Identifying Cladribine prescription pattern in MS: an Italian multicentre study

Background: Characterizing Cladribine tablets prescription pattern in daily clinical practice is crucial for optimizing multiple sclerosis (MS) treatment. Objectives: To describe efficacy, safety profile and new disease-modifying therapy (DMT) prescriptions following Cladribine treatment. Design: In...

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Main Authors: Aurora Zanghì, Roberta Fantozzi, Matteo Foschi, Elisabetta Signoriello, Matilde Inglese, Giacomo Lus, Diego Centonze, Andrea Surcinelli, Tommaso Sirito, Simona Bonavita, Carlo Avolio, Emanuele D’Amico
Format: Article
Language:English
Published: SAGE Publishing 2025-01-01
Series:Therapeutic Advances in Neurological Disorders
Online Access:https://doi.org/10.1177/17562864241304212
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author Aurora Zanghì
Roberta Fantozzi
Matteo Foschi
Elisabetta Signoriello
Matilde Inglese
Giacomo Lus
Diego Centonze
Andrea Surcinelli
Tommaso Sirito
Simona Bonavita
Carlo Avolio
Emanuele D’Amico
author_facet Aurora Zanghì
Roberta Fantozzi
Matteo Foschi
Elisabetta Signoriello
Matilde Inglese
Giacomo Lus
Diego Centonze
Andrea Surcinelli
Tommaso Sirito
Simona Bonavita
Carlo Avolio
Emanuele D’Amico
author_sort Aurora Zanghì
collection DOAJ
description Background: Characterizing Cladribine tablets prescription pattern in daily clinical practice is crucial for optimizing multiple sclerosis (MS) treatment. Objectives: To describe efficacy, safety profile and new disease-modifying therapy (DMT) prescriptions following Cladribine treatment. Design: Independent retrospective cohort study in patients followed at six Italian MS centres. Methods: Patients diagnosed with relapsing MS (RMS) according to 2017 McDonald criteria, who initiated Cladribine between January 2019 and May 2023, were included. A generalized linear regression model was built for the outcome DMT after Cladribine course. Heatmaps were generated based on weighted pivot tables to visualize the proportion of patients requiring DMT post-Cladribine. Results: A total cohort of 352 patients was enrolled, 134 naïve to any DMT, 218 switchers from other DMTs. The last DMT was an injectable first-line DMT for 48 (22%) patients, oral first-line DMT for 141 (64.7%) patients, SP1 inhibitor-Fingolimod for 23 (10.6%) patients, and Natalizumab for 6 (2.7%) patients. Overall, Cladribine was efficacious and well tolerated, 12% of patients required a new DMT prescription after a median time of 24 months. The regression model revealed that patients aged >40 years at Cladribine prescription had a 16% decrease in likelihood of receiving a new DMT. Heatmaps showed patients previously on Fingolimod had a lower rate (72.2%) of being free from therapy after Cladribine. Conclusion: In our multicentric real-world Italian study, Cladribine therapy is generally effective during the investigated follow-up period. Understanding key characteristics of patients responding best to Cladribine can help tailor therapeutic strategies for optimal outcomes.
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spelling doaj-art-6fb6c93899ff412dbe6e285819d828432025-01-08T15:03:28ZengSAGE PublishingTherapeutic Advances in Neurological Disorders1756-28642025-01-011810.1177/17562864241304212Identifying Cladribine prescription pattern in MS: an Italian multicentre studyAurora ZanghìRoberta FantozziMatteo FoschiElisabetta SignorielloMatilde IngleseGiacomo LusDiego CentonzeAndrea SurcinelliTommaso SiritoSimona BonavitaCarlo AvolioEmanuele D’AmicoBackground: Characterizing Cladribine tablets prescription pattern in daily clinical practice is crucial for optimizing multiple sclerosis (MS) treatment. Objectives: To describe efficacy, safety profile and new disease-modifying therapy (DMT) prescriptions following Cladribine treatment. Design: Independent retrospective cohort study in patients followed at six Italian MS centres. Methods: Patients diagnosed with relapsing MS (RMS) according to 2017 McDonald criteria, who initiated Cladribine between January 2019 and May 2023, were included. A generalized linear regression model was built for the outcome DMT after Cladribine course. Heatmaps were generated based on weighted pivot tables to visualize the proportion of patients requiring DMT post-Cladribine. Results: A total cohort of 352 patients was enrolled, 134 naïve to any DMT, 218 switchers from other DMTs. The last DMT was an injectable first-line DMT for 48 (22%) patients, oral first-line DMT for 141 (64.7%) patients, SP1 inhibitor-Fingolimod for 23 (10.6%) patients, and Natalizumab for 6 (2.7%) patients. Overall, Cladribine was efficacious and well tolerated, 12% of patients required a new DMT prescription after a median time of 24 months. The regression model revealed that patients aged >40 years at Cladribine prescription had a 16% decrease in likelihood of receiving a new DMT. Heatmaps showed patients previously on Fingolimod had a lower rate (72.2%) of being free from therapy after Cladribine. Conclusion: In our multicentric real-world Italian study, Cladribine therapy is generally effective during the investigated follow-up period. Understanding key characteristics of patients responding best to Cladribine can help tailor therapeutic strategies for optimal outcomes.https://doi.org/10.1177/17562864241304212
spellingShingle Aurora Zanghì
Roberta Fantozzi
Matteo Foschi
Elisabetta Signoriello
Matilde Inglese
Giacomo Lus
Diego Centonze
Andrea Surcinelli
Tommaso Sirito
Simona Bonavita
Carlo Avolio
Emanuele D’Amico
Identifying Cladribine prescription pattern in MS: an Italian multicentre study
Therapeutic Advances in Neurological Disorders
title Identifying Cladribine prescription pattern in MS: an Italian multicentre study
title_full Identifying Cladribine prescription pattern in MS: an Italian multicentre study
title_fullStr Identifying Cladribine prescription pattern in MS: an Italian multicentre study
title_full_unstemmed Identifying Cladribine prescription pattern in MS: an Italian multicentre study
title_short Identifying Cladribine prescription pattern in MS: an Italian multicentre study
title_sort identifying cladribine prescription pattern in ms an italian multicentre study
url https://doi.org/10.1177/17562864241304212
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