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Extended interval dosing of natalizumab shows comparable efficacy to standard interval dosing starting from the second year of treatment
Author(s): ,
S. Ruggieri
Affiliations:
Department of Human Neurosciences, Sapienza University of Rome; MS Center, Sant`Andrea Hospital; Department of Neuroscience, San Camillo-Forlanini Hospital, Rome
,
A. Ianniello
Affiliations:
MS Center, Sant`Andrea Hospital
,
L. De Giglio
Affiliations:
Department of Human Neurosciences, Sapienza University of Rome; MS Center, Sant`Andrea Hospital
,
M. Altieri
Affiliations:
Department of Human Neurosciences, Sapienza University of Rome
,
D. Centonze
Affiliations:
IRCCS Ist. Neurologico Mediterraneo (INM) Neuromed, Pozzilli; Department of Systems Medicine, Multiple Sclerosis Unit, Tor Vergata` University
,
A. Cortese
Affiliations:
Department of Human Neurosciences, Sapienza University of Rome
,
R. Fantozzi
Affiliations:
IRCCS Ist. Neurologico Mediterraneo (INM) Neuromed, Pozzilli
,
S. Galgani
Affiliations:
Department of Neuroscience, San Camillo-Forlanini Hospital, Rome
,
C. Gasperini
Affiliations:
Department of Neuroscience, San Camillo-Forlanini Hospital, Rome
,
D. Landi
Affiliations:
Department of Systems Medicine, Multiple Sclerosis Unit, Tor Vergata` University
,
G.A. Marfia
Affiliations:
Department of Systems Medicine, Multiple Sclerosis Unit, Tor Vergata` University
,
M. Mirabella
Affiliations:
Fondazione Policlinico Universitario `A. Gemelli` IRCCS, Università Cattolica del Sacro Cuore
,
R. Nistri
Affiliations:
MS Center, Sant`Andrea Hospital
,
V. Nociti
Affiliations:
Fondazione Policlinico Universitario `A. Gemelli` IRCCS, Università Cattolica del Sacro Cuore
,
S. Romano
Affiliations:
Center for Experimental Neurological Therapies, NESMOS Department, Sapienza University of Rome, S. Andrea Hospital, Rome, Italy
,
M. Salvetti
Affiliations:
Center for Experimental Neurological Therapies, NESMOS Department, Sapienza University of Rome, S. Andrea Hospital, Rome, Italy
C. Pozzilli
Affiliations:
Department of Human Neurosciences, Sapienza University of Rome; MS Center, Sant`Andrea Hospital
ECTRIMS Online Library. Ruggieri S.
Oct 12, 2018; 228148
Serena Ruggieri
Serena Ruggieri
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Abstract: P1770

Type: Poster Sessions

Abstract Category: N/A

Background: Natalizumab (NTZ) use in Multiple Sclerosis (MS) has been limited by the risk of progressive multifocal leukoencephalopathy. One approach suggested to minimize this risk is to move from standard interval dose (SD) to extended-interval dose (ED) of 35 days or longer. Effectiveness of ED is still a matter of debate
OBJECTIVE To assess the efficacy of ED vs SD in terms of annualized ''no evidence of disease activity-3'' (NEDA), in a real world setting.
Methods: This is an independent, multi-center, retrospective, study. Clinical and magnetic resonance imaging data from Relapsing Remitting MS patients treated with NTZ from 2007 to 2018, at 6 MS Centers in Italy were collected. Groups were defined by mean interval between dose per year as follows: 1) SD: ≤35 days; 2) ED: >35 days and ≤56 days; 3) Mixed dose (MD): patients receiving SD for ≥12 to ≤24 months and then switched to ED. Patients not meeting these definitions were excluded. Annualized NEDA was evaluated at the end of each year from year 1 to 4, by unadjusted comparisons using the Chi squared test and multivariable logistic regression adjusted for baseline characteristics and centers.
Results: From an initial dataset of 615 patients, 532 were included in the first year analysis [F:362; mean age 34,4±9,6;mean disease duration 8±6,3;median Expanded Disability Status Scale (EDSS): 2 (0-8);mean treatment duration: 4,2±2,5], 270 patients completed 4 years of follow-up. During the first year of treatment [SD (N=421), ED (N=111)],NEDA was achieved by 84.9% of SD patients and 73.6% of ED patients [Odds Ratio (OR)=1.83, 95% CI 1.1-3.05; p=0.018].NEDA rates in SD and ED groups did not significantly differ at year 2 (p= 0.18), year 3 (p= 0.53) and year 4 (p= 0.27). At year 2, 87.9% of SD patients (N=280) had NEDA, compared to 79.8% in the MD group (N=119) [OR=2.13, 95% CI 1.1-3.9; p=0.018]. At year 3, with 91.4% reached NEDA in the SD group (N=116) and 84.3% in MD group (N=159)[OR=2.88, 95% CI 1.1-7.3; p= 0.026]. At year 4 no significant differences in NEDA rates, were detected between groups [p=0.91; SD (N=65), MD (N=108)]
Conclusions: ED regimen up to 56 days did not reduce effectiveness of NTZ therapy at year 2 or beyond, but ED was less effective than SD during year 1. Moreover MD appeared to penalize efficacy of NTZ up to year 3. Altogether, these data suggest that many patients can still achieve NEDA with ED and differences in effectiveness between ED and SD lessen with increasing treatment duration.
Disclosure: Ruggieri S has received fee as speaking honoraria from Teva,Merck Serono, Biogen; travel grant from Biogen, Merck Serono; fee as advisory board consultant from Merck Serono and Novartis.
Ianniello A has nothting to disclose
De Giglio L received speaking onoraria from Genzyme and Novartis, travel grant from Biogen, Merck, Teva, consulting fee from Genzyme, Merk and Novartis.
Altieri M received payment for travel, accommodations, or meeting expenses from Merck Teva, Novartis, Bayer Schering, Genzyme and Biogen.
Centonze D is an Advisory Board member of Almirall, Bayer Schering, Biogen, GW
Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen, GW Pharmaceuticals, Merck Serono, Novartis, Roche, Sanofi-Genzyme, Teva. He is also the principal investigator in clinical trials for Bayer Schering, Biogen, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme, Teva. His preclinical and clinical research was supported by grants from Bayer Schering, Biogen Idec, Celgene, Merck Serono, Novartis, Roche, Sanofi- Genzyme e Teva.
Cortese A received speaker honoraria from Biogen, Teva; travel grants from Biogen, Merck, Sanofi Genzyme, Teva; advisory boards member honorariafrom Biogen, Merck, Novartis, Teva.
Fantozzi R received honoraria for speaking or consultation fees from Almirall, Merck Serono, Novartis, Sanofi, Teva, and Biogen; advisory board membership for Teva, Biogen, Merck Serono, and Novartis.
Galgani S received fees as invited speaker or travel expenses for attending meeting from Biogen, Merck-Serono, Teva, Almirall, Sanofi-Aventis, Novartis, and Genzyme.
Gasperini C has served on advisory boards and/or has received travel grants and/or speaker honoraria from Merck Serono, Roche, Teva Italia, Biogen, Almirall, Novartis, Sanofi-Genzyme.
Landi D received travel funding from Biogen, Merck Serono, Sanofi-Genzyme and Teva, honoraria for speaking from Sanofi-Genzyme and Teva, and consultation fees from Merck Serono and Teva. She is subinvestigator in clinical trials being conducted for Biogen, Merck Serono, Novartis, Roche and Teva.
Marfia GA is an Advisory Board member of Biogen Idec, Genzyme, Merck-Serono, Novartis, Teva and received honoraria for speaking or consultation fees from Almirall, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme, Teva. She is the principal investigator in clinical trials for Actelion, Biogen Idec, Merck Serono, Mitsubishi, Novartis, Roche, Sanofi-Genzyme, Teva.
Mirabella M scientific advisory board membership for Bayer Schering, Biogen, Sanofi- Genzyme, Merck Serono, Novartis, and Teva; consulting and/or speaking fees, research support, or travel grants from Almirall, Bayer Schering, Biogen, CSL Behring, Sanofi- Genzyme, Merck Serono, Novartis, Teva, and Ultragenix; principal investigator in clinical trials for Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, Teva, and Ultra- genix.
Nistri R has nothing to disclose.
Nociti V received honoraria for speaking, advisory board, consulting from Teva, Genzyme, Almirall, Biogen, Bayer Schering, Merck, and Novartis.
Romano S has received fees as a speaker from Biogen, Merck and Novartis.
Salvetti M consulting fees and/or honoraria for speaking and/or research grants from Biogen, Genzyme, Merck Serono, Novartis, Roche, and Teva
Pozzilli C scientific advisory boards for Actelion, Biogen, Genzyme, Hoffmann-La Roche Ltd, Merck Serono, Novartis, Sanofi, and Teva; con- sulting and/or speaking fees, research support, and travel grants from Allergan, Almirall, Biogen, Genzyme, Hoffmann-La Roche Ltd, Merck Serono, Novartis, Sanofi, and Teva.

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