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Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis: CLARIFY-MS study 6-month interim analysis

dc.rights.licenseopenen_US
hal.structure.identifierNeurocentre Magendie : Physiopathologie de la Plasticité Neuronale [U1215 Inserm - UB]
dc.contributor.authorBROCHET, Bruno
hal.structure.identifierMaastricht University Medical Centre [MUMC]
dc.contributor.authorHUPPERTS, Raymond
hal.structure.identifierRoyal Holloway [University of London] [RHUL]
dc.contributor.authorLANGDON, Dawn
hal.structure.identifierFondazione IRCCS Istituto Neurologico "Carlo Besta"
dc.contributor.authorSOLARI, Alessandra
hal.structure.identifierKarolinska Institutet [Stockholm]
dc.contributor.authorPIEHL, Fredrik
hal.structure.identifierUniversity of Newcastle [Callaghan, Australia] [UoN]
dc.contributor.authorLECHNER-SCOTT, Jeannette
hal.structure.identifierVall d'Hebron University Hospital [Barcelona]
hal.structure.identifierCentre d'Esclerosi Múltiple de Catalunya [CemCat]
dc.contributor.authorMONTALBAN, Xavier
hal.structure.identifierDepartment of Neurology and Stroke, Medical University of Lodz
dc.contributor.authorSELMAJ, Krzysztof
hal.structure.identifierFirst Faculty of Medicine Charles University
dc.contributor.authorVALIS, Martin
hal.structure.identifierMedical University of Lublin
dc.contributor.authorREJDAK, Konrad
dc.contributor.authorHAVRDOVA, Eva K.
hal.structure.identifierUniversità degli studi di Catania = University of Catania [Unict]
dc.contributor.authorPATTI, Francesco
hal.structure.identifierMerck KGaA [Darmstadt, Germany]
dc.contributor.authorALEXANDRI, Nektaria
hal.structure.identifierMerck KGaA [Darmstadt, Germany]
dc.contributor.authorNOLTING, Axel
hal.structure.identifierMerck KGaA [Darmstadt, Germany]
dc.contributor.authorKELLER, Birgit
dc.date.accessioned2023-01-09T13:51:26Z
dc.date.available2023-01-09T13:51:26Z
dc.date.issued2022-01
dc.identifier.issn2211-0348en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/171622
dc.description.abstractEnBackground Multiple sclerosis (MS) is a chronic disabling disease that is associated with negative effects on health-related quality of life (HRQoL) due to reduced physical and psychosocial functioning. Cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years) have been approved for the treatment of adult patients with highly active relapsing multiple sclerosis (RMS). The ongoing CLARIFY-MS study (NCT03369665; EudraCT number: 2017-002632-17) aims to assess the effect of cladribine tablets 3.5 mg/kg on HRQoL of patients with highly active RMS. Objective To report on the design of the CLARIFY-MS study, baseline patient characteristics, and results of a pre-planned interim analysis focusing on treatment satisfaction, safety, and tolerability that includes all data reported till 6 months after start of treatment. Methods The CLARIFY-MS study is a 2-year, open-label, single-arm, prospective, multicenter, phase IV study. Eligible patients with highly active RMS were assigned to receive cladribine tablets 3.5 mg/kg over 2 years. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM, v1.4; scale range from 0 to 100, higher values indicating higher satisfaction). Safety assessments, including occurrence of treatment-emergent adverse events (TEAEs; any adverse event reported after drug administration), serious adverse events (SAEs), and lymphocyte counts, were summarized descriptively. Results A total of 482 patients from 85 sites in Europe were treated with cladribine tablets. Mean patient age was 37.4 years, 338 (70.1%) were women, median EDSS was 2.5, and 345 (71.6%) were prior users of disease-modifying therapy (DMT). During the first 6 months after the start of treatment, and before reaching the full dose of cladribine tablets, mean TSQM global satisfaction score for the overall population was 70.4 (standard deviation, ± 18.48). The side effects score was 91.9 (± 17.68), convenience scored 86.6 (± 13.57), and effectiveness was 65.8 (± 21.14). A total of 275 patients (57.1%) reported at least one TEAE and 9 patients (1.9%) had a SAE. The majority of observed lymphopenia cases were of grade 1 or 2; 33 (6.8%) of the total study cohort had grade 3 lymphopenia, and no grade 4 lymphopenia was reported. Conclusion Patients reported high treatment satisfaction (TSQM) with cladribine tablets in this pre-planned interim analysis at 6 months. Few serious, and no unexpected, adverse events were reported, and there were no instances of grade 4 lymphopenia over the first 6 months. These preliminary data indicate good tolerability and convenience of administration of cladribine tablets in patients with highly active RMS. © 2021 The Author(s)
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.subject.enCladribine tablets
dc.subject.enTreatment satisfaction
dc.subject.enRelapsing multiple sclerosis
dc.title.enTreatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis: CLARIFY-MS study 6-month interim analysis
dc.title.alternativeMult Scler Relat Disorden_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.msard.2021.103385en_US
dc.subject.halSciences du Vivant [q-bio]/Neurosciences [q-bio.NC]en_US
dc.identifier.pubmed35158476en_US
bordeaux.journalMultiple Sclerosis and Related Disordersen_US
bordeaux.page103385en_US
bordeaux.volume57en_US
bordeaux.hal.laboratoriesNeurocentre Magendie - U1215en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamRelations glie-neuroneen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDMerck KGaAen_US
hal.identifierhal-03930938
hal.version1
hal.date.transferred2023-01-09T13:51:36Z
hal.exporttrue
dc.rights.ccCC BYen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Multiple%20Sclerosis%20and%20Related%20Disorders&rft.date=2022-01&rft.volume=57&rft.spage=103385&rft.epage=103385&rft.eissn=2211-0348&rft.issn=2211-0348&rft.au=BROCHET,%20Bruno&HUPPERTS,%20Raymond&LANGDON,%20Dawn&SOLARI,%20Alessandra&PIEHL,%20Fredrik&rft.genre=article


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