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

TL;DR

This study shows that cladribine is effective and safe for treating multiple sclerosis in Latin American patients, improving their quality of life and reducing disease activity.

Contribution

The study provides real-world evidence of cladribine's effectiveness and safety in Latin American populations with multiple sclerosis.

Findings

Cladribine significantly reduced annualized relapse rates in patients with multiple sclerosis over four years.

A majority of patients achieved no evidence of disease activity-3 (NEDA-3) in all four years of treatment.

Cladribine improved patient-reported outcomes, including visual memory, verbal memory, and anxiety levels.

Abstract

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.