Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFMG |
Texto Completo: | https://doi.org/10.1371/journal.pone.0238476 http://hdl.handle.net/1843/56588 https://orcid.org/0000-0002-9054-4794 https://orcid.org/0000-0003-2769-4615 https://orcid.org/0000-0001-6185-2686 https://orcid.org/0000-0003-0473-264X https://orcid.org/0000-0002-0210-0721 https://orcid.org/0000-0002-5880-5261 https://orcid.org/0000-0003-0890-594X https://orcid.org/0000-0001-5256-0577 |
Resumo: | Background Relapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS). Methods and findings We conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan–Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.08; P = 0,01), those with comorbidities at baseline (HR = 1.20; P<0,0001), in patients who developed comorbidities after starting treatment (i.e., rheumatoid arthritis—HR = 1.65; P<0,0001), those exclusive SUS patients (HR = 1.31; P<0,0001) and among patients using intramuscular interferon beta (IM βINF-1a) (28% to 60% compared to the other three treatments; P<0,0001). Lower risk of treatment failure was found among patients treated with glatiramer. Conclusions This retrospective cohort suggests that glatiramer is associated with greater effectiveness compared to the three presentations of interferon beta. When evaluating beta interferons, the results suggest that the intramuscular presentation is not effective in the treatment of multiple sclerosis. |
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2023-07-18T16:48:48Z2023-07-18T16:48:48Z2020159116https://doi.org/10.1371/journal.pone.02384761932-6203http://hdl.handle.net/1843/56588https://orcid.org/0000-0002-9054-4794https://orcid.org/0000-0003-2769-4615https://orcid.org/0000-0001-6185-2686https://orcid.org/0000-0003-0473-264Xhttps://orcid.org/0000-0002-0210-0721https://orcid.org/0000-0002-0210-0721https://orcid.org/0000-0002-5880-5261https://orcid.org/0000-0003-0890-594Xhttps://orcid.org/0000-0001-5256-0577Background Relapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS). Methods and findings We conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan–Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.08; P = 0,01), those with comorbidities at baseline (HR = 1.20; P<0,0001), in patients who developed comorbidities after starting treatment (i.e., rheumatoid arthritis—HR = 1.65; P<0,0001), those exclusive SUS patients (HR = 1.31; P<0,0001) and among patients using intramuscular interferon beta (IM βINF-1a) (28% to 60% compared to the other three treatments; P<0,0001). Lower risk of treatment failure was found among patients treated with glatiramer. Conclusions This retrospective cohort suggests that glatiramer is associated with greater effectiveness compared to the three presentations of interferon beta. When evaluating beta interferons, the results suggest that the intramuscular presentation is not effective in the treatment of multiple sclerosis.porUniversidade Federal de Minas GeraisUFMGBrasilFAR - DEPARTAMENTO DE FARMÁCIA SOCIALPLOS ONESaúde ColetivaEficáciaEsclerose multiplaEffectivenessMultiple sclerosisNon-concurrent cohortEffectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0238476Kathiaja Miranda SouzaIsabela Maia DinizLívia Lovato Pires de LemosNélio Gomes Ribeiro JuniorIsabella de Figueiredo ZuppoJuliana Alvares TeodoroFrancisco de Assis AcurcioÁlvaro Nagib AtallahAugusto Afonso Guerra Júniorinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da UFMGinstname:Universidade Federal de Minas Gerais (UFMG)instacron:UFMGLICENSELicense.txtLicense.txttext/plain; charset=utf-82042https://repositorio.ufmg.br/bitstream/1843/56588/1/License.txtfa505098d172de0bc8864fc1287ffe22MD51ORIGINALEffectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil A 16-year non-concurrent cohort study.pdfEffectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil A 16-year non-concurrent cohort study.pdfapplication/pdf33256989https://repositorio.ufmg.br/bitstream/1843/56588/2/Effectiveness%20of%20first-line%20treatment%20for%20relapsing-remitting%20multiple%20sclerosis%20in%20Brazil%20A%2016-year%20non-concurrent%20cohort%20study.pdfad532952b1a838eb9a01b4ec8b2b9dfeMD521843/565882023-07-18 13:48:48.599oai:repositorio.ufmg.br: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Repositório de PublicaçõesPUBhttps://repositorio.ufmg.br/oaiopendoar:2023-07-18T16:48:48Repositório Institucional da UFMG - Universidade Federal de Minas Gerais (UFMG)false |
dc.title.pt_BR.fl_str_mv |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
title |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
spellingShingle |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study Kathiaja Miranda Souza Effectiveness Multiple sclerosis Non-concurrent cohort Saúde Coletiva Eficácia Esclerose multipla |
title_short |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
title_full |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
title_fullStr |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
title_full_unstemmed |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
title_sort |
Effectiveness of first-line treatment for relapsing-remitting multiple sclerosis in Brazil: a 16-year non-concurrent cohort study |
author |
Kathiaja Miranda Souza |
author_facet |
Kathiaja Miranda Souza Isabela Maia Diniz Lívia Lovato Pires de Lemos Nélio Gomes Ribeiro Junior Isabella de Figueiredo Zuppo Juliana Alvares Teodoro Francisco de Assis Acurcio Álvaro Nagib Atallah Augusto Afonso Guerra Júnior |
author_role |
author |
author2 |
Isabela Maia Diniz Lívia Lovato Pires de Lemos Nélio Gomes Ribeiro Junior Isabella de Figueiredo Zuppo Juliana Alvares Teodoro Francisco de Assis Acurcio Álvaro Nagib Atallah Augusto Afonso Guerra Júnior |
author2_role |
author author author author author author author author |
dc.contributor.author.fl_str_mv |
Kathiaja Miranda Souza Isabela Maia Diniz Lívia Lovato Pires de Lemos Nélio Gomes Ribeiro Junior Isabella de Figueiredo Zuppo Juliana Alvares Teodoro Francisco de Assis Acurcio Álvaro Nagib Atallah Augusto Afonso Guerra Júnior |
dc.subject.por.fl_str_mv |
Effectiveness Multiple sclerosis Non-concurrent cohort |
topic |
Effectiveness Multiple sclerosis Non-concurrent cohort Saúde Coletiva Eficácia Esclerose multipla |
dc.subject.other.pt_BR.fl_str_mv |
Saúde Coletiva Eficácia Esclerose multipla |
description |
Background Relapsing-remitting multiple sclerosis (RRMM) is a chronic, progressive, inflammatory and immune-mediated disease that affects the central nervous system and is characterized by episodes of neurological dysfunction followed by a period of remission. The pharmacological strategy aims to delay the progression of the disease and prevent relapse. Interferon beta and glatiramer are commonly used in the Brazilian public health system and are available to patients who meet the guideline criteria. The scenario of multiple treatments available and in development brings the need for discussion and evaluation of the technologies already available before the incorporation of new drugs. This study analyses the effectiveness of first-line treatment of RRMS measured by real-world evidence data, from the Brazilian National Health System (SUS). Methods and findings We conducted a non-concurrent national cohort between 2000 and 2015. The study population consisted of 22,722 patients with RRMS using one of the following first-line drugs of interest: glatiramer or one of three presentations of interferon beta. Kaplan–Meier analysis was used to estimate the time to treatment failure. A univariate and multivariate Cox proportional hazard model was used to evaluate factors associated with treatment failure. In addition, patients were propensity score-matched (1:1) in six groups of comparative first-line treatments to evaluate the effectiveness among them. The analysis indicated a higher risk of treatment failure in female patients (HR = 1.08; P = 0,01), those with comorbidities at baseline (HR = 1.20; P<0,0001), in patients who developed comorbidities after starting treatment (i.e., rheumatoid arthritis—HR = 1.65; P<0,0001), those exclusive SUS patients (HR = 1.31; P<0,0001) and among patients using intramuscular interferon beta (IM βINF-1a) (28% to 60% compared to the other three treatments; P<0,0001). Lower risk of treatment failure was found among patients treated with glatiramer. Conclusions This retrospective cohort suggests that glatiramer is associated with greater effectiveness compared to the three presentations of interferon beta. When evaluating beta interferons, the results suggest that the intramuscular presentation is not effective in the treatment of multiple sclerosis. |
publishDate |
2020 |
dc.date.issued.fl_str_mv |
2020 |
dc.date.accessioned.fl_str_mv |
2023-07-18T16:48:48Z |
dc.date.available.fl_str_mv |
2023-07-18T16:48:48Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/1843/56588 |
dc.identifier.doi.pt_BR.fl_str_mv |
https://doi.org/10.1371/journal.pone.0238476 |
dc.identifier.issn.pt_BR.fl_str_mv |
1932-6203 |
dc.identifier.orcid.pt_BR.fl_str_mv |
https://orcid.org/0000-0002-9054-4794 https://orcid.org/0000-0003-2769-4615 https://orcid.org/0000-0001-6185-2686 https://orcid.org/0000-0003-0473-264X https://orcid.org/0000-0002-0210-0721 https://orcid.org/0000-0002-0210-0721 https://orcid.org/0000-0002-5880-5261 https://orcid.org/0000-0003-0890-594X https://orcid.org/0000-0001-5256-0577 |
url |
https://doi.org/10.1371/journal.pone.0238476 http://hdl.handle.net/1843/56588 https://orcid.org/0000-0002-9054-4794 https://orcid.org/0000-0003-2769-4615 https://orcid.org/0000-0001-6185-2686 https://orcid.org/0000-0003-0473-264X https://orcid.org/0000-0002-0210-0721 https://orcid.org/0000-0002-5880-5261 https://orcid.org/0000-0003-0890-594X https://orcid.org/0000-0001-5256-0577 |
identifier_str_mv |
1932-6203 |
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PLOS ONE |
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openAccess |
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Universidade Federal de Minas Gerais |
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UFMG |
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Brasil |
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FAR - DEPARTAMENTO DE FARMÁCIA SOCIAL |
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Universidade Federal de Minas Gerais |
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