03 to 0.05) with ocrelizumab, corresponding to an ARR ratio of 1.75 (1.43 to 2.13). Ofatumumab was associated with a lower risk of CDP (HR 0.66; 0.49 to 0.87) and PIRA (0.53; 0.39 to 0.73), but a lower probability of CDI (0.76; 0.60 to 0.96). No significant differences were observed in MRI activity or treatment discontinuation. CONCLUSIONS: Both therapies were highly effective in a large cohort of patients with RRMS, with very low relapse or CDP rates. Ofatumumab was associated with slightly greater disability control, while ocrelizumab more effectively suppressed relapses. These differences were modest, and their clinical relevance requires further evidence and should be interpreted with caution.

Journal of Neurology Neurosurgery & Psychiatry
Université Claude Bernard Lyon 1 (FR), University of Foggia (IT), Centre National de la Recherche Scientifique (FR), University of Tasmania (AU), The Royal Melbourne Hospital (AU), Box Hill Hospital (AU), University Hospital Centre Zagreb (HR), Université de Bordeaux (FR), İzmir University of Economics (TR), Universidad Regiomontana (MX), University of Ljubljana (SI), Inserm (FR), The University of Melbourne (AU), Murdoch University (AU), The University of Western Australia (AU), University of Zagreb (HR), Dokuz Eylül University (TR), Université de Montpellier (FR), Université Côte d'Azur (FR), Charles University (CZ), Masaryk University (CZ), Université de Lille (FR), John Hunter Hospital (AU), Liverpool Hospital (AU), Centre hospitalier national d'ophtalmologie des Quinze-Vingts (FR), Ghent University Hospital (BE), Ljubljana University Medical Centre (SI), Centre Hospitalier Universitaire de Sherbrooke (CA), The Alfred Hospital (AU), Royal Hobart Hospital (AU), Amiri Hospital (KW), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire Henri-Mondor (FR), Centre Hospitalier Universitaire de Toulouse (FR), Maastricht University (NL), Sorbonne Université (FR), Assistance Publique Hôpitaux de Marseille (FR), Hunter Medical Research Institute (AU), Centre Hospitalier Universitaire de Besançon (FR), Hospital Jihlava (CZ), Ospedale "Santa Maria delle Croci" di Ravenna (IT), Centre Hospitalier Universitaire de Tours (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Assistance Publique – Hôpitaux de Paris (FR), Eastern Health (AU), Hôpital Bretonneau (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), Hospices Civils de Lyon (FR), Traces (FR), University Hospital Brno (CZ), University of Clermont Auvergne (FR), Centre Hospitalier Universitaire de Nîmes (FR), Centre Hospitalier Universitaire de Reims (FR), Bordeaux Population Health (FR), Hôpital Notre-Dame (CA), Centre Hospitalier Intercommunal de Poissy (FR), Hôpital Gui de Chauliac (FR), Centre Hospitalier Universitaire de Caen Normandie (FR), Hôpital Nord (FR), CHU Dijon Bourgogne (FR), Centre Hospitalier Universitaire de Limoges (FR), Monash Health (AU), Pitié-Salpêtrière Hospital (FR), Fondation Ophtalmologique Adolphe de Rothschild (FR), Centre Hospitalier de Gonesse (FR), Fondation de Rothschild (FR), Centre d'Investigation Clinique de Nantes (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Services déconcentrés d'appui à la recherche Val de Loire (FR), Zuyderland Medisch Centrum (NL), BP (France) (FR), Centre Hospitalier Universitaire de Martinique (MQ), Groupe Hospitalier de l'Institut Catholique de Lille (FR), Ingham Institute (AU), Perron Institute for Neurological and Translational Science (AU), Centre Hospitalier Saint-Denis (FR), Hospital Universitario Virgen de la Arrixaca (ES), Centre Hospitalier Universitaire de Rouen (FR), Centre Hospitalier Universitaire de Rennes (FR), University Hospital Kralovske Vinohrady (CZ), Institut de Génomique Fonctionnelle (FR), Hôpital Foch (FR), Centre Hospitalier Universitaire de Saint-Étienne (FR), Centre Hospitalier de Versailles (FR), Bicêtre Hospital (FR), Monash University (AU), Université de Rouen Normandie (FR), Université de Strasbourg (FR), Université de Montréal (CA), Erciyes University (TR), Mazandaran University of Medical Sciences (IR), Université Grenoble Alpes (FR), Université de Reims Champagne-Ardenne (FR), Nantes Université (FR), Université de Caen Normandie (FR)
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Multiple Sclerosis Research Studies
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