Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis

Background 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 trea...

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Autores: Brochet, Bruno, Hupperts, Raymond, Langdon, Dawn, Solari, Alessandra|||0000-0001-9930-7579, Piehl, Fredrik|||0000-0001-8329-5219, Lechner-Scott, Jeannette, Montalban, Xavier|||0000-0002-0098-9918, Selmaj, Krzysztof, Valis, Martin, Rejdak, Konrad, Havrdova, Eva K., Patti, Francesco|||0000-0002-6923-0846, Alexandri, Nektaria, Nolting, Axel, Keller, Birgit|||0000-0001-6870-8003
Tipo de documento: artigo
Data de publicação:2022
País:España
Recursos:Universitat Autònoma de Barcelona
Repositório:Dipòsit Digital de Documents de la UAB
Idioma:inglês
OAI Identifier:oai:ddd.uab.cat:275757
Acesso em linha:https://ddd.uab.cat/record/275757
https://dx.doi.org/urn:doi:10.1016/j.msard.2021.103385
Access Level:Acceso aberto
Palavra-chave:Cladribine tablets
Relapsing multiple sclerosis
Treatment satisfaction
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oai_identifier_str oai:ddd.uab.cat:275757
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repository_id_str
dc.title.none.fl_str_mv Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
CLARIFY-MS study 6-month interim analysis
title Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
spellingShingle Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
Brochet, Bruno
Cladribine tablets
Relapsing multiple sclerosis
Treatment satisfaction
title_short Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
title_full Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
title_fullStr Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
title_full_unstemmed Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
title_sort Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosis
dc.creator.none.fl_str_mv Brochet, Bruno
Hupperts, Raymond
Langdon, Dawn
Solari, Alessandra|||0000-0001-9930-7579
Piehl, Fredrik|||0000-0001-8329-5219
Lechner-Scott, Jeannette
Montalban, Xavier|||0000-0002-0098-9918
Selmaj, Krzysztof
Valis, Martin
Rejdak, Konrad
Havrdova, Eva K.
Patti, Francesco|||0000-0002-6923-0846
Alexandri, Nektaria
Nolting, Axel
Keller, Birgit|||0000-0001-6870-8003
author Brochet, Bruno
author_facet Brochet, Bruno
Hupperts, Raymond
Langdon, Dawn
Solari, Alessandra|||0000-0001-9930-7579
Piehl, Fredrik|||0000-0001-8329-5219
Lechner-Scott, Jeannette
Montalban, Xavier|||0000-0002-0098-9918
Selmaj, Krzysztof
Valis, Martin
Rejdak, Konrad
Havrdova, Eva K.
Patti, Francesco|||0000-0002-6923-0846
Alexandri, Nektaria
Nolting, Axel
Keller, Birgit|||0000-0001-6870-8003
author_role author
author2 Hupperts, Raymond
Langdon, Dawn
Solari, Alessandra|||0000-0001-9930-7579
Piehl, Fredrik|||0000-0001-8329-5219
Lechner-Scott, Jeannette
Montalban, Xavier|||0000-0002-0098-9918
Selmaj, Krzysztof
Valis, Martin
Rejdak, Konrad
Havrdova, Eva K.
Patti, Francesco|||0000-0002-6923-0846
Alexandri, Nektaria
Nolting, Axel
Keller, Birgit|||0000-0001-6870-8003
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona. Departament de Medicina
dc.subject.none.fl_str_mv Cladribine tablets
Relapsing multiple sclerosis
Treatment satisfaction
topic Cladribine tablets
Relapsing multiple sclerosis
Treatment satisfaction
description Background 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.
publishDate 2022
dc.date.none.fl_str_mv 2
2022-01-01
2022
2022-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/275757
https://dx.doi.org/urn:doi:10.1016/j.msard.2021.103385
url https://ddd.uab.cat/record/275757
https://dx.doi.org/urn:doi:10.1016/j.msard.2021.103385
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
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eu_rights_str_mv openAccess
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dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
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spelling Treatment satisfaction, safety, and tolerability of cladribine tablets in patients with highly active relapsing multiple sclerosisCLARIFY-MS study 6-month interim analysisBrochet, BrunoHupperts, RaymondLangdon, DawnSolari, Alessandra|||0000-0001-9930-7579Piehl, Fredrik|||0000-0001-8329-5219Lechner-Scott, JeannetteMontalban, Xavier|||0000-0002-0098-9918Selmaj, KrzysztofValis, MartinRejdak, KonradHavrdova, Eva K.Patti, Francesco|||0000-0002-6923-0846Alexandri, NektariaNolting, AxelKeller, Birgit|||0000-0001-6870-8003Cladribine tabletsRelapsing multiple sclerosisTreatment satisfactionBackground 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.Universitat Autònoma de Barcelona. Departament de Medicina 22022-01-0120222022-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/275757https://dx.doi.org/urn:doi:10.1016/j.msard.2021.103385reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2757572026-06-06T12:50:31Z
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