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Background:  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.   Methods:  We included patients exposed to cladribine ( n  = 13) or placebo ( n  = 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.   Results:  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;  p  = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872;  p  = 0.036), and of SP conversion (HR = 0.010; 95%CI = 0.001, 0.329;  p  = 0.010), when compared with placebo.   Conclusions:  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.

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