Real-World Effectiveness of Cladribine for Patients with Multiple Sclerosis: A Sicilian Multicentric Experience (Rewind Study)


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Abstract

Background:Cladribine tablets are a highly effective option for the treatment of relapsingremitting multiple sclerosis (RRMS).

Objective:The study aims to evaluate the effectiveness of cladribine in a real-world setting.

Methods:This prospective real-world study consecutively screened all RRMS patients from seven different MS centers in Sicily (Italy) who completed the 2-year treatment course of cladribine tablets in the period between 11th March 2019 and 31st October 2021. Data about Expanded Disability Status Scale (EDSS), relapses, previous treatments, adverse events (AEs) and magnetic resonance imaging (MRI) were collected. Patients who were previously treated with other DMTs were further stratified into moderately active treatment (MAT) and highly active treatment (HAT) patients.

Results:A total of 217 patients (70% women, with a mean age of 38.4 ± 11.3 years) were enrolled. Fifty patients (23.0%) were naïve to treatment and 167 (77%) switched from other disease modifying therapies. After the second year of treatment, about 80% were EDSS progression free, 88% remained relapse-free at T24, and 48% of patients were MRI activity-free. Kaplan Meier analyses showed significant differences between MT and HAT in terms of time to first clinical relapse (HR: 2.43, IC 1.02- 5.76; p = 0.04), time to the first new T1-gadolinium enhancing lesion (HR: 3.43, IC 1.35-8.70; p = 0.009) and time to MRI worsening (HR: 2.42, IC 1.15-5.09; p = 0.02).

Conclusion:This study confirmed that cladribine is an effective treatment for MS, particularly in naïve patients and those who have switched from MATs.

About the authors

Sebastiano Arena

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Email: info@benthamscience.net

Clara Chisari

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Email: info@benthamscience.net

Simona Toscano

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Email: info@benthamscience.net

Sebastiano Bucello

, Multiple Sclerosis Center- PO Muscatello di Augusta

Email: info@benthamscience.net

Luigi Grimaldi

, Institute Foundation "G. Giglio", Multiple Sclerosis Centre

Email: info@benthamscience.net

Paolo Ragonese

Department of Biomedicine, Neurosciences and Advanced Diagnostics (BiND), University of Palermo

Email: info@benthamscience.net

Sabrina Realmuto

Multiple Sclerosis Centre, Neurology Unit and Stroke Unit, AOOR "Villa Sofia- Cervello", United Hospitals,

Email: info@benthamscience.net

Salvatore Cottone

, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Civico Di Cristina e Benfratelli"

Email: info@benthamscience.net

Davide Maimone

Centro Sclerosi Multipla, UOC Neurologia, ARNAS Garibaldi

Email: info@benthamscience.net

Chiara Finocchiaro

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Email: info@benthamscience.net

Paola Reitano

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Email: info@benthamscience.net

Francesco Patti

Department "GF Ingrassia" Section of Neurosciences, University of Catania

Author for correspondence.
Email: info@benthamscience.net

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