Cladribine is a nucleoside analog of deoxyadenosine, recently approved for treatment of active multiple sclerosis (RMS) defined by neuroimaging or clinical features.
We analyze our treated patients profile, efficacy and safety in real clinical practice after two years of experience.
Two-year retrospective observational study of our RMS patients treated with oral cladribine, analyzing demographic, clinical, efficacy and safety data.
n=81 (78% women), mean age 37.7 years (21-65) and a previous mean EDSS of 2.67(1-6). The mean time of evolution of RMS prior to treatment was 6.7 years and the mean annualized relapse rate 1,2. 50% of patients had at least 10 lesions in T2 with a mean of ehanced lesions of 0.9 (0-4). The mean of previous treatments was 1.25 and the mean time with last treatment was 2.44. Drug tolerance was good, with less than 15% adverse effects (Aes), all mild and self-limiting. Lymphocyte counts reached a mínimum mean value of 1.03x103/mm3 in month 3, with subsequent recovery and only 3 patients reaching asymptomatic grade 3 (0.04%). Currently 24 patients have received second year according to protocol, haveing detected previos radiological activity in four of them (0.05%) and clinical activity in two (0.02%), being reason for discontinuation in one patient without completing complete course of treatment.
In our experience, and after its first two years in clinical practice, oral cladribine is emerging as a treatment with a good efficacy and safety profile in active MS, in parallel with the available evidence.