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DC Field | Value | Language |
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dc.contributor.author | Oreja-Guevara, Celia | - |
dc.contributor.author | Brownlee, Wallace | - |
dc.contributor.author | Celius, Elisabeth G. | - |
dc.contributor.author | Centonze, Diego | - |
dc.contributor.author | Giovannoni, Gavin | - |
dc.contributor.author | Hodgkinson, Suzanne | - |
dc.contributor.author | Kleinschnitz, Christoph | - |
dc.contributor.author | Kubala Havrdova, Eva | - |
dc.contributor.author | Magyari, Melinda | - |
dc.contributor.author | Selchen, Daniel | - |
dc.contributor.author | Vermersch, Patrick | - |
dc.contributor.author | Wiendl, Heinz | - |
dc.contributor.author | VAN WIJMEERSCH, Bart | - |
dc.contributor.author | Salloukh, Hashem | - |
dc.contributor.author | Yamout, Bassem | - |
dc.date.accessioned | 2023-02-15T10:29:02Z | - |
dc.date.available | 2023-02-15T10:29:02Z | - |
dc.date.issued | 2023 | - |
dc.date.submitted | 2023-02-13T13:34:22Z | - |
dc.identifier.citation | Multiple Sclerosis and Related Disorders, 69 (Art N° 104459) | - |
dc.identifier.uri | http://hdl.handle.net/1942/39441 | - |
dc.description.abstract | Background: Treatment with cladribine tablets (CladT), an immune reconstitution therapy for relapsing multiple sclerosis (RMS), involves two short courses of treatment in Year 1 and Year 2. Most patients achieve sustained efficacy with CladT, but a small proportion may experience new disease activity (DA). Following completion of the indicated dose, physicians may have questions relating to the long-term management of these patients. Since the EU approval of CladT over 5 years ago, real-world evidence (RWE) is increasing and may provide some insights and guidance for clinical practice. We describe a systematic literature review (SLR) of RWE and provide expert opinions relating to six questions regarding the long-term use of CladT.Methods: Pertinent clinical questions were developed by a steering committee (SC) of 14 international multiple sclerosis (MS) experts regarding breakthrough DA in Year 1, new DA after 2 years or more of treatment, long-term management of stable patients, and whether additional courses of CladT may be required or safe. An SLR was performed in EMBASE and PubMed using the population, intervention, comparators, outcomes, study design (PICOS) framework to identify relevant studies within the last 15 years. Searches of key congress pro-ceedings for the last 2-3 years were also performed. Following review of the results and RWE, the SC drafted and agreed on expert opinion statements for each question. Results: A total of 35 publications reporting RWE for CladT were included in this review. In the real world, breakthrough DA in Year 1 is of low incidence (1.1-21.9%) but can occur, particularly in patients switching from anti-lymphocyte trafficking agents. In most patients, this DA did not lead to treatment discontinuation. Reported rates of DA after the full therapeutic effect of CladT has been achieved (end of Year 2, 3 or 4) range from 12.0 to 18.7% in the few studies identified. No RWE was identified to support management decisions for stable patients in Year 5 or later. Views among the group were also diverse on this question and voting on expert opinion statements was required. Only two studies reported the administration of additional courses of CladT, but detailed safety outcomes were not provided. Conclusions: RWE for the long-term use of CladT in the treatment of RMS is increasing, however, gaps in knowledge remain. Where possible, the RWE identified through the SLR informed expert statements, but, where RWE is still lacking, these were based solely on experiences and opinion, providing some guidance on topics and questions that occur in daily clinical practice. More real-world studies with longer-term follow-up periods are needed and highly anticipated. | - |
dc.description.sponsorship | Medical writing assistance was provided by Emma East, Bedrock Healthcare, UK, and supported by Merck Healthcare KGaA, Darmstadt, Germany. Assistance with the systematic literature review was provided by AccuScript and supported by Merck Healthcare KGaA, Darmstadt, Germany. | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCI LTD | - |
dc.rights | 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). | - |
dc.subject.other | Relapsing multiple sclerosis | - |
dc.subject.other | Cladribine tablets | - |
dc.subject.other | Disease-modifying therapy | - |
dc.subject.other | Expert opinion | - |
dc.subject.other | Systematic literature review | - |
dc.subject.other | Real-world evidence | - |
dc.title | Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence | - |
dc.type | Journal Contribution | - |
dc.identifier.volume | 69 | - |
local.bibliographicCitation.jcat | A1 | - |
dc.description.notes | Yamout, B (corresponding author), Harley St Med Ctr, Neurol Inst, Abu Dhabi, U Arab Emirates. | - |
dc.description.notes | yamoutba@gmail.com | - |
local.publisher.place | THE BOULEVARD, LANGFORD LANE, KIDLINGTON, OXFORD OX5 1GB, OXON, ENGLAND | - |
local.type.refereed | Refereed | - |
local.type.specified | Review | - |
local.bibliographicCitation.artnr | 104459 | - |
dc.identifier.doi | 10.1016/j.msard.2022.104459 | - |
dc.identifier.pmid | 36565573 | - |
dc.identifier.isi | 000911451200001 | - |
local.provider.type | wosris | - |
local.description.affiliation | [Oreja-Guevara, Celia] Hosp Clin San Carlos, IdISSC, Neurol, Madrid, Spain. | - |
local.description.affiliation | [Oreja-Guevara, Celia] Univ Complutense Madrid, Fac Med, Dept Med, Madrid, Spain. | - |
local.description.affiliation | [Brownlee, Wallace] Natl Hosp Neurol & Neurosurg, Queen Sq MS Ctr, London, England. | - |
local.description.affiliation | [Celius, Elisabeth G.] Oslo Univ Hosp, Dept Neurol, Oslo, Norway. | - |
local.description.affiliation | [Celius, Elisabeth G.] Univ Oslo, Inst Clin Med, Oslo, Norway. | - |
local.description.affiliation | [Centonze, Diego] Tor Vergata Univ, Dept Syst Med, Rome, Italy. | - |
local.description.affiliation | [Centonze, Diego] IRCCS Neuromed, Unit Neurol, Pozzilli, IS, Italy. | - |
local.description.affiliation | [Giovannoni, Gavin] Queen Mary Univ London, Barts & London Sch Med & Dent, Blizard Inst, London, England. | - |
local.description.affiliation | [Hodgkinson, Suzanne] UNSW Sydney, Dept Neurol, Liverpool Hosp, Sydney, NSW, Australia. | - |
local.description.affiliation | [Kleinschnitz, Christoph] Univ Hosp Essen, Dept Neurol, Essen, Germany. | - |
local.description.affiliation | [Kleinschnitz, Christoph] Univ Hosp Essen, Ctr Translat & Behav Neurosci C TNBS, Essen, Germany. | - |
local.description.affiliation | [Kubala Havrdova, Eva] Charles Univ Prague, Fac Med 1, Dept Neurol, Prague, Czech Republic. | - |
local.description.affiliation | [Kubala Havrdova, Eva] Charles Univ Prague, Fac Med 1, Ctr Clin Neurosci, Prague, Czech Republic. | - |
local.description.affiliation | [Kubala Havrdova, Eva] Gen Univ Hosp, Prague, Czech Republic. | - |
local.description.affiliation | [Magyari, Melinda] Copenhagen Univ Hosp, Rigshosp, Danish Multiple Sclerosis Ctr, Dept Neurol, Copenhagen, Denmark. | - |
local.description.affiliation | [Selchen, Daniel] Univ Toronto, Div Neurol, St Michaels Hosp, Toronto, ON, Canada. | - |
local.description.affiliation | [Vermersch, Patrick] Univ Lille, FHU Precise, CHU Lille, Inserm U1172, Lille, France. | - |
local.description.affiliation | [Wiendl, Heinz] Univ Munster, Inst Translat Neurol, Dept Neurol, Munster, Germany. | - |
local.description.affiliation | [Van Wijmeersch, Bart] Hasselt Univ, Univ MS Ctr, Hasselt Pelt, Belgium. | - |
local.description.affiliation | [Salloukh, Hashem] Ares Trading SA, Merck KGaA, Eysins, Switzerland. | - |
local.description.affiliation | [Yamout, Bassem] Harley St Med Ctr, Neurol Inst, Abu Dhabi, U Arab Emirates. | - |
local.description.affiliation | [Yamout, Bassem] Amer Univ Beirut, Beirut, Lebanon. | - |
local.uhasselt.international | yes | - |
item.fullcitation | Oreja-Guevara, Celia; Brownlee, Wallace; Celius, Elisabeth G.; Centonze, Diego; Giovannoni, Gavin; Hodgkinson, Suzanne; Kleinschnitz, Christoph; Kubala Havrdova, Eva; Magyari, Melinda; Selchen, Daniel; Vermersch, Patrick; Wiendl, Heinz; VAN WIJMEERSCH, Bart; Salloukh, Hashem & Yamout, Bassem (2023) Expert opinion on the long-term use of cladribine tablets for multiple sclerosis: Systematic literature review of real-world evidence. In: Multiple Sclerosis and Related Disorders, 69 (Art N° 104459). | - |
item.contributor | Oreja-Guevara, Celia | - |
item.contributor | Brownlee, Wallace | - |
item.contributor | Celius, Elisabeth G. | - |
item.contributor | Centonze, Diego | - |
item.contributor | Giovannoni, Gavin | - |
item.contributor | Hodgkinson, Suzanne | - |
item.contributor | Kleinschnitz, Christoph | - |
item.contributor | Kubala Havrdova, Eva | - |
item.contributor | Magyari, Melinda | - |
item.contributor | Selchen, Daniel | - |
item.contributor | Vermersch, Patrick | - |
item.contributor | Wiendl, Heinz | - |
item.contributor | VAN WIJMEERSCH, Bart | - |
item.contributor | Salloukh, Hashem | - |
item.contributor | Yamout, Bassem | - |
item.accessRights | Open Access | - |
item.fulltext | With Fulltext | - |
crisitem.journal.issn | 2211-0348 | - |
crisitem.journal.eissn | 2211-0356 | - |
Appears in Collections: | Research publications |
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