AUTHOR=Moccia Marcello , Lanzillo Roberta , Petruzzo Martina , Nozzolillo Agostino , De Angelis Marcello , Carotenuto Antonio , Palladino Raffaele , Brescia Morra Vincenzo 

TITLE=Single-Center 8-Years Clinical Follow-Up of Cladribine-Treated Patients From Phase 2 and 3 Trials

JOURNAL=Frontiers in Neurology

VOLUME=11

YEAR=2020

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2020.00489

DOI=10.3389/fneur.2020.00489

ISSN=1664-2295

ABSTRACT=<p><bold>Background:</bold> Cladribine is approved for the treatment of highly-active relapsing multiple sclerosis (MS), where it is also effective on disability progression. In the present single-center study, we aim to report on the 8-years clinical follow-up of 27 patients included in phase 2 and 3 clinical trials for cladribine.</p><p><bold>Methods:</bold> We included patients exposed to cladribine (<italic>n</italic> = 13) or placebo (<italic>n</italic> = 14) in ONWARD, CLARITY, and ORACLE-MS trials, and followed-up at the same center after trial termination. Outcomes of long-term disease progression were recorded.</p><p><bold>Results:</bold> During 8-year follow-up, patients treated with cladribine presented with reduced risk of EDSS progression (HR = 0.148; 95%CI = 0.031, 0.709; <italic>p</italic> = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872; <italic>p</italic> = 0.036), and of SP conversion (HR = 0.010; 95%CI = 0.001, 0.329; <italic>p</italic> = 0.010), when compared with placebo.</p><p><bold>Conclusions:</bold> Our exploratory study provides additional evidence that cladribine may be useful to prevent or, at least, mitigate the risk of disability progression after 8 years.</p>