Real Life Effectiveness and Tolerability of Cladribine Tablets (CladT) after Five Years of Treatment
Antonio Pato Pato1, José Ramón Lorenzo González2, Daniel Apolinar García Estévez3, Ana María López Real4, Ana Rodriguez Regal5, Eva Costa Arpin6, María Rodriguez Rodriguez7, Elena Alvarez Rodriguez1, Miguel Alberte Woodgard8, Marta Aguado Valcarcel1, Inés González Suarez1, José María Oscar Prieto Gonzalez8
1Neurology, Complexo Hospitalario de Vigo, 2Neurology, Hospital Povisa de Vigo, 3Neurology, Complexo Hospitalario de Ourense, 4Neurology, Complexo Hospitalario de A Coruña, 5Neurology, Complexo Hospitalario de Pontevedra, 6Neurology, Complexo Hospitalario de Ferrol, 7Neurology, Hospital Universitario Lucus Augusti, 8Neurology, Hospital Clínico Universitario de Santiago de Compostela
Objective:
To describe the effectiveness and tolerability of CladT in a clinical practice
setting after 5 years of treatment.
Background:
Cladribine is an immune reconstitution therapy approved for treating Relapsing-
Remitting Multiple Sclerosis. While its efficacy and adverse events are
documented in randomized controlled trials, additional data from clinical
practice is essential.
Design/Methods:
Observational, multicenter, retrospective study including patients from 8
hospitals in Spain. Data collected included demographics, disability, relapse
rates, gadolinium (Gd)-enhancing lesions, lymphocyte counts, adverse events,
and reasons for treatment discontinuation.
Results:
A total of 342 patients were included, with an average age of 42.87 years
(±10.78), 75.1% were females and 22.2% treatment naïve. The mean disease
duration was 9.18 years (±7.7) and the mean of previous treatments 1.26
(±0.95). The average annual relapse rate (ARR) was 0.80 (±0.71), the average
EDSS score 1.82 (±1.28) and the average number of Gd-enhancing lesions
1.03 (±2.31). CladT reduced the ARR significantly to 0.17 (±0.42), 0.13 (±0.40),
0.07 (±0.28), 0.13 (±0.37), and 0.05 (±0.22) (p<0.05) and the number of Gd-
enhancing lesions to 0.18 (±0.89), 0.16 (±0.77), 0.23 (±1.12), 0.15 (±0.69), 0.35
(±1.67) (p<0.05) over the 5 years. EDSS scores remained stable over the 5-
year period (p>0.05). Lymphocyte counts varied from 1368 (±525), 1171 (±524),
1387 (±643), 1480 (±651), 1520 (±618), p<0.05 and adverse events were
reported in 24%, 15%, 15%, 8% and 8% of patients over the 5 years,
respectively, with the most common being fatigue (6.0%), urinary (3.35%) and
respiratory infections (3.0%). Additionally, 98.3%, 95.9%, 91.5%, 87.5% and
91.5% of patients remained on treatment after years 1,2,3,4 and 5.
Conclusions:
CladT demonstrates effectiveness in real-life setting, indicated by stable EDSS
scores and reduced relapse rates and Gd-enhancing lesions. It is well tolerated,
with high treatment persistence after 5 years of follow-up.
Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff.