NEDA-3 achievement in early highly active relapsing remitting multiple sclerosis patients treated with Ocrelizumab or Natalizumab.

Simona Bonavita, Andrea Surcinelli, Maria Elena Di Battista, Paola Sofia Di Filippo, Aurora Zanghí, Emanuele D' Amico, Gianmarco Abbadessa, Matteo Foschi, Maria Pia Sormani, Antonio Carotenuto, Antonio Luca Spiezia, Girolama Alessandra Marfia, Giorgia Teresa Maniscalco, Giacomo Lus, Eleonora Cocco, Alessio Signori, Doriana Landi, Diego Centonze, Jessica Frau, Francesca Napoli, Elisabetta Signoriello, Maria Di Gregorio, Livia Pasquali, Massimiliano Mirabella, Giuseppe Romano, Irene Schiavetti, Roberta Fantozzi, Maria Teresa Ferrò, Matteo Lucchini, Daniele Caliendo

Journal: Multiple sclerosis and related disorders 2024;87():105594

PMID: 38718748

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Abstract

BACKGROUND

in the early stages of Multiple Sclerosis (MS), initiating high-efficacy disease-modifying therapy (HE DMTs) may represent an optimal strategy for delaying neurological damage and long-term disease progression, especially in highly active MS patients (HAMS). Natalizumab (NAT) and Ocrelizumab (OCR) are recognized as HE DMTs with significant anti-inflammatory effects. This study investigates NEDA-3 achievement in treatment-naïve HAMS patients receiving NAT or OCR over three years.

METHODS

we retrospectively enrolled treatment-naïve HAMS patients undergoing NAT or OCR, collecting demographic, clinical, and instrumental data before and after treatment initiation to compare with propensity score analysis disease activity, time to disability worsening, and NEDA-3 achievement.

RESULTS

we recruited 281 HAMS patients with a mean age of 32.7 years (SD 10.33), treated with NAT (157) or OCR (124). After three years, the Kaplan-Meier probability of achieving NEDA-3 was 66.0 % (95 % CI: 57.3 % - 76.0 %) with OCR and 68.2 % (95 % CI: 59.9 % - 77.7 %) with NAT without significant differences between the two groups (p = 0.27) DISCUSSION AND CONCLUSION: starting HE DMT with monoclonal antibodies for HAMS could achieve NEDA-3 in a high percentage of patients without differences between NAT or OCR.

Address: Second Division of Neurology, University of Campania Luigi Vanvitelli - Naples, Italy.; Department of Health Sciences, Section of Biostatistics, University of Genoa, Genoa, Italy.; Multiple Sclerosis Clinical and Research Unit, Department of System Medicine, Tor Vergata University, Rome, Italy.; Department of Medical and Surgical Sciences, University of Foggia, Italy.; Department of Neuroscience, Reproductive Science and Odontostomatology, Federico II University of Naples, Naples, Italy.; IRCCS Neuromed, 86077 Pozzilli, Italy.; IRCCS Neuromed, 86077 Pozzilli, Italy; Department of System Medicine, Tor Vergata University, 00133 Rome, Italy.; Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy; Università Cattolica del Sacro Cuore, CERSM, Roma, Italy.; Multiple Sclerosis Centre, ASL Cagliari, Cagliari, Italy; Dpt of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.; Multiple Sclerosis Centre, ASL Cagliari, Cagliari, Italy.; MS and Neuroimmunology Center, A Cardarelli Hospital,Naples, Italy.; Department of Neuroscience, Multiple Sclerosis Center - Neurology Unit, S.Mariadelle Croci Hospital, AUSL Romagna, Ravenna, Italy; Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.; Department of Neuroscience, Multiple Sclerosis Center - Neurology Unit, S.Mariadelle Croci Hospital, AUSL Romagna, Ravenna, Italy.; Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, I Clinic of Neurology, University of Campania "Luigi Vanvitelli," Naples, Italy.; Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.; Neurology Unit, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", Largo Città di Ippocrate, 84100, Salerno, Italy.; Neuroimmunology and Multiple Sclerosis Center, A.S.S.T. of Crema, Italy.; Department of Health Sciences, Section of Biostatistics, University of Genoa, Genoa, Italy; IRCCS Ospedale Policlinico San Martino, Genoa, Italy.; Department of Health Sciences, Section of Biostatistics, University of Genoa, Genoa, Italy. Electronic address: [email protected].

DOI: 10.1016/j.msard.2024.105594

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MeSH Terms: Humans, Natalizumab, Female, Male, Antibodies, Monoclonal, Humanized, Adult, Multiple Sclerosis, Relapsing-Remitting, Immunologic Factors, Retrospective Studies, Young Adult, Disease Progression