Title:Real-World Effectiveness of Cladribine for Patients with Multiple
Sclerosis: A Sicilian Multicentric Experience (Rewind Study)
Volume: 22
Issue: 7
Author(s): Sebastiano Arena, Clara Grazia Chisari, Simona Toscano, Sebastiano Bucello, Luigi Maria Grimaldi, Paolo Ragonese, Sabrina Realmuto, Salvatore Cottone, Davide Maimone, Chiara Finocchiaro, Paola Reitano and Francesco Patti*
Affiliation:
- Department "GF Ingrassia" Section of Neurosciences, University of Catania, Catania, Italy
Keywords:
Multiple sclerosis, disease modifying therapies, switching therapies, cladribine, moderately active treatment, highly active treatment.
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.
