Beyond Effectiveness: Impact of Cladribine on Patient-Reported Outcomes and Quality of Life in Latin American Populations With Multiple Sclerosis.

BACKGROUND

This multicenter, prospective, observational study evaluated the real-world effectiveness, safety, and impact on patient-reported outcomes (PROs) and functionality of cladribine (CLAD) in 167 relapsing multiple sclerosis (RMS) patients from Chile, Mexico, Argentina, and Ecuador between 2019 and 2024.

METHODS

Patients were assessed for clinical relapses, magnetic resonance imaging (MRI) activity, and disability progression. A subgroup underwent additional cognitive, motor, and PRO evaluations.

RESULTS

The annualized relapse rate (ARR) significantly decreased from 0.65 ± 0.6 pre-treatment to 0.12 ± 0.4 in year one, 0.08 ± 0.3 in year two, 0.06 ± 0.3 in year three, and 0.15 ± 0.5 in year four. No evidence of disease activity-3 (NEDA-3) was achieved by 68% (n = 100/147), 77% (n = 89/115), 86% (n = 61/71), and 82% (n = 37/45) of patients in years one, two, three, and four, respectively. Common adverse events were mild infections and lymphopenia (grade I 33% n = 48, grade II 30% n = 44, grade III 8% n = 12, and grade IV 0.01% n = 1 in year one). No treatment delays occurred due to lymphopenia. Two patients had healthy newborns after becoming pregnant between CLAD courses. Significant improvements were observed in visual memory, verbal memory, and anxiety levels at two years.

CONCLUSION

CLAD demonstrates an effectiveness and safety profile consistent with clinical trials in Latin American RMS populations, also improving PROs and functional outcomes, supporting its use as a viable treatment option.