Treatment modifiers across different regimens of natalizumab treatment in MS: An Italian real-world experience.

Autor: Ruggieri S; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy., Ianniello A; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy., Copetti M; Unit of Biostatistics, IRCCS - 'Casa Sollievo della Sofferenza' - Hospital, San Giovanni Rotondo (FG), Italy., Altieri M; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy., Buscarinu MC; Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), 'Sapienza' University of Rome, Rome, Italy; Neurology Unit, S. Andrea University Hospital, Rome, Italy., Centonze D; IRCCS Neuromed, Pozzilli (IS), Italy; Department of Systems Medicine, Multiple Sclerosis Unit, University of Rome 'Tor Vergata', Rome, Italy., Cortese A; Multiple Sclerosis Center, Neurology Unit, San Filippo Neri Hospital, Rome, Italy., De Giglio L; Multiple Sclerosis Center, Neurology Unit, San Filippo Neri Hospital, Rome, Italy., Fantozzi R; IRCCS Neuromed, Pozzilli (IS), Italy., Gasperini C; Department of Neurosciences, San Camillo-Forlanini Hospital, Rome, Italy., Grimaldi LME; Neurology and Multiple Sclerosis Center, Fondazione Instituto 'G. Giglio', Cefalù, Italy., Landi D; Department of Systems Medicine, Multiple Sclerosis Unit, University of Rome 'Tor Vergata', Rome, Italy., Marfia GA; Multiple Sclerosis Center, Neurology Unit, San Filippo Neri Hospital, Rome, Italy., Mirabella M; Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Nistri R; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy., Nociti V; Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy., Oddo O; Neurology and Multiple Sclerosis Center, Fondazione Instituto 'G. Giglio', Cefalù, Italy., Romano S; Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), 'Sapienza' University of Rome, Rome, Italy; Neurology Unit, S. Andrea University Hospital, Rome, Italy., Salemi G; Department of Biomedicine, Neuroscience and Advanced Diagnostics (BiND), University of Palermo, Palermo, Italy., Tortorella C; Department of Neurosciences, San Camillo-Forlanini Hospital, Rome, Italy., Pozzilli C; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy., Petracca M; Department of Human Neurosciences, 'Sapienza' University of Rome, Rome, Italy. Electronic address: maria.petracca@uniroma1.it.
Jazyk: angličtina
Zdroj: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics [Neurotherapeutics] 2024 Apr; Vol. 21 (3), pp. e00338. Date of Electronic Publication: 2024 Feb 26.
DOI: 10.1016/j.neurot.2024.e00338
Abstrakt: Despite its widespread use in clinical practice, the effectiveness of natalizumab extended interval dosing (EID) adopted from treatment start across different treatment intervals and individual modifiers (body mass index - BMI) is still under-investigated. Here, seven-hundred and forty-five multiple sclerosis (MS) patients, exposed to natalizumab for 3.30 ​± ​1.34 years, were retrospectively enrolled in an observational multicenter study. After stratifying patients in EID or standard interval dosing (SID), we assessed differences in time to relapse, MRI activity and Expanded Disability Status Scale (EDSS) progression. The primary analysis was conducted on patients exposed to EID interval from 5 weeks and 1 day to 7 weeks, while a secondary analysis included also EID periods up to 8 weeks. An additional analysis explored the impact of BMI. No differences in time to first relapse, time to radiological activity, time to EDSS progression or time to EDA (evidence of disease activity) were detected between SID and EID group (EID interval from 5 weeks to 1 day to 7 weeks). When including EID periods from 7 weeks and 1 day to 8 weeks, the EID group showed a trend towards higher risk of experience clinical relapses than the SID group. A higher EDA risk was also identified in EID patients with BMI above median. In conclusion, a higher risk of relapses seems to occur for EID above 7 weeks. Independently from the EID scheme adopted, higher BMI increases the risk of EDA in these patients.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Carlo Pozzilli reports financial support was provided by Biogen. Many authors (see manuscript) reports a relationship with Teva, Janssen, Merck, Biogen, Novartis, Eisai, Intercept, Bayer, Sanofi, Genzyme, Bristol, Almirall, GW, Roche, Mitsubishi, Celgene, Actelion, Serono Foundation, CSL, Behring, Ultragenix, Horizon, HEALTH&LIFE, AIM Education, FARECOMUNICAZIONE E20 that includes: board membership, consulting or advisory, funding grants, speaking and lecture fees, and travel reimbursement.
(Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
Externí odkaz: