Cladribine use trend in Latin America: the changes in patient profile impact in the drug effectiveness.

Abstract

Cladribine was approved for Multiple Sclerosis (MS) inour country in 2018. A previous study by our group showed that its use among high efficacy therapiesoptions has been increasing along the years. to analyze the cladribineuse trend across time since its approval. A retrospective cohort study was performed. People withMS (pwMS) treated with cladribinewere included. Two periods were defined: P1 = 2018 - 2020 and P2 = 2021 - 2023. A comparative analysis was carry outbetween P1and P2 to assessthe trend of use, clinical/demographic characteristics, and effectiveness. One hundred ninety- seven people with MS (pwMS) were included, mean EDSS: 2.2 ± 3.08, 72.6% female, mean age: 35.2 ± 9years, mean disease duration: 6.6 ± 5.6years, mean time lapse under cladribine: 26.1 ± 12.4months. Regarding patient profile, we found significant differences between P1 and P2 in the MS evolution (p = 0.001) and EDSS (p = 0.018) prior to initiation of cladribine.In the individualized analysis by year, we found a decrease in relapse number in the year prior to starting cladribine (p = 0.02). Ahigher proportion of No Evidence of Disease Activity (NEDA) was found in patients treated at P2 compared to those treated at P1 (p < 0.001). An earlier use of cladribineachieved a significant increase in reaching NEDA. This learning curve in the use of cladribine allows a better identification of the candidate patient and influences the treatment effectiveness.