Oral pulsed therapy of relapsing multiple sclerosis with cladribine tablets - expert opinion on issues in clinical practice.
Cladribine tablets
expert opinion
relapsing multiple sclerosis
therapeutic management
Journal
Multiple sclerosis and related disorders
ISSN: 2211-0356
Titre abrégé: Mult Scler Relat Disord
Pays: Netherlands
ID NLM: 101580247
Informations de publication
Date de publication:
Sep 2021
Sep 2021
Historique:
received:
07
05
2021
accepted:
01
06
2021
pubmed:
15
7
2021
medline:
6
10
2021
entrez:
14
7
2021
Statut:
ppublish
Résumé
Oral cladribine is the first oral pulsed therapy licensed for relapsing multiple sclerosis (RMS). Three years after the introduction into the European market, we evaluated practical aspects in the use of cladribine tablets, incorporating the experience gained in routine clinical practice and real-world studies. Based on a structured review process, a panel of nine neurologists experienced in MS therapy discussed salient statements regarding the use of cladribine tables. For each statement the level of evidence was determined according to the levels of evidence recommended by the Centre for Evidence-Based Medicine, Oxford. The strength of each expert statement was then evaluated by means of a linear scale from 1 (very strong rejection) to 9 (very strong approval). Votes were collected by a formalized blinded process. Consent was considered to be reached if at least 75% of the experts agreed on a particular statement (i.e. voted for 7-9 points on the linear scale). . Statements include efficacy in early RMS, risk of side effects and infections, vaccination, pregnancy, and monitoring requirements. The consented recommendations summarize the practical experience inthe use of cladribine tablets in a real-world setting. These may provide guidance for unanswered questions arising with the introduction of new treatments such as cladribine tablets.
Sections du résumé
BACKGROUND
BACKGROUND
Oral cladribine is the first oral pulsed therapy licensed for relapsing multiple sclerosis (RMS). Three years after the introduction into the European market, we evaluated practical aspects in the use of cladribine tablets, incorporating the experience gained in routine clinical practice and real-world studies.
METHODS
METHODS
Based on a structured review process, a panel of nine neurologists experienced in MS therapy discussed salient statements regarding the use of cladribine tables. For each statement the level of evidence was determined according to the levels of evidence recommended by the Centre for Evidence-Based Medicine, Oxford. The strength of each expert statement was then evaluated by means of a linear scale from 1 (very strong rejection) to 9 (very strong approval). Votes were collected by a formalized blinded process. Consent was considered to be reached if at least 75% of the experts agreed on a particular statement (i.e. voted for 7-9 points on the linear scale).
RESULTS
RESULTS
. Statements include efficacy in early RMS, risk of side effects and infections, vaccination, pregnancy, and monitoring requirements.
CONCLUSION
CONCLUSIONS
The consented recommendations summarize the practical experience inthe use of cladribine tablets in a real-world setting. These may provide guidance for unanswered questions arising with the introduction of new treatments such as cladribine tablets.
Identifiants
pubmed: 34261026
pii: S2211-0348(21)00342-4
doi: 10.1016/j.msard.2021.103075
pii:
doi:
Substances chimiques
Immunosuppressive Agents
0
Tablets
0
Cladribine
47M74X9YT5
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
103075Informations de copyright
Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.