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 dataA review of Bruton’s tyrosine kinase inhibitors in multiple sclerosis
Airas L, Bermel R, Chitnis T, Hartung H, Nakahara J, Stuve O, Williams M, Kieseier B, Wiendl H. A review of Bruton’s tyrosine kinase inhibitors in multiple sclerosis. Therapeutic Advances In Neurological Disorders 2024, 17: 17562864241233041. PMID: 38638671, PMCID: PMC11025433, DOI: 10.1177/17562864241233041.Peer-Reviewed Original ResearchBruton tyrosine kinase inhibitorChronic spontaneous urticariaFirst-generation BTK inhibitorSystemic lupus erythematosusBruton's tyrosine kinaseTyrosine kinase inhibitorsMS disease-modifying treatmentsBTK inhibitorsDisease-modifying treatmentsSafety profileB cellsMultiple sclerosisChronic useRheumatoid arthritisSecond-generation BTK inhibitorsB cell depletion therapyTreatment of B-cell malignanciesB-cell modulationDiverse autoimmune conditionsPhase II trialGadolinium-enhancing lesionsB-cell malignanciesMagnetic resonance imaging scansLong-term administrationFemale reproductive health
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 profileRemibrutinib: A Novel BTKi in Development for MS With a Favorable Safety Profile in Various Autoimmune Disorders (P7-3.015)
Williams M, Airas L, Chitnis T, Saini S, Hide M, Sussman G, Nakahara J, Bermel R, Dörner T, Loop B, Ziehn M, Willi R, Kieseier B, Nikolaev I, Haemmerle S, Zharkov A, Siegel R, Cenni B, Wiendl H, Maurer M, Giménez-Arnau A, Montalban X. Remibrutinib: A Novel BTKi in Development for MS With a Favorable Safety Profile in Various Autoimmune Disorders (P7-3.015). Neurology 2023, 100 DOI: 10.1212/wnl.0000000000202933.Peer-Reviewed Original Research
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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