2023
Phase 3 REMODEL I/II Trials: Efficacy, Safety, and Tolerability of Remibrutinib in Patients with Relapsing Multiple Sclerosis
Wiendl H, Airas L, Chitnis T, Williams M, Nakahara J, Bermel R, Loop B, Hayek G, Bhatt A, Hunter B, Zhang Y, Karan R, Willi R, Kieseier B, Montalban X. Phase 3 REMODEL I/II Trials: Efficacy, Safety, and Tolerability of Remibrutinib in Patients with Relapsing Multiple Sclerosis. Multiple Sclerosis And Related Disorders 2023, 80: 105315. DOI: 10.1016/j.msard.2023.105315.Peer-Reviewed Original ResearchBruton's tyrosine kinaseDisease activitySerum neurofilament light chain concentrationNeurofilament light chain concentrationOpen-label extensionKey secondary endpointDisability Status ScaleNew oral treatmentRecent disease activityLight chain concentrationsPercentage of participantsCovalent BTK inhibitorImmune regulatory networkRelated neuroinflammationDisability progressionPrimary endpointSecondary endpointsT1 lesionsTyrosine kinaseOral treatmentRelapse rateT2 lesionsMulticenter studyMultiple sclerosisSafety profile
2020
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, RodrÃguez 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, MartÃnez-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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