Abstract
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.
Highlights
Cladribine is approved for the treatment of highly-active relapsing multiple sclerosis (MS), where it is effective on disability progression
During 8-year follow-up, patients treated with cladribine presented with reduced risk of Expanded Disability Status Scale (EDSS) progression (HR = 0.148; 95% confidence interval (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
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 (Table 1; Figure 2)
Summary
Cladribine is approved for the treatment of highly-active relapsing multiple sclerosis (MS), where it is 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. Cladribine is a synthetic purine nucleoside analog, approved for the treatment of patients with highly active relapsing-remitting multiple sclerosis (RRMS), as defined by clinical and imaging features [1, 2]. Cladribine treatment was associated with reduced brain atrophy and, with reduced risk of disability progression over 2 years, compared with placebo [4, 5]. In a propensity score–matched cohort, cladribine was more frequently associated with confirmed disability improvement after 1 year, compared with interferon-beta, fingolimod, and natalizumab [6]. Disability should be ideally assessed over a longer observation time [7,8,9], in particular for disease modifying treatments (DMTs) that produce durable effects on the immune system (e.g., cladribine) [1]
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