Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study

Cladribine is currently registered as a 10-milligram tablet formulation with a fixed cumulative dosage of 3.5 mg/kg over 2 years. It is important to investigate if an increased dosage may lead to further clinical stability with preserved safety. This study used an off-label subcutaneous (s.c.) formu...

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Autores principales:	Konrad Rejdak, Adriana Zasybska, Aleksandra Pietruczuk, Dariusz Baranowski, Sebastian Szklener, Magda Kaczmarek, Zbigniew Stelmasiak
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	subcutaneous cladribine relapsing multiple sclerosis long-term efficacy safety Medicine R
Acceso en línea:	https://doaj.org/article/5ce9cff1154f4c1fa32b9b618856822a
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spelling	oai:doaj.org-article:5ce9cff1154f4c1fa32b9b618856822a2021-11-11T17:48:43ZLong-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study10.3390/jcm102152072077-0383https://doaj.org/article/5ce9cff1154f4c1fa32b9b618856822a2021-11-01T00:00:00Zhttps://www.mdpi.com/2077-0383/10/21/5207https://doaj.org/toc/2077-0383Cladribine is currently registered as a 10-milligram tablet formulation with a fixed cumulative dosage of 3.5 mg/kg over 2 years. It is important to investigate if an increased dosage may lead to further clinical stability with preserved safety. This study used an off-label subcutaneous (s.c.) formulation of cladribine and compared outcomes (Expanded Disability Status Scale (EDSS) scores and disease progression) between 52 relapsing multiple sclerosis (RMS) patients receiving different s.c. dosing regimens with up to 20 years of follow-up. The study group received induction therapy with s.c. cladribine (1.8 mg/kg cumulative dose; consistent with 3.5 mg/kg of cladribine tablets). Patients were subsequently offered maintenance therapy (repeated courses of 0.3 mg/kg s.c. cladribine during 5–20-year follow-up). Forty-one patients received an increased cumulative dose (higher than the induction dose of 1.8 mg/kg); 11 received the standard induction dose. Risk of progression on the EDSS correlated with lower cumulative dose (<i>p</i> < 0.05) and more advanced disability at treatment initiation (<i>p</i> < 0.05) as assessed by EDSS change between year 1 and years 5 and 10 as the last follow-up. Maintenance treatment was safe and well-tolerated, based on limited source data. Subcutaneous cladribine with increased cumulative maintenance dosage was associated with disease stability and favorable safety over a prolonged period of follow-up (up to 20 years) in RMS patients.Konrad RejdakAdriana ZasybskaAleksandra PietruczukDariusz BaranowskiSebastian SzklenerMagda KaczmarekZbigniew StelmasiakMDPI AGarticlesubcutaneous cladribinerelapsing multiple sclerosislong-term efficacysafetyMedicineRENJournal of Clinical Medicine, Vol 10, Iss 5207, p 5207 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	subcutaneous cladribine relapsing multiple sclerosis long-term efficacy safety Medicine R
spellingShingle	subcutaneous cladribine relapsing multiple sclerosis long-term efficacy safety Medicine R Konrad Rejdak Adriana Zasybska Aleksandra Pietruczuk Dariusz Baranowski Sebastian Szklener Magda Kaczmarek Zbigniew Stelmasiak Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
description	Cladribine is currently registered as a 10-milligram tablet formulation with a fixed cumulative dosage of 3.5 mg/kg over 2 years. It is important to investigate if an increased dosage may lead to further clinical stability with preserved safety. This study used an off-label subcutaneous (s.c.) formulation of cladribine and compared outcomes (Expanded Disability Status Scale (EDSS) scores and disease progression) between 52 relapsing multiple sclerosis (RMS) patients receiving different s.c. dosing regimens with up to 20 years of follow-up. The study group received induction therapy with s.c. cladribine (1.8 mg/kg cumulative dose; consistent with 3.5 mg/kg of cladribine tablets). Patients were subsequently offered maintenance therapy (repeated courses of 0.3 mg/kg s.c. cladribine during 5–20-year follow-up). Forty-one patients received an increased cumulative dose (higher than the induction dose of 1.8 mg/kg); 11 received the standard induction dose. Risk of progression on the EDSS correlated with lower cumulative dose (<i>p</i> < 0.05) and more advanced disability at treatment initiation (<i>p</i> < 0.05) as assessed by EDSS change between year 1 and years 5 and 10 as the last follow-up. Maintenance treatment was safe and well-tolerated, based on limited source data. Subcutaneous cladribine with increased cumulative maintenance dosage was associated with disease stability and favorable safety over a prolonged period of follow-up (up to 20 years) in RMS patients.
format	article
author	Konrad Rejdak Adriana Zasybska Aleksandra Pietruczuk Dariusz Baranowski Sebastian Szklener Magda Kaczmarek Zbigniew Stelmasiak
author_facet	Konrad Rejdak Adriana Zasybska Aleksandra Pietruczuk Dariusz Baranowski Sebastian Szklener Magda Kaczmarek Zbigniew Stelmasiak
author_sort	Konrad Rejdak
title	Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
title_short	Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
title_full	Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
title_fullStr	Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
title_full_unstemmed	Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study
title_sort	long-term safety and efficacy of subcutaneous cladribine used in increased dosage in patients with relapsing multiple sclerosis: 20-year observational study
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/5ce9cff1154f4c1fa32b9b618856822a
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Long-Term Safety and Efficacy of Subcutaneous Cladribine Used in Increased Dosage in Patients with Relapsing Multiple Sclerosis: 20-Year Observational Study

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