Author: "Alroughani, R. A." / Topic: neurology (clinical) - Searchworks@Jio Institute Digital Library Search Results

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1. Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: Results from MSBase registry

Author: Tim Spelman, Serkan Ozakbas, Raed Alroughani, Murat Terzi, Suzanne Hodgkinson, Guy Laureys, Tomas Kalincik, Anneke Van Der Walt, Bassem Yamout, Jeannette Lechner-Scott, Aysun Soysal, Jens Kuhle, Jose Luis Sanchez-Menoyo, Yolanda Blanco Morgado, Daniele LA Spitaleri, Vincent van Pesch, Dana Horakova, Radek Ampapa, Francesco Patti, Richard Macdonell, Abdullah Al-Asmi, Oliver Gerlach, Jiwon Oh, Ayse Altintas, Namita Tundia, Schiffon L Wong, Helmut Butzkueven, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Altıntaş, Ayşe (ORCID 0000-0002-8524-5087 & YÖK ID 11611), Spelman, T., Ozakbas, S., Alroughani, R., Terzi, M., Hodgkinson, S., Laureys, G., Kalincik, T., Van Der Walt, A., Yamout, B., Lechner-Scott, J., Soysal, A., Kuhle, J., Sanchez-Menoyo, J.L., Blanco Morgado, Y., Spitaleri, D., van Pesch, V., Horakova, D., Ampapa, R., Patti, F., Macdonell, R., Al-Asmi, A., Gerlach, O., Oh, J., Tundia, N., Wong, S.L., Butzkueven, H., Koç University Research Center for Translational Medicine (KUTTAM) / Koç Üniversitesi Translasyonel Tıp Araştırma Merkezi (KUTTAM), and School of Medicine
Subjects: relapse, Multiple Sclerosis, real-world data, Fingolimod Hydrochloride, switching, Dimethyl Fumarate, Neurosciences and neurology, MS, registry, Multiple Sclerosis, Relapsing-Remitting, Disability, Discontinuation, Real-world data, Registry, Relapse, Switching, Neurology, disability, Recurrence, Medicine and Health Sciences, Humans, Cladribine, Neurology (clinical), Registries, Immunosuppressive Agents, Retrospective Studies, Tablets, discontinuation
Abstract: Background: effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience. Objectives: use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs. Methods: retrospective treatment comparisons were based on data from the international MSBase registry. Eligible pwMS started treatment with cladribine, fingolimod, dimethyl fumarate, or teriflunomide tablets from 2018 to mid-2021 and were censored at treatment discontinuation/switch, death, loss to follow-up, pregnancy, or study period end. Treatment persistence was evaluated as time to discontinuation/switch; relapse outcomes included time to first relapse and annualized relapse rate (ARR). Results: cohorts included 633 pwMS receiving cladribine tablets, 1195 receiving fingolimod, 912 receiving dimethyl fumarate, and 735 receiving teriflunomide. Individuals treated with fingolimod, dimethyl fumarate, or teriflunomide switched treatment significantly more quickly than matched cladribine tablet cohorts (adjusted hazard ratio (95% confidence interval): 4.00 (2.54-6.32), 7.04 (4.16-11.93), and 6.52 (3.79-11.22), respectively). Cladribine tablet cohorts had significantly longer time-to-treatment discontinuation, time to first relapse, and lower ARR, compared with other oral DMT cohorts. Conclusion: cladribine tablets were associated with a significantly greater real-world treatment persistence and more favorable relapse outcomes than all oral DMT comparators., Financial support for this study was provided entirely by a contract with EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA (CrossRef Funder ID: 10.13039/100004755). The funding agreement ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report. The following authors are employed by the sponsor: NT and SLW.
Published: 2023

2. The MSBase pregnancy, neonatal outcomes, and women’s health registry

Author: Anneke van der Walt, Kerstin Hellwig, Ayse Altintas, Sara Eichau, Olga Skibina, Vilija Jokubaitis, Orla Gray, Helmut Butzkueven, Louise Rath, Raed Alroughani, Yara Dadalti Fragoso, Stella Hughes, Altıntaş, Ayşe (ORCID 0000-0002-8524-5087 & YÖK ID 11611), Jokubaitis, V. G., Skibina, O., Alroughani, R., Butzkueven, H., Eichau, S., Fragoso, Y., Hellwig, K., Hughes, S. E., Rath, L., van der Walt, A., Gray, O., and School of Medicine
Subjects: Registry, medicine.medical_specialty, Multiple Sclerosis, Women’s Health, MSBase, lcsh:RC346-429, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Pregnancy, medicine, Neurosciences, Neurology, lcsh:Neurology. Diseases of the nervous system, Pharmacology, 030219 obstetrics & reproductive medicine, business.industry, Multiple sclerosis, Neonatal outcomes, Women’s health, medicine.disease, Clinical neurology, Family planning, Family medicine, Neonatal Outcomes, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: Background: family planning and pregnancy decisions are key considerations in the management of women with multiple sclerosis (MS), who are typically diagnosed between the ages of 20–40 years. Despite a strong evidence base that pregnancy is not harmful for women with MS, many knowledge gaps remain. These include: best management strategies through pregnancy in the era of highly effective disease-modifying therapies (DMT); foetal risks associated with DMT exposure in utero or in relation to breastfeeding; knowledge base around the use of assisted reproductive technologies; the long-term impact of pregnancy on disease outcomes, as well as the impact of long-term DMT use on women’s health and cancer risk. Methods: here, we describe the new MSBase pregnancy, neonatal outcomes and women’s health registry. We provide the rationale for, and detailed description of, the variables collected within the registry, together with data acquisition details. Conclusion: the present paper will act as a reference document for future studies., National Health and Medical Research Council of Australia; MSBase Foundation; Roche; Merck; Biogen; Novartis; Bayer-Schering; Sanofi Genzyme; Teva
Published: 2021

3. The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies

Author: Alexis Montcuquet, Henrik Kahr Mathiesen, Tomas Kalincik, Marc Girard, Karolina Hankiewicz, Marco Onofrj, Francois Grand Maison, Raed Alroughani, Mathilde Lefort, Olivier Gout, Jeannette Lechner-Scott, Marc Debouverie, Julie Prevost, Eva Havrdova, Olivier Casez, Per Soelberg Sørensen, Pierre Duquette, Jean Pelletier, Claudio Solaro, Alessandra Lugaresi, Francesco Patti, Emmanuelle Leray, Johanna Balslev Andersen, Bassem Yamout, Céline Labeyrie, Karen Schreiber, Eric Thouvenot, Nils Koch-Henriksen, Michael Broksgaard Jensen, Elisabeth Maillart, Chantal Nifle, Stephan Bramow, Pierre Clavelou, Bruno Stankoff, Olivier Heinzlef, Finn Sellebjerg, Abir Wahab, Mark Slee, Gilles Defer, Pierre Labauge, Melinda Magyari, Steve Vucic, Guillermo Izquierdo, Helmut Butzkueven, Peter Vestergaard Rasmussen, Bertrand Bourre, Maria Trojano, Franco Granella, Corinne Pottier, Jette L. Frederiksen, Olga Skibina, Recai Turkoglu, Ivania Patry, Pierre Grammond, Bart Van Wijmeersch, Eric Berger, Aurélie Ruet, Serkan Ozakbas, Jonathan Ciron, Tünde Csépány, Jean Philippe Camdessanche, Sandra Vukusic, Nicolas Maubeuge, David Laplaud, Cavit Boz, Christine Lebrun, Claudia C. Hilt Christensen, Patrizia Sola, Vahid Shaygannejad, Romain Casey, Murat Terzi, Philippe Cabre, Jérôme De Seze, Abdullatif Al-Khedr, Dana Horakova, Pamela A. McCombe, Daniele Spitaleri, Alexandre Prat, Gilles Edan, Hélène Zéphir, Aude Marousset, Sifat Sharmin, Diana Ferraro, Sara Eichau, Rana Karabudak, Thibault Moreau, Sellebjerg, Finn/0000-0002-1333-9623, Lugaresi, Alessandra/0000-0003-2902-5589, frederiksen, jette/0000-0003-1661-7438, Ciron, Jonathan/0000-0002-3386-6308, University of Copenhagen = Københavns Universitet (KU), University of Melbourne, Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Aarhus University Hospital, Rigshospitalet [Copenhagen], Copenhagen University Hospital, Centre de recherche en neurosciences de Lyon (CRNL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre hospitalier universitaire de Nantes (CHU Nantes), The MSBase Foundation is a not-for-profit organization that receives support from Biogen, Novartis, Merck, Roche, Teva and Sanofi Genzyme. The study was conducted separately and apart from the guidance of the sponsors. CORe received funding from NHMRC [1140766, 1129789, 1157717] to support studies of comparative effectiveness of MS therapies.OFSEP was supported by a grant provided by the French State and handled by the 'Agence Nationale de la Recherche,' within the framework of the 'Investments for the Future' program, under the reference ANR-10-COHO-002, by the Eugène Devic EDMUS Foundation against multiple sclerosis and by the ARSEP Foundation.DMSR did not receive any funding to collaborate in this study., ANR-10-COHO-0002,OFSEP,Observatoire Français de la Sclérose en Plaques(2010), Andersen J.B., Sharmin S., Lefort M., Koch-Henriksen N., Sellebjerg F., Sorensen P.S., Hilt Christensen C.C., Rasmussen P.V., Jensen M.B., Frederiksen J.L., Bramow S., Mathiesen H.K., Schreiber K.I., Horakova D., Havrdova E.K., Alroughani R., Izquierdo G., Eichau S., Ozakbas S., Patti F., Onofrj M., Lugaresi A., Terzi M., Grammond P., Grand Maison F., Yamout B., Prat A., Girard M., Duquette P., Boz C., Trojano M., McCombe P., Slee M., Lechner-Scott J., Turkoglu R., Sola P., Ferraro D., Granella F., Shaygannejad V., Prevost J., Skibina O., Solaro C., Karabudak R., Wijmeersch B.V., Csepany T., Spitaleri D., Vucic S., Casey R., Debouverie M., Edan G., Ciron J., Ruet A., Seze J.D., Maillart E., Zephir H., Labauge P., Defer G., Lebrun C., Moreau T., Berger E., Clavelou P., Pelletier J., Stankoff B., Gout O., Thouvenot E., Heinzlef O., Al-Khedr A., Bourre B., Casez O., Cabre P., Montcuquet A., Wahab A., Camdessanche J.-P., Marousset A., Patry I., Hankiewicz K., Pottier C., Maubeuge N., Labeyrie C., Nifle C., Leray E., Laplaud D.A., Butzkueven H., Kalincik T., Vukusic S., Magyari M., University of Copenhagen = Københavns Universitet (UCPH), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), CHU Bordeaux [Bordeaux], CHU Strasbourg, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université de Montpellier (UM), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Universitaire de Nice (CHU Nice), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), CHU Clermont-Ferrand, Hôpital de la Timone [CHU - APHM] (TIMONE), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital de la Fondation Ophtalmologique Adolphe de Rothschild [AP-HP], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Centre hospitalier intercommunal de Poissy/Saint-Germain-en-Laye - CHIPS [Poissy], CHU Amiens-Picardie, CHU Rouen, Normandie Université (NU), Centre Hospitalier Universitaire [Grenoble] (CHU), CHU de la Martinique [Fort de France], CHU Limoges, Hôpital Henri Mondor, Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), CHU Trousseau [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Centre Hospitalier de Saint-Denis [Ile-de-France], Centre hospitalier universitaire de Poitiers (CHU Poitiers), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), and Centre Hospitalier de Versailles André Mignot (CHV)
Subjects: medicine.medical_specialty, Fingolimod, Head-to-head comparison, Multiple sclerosis, Natalizumab, Treatment effectiveness, [SDV]Life Sciences [q-bio], Relapse rate, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Internal medicine, Fingolimod Hydrochloride, Epidemiology, Humans, Medicine, Multiple sclerosi, Registries, 030212 general & internal medicine, business.industry, Hazard ratio, General Medicine, medicine.disease, 3. Good health, First relapse, Treatment Outcome, Neurology, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Neurology (clinical), business, Immunosuppressive Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract: Background: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. Methods: By re-analyzing original published results from MSBase, France, and Denmark using uniform meth-odologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/ exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. Results: The pooled analyses comprised 968 natalizumab-and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. Conclusion: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed. BiogenBiogen; NovartisNovartis; MerckMerck & Company; RocheRoche Holding; Teva; Sanofi GenzymeSanofi-AventisGenzyme Corporation; NHMRCNational Health and Medical Research Council of Australia [1140766,1129789, 1157717]; French State; Agence Nationale de la Recherche-French National Research Agency (ANR)European Commission [ANR-10-COHO-002]; Eugene Devic EDMUS Foundation; ARSEP Foundation
Published: 2021

4. Determinants of therapeutic lag in multiple sclerosis

Author: Tomas Kalincik, Marc Girard, Corinne Pottier, Murat Terzi, Jean Pelletier, Oliver Gerlach, Julie Prevost, Dana Horakova, Francois Grand'Maison, Raed Alroughani, Guillermo Izquierdo, Francesco Patti, Federico Frascoli, Maria Trojano, Franco Granella, Pamela A. McCombe, Charles B Malpas, Recai Turkoglu, Aurélie Ruet, Jonathan Ciron, Tünde Csépány, Nicolas Maubeuge, Helmut Butzkueven, Pierre Clavelou, Tamara Castillo Trivino, Marco Onofrj, Jean Philippe Camdessanche, Pierre Labauge, Vincent Van Pesch, Pierre Grammond, Abir Wahab, Roberto Bergamaschi, Aysun Soysal, Diana Ferraro, Bertrand Bourre, Olivier Gout, Jeannette Lechner-Scott, Sara Eichau, Emmanuelle Leray, Alexis Montcuquet, Pierre Duquette, Olivier Casez, Youssef Sidhom, Patrizia Sola, Bart Van Wijmeersch, Izanne Roos, Gilles Edan, Serkan Ozakbas, David Laplaud, Sandra Vukusic, Abdullatif Al Khedr, Céline Labeyrie, Philippe Cabre, Eric Thouvenot, Céline Louapre, Romain Casey, Alessandra Lugaresi, Riadh Gouider, Alasdair Coles, Eric Berger, Ivania Patry, Gerardo Iuliano, Elisabetta Cartechini, Cavit Boz, Karolina Hankiewicz, Eva Havrdova, Eduardo Aguera-Morales, J William L Brown, Jérôme De Seze, Bruno Stankoff, Olivier Heinzlef, Gilles Defer, Alexandre Prat, Chantal Nifle, Maria José Sá, Marc Debouverie, Daniele Spitaleri, Aude Maurousset, Thibault Moreau, Christine Lebrun-Frenay, Hélène Zéphir, University of Melbourne, Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), École des Hautes Études en Santé Publique [EHESP] (EHESP), Département Méthodes quantitatives en santé publique (METIS), Collectif de recherche handicap, autonomie et société inclusive (CoRHASI), Swinburne University of Technology [Melbourne], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Centre de recherche en neurosciences de Lyon (CRNL), Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hospices Civils de Lyon (HCL), Charles University [Prague], Università degli studi di Catania [Catania], Università degli studi 'G. d'Annunzio' Chieti-Pescara [Chieti-Pescara] (Ud'A), Università degli Studi di Modena e Reggio Emilia (UNIMORE), University of Queensland [Brisbane], Monash University [Clayton], UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de biochimie médicale, UCL - (SLuc) Service de neurologie, Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Pontchaillou [Rennes], Charles University [Prague] (CU), Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC), Université de Lorraine (UL), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), University of Bari Aldo Moro (UNIBA), University of Catania [Italy], Hospital Virgen Macarena, Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM), CHU Toulouse [Toulouse], INSERM, Neurocentre Magendie, U1215, Physiopathologie de la Plasticité Neuronale, F-33000 Bordeaux, France, CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), Dokuz Eylül Üniversitesi = Dokuz Eylül University [Izmir] (DEÜ), CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA)-Hôpital de Hautepierre [Strasbourg]-Nouvel Hôpital Civil de Strasbourg, Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Lille, Fernando Pessoa University, Azienda Ospedaleria Universitaria di Modena, CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Universitaire de Nice (CHU Nice), Karadeniz Technical University (KTU), Università degli Studi di Macerata = University of Macerata (UNIMC), CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Centre hospitalier universitaire de Nantes (CHU Nantes), University of Newcastle [Australia] (UoN), Zuyderland Hospital [Heerlen, The Netherlands], Ondokuz Mayis University, University of Parma = Università degli studi di Parma [Parme, Italie], Amiri hospital, University of Salerno (UNISA), Université Catholique de Louvain = Catholic University of Louvain (UCL), Hasselt University (UHasselt), San Giuseppe Moscati Hospital [Avellino, Italie], Bakirkoy Matern & Childrens State Hosp, Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Universidad de Córdoba [Cordoba], Hospital Donostia, CHU Clermont-Ferrand, Hôpital de la Timone [CHU - APHM] (TIMONE), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), CHI Poissy-Saint-Germain, Université de la Manouba [Tunisie] (UMA), University of Debrecen, Hôpital Charles Nicolle [Rouen], CHU Amiens-Picardie, CHU de la Martinique [Fort de France], CHU Limoges, CHU Henri Mondor, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre Hospitalier Sud Francilien, CH Evry-Corbeil, Centre Hospitalier de Saint-Denis [Ile-de-France], Centre Hospitalier René Dubos [Pontoise], This study was supported by the EDMUS Foundation and NHMRC [1140766,1129189, 1157717]. IR is supported by a MSIF-ARSEP McDonald fellowship grantand a Melbourne Research Scholarship. The MSBase Foundation is a not-for-profitorganization that receives support from Biogen, Novartis, Merck, Roche, Teva andSanofi Genzyme. The study was conducted separately and apart from the guidanceof the sponsors. The Observatoire Français de la Sclérose en Plaques (OFSEP) issupported by a grant provided by the French State and handled by the 'AgenceNationale de la Recherche,' within the framework of the 'Investments for the Future'program, under the reference ANR-10-COHO-002, by the Eugène Devic EDMUSFoundation against multiple sclerosis and by the ARSEP Foundation., ANR-10-COHO-0002,OFSEP,Observatoire Français de la Sclérose en Plaques(2010), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Roos I., Leray E., Frascoli F., Casey R., Brown J.W.L., Horakova D., Havrdova E.K., Debouverie M., Trojano M., Patti F., Izquierdo G., Eichau S., Edan G., Prat A., Girard M., Duquette P., Onofrj M., Lugaresi A., Grammond P., Ciron J., Ruet A., Ozakbas S., De Seze J., Louapre C., Zephir H., Sa M.J., Sola P., Ferraro D., Labauge P., Defer G., Bergamaschi R., Lebrun-Frenay C., Boz C., Cartechini E., Moreau T., Laplaud D., Lechner-Scott J., Grand'Maison F., Gerlach O., Terzi M., Granella F., Alroughani R., Iuliano G., Van Pesch V., Van Wijmeersch B., Spitaleri D.L.A., Soysal A., Berger E., Prevost J., Aguera-Morales E., McCombe P., Castillo Trivino T., Clavelou P., Pelletier J., Turkoglu R., Stankoff B., Gout O., Thouvenot E., Heinzlef O., Sidhom Y., Gouider R., Csepany T., Bourre B., Al Khedr A., Casez O., Cabre P., Montcuquet A., Wahab A., Camdessanche J.-P., Maurousset A., Patry I., Hankiewicz K., Pottier C., Maubeuge N., Labeyrie C., Nifle C., Coles A., Malpas C.B., Vukusic S., Butzkueven H., Kalincik T., Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), Università degli studi di Catania = University of Catania (Unict), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB), Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Università degli Studi di Modena e Reggio Emilia = University of Modena and Reggio Emilia (UNIMORE), University of Newcastle [Callaghan, Australia] (UoN), Ondokuz Mayis University (OMU), Università degli studi di Parma = University of Parma (UNIPR), Universidad de Córdoba = University of Córdoba [Córdoba], University of Debrecen Egyetem [Debrecen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), CHU Henri Mondor [Créteil], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Registrie, Male, medicine.medical_specialty, Treatment response, Pediatrics, Neurology, Lag, [SDV]Life Sciences [q-bio], Aucun, multiple sclerosis, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Recurrence, medicine, Humans, Treatment effect, Disabled Persons, Registries, 030304 developmental biology, 0303 health sciences, business.industry, Multiple sclerosis, Delayed onset, medicine.disease, 3. Good health, Clinical neurology, therapeutic lag, multiple sclerosi, Disease Progression, Disabled Person, Observational study, Female, observational study, Neurology (clinical), business, 030217 neurology & neurosurgery, Human
Abstract: International audience; Objective: To explore the associations of patient and disease characteristics with the duration of therapeutic lag for relapses and disability progression.Background: Therapeutic lag represents the delay from initiation of therapy to attainment of full treatment effect. Understanding the determinants of therapeutic lag provides valuable information for personalised choice of therapy in multiple sclerosis (MS).Design/Methods: Data from MSBase, a multinational MS registry, and OFSEP, the French national registry, were used. Patients diagnosed with MS, minimum 1-year exposure to MS treatment, minimum 3-year pre-treatment follow up and yearly review were included in the analysis. By studying incidence of relapses and 6-month confirmed disability progression, the duration of therapeutic lag was calculated by identifying the first local minimum of the first derivative after treatment start in subgroups stratified by patient and disease characteristics. Pairwise analyses of univariate predictors were performed. Combinations of determinants that consistently drove differences in therapeutic lag in pair by pair analyses were included in the final model.Results: Baseline EDSS, ARR and sex were associated with duration of therapeutic lag on disability progression in univariate and pairwise bivariable analyses. In the final model, therapeutic lag was 27.8 weeks shorter in females with ARR6 compared to those with EDSS>=6 (26.6, 18.2–34.9 vs 54.3, 47.2–61.5). Baseline EDSS, ARR, sex and MS phenotype were associated with duration of therapeutic lag on relapses in univariate analyses. Pairwise bivariable analyses of the pairs of determinants suggested ependently associated with therapeutic lag. In the final model, therapeutic lag was shortest in those with RRMS and EDSS
Published: 2021

5. Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts

Author: Mark Slee, Guillermo Izquierdo, Per Soelberg Soerensen, Karen Schreiber, Alexandre Prat, Francois Grand'Maison, Maria Trojano, Franco Granella, Pierre Duquette, David Laplaud, Elisabeth Maillart, Henrik Kahr Mathiesen, Bassem Yamout, Cavit Boz, Jean Pelletier, Corinne Pottier, Jette L. Frederiksen, Claudia Christina Pfleger, Tomas Kalincik, Olivier Gout, Daniele Spitaleri, Marc Girard, Marco Onofrj, Jérôme De Seze, Helmut Butzkueven, Emmanuelle Leray, Philippe Cabre, Julie Prevost, Abullatif Al-Khedr, Aude Maurousset, Eric Berger, Sifat Sharmin, Ivania Patry, Pamela A. McCombe, Patrizia Sola, Olga Skibina, Diana Ferraro, Pierre Clavelou, Francesco Patti, Finn Sellebjerg, Niels Koch-Henriksen, Alexis Montcuquet, Recai Turkoglu, Romain Casey, Bart Van Wijmeersch, Hélène Zéphir, Pierre Grammond, Dana Horakova, Davide Maimone, Serkan Ozakbas, Céline Labeyrie, Murat Terzi, Aurélie Ruet, Steve Vucic, Jonathan Ciron, Tünde Csépány, Nicolas Maubeuge, Bruno Stankoff, Mathilde Lefort, Katherine Buzzard, Karolina Hankiewicz, Jean-Philippe Camdessanché, Raed Alroughani, Michael Broksgaard Jensen, Pierre Labauge, Olivier Casez, Peter Vestergaard Rasmussen, Bertrand Bourre, Olivier Heinzlef, Gilles Defer, Gilles Edan, Alessandra Lugaresi, Abir Wahab, Melinda Magyari, Anneke van der Walt, Eva Havrdova, Johanna Balslev Andersen, Chantal Nifle, Stephan Bramow, Marc Debouverie, Thibault Moreau, Sandra Vukusic, Christine Lebrun-Frenay, Jeannette Lechner-Scott, Eric Thouvenot, Sharmin S., Lefort M., Andersen J.B., Leray E., Horakova D., Havrdova E.K., Alroughani R., Izquierdo G., Ozakbas S., Patti F., Onofrj M., Lugaresi A., Terzi M., Grammond P., Grand'Maison F., Yamout B., Prat A., Girard M., Duquette P., Boz C., Trojano M., McCombe P., Slee M., Lechner-Scott J., Turkoglu R., Sola P., Ferraro D., Granella F., Prevost J., Maimone D., Skibina O., Buzzard K., Van der Walt A., Van Wijmeersch B., Csepany T., Spitaleri D., Vucic S., Casey R., Debouverie M., Edan G., Ciron J., Ruet A., De Seze J., Maillart E., Zephir H., Labauge P., Defer G., Lebrun-Frenay C., Moreau T., Berger E., Clavelou P., Pelletier J., Stankoff B., Gout O., Thouvenot E., Heinzlef O., Al-Khedr A., Bourre B., Casez O., Cabre P., Montcuquet A., Wahab A., Camdessanche J.-P., Maurousset A., Patry I., Hankiewicz K., Pottier C., Maubeuge N., Labeyrie C., Nifle C., Laplaud D., Koch-Henriksen N., Sellebjerg F.T., Soerensen P.S., Pfleger C.C., Rasmussen P.V., Jensen M.B., Frederiksen J.L., Bramow S., Mathiesen H.K., Schreiber K.I., Magyari M., Vukusic S., Butzkueven H., Kalincik T., University of Melbourne, Recherche en Pharmaco-épidémiologie et Recours aux Soins (REPERES), Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP), CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Copenhagen = Københavns Universitet (UCPH), École des Hautes Études en Santé Publique [EHESP] (EHESP), Charles University [Prague] (CU), Amiri hospital, Hospital Virgen Macarena, Dokuz Eylül Üniversitesi = Dokuz Eylül University [Izmir] (DEÜ), University of Catania [Italy], G.F. Ingrassia Hospital, Università degli studi 'G. d'Annunzio' Chieti-Pescara [Chieti-Pescara] (Ud'A), Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Institute of Neurological Science of Bologna (IRCCS), Ondokuz Mayis University (OMU), American University of Beirut Faculty of Medicine and Medical Center (AUB), Centre Hospitalier de l'Université de Montréal (CHUM), Université de Montréal (UdeM), Karadeniz Technical University (KTU), Università degli studi di Bari Aldo Moro = University of Bari Aldo Moro (UNIBA), University of Queensland [Brisbane], Royal Brisbane & Women's Hospital [Brisbane, Australia] (RBWH), Flinders University [Adelaide, Australia], University of Newcastle [Callaghan, Australia] (UoN), Azienda Ospedaleria Universitaria di Modena, Università degli studi di Parma = University of Parma (UNIPR), University Hospital Parma, Monash University [Melbourne], The Alfred Hospital, Hasselt University (UHasselt), University of Debrecen Egyetem [Debrecen], San Giuseppe Moscati Hospital [Avellino, Italie], Westmead Hospital [Sydney], Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, Hospices Civils de Lyon (HCL), Centre de recherche en neurosciences de Lyon - Lyon Neuroscience Research Center (CRNL), Université de Lyon-Université de Lyon-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Fondation Eugène Devic EDMUS, Adaptation, mesure et évaluation en santé. Approches interdisciplinaires (APEMAC), Université de Lorraine (UL), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB), Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Bordeaux, Université Bordeaux Segalen - Bordeaux 2-Institut National de la Santé et de la Recherche Médicale (INSERM), CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Lille, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital Pasteur [Nice] (CHU), Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), CHU Clermont-Ferrand, Neuro-Dol (Neuro-Dol), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Clermont Auvergne (UCA), Hôpital de la Timone [CHU - APHM] (TIMONE), Institut du Cerveau = Paris Brain Institute (ICM), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Fondation Ophtalmologique Adolphe de Rothschild [Paris], Institut de Génomique Fonctionnelle (IGF), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), CHI Poissy-Saint-Germain, Service de neurologie [Amiens], CHU Amiens-Picardie, Service de neurologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Centre Hospitalier Universitaire [Grenoble] (CHU), CHU de la Martinique [Fort de France], Service de Neurologie [CHU Limoges], CHU Limoges, CHU Henri Mondor [Créteil], Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne] (CHU ST-E), Service de Neurologie [Tours], Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Hôpital Bretonneau, Hôpital Sud Francilien Corbeil Essonne, Centre Hospitalier de Saint-Denis [Ile-de-France], Centre Hospitalier René Dubos [Pontoise], Hôpital de la Milétrie, Centre hospitalier universitaire de Poitiers (CHU Poitiers), AP-HP Hôpital Bicêtre (Le Kremlin-Bicêtre), Centre Hospitalier de Versailles André Mignot (CHV), Centre d’Investigation Clinique de Nantes (CIC Nantes), Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherche en Transplantation et Immunologie (U1064 Inserm - CRTI), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN), Aarhus University Hospital, Aalborg University [Denmark] (AAU), University Hospital of Northern Sealand, Rigshospitalet [Copenhagen], Copenhagen University Hospital, The Royal Melbourne Hospital, 1140766, National Health and Medical Research Council, Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-École des Hautes Études en Santé Publique [EHESP] (EHESP), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Copenhagen = Københavns Universitet (KU), Università degli Studi di Bologna, University of Bari Aldo Moro (UNIBA), University of Newcastle [Australia] (UoN), University of Parma = Università degli studi di Parma [Parme, Italie], University of Debrecen, Université de Lyon-Université de Lyon-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), CHU Toulouse [Toulouse], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), CHU Henri Mondor, Centre Hospitalier Universitaire de Saint-Etienne (CHU de Saint-Etienne), Ondokuz Mayis University, Centre de recherche en neurosciences de Lyon (CRNL), Physiopathologie de la Plasticité Neuronale (Neurocentre Magendie - U1215 Inserm), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA)-Hôpital de Hautepierre [Strasbourg]-Nouvel Hôpital Civil de Strasbourg, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), and Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Internationality, Subgroup analysis, Rate ratio, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Multiple Sclerosis, Relapsing-Remitting, 030225 pediatrics, Internal medicine, Secondary Prevention, Medicine, Humans, Immunologic Factors, Pharmacology (medical), Longitudinal Studies, Registries, 10. No inequality, Expanded Disability Status Scale, business.industry, Proportional hazards model, Fingolimod Hydrochloride, Multiple sclerosis, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences, Middle Aged, medicine.disease, Fingolimod, 3. Good health, multiple sclerosis, sex, age, natalizumab, fingolimod, big data, Psychiatry and Mental health, Cohort, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Immunosuppressive Agents, medicine.drug, Follow-Up Studies
Abstract: 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 withweighted 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 withdisease duration ≤7 years (0.63; 0.53–0.76); in those with EDSS score 38 years (1.34; 1.04–1.73); those with disease duration >7 years (1.33; 1.01–1.74); those with EDSS score
Published: 2021

6. Disability outcomes of early cerebellar and brainstem symptoms in multiple sclerosis

Author: Bassem Yamout, Alessandra Lugaresi, Pierre Duquette, Anneke van der Walt, Eva Havrdova, Jose Luis Sanchez-Menoyo, Alexandre Prat, Raymond Hupperts, Vincent Van Pesch, Cristina Ramo-Tello, Jeannette Lechner-Scott, Francois Grand’ Maison, Guillermo Izquierdo, Steve Vucic, Roberto Bergamaschi, Cavit Boz, Ayse Altintas, Vahid Shaygannejad, Aysun Soysal, Youssef Sidhom, Tomas Kalincik, Charles B Malpas, Marc Girard, Serkan Ozakbas, Julie Prevost, Raed Alroughani, Catherine Larochelle, Michael Barnett, Daniele Spitaleri, Pamela A. McCombe, Thor Petersen, Mark Slee, Helmut Butzkueven, Maria Trojano, Franco Granella, Minh Le, Yara Dadalti Fragoso, Pierre Grammond, Radek Ampapa, Riadh Gouider, Gerardo Iuliano, Recai Turkoglu, Murat Terzi, Eugenio Pucci, Sifat Sharmin, Diana Ferraro, Sara Eichau, Patrizia Sola, Dana Horakova, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Le M., Malpas C., Sharmin S., Horakova D., Havrdova E., Trojano M., Izquierdo G., Eichau S., Ozakbas S., Lugaresi A., Prat A., Girard M., Duquette P., Larochelle C., Alroughani R., Bergamaschi R., Sola P., Ferraro D., Grammond P., Grand' Maison F., Terzi M., Boz C., Hupperts R., Butzkueven H., Pucci E., Granella F., Van Pesch V., Soysal A., Yamout B.I., Lechner-Scott J., Spitaleri D.L.A., Ampapa R., Turkoglu R., Iuliano G., Ramo-Tello C., Sanchez-Menoyo J.L., Sidhom Y., Gouider R., Shaygannejad V., Prevost J., Altintas A., Fragoso Y.D., McCombe P.A., Petersen T., Slee M., Barnett M.H., Vucic S., Van Der Walt A., and Kalincik T.
Subjects: Pediatrics, medicine.medical_specialty, Multivariate analysis, Multiple Sclerosis, brainstem, Multiple sclerosis, Cohort Studies, 03 medical and health sciences, Therapeutic approach, Disability Evaluation, 0302 clinical medicine, disability outcome, medicine, Humans, Multiple sclerosi, Disabled Persons, 030304 developmental biology, 0303 health sciences, Expanded Disability Status Scale, cerebellar, early symptomatology, prognostic marker, business.industry, medicine.disease, Natural history, Neurology, Cohort, Disease Progression, Neurology (clinical), Brainstem, Presentation (obstetrics), business, 030217 neurology & neurosurgery, Brain Stem
Abstract: Background:Cerebellar and brainstem symptoms are common in early stages of multiple sclerosis (MS) yet their prognostic values remain unclear.Objective:The aim of this study was to investigate long-term disability outcomes in patients with early cerebellar and brainstem symptoms.Methods:This study used data from MSBase registry. Patients with early cerebellar/brainstem presentations were identified as those with cerebellar/brainstem relapse(s) or functional system score ⩾ 2 in the initial 2 years. Early pyramidal presentation was chosen as a comparator. Andersen-Gill models were used to compare cumulative hazards of (1) disability progression events and (2) relapses between patients with and without early cerebellar/brainstem symptoms. Mixed effect models were used to estimate the associations between early cerebellar/brainstem presentations and expanded disability status scale (EDSS) scores.Results:The study cohort consisted of 10,513 eligible patients, including 2723 and 3915 patients with early cerebellar and brainstem symptoms, respectively. Early cerebellar presentation was associated with greater hazard of progression events (HR = 1.37, p Conclusion:Early cerebellar presentation is associated with unfavourable outcomes, while early brainstem presentation is associated with favourable prognosis. These presentations may be used as MS prognostic markers and guide therapeutic approach.
Published: 2020

7. Redefining the Multiple Sclerosis Severity Score (MSSS): The effect of sex and onset phenotype

Author: Riadh Gouider, Talal Al-Harbi, Krisztian Kasa, Ingrid van der Mei, Carmen Adella Sirbu, Richard Roxburgh, Alessandra Lugaresi, Daniele Spitaleri, Karim Kotkata, Steve Simpson, Javier Olascoaga, Edgardo Cristiano, Raed Alroughani, Tomas Kalincik, Cameron Shaw, Attila Sas, Bruce V. Taylor, Jim Stankovich, Ayse Altintas, Bassem Yamout, Yuan Zhou, Suzi B. Claflin, José C. Álvarez-Cermeño, Tünde Csépány, José Luis Sánchez Menoyo, Guy Laureys, Danny Decoo, Helmut Butzkueven, Seyed Aidin Sajedi, Leigh Blizzard, Franco Granella, Christopher McGuigan, Yara Dadalti Fragoso, Jorge Millán-Pascual, Eugenio Pucci, Allan G. Kermode, Todd A. Hardy, Stella Hughes, Zhou Y., Claflin S.B., Stankovich J., van der Mei I., Simpson S., Roxburgh R.H., Kalincik T., Blizzard L., Lugaresi A., Alroughani R., Sajedi S.A., Butzkueven H., Pucci E., Spitaleri D.L.A., Granella F., Cristiano E., Yamout B., Hughes S., Gouider R., Sanchez Menoyo J.L., Olascoaga J., McGuigan C., Shaw C., Kermode A.G., Kasa K., Al-Harbi T., Altintas A., Laureys G., Fragoso Y., Hardy T.A., Csepany T., Sirbu C.-A., Decoo D., Sas A., Alvarez-Cermeno J.C., Kotkata K., Millan-Pascual J., and Taylor B.V.
Subjects: Male, medicine.medical_specialty, Multiple Sclerosis, Severity of Illness Index, Disability Evaluation, 03 medical and health sciences, 0302 clinical medicine, Recurrence, Internal medicine, medicine, Humans, Disability progression, Multiple sclerosi, 030304 developmental biology, 0303 health sciences, business.industry, Multiple sclerosis, onset phenotype, medicine.disease, Phenotype, Clinical neurology, disability progression, Neurology, Disease Progression, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Multiple Sclerosis Severity Score
Abstract: Background: The Multiple Sclerosis Severity Score (MSSS) is a widely used measure of the disability progression rate. However, the global MSSS may not be the best basis for comparison between all patient groups. Objective: We evaluated sex-specific and onset phenotype–specific MSSS matrices to determine if they were more effective than the global MSSS as a basis for comparison within these subsets. Methods: Using a large international dataset of multiple sclerosis (MS) patient records and the original MSSS algorithm, we constructed global, sex-specific and onset phenotype–specific MSSS matrices. We compared matrices using permutation analysis. Results: Our final dataset included 30,203 MS cases, with 28.9% males and 6.5% progressive-onset cases. Our global MSSS matrix did not differ from previously published data ( p > 0.05). The progressive-onset-specific matrix differed significantly from the relapsing-onset-specific matrix ( p Conclusion: The differences in the disability accrual rate between progressive- and relapsing-onset MS have a significant effect on MSSS. An onset-specific MSSS should be used when comparing the rate of disability progression among progressive-onset cases and for mixed cohorts.
Published: 2020

8. Clinical and therapeutic predictors of disease outcomes in AQP4-IgG+ neuromyelitis optica spectrum disorder

Author: Guillermo Izquierdo, Ayse Altintas, Tomas Kalincik, Petra Nytrova, Charles B Malpas, Roberto Bergamaschi, Ilya Kister, Diana Ferraro, Aysun Soysal, Helmut Butzkueven, Sara Eichau, Francois Grand'Maison, Guy Laureys, Jeannette Lechner-Scott, Jyh Yung Hor, Pamela A. McCombe, Yara Dadalti Fragoso, Steve Vucic, Rana Karabudak, Raed Alroughani, Cavit Boz, Celia Oreja-Guevara, Eugenio Pucci, Tünde Csépány, Patrizia Sola, Serkan Ozakbas, Bhim Singhal, Francesco Patti, Maria Trojano, Franco Granella, Marco Onofrj, Alessandra Lugaresi, Recai Turkoglu, Mark Marriott, Murat Terzi, Amy Kunchok, Talal Al-Harbi, Magdolna Simó, Javier Olascoaga, Eva Havrdova, Bassem Yamout, Kunchok A., Malpas C., Nytrova P., Havrdova E.K., Alroughani R., Terzi M., Yamout B., Hor J.Y., Karabudak R., Boz C., Ozakbas S., Olascoaga J., Simo M., Granella F., Patti F., McCombe P., Csepany T., Singhal B., Bergamaschi R., Fragoso Y., Al-Harbi T., Turkoglu R., Lechner-Scott J., Laureys G., Oreja-Guevara C., Pucci E., Sola P., Ferraro D., Altintas A., Soysal A., Vucic S., Grand'Maison F., Izquierdo G., Eichau S., Lugaresi A., Onofrj M., Trojano M., Marriott M., Butzkueven H., Kister I., Kalincik T., and Ondokuz Mayıs Üniversitesi
Subjects: Male, Time Factors, Azathioprine, Severity of Illness Index, 0302 clinical medicine, Natalizumab, Recurrence, Outcome Assessment, Health Care, Disability, Immunosuppression, Neuromyelitis optica spectrum disorder, Predictors, Relapses, Therapy, 030212 general & internal medicine, Registries, Relapse, Hazard ratio, Neuromyelitis Optica, Age Factors, General Medicine, Middle Aged, Neurology, Cohort, Disease Progression, Female, Rituximab, medicine.drug, Cohort study, Adult, medicine.medical_specialty, 03 medical and health sciences, Internal medicine, medicine, Humans, Immunologic Factors, Aquaporin 4, Neuromyelitis optica, Expanded Disability Status Scale, Proportional hazards model, business.industry, Mycophenolic Acid, medicine.disease, Immunoglobulin G, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies, Predictor
Abstract: Altintas, Ayse/0000-0002-8524-5087; Laureys, Guy/0000-0002-1708-4373; Vucic, Steve/0000-0002-8323-873X; patti, francesco/0000-0002-6923-0846; Kister, Ilya/0000-0003-3549-949X; Lugaresi, Alessandra/0000-0003-2902-5589 WOS: 000521648000049 PubMed: 31877445 Background: Aquaporin-4-IgG positive (AQP4-IgG(+)) Neuromyelitis Optica Spectrum Disorder (NMOSD) is an uncommon central nervous system autoimmune disorder. Disease outcomes in AQP4-IgG + NMOSD are typically measured by relapse rate and disability. Using the MSBase, a multi-centre international registry, we aimed to examine the impact immunosuppressive therapies and patient characteristics as predictors of disease outcome measures in AQP4-IgG + NMOSD. Method: This MSBase cohort study of AQP4-IgG + NMOSD patients examined modifiers of relapse in a multivariable proportional hazards model and expanded disability status score (EDSS) using a mixed effects model. Results: 206 AQP4-IgG + patients were included (median follow-up 3.7 years). Age (hazard ratio [HR] = 0.82 per decade, p = 0.001), brainstem onset (HR = 0.45, p = 0.009), azathioprine (HR = 0.46, p < 0.001) and mycophenolate mofetil (HR = 0.09, p = 0.012) were associated with a reduced risk of relapse. A greater EDSS was associated with age (beta = 0.45 (per decade), p < 0.001) and disease duration (beta = 0.07 per year, p < 0.001). A slower increase in EDSS was associated with azathioprine (beta = -0.48, p < 0.001), mycophenolate mofetil (beta = -0.69, p = 0.04) and rituximab (beta = -0.35, p = 0.024). Interpretation: This study has demonstrated that azathioprine and mycophenolate mofetil reduce the risk of relapses and disability progression is modified by azathioprine, mycophenolate mofetil and rituximab. Age and disease duration were the only patient characteristics that modified the risk of relapse and disability in our cohort. National Health and Medical Research Council of AustraliaNational Health and Medical Research Council of Australia [1083539, 1129189, 1140766, 1080518]; MerckMerck & Company; BiogenBiogen; NovartisNovartis; Bayer-ScheringBayer AG; Sanofi-Genzyme; Teva This study was financially supported by National Health and Medical Research Council of Australia [project grants 1083539 and 1129189, and fellowships 1140766 and 1080518]. The MSBase Foundation is a not-for-profit organization that receives support from Merck, Biogen, Novartis, Bayer-Schering, Sanofi-Genzyme and Teva. The study was conducted separately and apart from the guidance of the sponsors.
Published: 2020

9. Prediction of on-treatment disability worsening in RRMS with the MAGNIMS score

Author: Jeannette Lechner-Scott, Patrizia Sola, Pierre Grammond, Daniele Spitaleri, Jose Luis Sanchez-Menoyo, Raed Alroughani, Maria Trojano, Franco Granella, Tomas Kalincik, Cavit Boz, Diana Ferraro, Pamela A. McCombe, Bart Van Wijmeersch, Serkan Ozakbas, Alessandra Lugaresi, Raymond Hupperts, Guillermo Izquierdo, Francois Grand'Maison, Maria Pia Sormani, Vilija Jokubaitis, Steve Vucic, Eugenio Pucci, Marco Onofrj, Helmut Butzkueven, Amy Kunchok, Kunchok A., Lechner-Scott J., Granella F., Trojano M., Alroughani R., Sola P., Ferraro D., Lugaresi A., Onofrj M., Ozakbas S., Izquierdo G., Grammond P., Luis Sanchez-Menoyo J., Van Wijmeersch B., Boz C., Pucci E., McCombe P., Grand'Maison F., Spitaleri D., Vucic S., Hupperts R., Jokubaitis V., Sormani M.P., Butzkueven H., and Kalincik T.
Subjects: medicine.medical_specialty, outcomes, Cohort Studies, Multiple sclerosis, Neoplasm Recurrence, Multiple Sclerosis, Relapsing-Remitting, medicine, Humans, magnetic resonance imaging, Multiple sclerosi, therapy, medicine.diagnostic_test, Interferon beta, business.industry, Disease progression, Magnetic resonance imaging, prediction, medicine.disease, Clinical neurology, Neurology, Relapsing remitting, prognosis, outcome, Disease Progression, Neurology (clinical), Radiology, Neoplasm Recurrence, Local, business, prognosi, Cohort study
Abstract: Background: The magnetic resonance imaging in multiple sclerosis (MAGNIMS) score combines relapses and magnetic resonance imaging (MRI) lesions to predict disability outcomes in relapsing–remitting multiple sclerosis (RRMS) treated with interferon-β. Objective: To validate the MAGNIMS score and extend to other disease-modifying therapies (DMTs). To examine the prognostic value of gadolinium contrast-enhancing (Gd+) lesions. Methods: This RRMS MSBase cohort study ( n = 2293) used a Cox model to examine the prognostic value of relapses, MRI activity and the MAGNIMS score for disability worsening during treatment with interferon-β and three other DMTs. Results: Three new T2 lesions (hazard ratio (HR) = 1.60, p = 0.028) or two relapses (HR = 2.24, p = 0.002) on interferon-β (for 12 months) were predictive of disability worsening over 4 years. MAGNIMS score = 2 (1 relapse and ⩾3 T2 lesions or ⩾2 relapses) was associated with a greater risk of disability worsening on interferon-β (HR = 2.0, p = 0.001). In pooled cohort of four DMTs, similar associations were seen (MAGNIMS score = 2: HR = 1.72, p = 0.001). Secondary analyses demonstrated that the addition of Gd+ to the MAGNIMS did not materially improve its prediction of disability worsening. Conclusion: We have validated the MAGNIMS score in RRMS and extended its application to three other DMTs: 1 relapse and ⩾3 T2 lesions or ⩾2 relapses predicted worsening of disability. Contrast-enhancing lesions did not substantially improve the prognostic score.
Published: 2020

10. Risk of secondary progressive multiple sclerosis: A longitudinal study

Author: Michael Barnett, Bhim Singhal, Maria Trojano, Franco Granella, Neil Shuey, Guillermo Izquierdo, Dana Horakova, Helmut Butzkueven, Talal Al-Harbi, Maria Laura Saladino, Cameron Shaw, Adam Fambiatos, Bart Van Wijmeersch, Serkan Ozakbas, Tünde Csépány, Freek Verheul, Cavit Boz, Tim Spelman, Pierre Duquette, Jeannette Lechner-Scott, Bassem Yamout, Roberto Bergamaschi, Vincent Van Pesch, Claudio Solaro, Edgardo Cristiano, Patrizia Sola, Vilija Jokubaitis, Jae Kwan Jun, Alessandra Lugaresi, Javier Olascoaga, Aysun Soysal, Thor Petersen, Mark Slee, Raed Alroughani, Francois Grand'Maison, Orla Gray, Tomas Kalincik, Marc Girard, Gerardo Iuliano, Anneke van der Walt, Eva Havrdova, Jose Luis Sanchez-Menoyo, Radek Ampapa, Julie Prevost, Steve Vucic, Pamela A. McCombe, Recai Turkoglu, Yara Dadalti Fragoso, Jordana Hughes, Olga Skibina, Murat Terzi, Eugenio Pucci, Diana Ferraro, Pierre Grammond, Fraser Moore, Ayse Altintas, Suzanne Hodgkinson, Youssef Sidhom, Norma Deri, Alexandre Prat, Raymond Hupperts, Daniele Spitaleri, Bruce V. Taylor, Fambiatos A., Jokubaitis V., Horakova D., Kubala Havrdova E., Trojano M., Prat A., Girard M., Duquette P., Lugaresi A., Izquierdo G., Grand'Maison F., Grammond P., Sola P., Ferraro D., Alroughani R., Terzi M., Hupperts R., Boz C., Lechner-Scott J., Pucci E., Bergamaschi R., Van Pesch V., Ozakbas S., Granella F., Turkoglu R., Iuliano G., Spitaleri D., McCombe P., Solaro C., Slee M., Ampapa R., Soysal A., Petersen T., Sanchez-Menoyo J.L., Verheul F., Prevost J., Sidhom Y., Van Wijmeersch B., Vucic S., Cristiano E., Saladino M.L., Deri N., Barnett M., Olascoaga J., Moore F., Skibina O., Gray O., Fragoso Y., Yamout B., Shaw C., Singhal B., Shuey N., Hodgkinson S., Altintas A., Al-Harbi T., Csepany T., Taylor B., Hughes J., Jun J.-K., van der Walt A., Spelman T., Butzkueven H., Kalincik T., Ondokuz Mayıs Üniversitesi, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, and UCL - (SLuc) Service de neurologie
Subjects: Adult, Male, Risk, medicine.medical_specialty, Longitudinal study, Immunologic Factors, multiple sclerosis, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, disease modifying therapies, prognostics, Internal medicine, Severity of illness, Medicine, Humans, Longitudinal Studies, 030304 developmental biology, 0303 health sciences, business.industry, Multiple sclerosis, Disease progression, prediction, Multiple Sclerosis, Chronic Progressive, medicine.disease, SPMS, Clinical neurology, Natural history, Neurology, multiple sclerosi, disease modifying therapie, Disease Progression, Secondary progressive multiple sclerosis, Female, Neurology (clinical), business, prognostic, 030217 neurology & neurosurgery
Abstract: Turkoglu, Recai/0000-0001-9724-851X; Ferraro, Diana/0000-0003-4818-3806; McCombe, Pamela/0000-0003-2704-8517; Altintas, Ayse/0000-0002-8524-5087; Jokubaitis, Vilija G./0000-0002-3942-4340; Slee, Mark/0000-0003-4323-2453; Lugaresi, Alessandra/0000-0003-2902-5589; van Pesch, Vincent/0000-0003-2885-9004; Vucic, Steve/0000-0002-8323-873X WOS: 000481049900001 PubMed: 31397221 Background: The risk factors for conversion from relapsing-remitting to secondary progressive multiple sclerosis remain highly contested. Objective: The aim of this study was to determine the demographic, clinical and paraclinical features that influence the risk of conversion to secondary progressive multiple sclerosis. Methods: Patients with adult-onset relapsing-remitting multiple sclerosis and at least four recorded disability scores were selected from MSBase, a global observational cohort. The risk of conversion to objectively defined secondary progressive multiple sclerosis was evaluated at multiple time points per patient using multivariable marginal Cox regression models. Sensitivity analyses were performed. Results: A total of 15,717 patients were included in the primary analysis. Older age (hazard ratio (HR) = 1.02, p < 0.001), longer disease duration (HR = 1.01, p = 0.038), a higher Expanded Disability Status Scale score (HR = 1.30, p < 0.001), more rapid disability trajectory (HR = 2.82, p < 0.001) and greater number of relapses in the previous year (HR = 1.07, p = 0.010) were independently associated with an increased risk of secondary progressive multiple sclerosis. Improving disability (HR = 0.62, p = 0.039) and disease-modifying therapy exposure (HR = 0.71, p = 0.007) were associated with a lower risk. Recent cerebral magnetic resonance imaging activity, evidence of spinal cord lesions and oligoclonal bands in the cerebrospinal fluid were not associated with the risk of conversion. Conclusion: Risk of secondary progressive multiple sclerosis increases with age, duration of illness and worsening disability and decreases with improving disability. Therapy may delay the onset of secondary progression. National Health and Medical Research Council of AustraliaNational Health and Medical Research Council of Australia [1083539, 1129189, 1140766]; BiogenBiogen; RocheRoche Holding; Bayer ScheringBayer AG; Sanofi Genzyme; Teva; MerckMerck & Company; NovartisNovartis The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was financially supported by National Health and Medical Research Council of Australia (project grants 1083539 and 1129189 and fellowship 1140766). The MSBase Foundation is a not-for-profit organisation that receives support from Merck, Biogen, Roche, Novartis, Bayer Schering, Sanofi Genzyme and Teva. The study was conducted separately and apart from the guidance of the sponsors.
Published: 2020

11. Long-term outcomes in patients presenting with optic neuritis: Analyses of the MSBase registry

Author: Kenney, Rachel, Liu, Mengling, Patil, Sachi, Alroughani, Raed, Ampapa, Radek, Bergamaschi, Roberto, Boz, Cavit, Butzkueven, Helmut, Gomez, Jose Cabrera, Cartechini, Elisabetta, Madueño, Sara Eichau, Ferraro, Diana, Grand-Maison, Francois, Granella, Franco, Horakova, Dana, Izquierdo Ayuso, Guillermo, Kalincik, Tomas, Lizrova Preiningerova, Jana, Lugaresi, Alessandra, Onofrj, Marco, Ozakbas, Serkan, Patti, Francesco, Sola, Patrizia, Soysal, Aysun, Spitaleri, Daniele Litterio A, Terzi, Murat, Turkoglu, Recai, Van Pesch, Vincent, Saidha, Shiv, Thorpe, Lorna E, Galetta, Steven L, Balcer, Laura J, Kister, Ilya, Spelman, Tim, MSBase Study Group, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, Kenney R., Liu M., Patil S., Alroughani R., Ampapa R., Bergamaschi R., Boz C., Butzkueven H., Gomez J.C., Cartechini E., Madueno S.E., Ferraro D., Grand-Maison F., Granella F., Horakova D., Izquierdo Ayuso G., Kalincik T., Lizrova Preiningerova J., Lugaresi A., Onofrj M., Ozakbas S., Patti F., Sola P., Soysal A., Spitaleri D.L.A., Terzi M., Turkoglu R., van Pesch V., Saidha S., Thorpe L.E., Galetta S.L., Balcer L.J., Kister I., and Spelman T.
Subjects: Registrie, Adult, Optic neuriti, medicine.medical_specialty, Multiple Sclerosis, Optic Neuritis, Adolescent, Expanded disability status scale (EDSS), Vision, Cohort Studies, Disability Evaluation, Young Adult, Internal medicine, Multiple Sclerosi, medicine, Humans, Optic neuritis, Registries, Young adult, Survival analysis, Clinically isolated syndrome, Expanded Disability Status Scale, business.industry, Demyelinating Disease, medicine.disease, Clinical research, MSBase registry, Neurology, Cohort, Disease Progression, Female, Neurology (clinical), Cohort Studie, business, Human, Demyelinating Diseases, Cohort study
Abstract: Background: Short-term outcomes of optic neuritis (ON) have been well characterized. Limited data exists on longer-term visual outcomes in patients who present with ON. The large MSBase registry allows for characterization of long-term visual outcomes after ON. Methods: Via the MSBase Registry, data on patients from 41 centers was collected during routine clinical and research visits. Physical and visual disability were measured using the expanded disability status scale (EDSS) and the visual function score (VFS). Inclusion criteria for this analysis included age ≥ 18 years, clinically isolated syndrome (CIS), ON-onset, baseline visit within 6 months of onset, and at least one follow-up visit. Survival analysis was used to evaluate the association of disease-modifying treatment with time to conversion to clinically definite MS or sustained EDSS/VFS progression. Results: Data from 60,933 patients were obtained from the MSBase registry in July 2019. Of these, 1317 patients met inclusion criteria; 935 were treated at some point in disease course, while 382 were never treated. At baseline, mean age was 32.3 ± 8.8 years, 74% were female, median EDSS was 2 (IQR 1–2), and median VFS was 1 (IQR 0–2). Median follow-up time was 5.2 years (IQR 2.4–9.3). Treatment was associated with reduced risk and delayed conversion to clinically definite MS (HR = 0.70, p < 0.001), sustained EDSS progression (HR = 0.46, p < 0.0001) and sustained VFS (HR = 0.41, p < 0.001) progression. Conclusions: In the MSBase cohort, treatment after ON was associated with better visual and neurological outcomes compared to no treatment. These results support early treatment for patients presenting with ON as the first manifestation of MS.
Published: 2021

12. Retinal inner nuclear layer volume reflects inflammatory disease activity in multiple sclerosis; a longitudinal OCT study

Author: Elena H. Martinez-Lapiscina, Joachim Havla, Olivier Outteryck, Axel Petzold, Friedemann Paul, Raed Behbehani, Marco Pisa, Letizia Leocani, Angela Vidal-Jordana, Philipp Albrecht, Thomas Korn, Alexander U. Brandt, Rachel Nolan, Danko Coric, Valeria Koska, Xavier Montalban, Bernardo Sanchez-Dalmau, Hanna Zimmermann, Lisanne J. Balk, Raed Alroughani, Benjamin Knier, Orhan Aktas, Pablo Villoslada, Laura J. Balcer, [Balk LJ, Coric D] Department of Neurology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. [Knier B] Department of Neurology, Klinikum rechts der Isar, Technische Universität München, Germany. [Zimmermann HG] Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin, Germany. Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany. [Behbehani R] Al-Bahar Ophthalmology Centre, Ibn Sina Hospital, Kuwait. [Alroughani R] Division of Neurology, Department of Medicine, Amiri Hospital, Kuwait. [Vidal-Jordana A] Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Servei de Neuroimmunologia Clínica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Montalban X] Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Servei de Neuroimmunologia Clínica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Division of Neurology, Department of Medicine, St. Michael's Hospital, University of Toronto, Canada, Hospital Universitari Vall d'Hebron, Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Ophthalmology, APH - Mental Health, APH - Methodology, Balk, Lisanne J, Coric, Danko, Knier, Benjamin, Zimmermann, Hanna G, Behbehani, Raed, Alroughani, Raed, Martinez-Lapiscina, Elena H, Brandt, Alexander U, Sánchez-Dalmau, Bernardo, Vidal-Jordana, Angela, Albrecht, Philipp, Koska, Valeria, Havla, Joachim, Pisa, Marco, Nolan, Rachel C, Leocani, Letizia, Paul, Friedemann, Aktas, Orhan, Montalban, Xavier, Balcer, Laura J, Villoslada, Pablo, Outteryck, Olivier, Korn, Thoma, Petzold, Axel, and Vall d'Hebron Barcelona Hospital Campus
Subjects: medicine.medical_specialty, Ulls - Tomografia, inner nuclear layer, Órganos de los Sentidos::Ojo::Retina [ANATOMÍA], Nerve fibre layer, Esclerosi múltiple, Investigative Techniques::Optical Imaging::Tomography, Optical::Tomography, Optical Coherence [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], multiple sclerosis, Retina, Disease activity, Multiple sclerosis, Cellular and Molecular Neuroscience, chemistry.chemical_compound, Ophthalmology, Medicine, Inner nuclear layer, Inflammation, optical coherence tomography, técnicas de investigación::imágenes ópticas::tomografía óptica::tomografía de coherencia óptica [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Optical coherence tomography, Técnicas de Investigación::Imagen Óptica::Tomografía Óptica::Tomografía de Coherencia Óptica [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], business.industry, Neurodegeneration, enfermedades del sistema nervioso::enfermedades del sistema nervioso::enfermedades desmielinizantes::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], Retinal, medicine.disease, Ganglion, Original Research Paper, medicine.anatomical_structure, chemistry, multiple sclerosi, Neurology (clinical), sense organs, Sense Organs::Eye::Retina [ANATOMY], Function and Dysfunction of the Nervous System, business
Abstract: Inner nuclear layer; Multiple sclerosis; Optical coherence tomography Capa nuclear interna; Esclerosis múltiple; Tomografía de coherencia óptica Capa nuclear interior; Esclerosi múltiple; Tomografia de coherència òptica Background: The association of peripapillary retinal nerve fibre layer (pRNFL) and ganglion cell-inner plexiform layer (GCIPL) thickness with neurodegeneration in multiple sclerosis (MS) is well established. The relationship of the adjoining inner nuclear layer (INL) with inflammatory disease activity is less well understood. Objective: The objective of this paper is to investigate the relationship of INL volume changes with inflammatory disease activity in MS. Methods In this longitudinal, multi-centre study, optical coherence tomography (OCT) and clinical data (disability status, relapses and MS optic neuritis (MSON)) were collected in 785 patients with MS (68.3% female) and 92 healthy controls (63.4% female) from 11 MS centres between 2010 and 2017 and pooled retrospectively. Data on pRNFL, GCIPL and INL were obtained at each centre. Results: There was a significant increase in INL volume in eyes with new MSON during the study (N=61/1562, β=0.01mm3, p
Published: 2019

13. Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

Author: Dana Horakova, Marco Onofrj, Jose Luis Sanchez-Menoyo, Roberto Bergamaschi, Patrizia Sola, Bassem Yamout, Jeannette Lechner-Scott, Vincent Van Pesch, Cavit Boz, Daniele Spitaleri, Tim Spelman, Ludwig Kappos, Claudio Solaro, Francois Grand'Maison, Alessandra Lugaresi, Radek Ampapa, Tomas Kalincik, Marc Girard, Vahid Shaygannejad, Jens Kuhle, Maria Trojano, Franco Granella, Steve Vucic, Julie Prevost, Rana Karabudak, Murat Terzi, Cristina Ramo-Tello, Eugenio Pucci, Alexandre Prat, Bart Van Wijmeersch, Recai Turkoglu, Pamela A. McCombe, Serkan Ozakbas, Raed Alroughani, Pierre Grammond, Vilija Jokubaitis, Diana Ferraro, Mark Slee, Eva Havrdova, Helmut Butzkueven, Ernest Butler, Suzanne Hodgkinson, Guillermo Izquierdo, Pierre Duquette, Ondokuz Mayıs Üniversitesi, Kalincik T., Kubala Havrdova E., Horakova D., Izquierdo G., Prat A., Girard M., Duquette P., Grammond P., Onofrj M., Lugaresi A., Ozakbas S., Kappos L., Kuhle J., Terzi M., Lechner-Scott J., Boz C., Grand'maison F., Prevost J., Sola P., Ferraro D., Granella F., Trojano M., Bergamaschi R., Pucci E., Turkoglu R., McCombe P.A., Pesch V.V., Van Wijmeersch B., Solaro C., Ramo-Tello C., Slee M., Alroughani R., Yamout B., Shaygannejad V., Spitaleri D., Sanchez-Menoyo J.L., Ampapa R., Hodgkinson S., Karabudak R., Butler E., Vucic S., Jokubaitis V., Spelman T., Butzkueven H., UCL - SSS/IONS - Institute of NeuroScience, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, and UCL - (SLuc) Service de neurologie
Subjects: Adult, Male, Oncology, medicine.medical_specialty, Toluidines, Dimethyl Fumarate, Hydroxybutyrates, Cohort Studies, 03 medical and health sciences, chemistry.chemical_compound, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Natalizumab, Recurrence, multiple sclerosis, oral drugs, efficacy, persistence, safety, tolerability, Internal medicine, Fingolimod Hydrochloride, Nitriles, Teriflunomide, medicine, Humans, 030212 general & internal medicine, Propensity Score, Proportional Hazards Models, Dimethyl fumarate, business.industry, Multiple sclerosis, Standard treatment, Middle Aged, medicine.disease, Fingolimod, Discontinuation, Psychiatry and Mental health, chemistry, Crotonates, Female, Surgery, Neurology (clinical), business, Immunosuppressive Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract: Turkoglu, Recai/0000-0001-9724-851X; Ferraro, Diana/0000-0003-4818-3806; Jokubaitis, Vilija G./0000-0002-3942-4340; McCombe, Pamela/0000-0003-2704-8517; Lugaresi, Alessandra/0000-0003-2902-5589; Slee, Mark/0000-0003-4323-2453; Kalincik, Tomas/0000-0003-3778-1376; Vucic, Steve/0000-0002-8323-873X; Ramo-Tello, Cristina/0000-0001-8643-5053 WOS: 000471115600018 PubMed: 30636699 Objective Oral immunotherapies have become a standard treatment in relapsing-remitting multiple sclerosis. Direct comparison of their effect on relapse and disability is needed. Methods We identified all patients with relapsing-remitting multiple sclerosis treated with teriflunomide, dimethyl fumarate or fingolimod, with minimum 3-month treatment persistence and disability follow-up in the global MSBase cohort study. Patients were matched using propensity scores. Three pairwise analyses compared annualised relapse rates and hazards of disability accumulation, disability improvement and treatment discontinuation (analysed with negative binomial models and weighted conditional survival models, with pairwise censoring). Results The eligible cohorts consisted of 614 (teriflunomide), 782 (dimethyl fumarate) or 2332 (fingolimod) patients, followed over the median of 2.5 years. Annualised relapse rates were lower on fingolimod compared with teriflunomide (0.18 vs 0.24; p=0.05) and dimethyl fumarate (0.20 vs 0.26; p=0.01) and similar on dimethyl fumarate and teriflunomide (0.19 vs 0.22; p=0.55). No differences in disability accumulation (p >= 0.59) or improvement (p >= 0.14) were found between the therapies. In patients with >= 3-month treatment persistence, subsequent discontinuations were less likely on fingolimod than teriflunomide and dimethyl fumarate (p
Published: 2019

14. BREMSO: a simple score to predict early the natural course of multiple sclerosis

Author: Guillermo Izquierdo, Pierre Duquette, M. P. Pia Amato, Tim Spelman, Giulia Mallucci, Maria Trojano, Eva Havrdova, Jeannette Lechner-Scott, G. Iuliano, François Grand'Maison, Raed Alroughani, Raymond Hupperts, Edgardo Cristiano, Roberto Bergamaschi, Vahid Shaygannejad, Cristina Montomoli, Thor Petersen, Alessandra Lugaresi, Eugenio Pucci, C Zwanikken, Cavit Boz, Helmut Butzkueven, P. Grammond, Celia Oreja-Guevara, Ricardo Fernandez-Bolanos, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Bergamaschi, R, Montomoli, C., Mallucci, G., Lugaresi, A., Izquierdo, G., Grand'Maison, F., Duquette, P., Shaygannejad, V., Alroughani, R., Grammond, P., Boz, C., Iuliano, G., Zwanikken, C., Petersen, T., Lechner-Scott, J., Hupperts, R., Butzkueven, H., Pucci, E., Oreja-Guevara, C., Cristiano, E., Pia Amato, M.P., Havrdova, E., Fernandez-Bolanos, R., Spelman, T., and Trojano, M.
Subjects: Registrie, Adult, Male, Risk, medicine.medical_specialty, Bayes, Neurology, Prognosi, Baye, Disease, registry, multiple sclerosis, Severity of Illness Index, Internal medicine, Severity of illness, Multiple Sclerosi, Medicine, Humans, score, Registries, business.industry, Multiple sclerosis, Medicine (all), medicine.disease, Management of multiple sclerosis, Natural history, Quartile, natural history, Physical therapy, Disease Progression, Observational study, Female, Neurology (clinical), prognosis, business, Human
Abstract: Background and purpose Early prediction of long-term disease evolution is a major challenge in the management of multiple sclerosis (MS). Our aim was to predict the natural course of MS using the Bayesian Risk Estimate for MS at Onset (BREMSO), which gives an individual risk score calculated from demographic and clinical variables collected at disease onset. Methods An observational study was carried out collecting data from MS patients included in MSBase, an international registry. Disease impact was studied using the Multiple Sclerosis Severity Score (MSSS) and time to secondary progression (SP). To evaluate the natural history of the disease, patients were analysed only if they did not receive immune therapies or only up to the time of starting these therapies. Results Data from 14 211 patients were analysed. The median BREMSO score was significantly higher in the subgroups of patients whose disease had a major clinical impact (MSSS≥ third quartile vs. ≤ first quartile, P
Published: 2015

15. Risk of relapse phenotype recurrence in multiple sclerosis

Author: Daniele Spitaleri, Joseph Herbert, Jeannette Lechner-Scott, Bhim Singhal, Tomas Kalincik, Carmen Adella Sirbu, Maria Edite Rio, Marc Girard, Celia Oreja-Guevara, Norbert Vella, Pierre Duquette, Raymond Hupperts, Francois Grand'Maison, Vincent Van Pesch, Alessandra Lugaresi, Maria Pia Amato, Raed Alroughani, Thor Petersen, Marcela Fiol, Gerardo Iuliano, Steve Vucic, Giorgio Giuliani, Ricardo Fernandez-Bolanos, Guillermo Izquierdo, Tatjana Petkovska-Boskova, Freek Verheul, Michael Barnett, Helmut Butzkueven, Mark Paine, Maria Laura Saladino, Jose Antonio Cabrera-Gomez, Erik van Munster, Maria Trojano, Roberto Bergamaschi, S. Flechter, Danny Liew, Orla Gray, Katherine Buzzard, Edgardo Cristiano, Cavit Boz, Mark Slee, Cameron Shaw, Aldo Savino, Vilija Jokubaitis, Csilla Rozsa, Fraser Moore, Pierre Grammond, John Parratt, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Kalincik T, Buzzard K, Jokubaitis V, Trojano M, Duquette P, Guillermo I, Girard M, Lugaresi A, Grammond P, Grand'maison F, Oreja-Guevara C, Boz C, Hupperts R, Petersen T, Giuliani G, Iuliano G, Lechner-Scott J, Barnett M, Bergamaschi R, Van Pesch V, Amato MP, van Munster E, Fernandez-Bolanos R, Verheul F, Fiol M, Cristiano E, Slee M, Rio ME, Spitaleri D, Alroughani R, Gray O, Saladino ML, Flechter S, Herbert J, Cabrera-Gomez JA, Vella N, Paine M, Shaw C, Moore F, Vucic S, Savino A, Singhal B, Petkovska-Boskova T, Parratt J, Sirbu CA, Rozsa C, Liew D, Butzkueven H, and on behalf of the MSBase Study Group
Subjects: Adult, Male, Risk, medicine.medical_specialty, phenotype, Disease, Logistic regression, MSBase, Multiple sclerosis, Disability Evaluation, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Internal medicine, medicine, Humans, multiple sclerosis, relapse, symptom, prognosis, Aged, business.industry, Age Factors, presentation of neurological diseases, Middle Aged, medicine.disease, Phenotype, Natural history, Institutional repository, Neurology, Immunology, Disease Progression, Female, Observational study, prognosis, Neurology (clinical), business, Progressive disease
Abstract: Objectives: The aim was to analyse risk of relapse phenotype recurrence in multiple sclerosis and to characterise the effect of demographic and clinical features on this phenotype. Methods: Information about relapses was collected using MSBase, an international observational registry. Associations between relapse phenotypes and history of similar relapses or patient characteristics were tested with multivariable logistic regression models. Tendency of relapse phenotypes to recur sequentially was assessed with principal component analysis. Results: Among 14,969 eligible patients (89,949 patient-years), 49,279 phenotypically characterised relapses were recorded. Visual and brainstem relapses occurred more frequently in early disease and in younger patients. Sensory relapses were more frequent in early or non-progressive disease. Pyramidal, sphincter and cerebellar relapses were more common in older patients and in progressive disease. Women presented more often with sensory or visual symptoms. Men were more prone to pyramidal, brainstem and cerebellar relapses. Importantly, relapse phenotype was predicted by the phenotypes of previous relapses. (OR = 1.8–5, p = 10-14). Sensory, visual and brainstem relapses showed better recovery than other relapse phenotypes. Relapse severity increased and the ability to recover decreased with age or more advanced disease. Conclusion: Relapse phenotype was associated with demographic and clinical characteristics, with phenotypic recurrence significantly more common than expected by chance.
Published: 2014

16. Fingolimod after natalizumab and the risk of short-term relapse

Author: Giorgio Giuliani, Danny Liew, Freek Verheul, Alessandra Lugaresi, Michael Barnett, Mark Slee, Vivien Li, Tomas Kalincik, Marc Girard, Jeannette Lechner-Scott, Helmut Butzkueven, Francois Grand'Maison, Pierre Duquette, Daniele Spitaleri, Maria Trojano, Cavit Boz, Guillermo Izquierdo, Raed Alroughani, Jodi Haartsen, Suzanne Hodgkinson, Cameron Shaw, Vilija Jokubaitis, Jokubaitis Vg, Li V, Kalincik T, Izquierdo G, Hodgkinson S, Alroughani R, Lechner-Scott J, Lugaresi A, Duquette P, Girard M, Barnett M, Grand'Maison F, Trojano M, Slee M, Giuliani G, Shaw C, Boz C, Spitaleri Dl, Verheul F, Haartsen J, Liew D, and Butzkueven H
Subjects: Adult, Male, Oncology, medicine.medical_specialty, Antibodies, Monoclonal, Humanized, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Risk Factors, Sphingosine, Internal medicine, Fingolimod Hydrochloride, Secondary Prevention, risk, natalizumab, fingolimod, switch, multiple sclerosis, interferon, glatiramer acetate, Humans, Immunologic Factors, Medicine, Glatiramer acetate, business.industry, Proportional hazards model, Multiple sclerosis, Hazard ratio, Interferon-beta, Middle Aged, medicine.disease, Fingolimod, Surgery, Treatment Outcome, Clinical research, Propylene Glycols, Female, Neurology (clinical), business, Immunosuppressive Agents, medicine.drug
Abstract: Objective: To determine early risk of relapse after switch from natalizumab to fingolimod; to compare the switch experience to that in patients switching from interferon-b/glatiramer acetate (IFN-b/GA) and those previously treatment naive; and to determine predictors of time to first relapse on fingolimod. Methods: Data were obtained from the MSBase Registry. Relapse rates (RRs) for each patient group were compared using adjusted negative binomial regression. Survival analyses coupled with adjusted Cox regression were used to model predictors of time to first relapse on fingolimod. Results: A total of 536 patients (natalizumab-fingolimod [n 5 89]; IFN-b/GA-fingolimod [n 5 350]; naive-fingolimod [n 5 97]) were followed up for a median 10 months. In the natalizumab-fingolimod group, there was a small increase in RR on fingolimod (annualized RR [ARR] 0.38) relative to natalizumab (ARR 0.26; p 5 0.002). RRs were generally low across all patient groups in the first 9 months on fingolimod (RR 0.001–0.13). However, 30% of patients with disease activity on natalizumab relapsed within the first 6 months on fingolimod. Independent predictors of time to first relapse on fingolimod were the number of relapses in the prior 6 months (hazard ratio [HR] 1.59 per relapse; p 5 0.002) and a gap in treatment of 2–4 months compared to no gap (HR 2.10; p 5 0.041). Conclusions: RRs after switch to fingolimod were lowin all patient groups. The strongest predictor of relapse on fingolimod was prior relapse activity. Based on our data, we recommend a maximum 2-month treatment gap for switches to fingolimod to decrease the hazard of relapse. Classification of evidence: This study provides Class IV evidence that RRs are not higher in patients with multiple sclerosis switching to fingolimod from natalizumab compared to those patients switching to fingolimod from other therapies. Neurology® 2014;82:1–8
Published: 2014

17. Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis

Author: Eugenio Pucci, Alessandra Lugaresi, Jeannette Lechner-Scott, Michael Barnett, Suzanne Hodgkinson, Maria Trojano, Franco Granella, Therese Burke, L. Mekhael, Helmut Butzkueven, Raed Alroughani, Guillermo Izquierdo, Pierre Grammond, Steve Vucic, Pierre Duquette, Eva Havrdova, Tim Spelman, Dana Horakova, Francois Grand'Maison, Spelman, T., Mekhael, L., Burke, T., Butzkueven, H., Hodgkinson, S., Havrdova, E., Horakova, D., Duquette, P., Izquierdo, G., Grand'Maison, F., Grammond, P., Barnett, M., Lechner-Scott, J., Alroughani, R., Trojano, M., Lugaresi, A., Granella, F., Pucci, E., Vucic, S, and MSBase Study Group
Subjects: Adult, Male, medicine.medical_specialty, Population, Administration, Oral, Dimethyl fumarate, 03 medical and health sciences, chemistry.chemical_compound, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Natalizumab, Recurrence, Internal medicine, Outcome Assessment, Health Care, Teriflunomide, medicine, Humans, Immunologic Factors, Multiple sclerosi, Longitudinal Studies, Registries, 030212 general & internal medicine, Treatment switching, Glatiramer acetate, Relapse, education, education.field_of_study, Progression, business.industry, Hazard ratio, Fingolimod, Glatiramer Acetate, Interferon-beta, Middle Aged, Confidence interval, Surgery, chemistry, Neurology, Disease Progression, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug, Cohort study
Abstract: Background and Purpose Early relapse outcomes in long-term stable patients switching from interferon β/glatiramer acetate (IFNβ/GA) to oral therapy are unknown. Objective The objective of this study was to compare early relapse and progression in multiple sclerosis (MS) patients switching to oral therapy following a period of stable disease on IFNβ/GA, relative to a propensity-matched comparator of patients remaining on IFNβ/GA. Methods The MSBase cohort study is a global, longitudinal registry for MS. Time to first 6-month relapse in previously stable MS patients switching from platform injectables (‘switchers’) to oral agents were compared with propensity-matched patients remaining on IFNβ/GA (‘stayers’) using a Cox marginal model. Results Three-hundred and ninety-six switchers were successfully matched to 396 stayers on a 1:1 basis. There was no difference in the proportion of patients recording at least one relapse in the first 1−6 months by treatment arm (7.3% switchers, 6.6% stayers; P = 0.675). The mean annualized relapse rate (P = 0.493) and the rate of first 6-month relapse by treatment arm (hazard ratio 1.22, 95% confidence interval 0.70, 2.11) were also comparable. There was no difference in the rate of disability progression by treatment arm (hazard ratio 1.43, 95% confidence interval 0.63, 3.26). Conclusion This is the first study to compare early relapse switch probability in the period immediately following switch to oral treatment in a population previously stable on injectable therapy. There was no evidence of disease reactivation within the first 6 months of switching to oral therapy.
Published: 2016

18. The effect of oral immunomodulatory therapy on treatment uptake and persistence in multiple sclerosis

Author: Warrender-Sparkes, Matthew, Spelman, Tim, Izquierdo, Guillermo, Trojano, Maria, Lugaresi, Alessandra, Grand'Maison, François, Havrdova, Eva, Horakova, Dana, Boz, Cavit, Oreja-Guevara, Celia, Alroughani, Raed, Iuliano, Gerardo, Duquette, Pierre, Girard, Marc, Terzi, Murat, Hupperts, Raymond, Grammond, Pierre, Petersen, Thor, Fernandez-Bolanos, Ricardo, Fiol, Marcela, Pucci, Eugenio, Lechner-Scott, Jeannette, Verheul, Freek, Cristiano, Edgardo, Van Pesch, Vincent, Petkovska-Boskova, Tatjana, Moore, Fraser, Kister, Ilya, Bergamaschi, Roberto, Saladino, Maria Laura, Slee, Mark, Barnett, Michael, Amato, Maria Pia, Shaw, Cameron, Shuey, Neil, Young, Carolyn, Gray, Orla, Kappos, Ludwig, Butzkueven, Helmut, Kalincik, Tomas, Jokubaitis, Vilija, MSBase study group, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie, Ondokuz Mayıs Üniversitesi, Warrender-Sparkes M, Spelman T, Izquierdo G, Trojano M, Lugaresi A, Grand'Maison F, Havrdova E, Horakova D, Boz C, Oreja-Guevara C, Alroughani R, Iuliano G, Duquette P, Girard M, Terzi M, Hupperts R, Grammond P, Petersen T, Fernandez-Bolaños R, Fiol M, Pucci E, Lechner-Scott J, Verheul F, Cristiano E, Van Pesch V, Petkovska-Boskova T, Moore F, Kister I, Bergamaschi R, Saladino Ml, Slee M, Barnett M, Amato Mp, Shaw C, Shuey N, Young C, Gray O, Kappos L, Butzkueven H, Kalincik T, Jokubaitis V, and Msbase study group.
Subjects: Oncology, Male, Time Factors, Administration, Oral, Kaplan-Meier Estimate, Pharmacology, Persistence (computer science), 0302 clinical medicine, Natalizumab, Risk Factors, 030212 general & internal medicine, Prospective Studies, Registries, Prospective cohort study, Drug Substitution, Research Support, Non-U.S. Gov't, Middle Aged, Fingolimod, disease-modifying therapy, Treatment Outcome, Neurology, Cohort, Female, Immunosuppressive Agents, medicine.drug, Adult, medicine.medical_specialty, MSBase, Medication Adherence, Multiple sclerosis, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, Fingolimod Hydrochloride, medicine, Journal Article, Humans, Multiple sclerosi, fingolimod, Aged, Proportional Hazards Models, business.industry, medicine.disease, Medication Persistence, Multivariate Analysis, Neurology (clinical), business, 030217 neurology & neurosurgery, medication persistence, Demyelinating Diseases
Abstract: Lugaresi, Alessandra/0000-0003-2902-5589; Horakova, Dana/0000-0003-1915-0036; amato, Maria Pia/0000-0003-3325-3760; Havrdova, Eva Kubala/0000-0002-9543-4359; Slee, Mark/0000-0003-4323-2453; Jokubaitis, Vilija G./0000-0002-3942-4340; Oreja-Guevara, Celia/0000-0002-9221-5716; Petersen, Thor/0000-0001-5633-2600; pucci, eugenio/0000-0001-7606-7330; , Carolyn/0000-0001-6971-8203; van Pesch, Vincent/0000-0003-2885-9004; Butzkueven, Helmut/0000-0003-3940-8727; Trojano, Maria/0000-0002-6329-8946; Young, Carolyn/0000-0003-1745-7720; Kalincik, Tomas/0000-0003-3778-1376; Kister, Ilya/0000-0003-3549-949X WOS: 000372890900008 PubMed: 26199347 Objective: We aimed to analyse the effect of the introduction of fingolimod, the first oral disease-modifying therapy, on treatment utilisation and persistence in an international cohort of patients with multiple sclerosis (MS). Methods: MSBASIS, a prospective, observational sub-study of the MSBase registry, collects demographic, clinical and paraclinical data on patients followed from MS onset (n=4718). We conducted a multivariable conditional risk set survival analysis to identify predictors of treatment discontinuation, and to assess if the introduction of fingolimod has altered treatment persistence. Results: A total of 2640 patients commenced immunomodulatory therapy. Following the introduction of fingolimod, patients were more likely to discontinue all other treatments (hazard ratio 1.64, p
Published: 2016

19. Predictors of disability worsening in clinically isolated syndrome

Author: Freek Verheul, Jeannette Lechner-Scott, Francois Grand'Maison, Cameron Shaw, Helmut Butzkueven, Pierre Grammond, Jose Antonio Cabrera-Gomez, Michael Barnett, Norbert Vella, Pierre Duquette, Marcela Fiol, Edgardo Cristiano, Joseph Herbert, Maria Trojano, Mark Slee, Guillermo Izquierdo, Roberto Bergamaschi, Tatjana Petkovska-Boskova, Gerardo Iuliano, Fraser Moore, Damiano Paolicelli, Maria Laura Saladino, Danny Liew, Alessandra Lugaresi, Raymond Hupperts, Raed Alroughani, Vincent Van Pesch, Giorgio Giuliani, Celia Oreja-Guevara, Tim Spelman, Ricardo Fernandez-Bolanos, Cavit Boz, Vilija Jokubaitis, Maria Pia Amato, Tomas Kalincik, Marc Girard, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Jokubaitis Vg, Spelman T, Kalincik T, Izquierdo G, Grand'Maison F, Duquette P, Girard M, Lugaresi A, Grammond P, Hupperts R, Cabrera-Gomez J, Oreja-Guevara C, Boz C, Giuliani G, Fernández-Bolaños R, Iuliano G, Lechner-Scott J, Verheul F, van Pesch V, Petkovska-Boskova T, Fiol M, Moore F, Cristiano E, Alroughani R, Bergamaschi R, Barnett M, Slee M, Vella N, Herbert J, Shaw C, Saladino Ml, Amato Mp, Liew D, Paolicelli D, Butzkueven H, and Trojano M
Subjects: Pediatrics, medicine.medical_specialty, Clinically isolated syndrome, Expanded Disability Status Scale, business.industry, General Neuroscience, Multiple sclerosis, Hazard ratio, Placebo-controlled study, Interferon beta-1a, Multiple sclerosis, clinically isolated syndrome, predictor, prognosis, disability, medicine.disease, 3. Good health, Cohort, medicine, Neurology (clinical), 10. No inequality, business, Prospective cohort study, Research Articles, medicine.drug
Abstract: Objective To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS). Methods We utilized the MSBase Incident Study (MSBasis), a prospective cohort study of outcome after CIS. Predictors of time to first 3 and 12-month confirmed expanded disability status scale worsening were analyzed using Cox proportional hazards regression. Results About 1989 patients were analyzed, the largest seen-from-onset cohort reported to-date. A total of 391 patients had a first 3-month confirmed disability worsening event, of which 307 were sustained for 12 months. Older age at CIS onset (adjusted hazard ratio: aHR 1.17, 95% 1.06, 1.30), pyramidal (aHR 1.45, 95% CI 1.13, 1.89) and ambulation (HR 1.60, 95% CI 1.09, 2.34) system dysfunction, annualized relapse rate (aHR 1.20, 95% CI 1.18, 1.22), and lower proportion of observation time on treatment were associated with 3-month confirmed worsening. Predictors of time to 12-month sustained worsening included pyramidal system dysfunction (Hazard ratio: aHR 1.38, 95% CI 1.05, 1.83), and older age at CIS onset (aHR 1.17, 95% CI 1.04, 1.31). Greater proportion of follow-up time exposed to treatment was associated with greater reductions in the rate of worsening. Interpretation This study provides class IV evidence for a strong protective effect of disease-modifying treatment to reduce disability worsening events in patients with CIS and early MS, and confirms age and pyramidal dysfunction at onset as risk factors.
Published: 2015

20. Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis

Author: Daniele Spitaleri, Jeannette Lechner-Scott, Patrizia Sola, Vilija Jokubaitis, Helmut Butzkueven, Murat Terzi, Suzanne Hodgkinson, Dana Horakova, Eugenio Pucci, Francois Grand'Maison, Maria Trojano, Franco Granella, Guillermo Izquierdo, Alessandra Lugaresi, Raed Alroughani, Tim Spelman, Anna He, Tomas Kalincik, Marc Girard, Raymond Hupperts, Jose Luis Sanchez-Menoyo, Eva Havrdova, Pierre Duquette, Ricardo Fernandez-Bolanos, Vincent Van Pesch, Celia Oreja-Guevara, Gerardo Iuliano, Freek Verheul, Pierre Grammond, Csilla Rozsa, OMÜ, Anna He, Tim Spelman, Vilija Jokubaiti, Eva Havrdova, Dana Horakova, Maria Trojano, Alessandra Lugaresi, Guillermo Izquierdo, Pierre Grammond, Pierre Duquette, Marc Girard, Eugenio Pucci, Gerardo Iuliano, Raed Alroughani, Celia Oreja-Guevara, Ricardo Fernandez-Bolaño, Francois Grand’Maison, Patrizia Sola, Daniele Spitaleri, Franco Granella, Murat Terzi, Jeannette Lechner-Scott, Vincent Van Pesch, Raymond Huppert, José Luis Sánchez-Menoyo, Suzanne Hodgkinson, Csilla Rozsa, Freek Verheul, Helmut Butzkueven, Tomas Kalincik, MSBase Study Group., [He,A, Butzkueven,H, Kalincik,T] Department of Neurology,Royal Melbourne Hospital, Melbourne, Australia. [Spelman,T, Jokubaitis,V, Kalincik,T] Department of Medicine, University of Melbourne, Melbourne, Australia. [Havrdova,E, Horakova,A] Department of Neurology and Center of Clinical Neuroscience, General University Hospital, Prague, Czech Republic. [Havrdova,E, Horakova,A] Department of Neurology and Center for Clinical Neuroscience, Charles University, Prague, Czech Republic. [Trojano,M] Department of Basic Medical Sciences, Neuroscience, and Sense Organs, University of Bari, Bari, Italy. [Lugaresi,A] MS Center, Department of Neuroscience, Imaging, and Clinical Sciences, University G. d’Annunzio, Chienti, Italy. [Izquierdo,G] Department of Neurology, Hospital Universitario Virgen Macarena, Sevilla, Spain. [Grammond,P] Department of Neurology, Hotel-Dieu de Lévis, Lévis, Quebec, Canada. [Duquette,P, Girard,M] Department of Neurology, Hôpital Notre Dame, Montreal, Quebec, Canada. [Pucci,E] Neurology Unit, Azienda Sanitaria Unica Regionale Marche, Macerata, Italy. [Iuliano,G] Department of Neurology, Ospedali Riuniti di Salerno, Salerno, Italy. [Alroughani,R] Department of Neurology, Amiri Hospital, Kuwait City, Kuwait. [Oreja-Guevara,C] Multiple Sclerosis Unit, University Hospital San Carlos, Madrid, Spain. [Fernandez-Bolaños,R] Department of Neurology, Hospital Universitario Virgen de Valme, Seville, Spain. [Grand'Maison,F] Neuro Rive-Sud, Hôpital Charles LeMoyne, Quebec City, Quebec, Canada. [Sola,P] Department of Neurology, Nuovo Ospedale Civile San Agostino, Modena, Italy. [Spitaleri,D] Department of Neurology, Azienda Ospedaliera di Rilievo Nazionale, San Giuseppe Moscati, Avellino, Italy. [Granella,F] Institute of Neurology, University of Parma, Parma, Italy. [Terzi,M] Medical Faculty, Department of Neurology, Ondokuz Mayis University, Samsun, Turkey. [Lechner-Scott,J] Department of Medicine, JohnHunter Hospital, Newcastle, Australia. Hunter Medical Research Institute, University of Newcastle, Newcastle, Australia. [Van Pesch,V] Department of Neurology, Cliniques Universitaires Saint-Luc, Brussels, Belgium. [Hupperts,R] Department of Neurology, Orbis Medical Center, Sittard, the Netherlands. [Sánchez-Menoyo,JL] Department of Neurology, Hospital de Galdakao-Usansolo, Galdakao, Spain. [Hodgkinson,S] Department of Nephrology, Liverpool Hospital, Liverpool, Australia. [Rozsa,C] Department of Neurology, Jahn Ferenc Teaching Hospital,Budapest, Hungary. [Verheul,F] Neurology Unit, Groen Hart Ziekenhuis, Gouda, the Netherlands. [Butzkueven,H] Department of Neurology, Box Hill Hospital, Monash University, Melbourne, Australia., MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, and RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience
Subjects: Oncology, Male, Imagen por resonancia magnética, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective Studies [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Imaging::Magnetic Resonance Imaging [Medical Subject Headings], Cohort Studies, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Sphingosine, Medicine, media_common, Research Support, Non-U.S. Gov't, Chemicals and Drugs::Organic Chemicals::Alcohols::Amino Alcohols::Sphingosine [Medical Subject Headings], Fingolimod, Magnetic Resonance Imaging, Treatment Outcome, Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines::Interferons::Interferon Type I::Interferon-beta [Medical Subject Headings], Female, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Immunosuppressive Agents [Medical Subject Headings], Immunosuppressive Agents, medicine.drug, Drug, Adult, medicine.medical_specialty, Multiple Sclerosis, Immunologic Factors, media_common.quotation_subject, Resultado del Tratamiento, Check Tags::Male [Medical Subject Headings], Chemicals and Drugs::Organic Chemicals::Alcohols::Glycols::Propylene Glycols::Fingolimod Hydrochloride [Medical Subject Headings], Fingolimod Hydrochloride, Internal medicine, Journal Article, Glicoles de propileno, Named Groups::Persons::Age Groups::Adult [Medical Subject Headings], Humans, Diseases::Nervous System Diseases::Demyelinating Diseases::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [Medical Subject Headings], Comparative Study, Glatiramer acetate, Retrospective Studies, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], Factores inmunológicos, Interferón beta, Interferon beta, business.industry, Multiple sclerosis, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors [Medical Subject Headings], Interferon-beta, medicine.disease, Inmunosupresores, multiple sclerosis, treatment, fingolimod, injectable, oral, interferon, glatiramer acetate, Esclerosis Múltiple, Check Tags::Female [Medical Subject Headings], Propylene Glycols, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies [Medical Subject Headings], Immunology, Neurology (clinical), business, Recombinant Interferon Beta
Abstract: Havrdova, Eva Kubala/0000-0002-9543-4359; Horakova, Dana/0000-0003-1915-0036; Lugaresi, Alessandra/0000-0003-2902-5589; amato, Maria Pia/0000-0003-3325-3760; pietrolongo, erika/0000-0002-6311-5994; Shaygannejad, Vahid/0000-0002-6226-0161; McCombe, Pamela/0000-0003-2704-8517; Jokubaitis, Vilija G./0000-0002-3942-4340; Oreja-Guevara, Celia/0000-0002-9221-5716; pucci, eugenio/0000-0001-7606-7330; Sanchez Menoyo, Jose Luis/0000-0003-2634-8294; Trojano, Maria/0000-0002-6329-8946; Shaygannejad, Vahid/0000-0002-9732-4153; Skibina, Olga/0000-0002-6275-8138; Vucic, Steve/0000-0002-8323-873X; Kalincik, Tomas/0000-0003-3778-1376; Sirbu, Carmen Adella/0000-0002-1982-1066; van Pesch, Vincent/0000-0003-2885-9004; Slee, Mark/0000-0003-4323-2453; Butzkueven, Helmut/0000-0003-3940-8727; Hodgkinson, Suzanne/0000-0002-9029-6663; Petersen, Thor/0000-0001-5633-2600 WOS: 000354353900008 PubMed: 25665031 IMPORTANCE After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch decisions is often uncertain. OBJECTIVE To compare the effect of the oral immunomodulator fingolimod with that of all injectable immunomodulators (interferons or glatiramer acetate) on relapse rate, disability, and treatment persistence in patients with active MS. DESIGN, SETTING, AND PARTICIPANTS Matched retrospective analysis of data collected prospectively from MSBase, an international, observational cohort study. The MSBase cohort represents a population of patients with MS monitored at large MS centers. The analyzed data were collected between July 1996 and April 2014. Participants included patients with relapsing-remitting MS who were switching therapy to fingolimod or injectable immunomodulators up to 12 months after on-treatment clinical disease activity (relapse or progression of disability), matched on demographic and clinical variables. Median follow-up duration was 13.1 months (range, 3-80). Indication and attrition bias were controlled with propensity score matching and pairwise censoring, respectively. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity analyses were conducted. EXPOSURES Patients had received fingolimod, interferon beta, or glatiramer acetate for a minimum of 3 months following a switch of immunomodulatory therapy. MAIN OUTCOMES AND MEASURES Annualized relapse rate and proportion of relapse-free patients, as well as the proportion of patients without sustained disability progression. RESULTS Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. The fingolimod group had a lower mean annualized relapse rate (0.31 vs 0.42; 95% CI, 0.02-0.19; P = .009), lower hazard of first on-treatment relapse (hazard ratio [HR], 0.74; 95% CI, 0.56-0.98; P = .04), lower hazard of disability progression (HR, 0.53; 95% CI, 0.31-0.91; P = .02), higher rate of disability regression (HR, 2.0; 95% CI, 1.2-3.3; P = .005), and lower hazard of treatment discontinuation (HR, 0.55; P = .04) compared with the injectable group. CONCLUSIONS AND RELEVANCE Switching from injectable immunomodulators to fingolimod is associated with fewer relapses, more favorable disability outcomes, and greater treatment persistence compared with switching to another injectable preparation following on-treatment activity of MS. Novartis Pharma; Multiple Sclerosis Research Australia [11-054]; National Health and Medical Research CouncilNational Health and Medical Research Council of Australia [628856, 1071124, 1032484]; Centre For Research Excellence grant [1001216]; MSBase Foundation; Biogen IdecBiogen; Sanofi; Merck SeronoMerck SeronoMerck & Company; Bayer ScheringBayer AG This investigator-initiated analysis was financially supported by Novartis Pharma, Multiple Sclerosis Research Australia (fellowship 11-054), National Health and Medical Research Council (fellowships 628856 and 1071124, grant 1032484, and Centre For Research Excellence grant 1001216), and MSBase Foundation (a not-for-profit organization that receives support from Bayer Schering, Biogen Idec, Merck Serono, Novartis Pharma, and Sanofi).
Published: 2015

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20 results on '"Alroughani, R. A."'

1. Comparative effectiveness of cladribine tablets versus other oral disease-modifying treatments for multiple sclerosis: Results from MSBase registry

2. The MSBase pregnancy, neonatal outcomes, and women’s health registry

3. The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies

4. Determinants of therapeutic lag in multiple sclerosis

5. Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: A Subgroup Analysis From Three International Cohorts

6. Disability outcomes of early cerebellar and brainstem symptoms in multiple sclerosis

7. Redefining the Multiple Sclerosis Severity Score (MSSS): The effect of sex and onset phenotype

8. Clinical and therapeutic predictors of disease outcomes in AQP4-IgG+ neuromyelitis optica spectrum disorder

9. Prediction of on-treatment disability worsening in RRMS with the MAGNIMS score

10. Risk of secondary progressive multiple sclerosis: A longitudinal study

11. Long-term outcomes in patients presenting with optic neuritis: Analyses of the MSBase registry

12. Retinal inner nuclear layer volume reflects inflammatory disease activity in multiple sclerosis; a longitudinal OCT study

13. Comparison of fingolimod, dimethyl fumarate and teriflunomide for multiple sclerosis

14. BREMSO: a simple score to predict early the natural course of multiple sclerosis

15. Risk of relapse phenotype recurrence in multiple sclerosis

16. Fingolimod after natalizumab and the risk of short-term relapse

17. Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis

18. The effect of oral immunomodulatory therapy on treatment uptake and persistence in multiple sclerosis

19. Predictors of disability worsening in clinically isolated syndrome

20. Comparison of Switch to Fingolimod or Interferon Beta/Glatiramer Acetate in Active Multiple Sclerosis

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