Real-world therapy management of patients with multiple sclerosis receiving cladribine tablets beyond year 4 - Results from a German cladribine cohort.
Mult Scler Relat Disord
; 88: 105704, 2024 Aug.
Article
en En
| MEDLINE
| ID: mdl-38878625
ABSTRACT
BACKGROUND:
The current approval of oral cladribine covers four years, with two treatment courses in the first two years, followed by two treatment-free years. For decision-making in year 5, experts recommend three scenarios Extending the treatment-free period, retreatment with cladribine, or therapy switch.OBJECTIVE:
To assess the implementation of the three year-5-scenarios in clinical practice in a large multicentric real-world cohort in Germany.METHODS:
Data from adult patients diagnosed with highly active RMS (first dose between 8/2017 and 8/2018) were included. The primary outcome was the percentages of patients who remained treatment-free in year 5, were retreated with cladribine, or switched to another therapy.RESULTS:
In total, 187 patients (75 % female, mean age 38.6 years, median EDSS 2.5, 21 % DMT-naive) were evaluated. Overall, 27 (14 %) switched treatment within year 1-4, 36 (19 %) continued therapy with cladribine tablets in year 5, and 8 (4 %) switched therapy in year 5. All other patients (n = 118, 63 %) continued to be monitored without therapy in year 5.CONCLUSION:
The recommended three treatment scenarios in year 5 appear to be feasible in clinical practice. Treatment-free structured monitoring is the most frequently applied strategy, highly likely due to the prospect of continuing low disease activity under cladribine treatment.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Cladribina
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Inmunosupresores
Límite:
Adult
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Female
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Humans
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Male
/
Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
Mult Scler Relat Disord
Año:
2024
Tipo del documento:
Article
Pais de publicación:
Países Bajos