Abstract Details

Title Real Life Effectiveness and Tolerability of Cladribine Tablets (CladT) after Five Years of Treatment

Topic Multiple Sclerosis

Presentation(s) P4 - Poster Session 4 (8:00 AM-9:00 AM)

Poster/Presentation
Number 20-004

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.

Authors/Disclosures
Antonio Pato PRESENTER	Antonio Pato has nothing to disclose.
Jose Ramon Lorenzo Gonzalez, Sr., MD (Hospital POVISA)	Dr. Lorenzo Gonzalez has nothing to disclose.
Daniel García Estévez	The institution of Daniel García Estévez has received research support from MERCK. The institution of Daniel García Estévez has received research support from ROCHE.
Ana Lopez Real	Ana Lopez Real has received personal compensation in the range of $0-$499 for serving as a Consultant for Janssen. Ana Lopez Real has received personal compensation in the range of $0-$499 for serving as a Consultant for Sanofi Genzyme. Ana Lopez Real has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Ana Lopez Real has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Ana Rodriguez Regal	Ana Rodriguez Regal has nothing to disclose.
Eva Costa Arpín	Eva Costa Arpín has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono.
Maria Rodriguez Rodriguez, MD	Dr. Rodriguez Rodriguez has nothing to disclose.
Elena Alvarez Rodriguez	Elena Alvarez Rodriguez has nothing to disclose.
Miguel Alberte-Woodward (Hospital Clínico Universitario de Santiago de Compostela)	No disclosure on file
Marta Aguado Valcarcel	Marta Aguado Valcarcel has nothing to disclose.
Ines Gonzalez	Ines Gonzalez has nothing to disclose.
Jose M. Prieto, MD (Hospital Clínico Universitario de Santiago de Compostela)	Dr. Prieto has nothing to disclose.

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