Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP)
Butzkueven H, Kappos L, Wiendl H, Trojano M, Spelman T, Chang I, Kasliwal R, Jaitly S, Campbell N, Ho P, Licata S, Abraham R, Adamkova J, Airas L, Aktas O, Albrecht H, Alsassa R, de Arcaya Esquide A, Angstwurm K, Anne O, Anvari K, Aram J, Atula S, Augspach-Hofmann R, Barnett M, Barroso B, Barthomolé E, Nadal J, Bayas A, Bergmann A, Berkenfeld R, Berthele A, Bertolotto A, Billy C, Bitsch A, Bohr K, Böhringer J, Borsotti J, Bos M, Bouquiaux O, Bourteel H, Brosch T, Buehler B, Bureau M, Busson P, Butzkueven H, Caekebeke J, Hernández C, Rodríguez A, Caride A, Triviño T, Constantinescu C, Correale J, Guerra J, Crols R, D’Haeseleer M, de Gans K, de Jesus Jimeez M, de la Luz Villalpando M, De Pauw A, Decoo D, Delalande S, Delerue O, Delvaux V, Dereeper O, Deri N, Deryck O, Devy R, D'Hooghe M, Domke S, Dubois B, Duddy M, Dufek M, Duhin E, Dupuis M, Eck P, Eder H, Edland A, Ehrlich S, Eisenberg E, Elias W, Erdmann E, Ernst M, Estudillo R, Faiss J, Fanjaud G, Farbu E, Faucheux J, Fiedler J, Flores J, Ramirez F, de Jesus Flores Rivera J, Florio C, Frank B, Gasperini C, Geens K, Gehring K, Ghalamfarsa S, Giraud P, Godet E, Guardado A, Gössling J, Grand'Maison F, Gratz T, Gray O, Grimaldi L, Grothe C, Guillaume D, Günther S, Vasilescu C, Guthke K, Haas J, Harms L, Harrower T, Hartikainen P, Hautecoeur P, Havrdova E, Hellwig K, Hengstman G, Hermans M, Herting B, Hodgkinson S, Hoffmann O, Hogenesch R, Hognestad T, Horn M, Horn R, Hupperts R, N'gbo R, Ikazabo N, Ille O, Ingvaldsen T, Ismail S, Jacques F, Jaeger J, Jichici D, Sá M, Kafke W, Kallmann B, Kastnerová I, Kausch U, Kendjuo J, Kermode A, King J, Kirsch M, Kittlitz M, Kneebone C, Knop K, Koivisto K, Krug R, Kukowski B, Kwiatkowski A, Landefeld H, Lang M, Lange T, Larrieu J, Lassek C, Laureys G, Lechner-Scott J, López L, Lund C, Macdonell R, MacLean G, de Noordhout A, Vioud M, Mainella C, Malessa R, Malkoun I, Mantegazza R, Marchetti P, Mares J, Ozaeta G, Martínez-Yélamos S, Sola M, Masri S, Mauz U, Medaer R, Melin A, Meluzinová E, Menges C, Merienne M, Meuth S, Midgard R, Millefiorini E, Molitor D, Moll J, Morganho A, Moulignier A, Myhr K, Neudert C, Nicholas R, Nifle C, Novotna A, Odeh F, Ondze B, Osei-Bonsu M, Pandolfo M, Peeters K, Peglau I, Ruiz D, Pesci I, Pfeffer O, Amato M, Pilz C, Plummer C, Polzer U, Pouliquen A, Aguilar S, Torrenta L, Ramo C, Rauer S, Redmond I, Rehkopf E, Reifschneider G, Rente J, Retif C, Richter N, Roch K, Roth R, Rottoli M, Ruhnke O, Ruprecht K, Sailer M, Saines N, Montero R, Scarel S, Scarpini E, Schierenbeck J, Schimrigk S, Schlegel E, Schlemilch-Paschen S, Schmidt S, Schmitz F, Scholz P, Schroeter M, Schuetze I, Schüler S, Schwab M, Schyns-Soeterboek A, Seeldrayers P, Seiller N, Sellal F, Seppä J, Shawush M, Siever A, Sinnige L, Skoda O, Smetcoren C, Soares D, Stankiewicz T, Stetkarova I, Stienker-Fisse H, Stolarikova K, Stourac P, Stratmann H, Suárez S, Suceveanu M, Tackenberg B, Thenint J, Tiedge O, Trojano M, Tumani H, Ukkonen M, Urbain E, Uriot M, Ursell M, Vachova M, Valis M, Van Der Walt A, van Munster C, Van Pesch V, Van Steenbergen W, Van Wijmeersch B, Vanderdonckt P, Vanroose E, Verhagen W, Viallet F, Wagner B, Wagner M, Wersching R, Wiehler S, Wildemann B, Willekens B, Willems C, Wilson M, Windsheimer J, Zapletalová O, Ziebold U, Ziegler F. Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP). Journal Of Neurology Neurosurgery & Psychiatry 2020, 91: 660-668. PMID: 32234967, PMCID: PMC7279201, DOI: 10.1136/jnnp-2019-322326.Peer-Reviewed Original ResearchConceptsAnnualised relapse rateMedian follow-up timeFollow-up timeLong-term safetyDiscontinued natalizumabInterim analysisSafety profileSafety profile of natalizumabEffects of natalizumab treatmentRelapsing-remitting multiple sclerosis patientsConsistent with natalizumaTysabri Observational ProgramEffect of natalizumabProgressive multifocal leukoencephalopathyKaplan-Meier methodProspective observational studyMultiple sclerosis patientsNatalizumab treatmentOpen-labelMultifocal leukoencephalopathyDisability worseningRelapse rateMedian timeAdverse eventsNatalizumab
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