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Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts
S. Sharmin, M. Lefort, JB. Andersen, E. Leray, D. Horakova, EK. Havrdova, R. Alroughani, G. Izquierdo, S. Ozakbas, F. Patti, M. Onofrj, A. Lugaresi, M. Terzi, P. Grammond, F. Grand'Maison, B. Yamout, A. Prat, M. Girard, P. Duquette, C. Boz, M....
Language English Country New Zealand
Document type Comparative Study, Journal Article, Observational Study, Research Support, Non-U.S. Gov't
NLK
ProQuest Central
from 2008-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 2008-01-01 to 1 year ago
Psychology Database (ProQuest)
from 2008-01-01 to 1 year ago
- MeSH
- Adult MeSH
- Fingolimod Hydrochloride therapeutic use MeSH
- Immunologic Factors therapeutic use MeSH
- Immunosuppressive Agents therapeutic use MeSH
- Internationality * MeSH
- Cohort Studies MeSH
- Middle Aged MeSH
- Humans MeSH
- Longitudinal Studies MeSH
- Follow-Up Studies MeSH
- Natalizumab therapeutic use MeSH
- Registries * MeSH
- Multiple Sclerosis, Relapsing-Remitting diagnosis drug therapy epidemiology MeSH
- Secondary Prevention MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Observational Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Comparative Study MeSH
INTRODUCTION: Natalizumab has proved to be more effective than fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). Whether this association is universal for all patient groups remains to be determined. OBJECTIVE: The aim of this study was to compare the relative effectiveness of natalizumab and fingolimod in RRMS subgroups defined by the baseline demographic and clinical characteristics of interest. METHODS: Patients with RRMS who were given natalizumab or fingolimod were identified in a merged cohort from three international registries. Efficacy outcomes were compared across subgroups based on patients' sex, age, disease duration, Expanded Disability Status Scale (EDSS) score, and disease and magnetic resonance imaging (MRI) activity 12 months prior to treatment initiation. Study endpoints were number of relapses (analyzed with weighted negative binomial generalized linear model) and 6-month confirmed disability worsening and improvement events (weighted Cox proportional hazards model), recorded during study therapy. Each patient was weighted using inverse probability of treatment weighting based on propensity score. RESULTS: A total of 5148 patients (natalizumab 1989; fingolimod 3159) were included, with a mean ± standard deviation age at baseline of 38 ± 10 years, and the majority (72%) were women. The median on-treatment follow-up was 25 (quartiles 15-41) months. Natalizumab was associated with fewer relapses than fingolimod (incidence rate ratio [IRR]; 95% confidence interval [CI]) in women (0.76; 0.65-0.88); in those aged ≤ 38 years (0.64; 0.54-0.76); in those with disease duration ≤ 7 years (0.63; 0.53-0.76); in those with EDSS score < 4 (0.75; 0.64-0.88), < 6 (0.80; 0.70-0.91), and ≥ 6 (0.52; 0.31-0.86); and in patients with pre-baseline relapses (0.74; 0.64-0.86). A higher probability of confirmed disability improvement on natalizumab versus fingolimod (hazard ratio [HR]; 95% CI) was observed among women (1.36; 1.10-1.66); those aged > 38 years (1.34; 1.04-1.73); those with disease duration > 7 years (1.33; 1.01-1.74); those with EDSS score < 6 (1.21; 1.01-1.46) and ≥ 6 (1.93; 1.11-3.34); and patients with no new MRI lesion (1.73; 1.19-2.51). CONCLUSIONS: Overall, in women, younger patients, those with shorter disease durations, and patients with pre-treatment relapses, natalizumab was associated with a lower frequency of multiple sclerosis relapses than fingolimod. It was also associated with an increased chance of recovery from disability among most patients, particularly women and those with no recent MRI activity.
Aarhus University Hospital Neurology PPJ Boulevard 8200 Aarhus N Denmark
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Italy
Central Clinical School Monash University Melbourne Australia
Centre de Ressources et de Compétences SEP Paris France
CHU de Besançon Service de Neurologie 25 030 Besançon France
CHU de Nantes Service de Neurologie and CIC015 INSERM 44093 Nantes France
CHU Lille CRCSEP Lille Univ Lille U1172 59000 Lille France
CHU Pontchaillou CIC1414 INSERM 35000 Rennes France
CHUM MS Center and Universite de Montreal Montreal Canada
CISSS Chaudière Appalache Levis Canada
College of Medicine and Public Health Flinders University Adelaide Australia
CORe Department of Medicine University of Melbourne L4 East Grattan St Melbourne VIC 3050 Australia
CRC SEP and Department of Neurology CHU de Tours Hôpital Bretonneau 37000 Tours France
CRCSEP Nice UR2CA Université Nice Cote d'Azur Hopital Pasteur2 06002 Nice France
CRTI Inserm U1064 44000 Nantes France
CSSS Saint Jérôme Saint Jerome Canada
Département de neurologie Hôpital Pitié Salpêtrière APHP Paris France
Department of Basic Medical Sciences Neuroscience and Sense Organs University of Bari Bari Italy
Department of Clinical Epidemiology Aarhus University Hospital Aarhus Denmark
Department of Emergency and General Medicine Parma University Hospital Parma Italy
Department of Medical and Surgical Sciences and Advanced Technologies GF Ingrassia Catania Italy
Department of Medicine and Surgery University of Parma Parma Italy
Department of Neurology AP HP Saint Antoine Hospital 75000 Paris France
Department of Neurology APHP Hôpital Henri Mondor 94000 Créteil France
Department of Neurology Box Hill Hospital Monash University Melbourne Australia
Department of Neurology Centre Hospitalier de Versailles 78150 Le Chesnay France
Department of Neurology CH de Pontoise Hôpital René Dubos 95300 Pontoise France
Department of Neurology CHU Bicêtre 94275 Le Kremlin Bicêtre France
Department of Neurology CHU Clermont Ferrand 63000 Clermont Ferrand France
Department of Neurology CHU d'Amiens 80000 Amiens France
Department of Neurology CHU de Bordeaux CIC Bordeaux CIC1401 33000 Bordeaux France
Department of Neurology CHU de Dijon EA4184 21000 Dijon France
Department of Neurology CHU de la Martinique 97200 Fort de France France
Department of Neurology CHU de Limoges Hôpital Dupuytren 87000 Limoges France
Department of Neurology CHU de Rouen 76000 Rouen France
Department of Neurology CHU de Saint Étienne Hôpital Nord 42000 Saint Étienne France
Department of Neurology CHU Grenoble Alpes La Tronche 38700 Grenoble France
Department of Neurology CHU La Milétrie Hôpital Jean Bernard 86000 Poitiers France
Department of Neurology Copenhagen University Hospital Herlev Herlev Denmark
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Neurology Fondation Rotschild 75000 Paris France
Department of Neurology Hôpital de Poissy 78300 Poissy France
Department of Neurology Hôpital Sud Francilien 91160 Corbeil Essonnes France
Department of Neurology John Hunter Hospital Hunter New England Health Newcastle Australia
Department of Neurology Nancy University Hospital Nancy France
Department of Neurology Nimes University Hospital 30029 Nimes Cedex 9 France
Department of Neurology Rigshospitalet Glostrup Copenhagen Denmark
Department of Neurology The Alfred Hospital Melbourne Australia
Department of Neurology University Hospital of Northern Sealand Helsingør Denmark
Department of Neuroscience Azienda Ospedaliera Universitaria Modena Italy
Department of Neuroscience Imaging and Clinical Sciences University G d'Annunzio Chieti Italy
Department of Neuroscience Monash University Melbourne Australia
Dipartimento di Scienze Biomediche e Neuromotorie Università di Bologna Bologna Italia
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Dokuz Eylul University Konak Izmir Turkey
EUGENE DEVIC EDMUS Foundation Against Multiple Sclerosis State Approved Foundation 69677 Bron France
Haydarpasa Numune Training and Research Hospital Istanbul Turkey
Hospital Universitario Virgen Macarena Seville Spain
INSERM U1215 Neurocentre Magendie 33000 Bordeaux France
Institute of Clinical Medicine University of Copenhagen Copenhagen Denmark
IRCCS Istituto delle Scienze Neurologiche di Bologna Bologna Italy
KTU Medical Faculty Farabi Hospital Trabzon Turkey
Medical Faculty 19 Mayis University Samsun Turkey
MS Centre Department of Neurology Royal Melbourne Hospital Melbourne Australia
MS Unit CHU de Montpellier 34295 Montpellier Cedex 5 France
Multiple Sclerosis Center University of Catania Catania Italy
Multiple Sclerosis Unit Department of Neurology Aalborg University Hospital Aalborg Denmark
Neuro Rive Sud Greenfield Park Quebec Canada
Neurocentre Magendie Université de Bordeaux 33000 Bordeaux France
Neurology Unit Garibaldi Hospital Catania Italy
Neurophysiology Department Westmead Hospital Sydney Australia
Rehabilitation and MS Centre Overpelt and Hasselt University Hasselt Belgium
Rennes University EHESP REPERES EA 7449 Rennes France
Royal Brisbane and Women's Hospital Brisbane Australia
School of Medicine and Public Health University Newcastle Newcastle Australia
Univ Rennes CHU Rennes Inserm CIC 1414 Rennes France
Université Claude Bernard Lyon 1 Faculté de médecine Lyon Est F 69000 Lyon France
Université Clermont Auvergne Inserm Neuro Dol 63000 Clermont Ferrand France
Université de Lorraine APEMAC 54000 Nancy France
Université de Lyon Université Claude Bernard Lyon 1 F 69000 Lyon France
References provided by Crossref.org
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- $a Sharmin, Sifat $u CORe, Department of Medicine, University of Melbourne, L4 East, Grattan St, Melbourne, VIC, 3050, Australia
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- $a INTRODUCTION: Natalizumab has proved to be more effective than fingolimod in reducing disease activity in relapsing-remitting multiple sclerosis (RRMS). Whether this association is universal for all patient groups remains to be determined. OBJECTIVE: The aim of this study was to compare the relative effectiveness of natalizumab and fingolimod in RRMS subgroups defined by the baseline demographic and clinical characteristics of interest. METHODS: Patients with RRMS who were given natalizumab or fingolimod were identified in a merged cohort from three international registries. Efficacy outcomes were compared across subgroups based on patients' sex, age, disease duration, Expanded Disability Status Scale (EDSS) score, and disease and magnetic resonance imaging (MRI) activity 12 months prior to treatment initiation. Study endpoints were number of relapses (analyzed with weighted negative binomial generalized linear model) and 6-month confirmed disability worsening and improvement events (weighted Cox proportional hazards model), recorded during study therapy. Each patient was weighted using inverse probability of treatment weighting based on propensity score. RESULTS: A total of 5148 patients (natalizumab 1989; fingolimod 3159) were included, with a mean ± standard deviation age at baseline of 38 ± 10 years, and the majority (72%) were women. The median on-treatment follow-up was 25 (quartiles 15-41) months. Natalizumab was associated with fewer relapses than fingolimod (incidence rate ratio [IRR]; 95% confidence interval [CI]) in women (0.76; 0.65-0.88); in those aged ≤ 38 years (0.64; 0.54-0.76); in those with disease duration ≤ 7 years (0.63; 0.53-0.76); in those with EDSS score < 4 (0.75; 0.64-0.88), < 6 (0.80; 0.70-0.91), and ≥ 6 (0.52; 0.31-0.86); and in patients with pre-baseline relapses (0.74; 0.64-0.86). A higher probability of confirmed disability improvement on natalizumab versus fingolimod (hazard ratio [HR]; 95% CI) was observed among women (1.36; 1.10-1.66); those aged > 38 years (1.34; 1.04-1.73); those with disease duration > 7 years (1.33; 1.01-1.74); those with EDSS score < 6 (1.21; 1.01-1.46) and ≥ 6 (1.93; 1.11-3.34); and patients with no new MRI lesion (1.73; 1.19-2.51). CONCLUSIONS: Overall, in women, younger patients, those with shorter disease durations, and patients with pre-treatment relapses, natalizumab was associated with a lower frequency of multiple sclerosis relapses than fingolimod. It was also associated with an increased chance of recovery from disability among most patients, particularly women and those with no recent MRI activity.
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- $a Horakova, Dana $u Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University in Prague and General University Hospital, Prague, Czech Republic
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- $a Patti, Francesco $u Department of Medical and Surgical Sciences and Advanced Technologies, GF Ingrassia, Catania, Italy $u Multiple Sclerosis Center, University of Catania, Catania, Italy
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- $a Onofrj, Marco $u Department of Neuroscience, Imaging, and Clinical Sciences, University G. d'Annunzio, Chieti, Italy
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- $a Lugaresi, Alessandra $u IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy $u Dipartimento di Scienze Biomediche e Neuromotorie, Università di Bologna, Bologna, Italia
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- $a Terzi, Murat $u Medical Faculty, 19 Mayis University, Samsun, Turkey
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- $a Lechner-Scott, Jeannette $u School of Medicine and Public Health, University Newcastle, Newcastle, Australia $u Department of Neurology, John Hunter Hospital, Hunter New England Health, Newcastle, Australia
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- $a Sola, Patrizia $u Department of Neuroscience, Azienda Ospedaliera Universitaria, Modena, Italy
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- $a Spitaleri, Daniele $u Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino, Avellino, Italy
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- 700 1_
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- $a Pfleger, Claudia Christina $u Multiple Sclerosis Unit, Department of Neurology, Aalborg University Hospital, Aalborg, Denmark
- 700 1_
- $a Rasmussen, Peter Vestergaard $u Aarhus University Hospital, Neurology, PPJ Boulevard, 8200, Aarhus N, Denmark
- 700 1_
- $a Jensen, Michael Broksgaard $u Department of Neurology, University Hospital of Northern Sealand, Helsingør, Denmark
- 700 1_
- $a Frederiksen, Jette Lautrup $u Department of Neurology, Rigshospitalet Glostrup, Copenhagen, Denmark $u Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
- 700 1_
- $a Bramow, Stephan $u Department of Neurology, Danish Multiple Sclerosis Centre, Copenhagen University Hospital, Rigshospitalet in Glostrup, 2600, Glostrup, Denmark
- 700 1_
- $a Mathiesen, Henrik Kahr $u Department of Neurology, Copenhagen University Hospital Herlev, Herlev, Denmark
- 700 1_
- $a Schreiber, Karen Ingrid $u Department of Neurology, The Danish Multiple Sclerosis Center, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
- 700 1_
- $a Magyari, Melinda $u The Danish Multiple Sclerosis Registry, Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark $u Department of Neurology, The Danish Multiple Sclerosis Center, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark
- 700 1_
- $a Vukusic, Sandra $u Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron, Lyon, France $u Centre des Neurosciences de Lyon, Observatoire Français de la Sclérose en Plaques, INSERM 1028 et CNRS UMR5292, 69003, Lyon, France $u Université Claude Bernard Lyon 1, Faculté de médecine Lyon Est, F-69000, Lyon, France
- 700 1_
- $a Butzkueven, Helmut $u Department of Neurology, The Alfred Hospital, Melbourne, Australia $u Central Clinical School, Monash University, Melbourne, Australia $u Department of Neurology, Box Hill Hospital, Monash University, Melbourne, Australia
- 700 1_
- $a Kalincik, Tomas $u CORe, Department of Medicine, University of Melbourne, L4 East, Grattan St, Melbourne, VIC, 3050, Australia. tomas.kalincik@unimelb.edu.au $u MS Centre, Department of Neurology, Royal Melbourne Hospital, Melbourne, Australia. tomas.kalincik@unimelb.edu.au $1 https://orcid.org/0000000337781376
- 710 2_
- $a Danish Multiple Sclerosis Registry, OFSEP and the MSBase investigators
- 773 0_
- $w MED00001186 $t CNS drugs $x 1179-1934 $g Roč. 35, č. 11 (2021), s. 1217-1232
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34536228 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220425 $b ABA008
- 991 __
- $a 20220506125832 $b ABA008
- 999 __
- $a ok $b bmc $g 1789521 $s 1163175
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2021 $b 35 $c 11 $d 1217-1232 $e 20210918 $i 1179-1934 $m CNS drugs $n CNS Drugs $x MED00001186
- LZP __
- $a Pubmed-20220425
