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Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres

BACKGROUND: Oral cladribine has been approved for the treatment of relapsing multiple sclerosis (MS) yet real-world evidence regarding its effectiveness and safety remains scarce. OBJECTIVE: To evaluate efficacy and safety outcomes of MS patients following induction of cladribine. METHODS: We evalua...

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Autores principales: Pfeuffer, Steffen, Rolfes, Leoni, Hackert, Jana, Kleinschnitz, Konstanze, Ruck, Tobias, Wiendl, Heinz, Klotz, Luisa, Kleinschnitz, Christoph, Meuth, Sven G, Pul, Refik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8795224/
https://www.ncbi.nlm.nih.gov/pubmed/33975489
http://dx.doi.org/10.1177/13524585211012227
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author Pfeuffer, Steffen
Rolfes, Leoni
Hackert, Jana
Kleinschnitz, Konstanze
Ruck, Tobias
Wiendl, Heinz
Klotz, Luisa
Kleinschnitz, Christoph
Meuth, Sven G
Pul, Refik
author_facet Pfeuffer, Steffen
Rolfes, Leoni
Hackert, Jana
Kleinschnitz, Konstanze
Ruck, Tobias
Wiendl, Heinz
Klotz, Luisa
Kleinschnitz, Christoph
Meuth, Sven G
Pul, Refik
author_sort Pfeuffer, Steffen
collection PubMed
description BACKGROUND: Oral cladribine has been approved for the treatment of relapsing multiple sclerosis (MS) yet real-world evidence regarding its effectiveness and safety remains scarce. OBJECTIVE: To evaluate efficacy and safety outcomes of MS patients following induction of cladribine. METHODS: We evaluated our prospective cohort of cladribine-treated MS patients from two tertiary centres in Germany. Relapses, disability worsening and occurrence of new or enlarging T2-hyperintense magnetic resonance imaging (MRI) lesions were assessed as well as lymphocyte counts and herpes virus infections. RESULTS: Among 270 patients treated with cladribine, we observed a profound reduction of both relapses and new or enlarging MRI lesions. Treatment appeared more efficacious, especially in patients without previous therapy or following platform substances. Patients switching from natalizumab were prone to re-emerging disease activity. Among patients following dimethyl fumarate pre-treatment, severe lymphopenia was common and associated with increased rates of herpes virus manifestations. CONCLUSION: Overall, we observed an efficacy and safety profile of cladribine consistent with data from the phase 3 clinical trial. However, patients switching from natalizumab experienced suboptimal disease control beyond rebound activity following cessation of natalizumab. Furthermore, dimethyl fumarate pre-treatment was associated with a profound risk of developing severe lymphopenia and subsequent herpes virus infections.
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spelling pubmed-87952242022-01-29 Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres Pfeuffer, Steffen Rolfes, Leoni Hackert, Jana Kleinschnitz, Konstanze Ruck, Tobias Wiendl, Heinz Klotz, Luisa Kleinschnitz, Christoph Meuth, Sven G Pul, Refik Mult Scler Original Research Papers BACKGROUND: Oral cladribine has been approved for the treatment of relapsing multiple sclerosis (MS) yet real-world evidence regarding its effectiveness and safety remains scarce. OBJECTIVE: To evaluate efficacy and safety outcomes of MS patients following induction of cladribine. METHODS: We evaluated our prospective cohort of cladribine-treated MS patients from two tertiary centres in Germany. Relapses, disability worsening and occurrence of new or enlarging T2-hyperintense magnetic resonance imaging (MRI) lesions were assessed as well as lymphocyte counts and herpes virus infections. RESULTS: Among 270 patients treated with cladribine, we observed a profound reduction of both relapses and new or enlarging MRI lesions. Treatment appeared more efficacious, especially in patients without previous therapy or following platform substances. Patients switching from natalizumab were prone to re-emerging disease activity. Among patients following dimethyl fumarate pre-treatment, severe lymphopenia was common and associated with increased rates of herpes virus manifestations. CONCLUSION: Overall, we observed an efficacy and safety profile of cladribine consistent with data from the phase 3 clinical trial. However, patients switching from natalizumab experienced suboptimal disease control beyond rebound activity following cessation of natalizumab. Furthermore, dimethyl fumarate pre-treatment was associated with a profound risk of developing severe lymphopenia and subsequent herpes virus infections. SAGE Publications 2021-05-12 2022-02 /pmc/articles/PMC8795224/ /pubmed/33975489 http://dx.doi.org/10.1177/13524585211012227 Text en © The Author(s), 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Original Research Papers
Pfeuffer, Steffen
Rolfes, Leoni
Hackert, Jana
Kleinschnitz, Konstanze
Ruck, Tobias
Wiendl, Heinz
Klotz, Luisa
Kleinschnitz, Christoph
Meuth, Sven G
Pul, Refik
Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title_full Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title_fullStr Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title_full_unstemmed Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title_short Effectiveness and safety of cladribine in MS: Real-world experience from two tertiary centres
title_sort effectiveness and safety of cladribine in ms: real-world experience from two tertiary centres
topic Original Research Papers
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8795224/
https://www.ncbi.nlm.nih.gov/pubmed/33975489
http://dx.doi.org/10.1177/13524585211012227
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