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1. Critical appraisal of the role of fingolimod in the treatment of multiple sclerosis

Author

Warnke C, Stüve O, Hartung HP, Fogdell-Hahn A, and Kieseier B

Subjects
Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571, Neurology. Diseases of the nervous system, RC346-429
Abstract

Clemens Warnke1,2, Olaf Stüve3,4, Hans-Peter Hartung1, Anna Fogdell-Hahn2, Bernd C Kieseier11Department of Neurology, Heinrich-Heine-University, Düsseldorf, Germany; 2Department of Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden; 3Department of Neurology, Dallas Veterans Affairs Medical Center, TX, USA; 4Department of Neurology, University of Texas Southwestern Medical Center at Dallas, TX, USAAbstract: This review summarizes Phase III clinical trial data available for fingolimod. The main purpose is to evaluate the benefit-risk profile of fingolimod, the first oral compound available for treatment of multiple sclerosis (MS) and just recently approved by the European authorities. The authors place this evaluation in the context of the known safety and efficacy profile of established compounds for therapy of MS to outline the current and future potential of fingolimod. The authors conclude that only long-term safety data from post-marketing surveillance plans, together with additional head-to-head studies, would allow evidence-based treatment decisions. Furthermore, risk-profile analyses including patient history, exposure data to certain pathogens, and genetic analyses may potentially help to choose the right drug for individual patients in the future. Until these approaches toward an individualized medicine have been validated, treatment decisions for one or the other compound will have to be based partly on class IV evidence. Therefore, a close dialog with the well-informed patient, secured by effective risk mitigation plans, is required to choose the compound.Keywords: FTY720, oral drug, spingosine 1-phosphate receptor

Published
2011

6. MS disease activity in RESTORE: A randomized 24-week natalizumab treatment interruption study

Author

Cree, Bruce, Fox, RJ, Cree, BAC, De, J, Gold, R, Hartung, HP, Jeffery, D, Kappos, L, Kaufman, M, Montalbán, X, and Weinstock-Guttman, B

Abstract

Objective: RESTORE was a randomized, partially placebo-controlled exploratory study evaluating multiple sclerosis (MS) disease activity during a 24-week interruption of natalizumab. Methods: Eligible patients were relapse-free through the prior year on nat

Published
2014

7. Anti-SARS-CoV-2 vaccination in people with multiple sclerosis: Lessons learnt a year in

Author

Pugliatti, M, Hartung, HP, Oreja-Guevara, C, Pozzilli, C, Airas, L, Alkhawajah, M, Grigoriadis, N, Magyari, M, VAN WIJMEERSCH, Bart, Zakaria, M, Linker, R, Chan, A, Vermersch, P, Berger, T, Pugliatti, M, Hartung, HP, Oreja-Guevara, C, Pozzilli, C, Airas, L, Alkhawajah, M, Grigoriadis, N, Magyari, M, VAN WIJMEERSCH, Bart, Zakaria, M, Linker, R, Chan, A, Vermersch, P, and Berger, T

Subjects
SARS-CoV-2, disease modifying therapies, COVID-19, vaccines, multiple sclerosis, immune response, adverse events
Abstract

It has been over a year since people with multiple sclerosis (pwMS) have been receiving vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With a negligible number of cases in which vaccination led to a relapse or new onset MS, experts around the world agree that the potential consequences of COVID-19 in pwMS by far outweigh the risks of vaccination. This article reviews the currently available types of anti-SARS-CoV-2 vaccines and the immune responses they elicit in pwMS treated with different DMTs. Findings to date highlight the importance of vaccine timing in relation to DMT dosing to maximize protection, and of encouraging pwMS to get booster doses when offered.

Published
2022

9. Original research: Second IVIg course in Guillain-Barré syndrome with poor prognosis: the non-randomised ISID study

Author

Verboon, C, van den Berg, B, Cornblath, Dr, Venema, E, Gorson, Kc, Lunn, Mp, Lingsma, H, Van den Bergh, P, Harbo, T, Bateman, K, Pereon, Y, Sindrup, Sh, Kusunoki, S, Miller, J, Islam, Z, Hartung, Hp, Chavada, G, Jacobs, Bc, Hughes, Rac, van Doorn PA, Ajroud-Driss S, IGOS Consortium., Antonini, G, Attarian, S, Barroso, Fa, Benedetti, L, Bertorini, Te, Brannagan, Th, Briani, C, Bhavaraju-Sanka, R, Butterworth, S, Casasnovas, C, Cavaletti, G, Chen, S, Claeys, Kg, Cosgrove, Js, Davidson, A, Dardiotis, E, Dornonville de la Cour, C, Faber, Cg, Feasby, Te, Fujioka, T, Galassi, G, Gilchrist, Jm, Goyal, Na, Granit, V, Gutiérrez-Gutiérrez, G, Hadden, Rdm, Holt, Jkl, Htut, M, Jericó Pascual, I, Karafiath, S, Katzberg, Hd, Kiers, L, Kieseier, Bc, Kimpinski, K, Kuwabara, S, Kwan, Jy, Ladha, Ss, Lawson, V, Lehmann, H, Manji, H, Marfia, Ga, Márquez Infante, C, Mattiazzi, Mg, Mcdermott, Cj, Monges, Ms, Morís de la Tassa, G, Nascimbene, C, Nobile Orazio, E, Nowak, Rj, Osei-Bonsu, M, Pardo Fernandez, J, Querol Gutierrez, L, Reisin, R, Rinaldi, S, Rojas-Marcos, I, Rudnicki, Sa, Schenone, A, Sedano Tous MJ, Shahrizaila, N, Sheikh, K, Silvestri, Nj, Sommer, Cl, Varrato, Jd, Verschuuren, J, Vytopil, Mv, Zhou, L, Bella, Ir, Bunschoten, C, Bürmann, J, Busby, M, Chao, Cc, Conti, Me, Dalakas, Mc, Van Damme, P, Doets, A, van Dijk GW, Dimachkie, Mm, Doppler, K, Echaniz-Laguna, A, Eftimov, F, Fazio, R, Fokke, C, Fulgenzi, Ea, Garssen, Mpj, Gijsbers, Cj, Gilhuis, J, Grapperon, A, Hsieh, St, Illa, I, Islam, B, Jellema, K, Kaida, K, Kokubun, N, Kolb, N, van Koningsveld, R, van der Kooi AJ, Kuitwaard, K, Landschoff Lassen, L, Leonhard, Se, Mandarakas, M, Martinez Hernandez, E, Mohammad, Qd, Pulley, M, Rajabally, Ya, Reddel, Sw, van der Ree, T, Roodbol, J, Sachs, Gm, Samijn, Jpa, Santoro, L, Stein, B, Vermeij, Fh, Visser, Lh, Willison, Hj, Wirtz, P, Zivkovich, Sa., Neurology, Public Health, Immunology, and ANS - Neuroinfection & -inflammation

Subjects
Adult, Male, second IVIg course, Pediatrics, medicine.medical_specialty, Poor prognosis, Time Factors, Guillain-Barre Syndrome, Original research, Drug Administration Schedule, Disease course, Disability Evaluation, 03 medical and health sciences, 0302 clinical medicine, hemic and lymphatic diseases, Clinical endpoint, Humans, Immunologic Factors, Medicine, In patient, Aged, treatment, Guillain-Barre syndrome, business.industry, Immunoglobulins, Intravenous, Middle Aged, poor prognosis, Prognosis, Guillain-Barré syndrome, medicine.disease, Psychiatry and Mental health, Treatment Outcome, Immunoglobulin G, 030220 oncology & carcinogenesis, Female, Surgery, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo compare disease course in patients with Guillain-Barré syndrome (GBS) with a poor prognosis who were treated with one or with two intravenous immunoglobulin (IVIg) courses.MethodsFrom the International GBS Outcome Study, we selected patients whose modified Erasmus GBS Outcome Score at week 1 predicted a poor prognosis. We compared those treated with one IVIg course to those treated with two IVIg courses. The primary endpoint, the GBS disability scale at 4 weeks, was assessed with multivariable ordinal regression.ResultsOf 237 eligible patients, 199 patients received a single IVIg course. Twenty patients received an ‘early’ second IVIg course (1–2 weeks after start of the first IVIg course) and 18 patients a ‘late’ second IVIg course (2–4 weeks after start of IVIg). At baseline and 1 week, those receiving two IVIg courses were more disabled than those receiving one course. Compared with the one course group, the adjusted OR for a better GBS disability score at 4 weeks was 0.70 (95%CI 0.16 to 3.04) for the early group and 0.66 (95%CI 0.18 to 2.50) for the late group. The secondary endpoints were not in favour of a second IVIg course.ConclusionsThis observational study did not show better outcomes after a second IVIg course in GBS with poor prognosis. The study was limited by small numbers and baseline imbalances. Lack of improvement was likely an incentive to start a second IVIg course. A prospective randomised trial is needed to evaluate whether a second IVIg course improves outcome in GBS.

Published
2019

10. Conversion from clinically isolated syndrome to multiple sclerosis: A large multicentre study

Author

Kuhle, J, primary, Disanto, G, additional, Dobson, R, additional, Adiutori, R, additional, Bianchi, L, additional, Topping, J, additional, Bestwick, JP, additional, Meier, U-C, additional, Marta, M, additional, Costa, G Dalla, additional, Runia, T, additional, Evdoshenko, E, additional, Lazareva, N, additional, Thouvenot, E, additional, Iaffaldano, P, additional, Direnzo, V, additional, Khademi, M, additional, Piehl, F, additional, Comabella, M, additional, Sombekke, M, additional, Killestein, J, additional, Hegen, H, additional, Rauch, S, additional, D’Alfonso, S, additional, Alvarez-Cermeño, JC, additional, Kleinová, P, additional, Horáková, D, additional, Roesler, R, additional, Lauda, F, additional, Llufriu, S, additional, Avsar, T, additional, Uygunoglu, U, additional, Altintas, A, additional, Saip, S, additional, Menge, T, additional, Rajda, C, additional, Bergamaschi, R, additional, Moll, N, additional, Khalil, M, additional, Marignier, R, additional, Dujmovic, I, additional, Larsson, H, additional, Malmestrom, C, additional, Scarpini, E, additional, Fenoglio, C, additional, Wergeland, S, additional, Laroni, A, additional, Annibali, V, additional, Romano, S, additional, Martínez, AD, additional, Carra, A, additional, Salvetti, M, additional, Uccelli, A, additional, Torkildsen, Ø, additional, Myhr, KM, additional, Galimberti, D, additional, Rejdak, K, additional, Lycke, J, additional, Frederiksen, JL, additional, Drulovic, J, additional, Confavreux, C, additional, Brassat, D, additional, Enzinger, C, additional, Fuchs, S, additional, Bosca, I, additional, Pelletier, J, additional, Picard, C, additional, Colombo, E, additional, Franciotta, D, additional, Derfuss, T, additional, Lindberg, RLP, additional, Yaldizli, Ö, additional, Vécsei, L, additional, Kieseier, BC, additional, Hartung, HP, additional, Villoslada, P, additional, Siva, A, additional, Saiz, A, additional, Tumani, H, additional, Havrdová, E, additional, Villar, LM, additional, Leone, M, additional, Barizzone, N, additional, Deisenhammer, F, additional, Teunissen, C, additional, Montalban, X, additional, Tintoré, M, additional, Olsson, T, additional, Trojano, M, additional, Lehmann, S, additional, Castelnovo, G, additional, Lapin, S, additional, Hintzen, R, additional, Kappos, L, additional, Furlan, R, additional, Martinelli, V, additional, Comi, G, additional, Ramagopalan, SV, additional, and Giovannoni, G, additional

Published
2015
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11. Acute Cerebrovascular Disease in the Young

Author

Rolfs, Arndt, primary, Fazekas, Franz, additional, Grittner, Ulrike, additional, Dichgans, Martin, additional, Martus, Peter, additional, Holzhausen, Martin, additional, Böttcher, Tobias, additional, Heuschmann, Peter U., additional, Tatlisumak, Turgut, additional, Tanislav, Christian, additional, Jungehulsing, Gerhard J., additional, Giese, Anne-Katrin, additional, Putaala, Jukaa, additional, Huber, Roman, additional, Bodechtel, Ulf, additional, Lichy, Christoph, additional, Enzinger, Christian, additional, Schmidt, Reinhold, additional, Hennerici, Michael G., additional, Kaps, Manfred, additional, Kessler, Christof, additional, Lackner, Karl, additional, Paschke, Eduard, additional, Meyer, Wolfgang, additional, Mascher, Hermann, additional, Riess, Olaf, additional, Kolodny, Edwin, additional, Norrving, Bo, additional, Rolfs, A, additional, Ginsberg, M, additional, Hennerici, MG, additional, Kessler, C, additional, Kolodny, E, additional, Martus, P, additional, Norrving, B, additional, Ringelstein, EB, additional, Rothwell, PM, additional, Venables, G, additional, Bornstein, N, additional, deDeyn, P, additional, Dichgans, M, additional, Fazekas, F, additional, Markus, H, additional, Rieß, O, additional, Biedermann, C, additional, Böttcher, T, additional, Brüderlein, K, additional, Burmeister, J, additional, Federow, I, additional, König, F, additional, Makowei, G, additional, Niemann, D, additional, Rösner, S, additional, Zielke, S, additional, Grittner, U, additional, Holzhausen, M, additional, Enzinger, C, additional, Schmidt, R, additional, Ropele, S, additional, Windisch, M, additional, Sterner, E, additional, Bodamer, O, additional, Fellgiebel, A, additional, Hillen, U, additional, Jonas, L, additional, Kampmann, C, additional, Kropp, P, additional, Lackner, K, additional, Laue, M, additional, Mascher, H, additional, Meyer, W, additional, Paschke, E, additional, Weidemann, F, additional, Berrouschot, J, additional, Stoll, A, additional, Rokicha, A, additional, Sternitzky, C, additional, Thomä, M, additional, DeDeyn, PP, additional, Sheorajpanday, R, additional, De Brabander, I, additional, Yperzeele, L, additional, Brouns, R, additional, Oschmann, P, additional, Pott, M, additional, Schultes, K, additional, Schultze, C, additional, Hirsekorn, J, additional, Jungehulsing, GJ, additional, Villringer, A, additional, Schmidt, W, additional, Liman, T, additional, Nowe, T, additional, Ebinger, M, additional, Wille, A, additional, Loui, H, additional, Objartel, A, additional, übelacker, A, additional, Mette, R, additional, Jegzentis, K, additional, Nabavi, DG, additional, Crome, O, additional, Bahr, D, additional, Ebke, M, additional, Platte, B, additional, Kleinen, C, additional, Mermolja Gunther, K, additional, Heide, W, additional, Pape, O, additional, Hanssen, JR, additional, Stangenberg, D, additional, Klingelhofer, J, additional, Schmidt, B, additional, Schwarz, S, additional, Schwarze, J, additional, Frandlih, L, additional, Iwanow, J, additional, Steinbach, I, additional, Krieger, D, additional, Boysen, G, additional, Leth Jeppesen, L, additional, Petersen, A, additional, Reichmann, H, additional, Becker, U, additional, Dzialkowski, I, additional, Hentschel, H, additional, Lautenschlager, C, additional, Hanso, H, additional, Gahn, G, additional, Ziemssen, T, additional, Fleischer, K, additional, Sehr, B, additional, McCabe, DJH, additional, Tobin, O, additional, Kinsella, J, additional, Murphy, RP, additional, Jander, S, additional, Hartung, HP, additional, Siebler, M, additional, Bottcher, C, additional, Kohne, A, additional, Platzen, J, additional, Brosig, TC, additional, Rothhammer, V, additional, Henseler, C, additional, Neumann-Haefelin, T, additional, Singer, OC, additional, Ermis, U, additional, dos Santos, IMRM, additional, Schuhmann, C, additional, van de Loo, S, additional, Kaps, M, additional, Allendorfer, J, additional, Tanislav, C, additional, Brandtner, M, additional, Muir, K, additional, Dani, K, additional, MacDougall, N, additional, Smith, W, additional, Rowe, A, additional, Welch, A, additional, Schrotter, G, additional, Krenn, U, additional, Horner, S, additional, Pendl, B, additional, Pluta-Fuerst, A, additional, Trummer, U, additional, Chatzopoulos, M, additional, v Sarnowski, Bettina, additional, Schminke, Ulf, additional, Link, T, additional, Khaw, A, additional, Nieber, E, additional, Zierz, S, additional, Muller, T, additional, Wegener, N, additional, Wartenberg, K, additional, Gaul, C, additional, Richter, D, additional, Rosenkranz, M, additional, Krützelmann, AC, additional, Hoppe, J, additional, Choe, CU, additional, Narr, S, additional, Magnus, TU, additional, Thomalla, G, additional, Leypoldt, F, additional, Otto, D, additional, Lichy, C, additional, Hacke, W, additional, Barrows, RJ, additional, Tatlisumak, T, additional, Putaala, J, additional, Curtze, S, additional, Metso, M, additional, Willeit, J, additional, Furtner, M, additional, Spiegel, M, additional, Knoflach, MH, additional, Prantl, B, additional, Witte, OW, additional, Brämer, D, additional, Günther, A, additional, Prell, T, additional, Herzau, C, additional, Aurich, K, additional, Deuschl, G, additional, Wodarg, F, additional, Zimmermann, P, additional, Eschenfelder, CC, additional, Levsen, M, additional, Weber, JR, additional, Marecek, SM, additional, Schneider, D, additional, Michalski, D, additional, Kloppig, W, additional, Küppers-Tiedt, L, additional, Schneider, M, additional, Schulz, A, additional, Matzen, P, additional, Weise, C, additional, Hobohm, C, additional, Meier, H, additional, Langos, R, additional, Urban, D, additional, Gerhardt, I, additional, Thijs, V, additional, Lemmens, R, additional, Marcelis, E, additional, Hulsbosch, C, additional, Aichner, F, additional, Haring, HP, additional, Bach, E, additional, Machado Candido, J, additional, e Silva, AA, additional, Lourenco, M, additional, de Sousa, AIM, additional, Derex, L, additional, Cho, TH, additional, Díez-Tejedor, E, additional, Fuentes, B, additional, Martínez-Sanchez, P, additional, Pérez-Guevara, MI, additional, Hamer, H, additional, Metz, A, additional, Hallenberger, K, additional, Müller, P, additional, Baron, P, additional, Bersano, A, additional, Gattinoni, M, additional, Vella, N, additional, Mallia, M, additional, Jauss, M, additional, Adam, L, additional, Heidler, F, additional, Gube, C, additional, Kiszka, M, additional, Karpinska, A, additional, Mewald, Y, additional, Straub, V, additional, Dörr, A, additional, Zollver, A, additional, Schilling, M, additional, Borchert, A, additional, Preuth, N, additional, Duning, T, additional, Kuhlenbäumer, G, additional, Schulte, D, additional, Marquardt, L, additional, Schlachetzki, F, additional, Boy, S, additional, Mädl, J, additional, Ertl, GM, additional, Fehm, NPR, additional, Stadler, C, additional, Benecke, R, additional, Dudesek, A, additional, Kolbaske, S, additional, Lardurner, G, additional, Sulzer, C, additional, Zerbs, A, additional, Lilek, S, additional, Walleczek, AM, additional, Sinadinowska, D, additional, Janelidze, M, additional, Beridze, M, additional, Lobjanidze, N, additional, Dzagnidze, A, additional, Melms, A, additional, Horber, K, additional, Fink, I, additional, Liske, B, additional, Ludolph, AC, additional, Huber, R, additional, Knauer, K, additional, Hendrich, C, additional, Raubold, S, additional, Czlonkowska, A, additional, Baranowska, A, additional, Blazejewska-Hyzorek, B, additional, Lang, W, additional, Kristoferitsch, W, additional, Ferrari, J, additional, Ulrich, E, additional, Flamm-Horak, A, additional, Lischka-Lindner, A, additional, Schreiber, W, additional, Demarin, V, additional, Tranjec, Z, additional, Bosner-Puretic, M, additional, Jurašić, MJ, additional, Basic Kes, V, additional, Budisic, M, additional, and Kopacevic, L, additional

Published
2013
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14. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial

Author

Comi, G, primary, Martinelli, V, additional, Rodegher, M, additional, Moiola, L, additional, Bajenaru, O, additional, Carra, A, additional, Elovaara, I, additional, Fazekas, F, additional, Hartung, HP, additional, Hillert, J, additional, King, J, additional, Komoly, S, additional, Lubetzki, C, additional, Montalban, X, additional, Myhr, KM, additional, Ravnborg, M, additional, Rieckmann, P, additional, Wynn, D, additional, Young, C, additional, and Filippi, M, additional

Published
2009
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31. Untersuchung von RRMS Patienten zu Therapietreue und Lebensqualität im ersten Behandlungsjahr mit Interferon beta-1a (i.m.) – Ergebnisse der Datenerhebung “Mensch im Mittelpunkt“

Author

Putzki, N, primary, Fischer, J, additional, Käfferlein, W, additional, Gottwald, K, additional, Reifschneider, G, additional, Schreiber, K, additional, Siever, A, additional, Hoffmann, F, additional, Kausch, U, additional, Richter, A, additional, Schicklmaier, P, additional, Niemczyk, G, additional, Wernsdörfer, C, additional, and Hartung, HP, additional

Published
2007
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38. Die frühzeitige Behandlung von Patienten nach dem ersten Schub einer Multiplen Sklerose mit Interferon beta-1b verzögert die Entwicklung bleibender neurologischer Schäden

Author

Hartung, HP, primary, Kappos, L, additional, Edan, G, additional, Freedman, MS, additional, Miller, D, additional, Montalban, X, additional, Polman, C, additional, Barkhof, F, additional, Bauer, L, additional, Dahms, S, additional, Pohl, C, additional, and Sandbrink, R, additional

Published
2007
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