There are different disease-modifying therapies (DMTs) for treating patients with Relapsing-Remitting Multiple Sclerosis (RRMS). Oral Cladribine was commercialized in 2018.
To analyze the first year of treatment with Cladribine in RRMS patients: tolerability, security and initial approach to its effectiveness.
Retrospective, longitudinal and unicenter study in RRMS patients treated with Cladribine. We analyzed its security measuring overall lymphocyte count by Friedman Test and time to appearance of lymphopenia by Kaplan-Meier. We studied its effectiveness by comparing the following variables with the Wilcoxon Test: relapses, Expanded Disability Status Scale (EDSS) score and gadolinium enhancing lesions before and one year after starting Cladribine (statistically significant p<0’05).
53 patients were studied. 88,7% were women with a mean age of 44,8 years old (DS10,25). 56,6% of the patients had a RRMS evolution of less than 10 years, 32,1% between 10 and 20 years, and 9,4% between 20 and 30 years. 64,1% had been previously treated with one or two DMTs. Patients were exposed to Cladribine for 8 months as a median (percentiles P15=2 months, P85=15 months): 36,4% patients for 6 months, 34,1% between 6-12 months and 29,5% for more than 12 months. The overall lymphocyte count reduction regarding the basal level after starting the drug was statistically significant (p<0’05). The lymphocyte count reduction rate was 52,89% during the first year of treatment and 58,99% during the second one. Tolerability was good in 93,02% of the patients. We observed significant reduction of the relapses rate after one year of treatment.
Cladribine seems to be a secure treatment. The most common adverse effect was lymphopenia (81,8%) but it was severe only in 9,09% of the patients and not associated with severe infections. Its tolerability was very good. Effectiveness results are positive, but, to date, they are preliminary.