Multiple sclerosis and related disorders · 2026
Long-term outcomes of cladribine tablets in multiple sclerosis: Treatment completion, persistence, and subsequent therapy transitions in Southeast Europe.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Krbot Skorić Magdalena, Brecl Jakob Gregor, Rajda Cecilia, Jerčinović Katy, Abičić Ana, Adamec Ivan, Rot Uroš, Barun Barbara, Gabelić Tereza, Horvat Ledinek Alenka, Gomezelj Sarah, Klivényi Péter, Habek Mario
Аннотация
OBJECTIVES: This study aimed to assess treatment completion rates, persistence, administration of a third course of cladribine tablets, and switching to other disease-modifying therapies (DMTs) in people with multiple sclerosis (pwMS) treated with cladribine tablets in Southeast European MS centers.
METHODS: We conducted a retrospective, observational, multi-center, and multi-national study including 195 pwMS who initiated cladribine tablets at three centers across three European countries. The mean follow-up period was 4.06±1.17 years.
RESULTS: Among the participants, 184 (94.4 %) completed both courses of cladribine tablets, while 7 (3.6 %) were lost to follow-up. Four (2.1 %) switched to another DMT due to disease activity before receiving the second course. Over the follow-up period, 132 (67.7 %) did not require any additional treatment after completing two courses. Eighteen (9.2 %) received a third course of cladribine tablets, while 40 (20.5 %) switched to another DMT, with two of these switches occurring after the third course. The median time to the third course was significantly longer (3.18 years [IQR 2.20-3.91]) compared to the median time to switch (2.27 years [IQR 1.79-3.13]) from the administration of the second course (p = 0.009). An exploratory and hypothesis-generating multivariate logistic regression analysis identified prior DMT use as the only significant predictor for requiring a third course of cladribine tablets and/or switching to another DMT (exp(B) 2.429, 95 % CI 1.034-5.707, p = 0.042).
CONCLUSION: A substantial proportion of pwMS treated with cladribine tablets remain treatment-free for over four years. In selected cases, a third course of cladribine tablets may be beneficial.
METHODS: We conducted a retrospective, observational, multi-center, and multi-national study including 195 pwMS who initiated cladribine tablets at three centers across three European countries. The mean follow-up period was 4.06±1.17 years.
RESULTS: Among the participants, 184 (94.4 %) completed both courses of cladribine tablets, while 7 (3.6 %) were lost to follow-up. Four (2.1 %) switched to another DMT due to disease activity before receiving the second course. Over the follow-up period, 132 (67.7 %) did not require any additional treatment after completing two courses. Eighteen (9.2 %) received a third course of cladribine tablets, while 40 (20.5 %) switched to another DMT, with two of these switches occurring after the third course. The median time to the third course was significantly longer (3.18 years [IQR 2.20-3.91]) compared to the median time to switch (2.27 years [IQR 1.79-3.13]) from the administration of the second course (p = 0.009). An exploratory and hypothesis-generating multivariate logistic regression analysis identified prior DMT use as the only significant predictor for requiring a third course of cladribine tablets and/or switching to another DMT (exp(B) 2.429, 95 % CI 1.034-5.707, p = 0.042).
CONCLUSION: A substantial proportion of pwMS treated with cladribine tablets remain treatment-free for over four years. In selected cases, a third course of cladribine tablets may be beneficial.