Identifying Cladribine prescription pattern in MS: an Italian multicentre study

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

doi:10.1177/17562864241304212

Identifying Cladribine prescription pattern in MS: an Italian multicentre study

Ther Adv Neurol Disord. 2025 Jan 8:18:17562864241304212. doi: 10.1177/17562864241304212. eCollection 2025.

Authors

Affiliations

¹ Department of Medical and Surgical Sciences, University of Foggia, Foggia, Italy.
² IRCCS Neuromed, Pozzilli, Italy.
³ Department of Neuroscience, Multiple Sclerosis Center - Neurology Unit, S. Maria delle Croci Hospital, Azienda USL Romagna, Ravenna, Italy.
⁴ Multiple Sclerosis Centre, II Division of Neurology, Department of Clinical and Experimental Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
⁵ Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, and Mother-Child Health (DINOGMI), University of Genoa, Genoa, Italy.
⁶ Department of System Medicine, Tor Vergata University, Rome, Italy.
⁷ Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.
⁸ Department of Medical and Surgical Sciences, University of Foggia, Foggia 71122, Italy.

Abstract

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.

Keywords: cladribine; long-term management; multiple sclerosis; prescription pattern.

Plain language summary

Cladribine prescription pattern and MS Independent retrospective cohort study in patients followed at six Italian Multiple Sclerosis centres. The aim was to describe efficacy, safety profile, and new disease-modifying therapy (DMT) prescriptions following Cladribine treatment. Cladribine therapy was generally effective during the investigated follow-up period in this multicentric real-world Italian study. Understanding key characteristics of patients responding best to Cladribine can help tailor therapeutic strategies for optimal outcomes.