2024
156. Safety of Remibrutinib across Immune-mediated Diseases Supports Development in Multiple Sclerosis
Kieseier B, Montalban X, Williams M, Airas L, Saini S, Hide M, Sussman G, Nakahara J, Bermel R, Dörner T, Loop B, DeLasHeras V, Willi R, Haemmerle S, Zharkov A, Barbier N, Azmon A, Siegel R, Cenni B, Haddad I, Wiendl H, Maurer M, Giménez-Arnau A, Chitnis T. 156. Safety of Remibrutinib across Immune-mediated Diseases Supports Development in Multiple Sclerosis. Multiple Sclerosis And Related Disorders 2024, 92: 106117. DOI: 10.1016/j.msard.2024.106117.Peer-Reviewed Original ResearchAdverse eventsSafety profileOral Bruton's tyrosine kinase inhibitorTreatment of relapsing multiple sclerosisBruton tyrosine kinase inhibitorSkin/subcutaneous tissue disordersUpper respiratory tract infectionMultiple sclerosisTyrosine kinase inhibitorsPhase 3 trialRespiratory tract infectionsGrouped adverse eventsIntegrated safety analysisNervous system disordersTreatment discontinuationTract infectionsRemibrutinibTissue disordersKinase inhibitorsSystem disordersOff-target effectsGastrointestinal disordersDoseInfectionPooled data
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, BarthomolĂ© 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, RodrĂguez 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, GĂĽnther 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, LĂłpez 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, MartĂnez-YĂ©lamos 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, SchĂĽler 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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