Your browser doesn't support javascript.
loading
Use of follow-on disease-modifying treatments for multiple sclerosis: Consensus recommendations.
Brownlee, Wallace J; Wolf, Christian; Hartung, Hans-Peter; Dingermann, Theo; Anshasi, Nadia; Clark, Richard Ac; Trojano, Maria; Selmaj, Krzysztof; Uitdehaag, Bernard Mj; Tur, Carmen; Wuerfel, Jens; Dallmann, Gabriele; Witte, Julian; Sintzel, Martina; Bobrovnikova, Olga; Cohen, Jeffrey A.
Afiliação
  • Brownlee WJ; Queen Square Multiple Sclerosis Centre, National Hospital for Neurology and Neurosurgery, London, UK.
  • Wolf C; Lycalis sprl, Brussels, Belgium.
  • Hartung HP; Department of Neurology, Heinrich Heine University Medical Faculty, Düsseldorf, Germany/Brain and Mind Center, Medical Faculty, The University of Sydney, Sydney, NSW, Australia/Department of Neurology, Medical University of Vienna, Vienna, Austria/Department of Neurology, Palacky University, Olomouc
  • Dingermann T; Institute for Pharmaceutical Biology, Goethe University Frankfurt, Frankfurt, Germany.
  • Anshasi N; European Multiple Sclerosis Platform, Brussels, Belgium.
  • Clark RA; Dr Richard Clark Medical Writing, Dunchurch, UK.
  • Trojano M; Department of Basic Medical Sciences, Neurosciences and Sense Organs, University 'Aldo Moro', Bari, Italy.
  • Selmaj K; Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland/Center of Neurology, Lodz, Poland.
  • Uitdehaag BM; Department of Neurology, Amsterdam Neuroscience, Amsterdam MS Center, Amsterdam UMC, Amsterdam, The Netherlands.
  • Tur C; Multiple Sclerosis Centre of Catalonia (Cemcat), Department of Neurology, Vall d'Hebron University Hospital, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain/Queen Square Multiple Sclerosis Centre, National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.
  • Wuerfel J; Medical Image Analysis Center (MIAC AG) and University of Basel, Basel, Switzerland/Department of Radiology, University Hospital Magdeburg, Magdeburg, Germany.
  • Dallmann G; Biopharma Excellence by PharmaLex, Munich, Germany.
  • Witte J; Vandage GmbH, Bielefeld, Germany.
  • Sintzel M; mcs.medical communication services, Erlenbach, Switzerland.
  • Bobrovnikova O; European Multiple Sclerosis Platform, Brussels, Belgium.
  • Cohen JA; Mellen Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Mult Scler ; 28(14): 2177-2189, 2022 12.
Article em En | MEDLINE | ID: mdl-36000489
BACKGROUND: As patents for multiple sclerosis (MS) therapies expire, follow-on disease-modifying treatments (FO-DMTs) become available at reduced cost. Concerns exist that cheaper FO-DMTs are used simply to reduce healthcare costs. However, the well-being of people with MS should take priority. OBJECTIVES: To identify best practices for FO-DMT development and use by agreeing on principles and consensus statements through appraisal of published evidence. METHODS: Following a systematic review, we formulated five overarching principles and 13 consensus statements. Principles and statements were voted on by a multidisciplinary panel from 17 European countries, Argentina, Canada and the United States. RESULTS: All principles and statements were endorsed by >80% of panellists. In brief, FO-DMTs approved within highly regulated areas can be considered effective and safe as their reference products; FO-DMTs can be evaluated case by case and do not always require Phase III trials; long-term pharmacovigilance and transparency are needed; there is lack of evidence for multiple- and cross-switching among FO-DMTs; and education is needed to address remaining concerns. CONCLUSION: Published data support the use of FO-DMTs in MS. The consensus may aid shared decision-making. While our consensus focused on Europe, the results may contribute to enhanced quality standards for FO-DMTs use elsewhere.
Assuntos
Palavras-chave
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Tipo de estudo: Guideline / Systematic_reviews Limite: Humans País/Região como assunto: America do norte / America do sul / Argentina Idioma: En Revista: Mult Scler Assunto da revista: NEUROLOGIA Ano de publicação: 2022 Tipo de documento: Article País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Esclerose Múltipla Tipo de estudo: Guideline / Systematic_reviews Limite: Humans País/Região como assunto: America do norte / America do sul / Argentina Idioma: En Revista: Mult Scler Assunto da revista: NEUROLOGIA Ano de publicação: 2022 Tipo de documento: Article País de publicação: Reino Unido