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Subcutaneous cladribine to treat multiple sclerosis : experience in 208 patients

Allen-Philbey, Kimberley ; De Trane, Stefania ; Mao, Zhifeng ; Álvarez-González, Cesar ; Mathews, Joela ; MacDougall, Amy ; Stennett, Andrea ; Zhou, Xia ; Yildiz, Ozlem and Adams, Ashok , et al. (2021) In Therapeutic Advances in Neurological Disorders 14.
Abstract

Objective: To report on safety and effectiveness of subcutaneous cladribine (Litak®) in multiple sclerosis (MS) patients. Methods: Litak® was offered to MS-patients irrespective of disease course. Litak® 10 mg was administered for 3–4 days during week 1. Based on lymphocyte count at week 4, patients received another 0–3 doses at week 5. A second course was administered 11 months later. Follow-up included adverse events, relapses, expanded disability status scale (EDSS), 9-hole-peg and Timed-25-foot-walking tests, no-evidence-of-disease-activity (NEDA), no-evidence-of-progression-or-active-disease (NEPAD), MRI, cerebrospinal fluid (CSF) neurofilament light chain (NfL), and lymphocyte counts. Results: In... (More)

Objective: To report on safety and effectiveness of subcutaneous cladribine (Litak®) in multiple sclerosis (MS) patients. Methods: Litak® was offered to MS-patients irrespective of disease course. Litak® 10 mg was administered for 3–4 days during week 1. Based on lymphocyte count at week 4, patients received another 0–3 doses at week 5. A second course was administered 11 months later. Follow-up included adverse events, relapses, expanded disability status scale (EDSS), 9-hole-peg and Timed-25-foot-walking tests, no-evidence-of-disease-activity (NEDA), no-evidence-of-progression-or-active-disease (NEPAD), MRI, cerebrospinal fluid (CSF) neurofilament light chain (NfL), and lymphocyte counts. Results: In all, 208 patients received at least one course of treatment. Age at baseline was 44 (17–72) years and EDSS 0–8.5. Cladribine was generally well tolerated. One myocardial infarction, one breast cancer, and three severe skin reactions occurred without long-term sequelae. Two patients died (one pneumonia, one encephalitis). Lymphopenia grade 3 occurred in 5% and grade 4 in 0.5%. In 94 out of 116 pwMS with baseline and follow-up (BaFU) data after two treatment courses, EDSS remained stable or improved. At 18 months, 64% of patients with relapsing MS and BaFU data (n = 39) had NEDA. At 19 months, 62% of patients with progressive MS and BaFU data (n = 13) had NEPAD. Of n = 13 patients whose CSF-NfL at baseline was elevated, 77% were normalised within 12 months. Conclusions: Litak® was well tolerated. Effectiveness in relapsing MS appeared similar to cladribine tablets and was encouraging in progressive MS. Our data suggest cladribine may be safe and effective in MS-patients irrespective of their disease stage.

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type
Contribution to journal
publication status
published
subject
keywords
cladribine, disease-modifying treatment, multiple sclerosis, NEDA, NEPAD, treatment access
in
Therapeutic Advances in Neurological Disorders
volume
14
publisher
SAGE Publications
external identifiers
  • scopus:85120475861
  • pmid:35173808
ISSN
1756-2856
DOI
10.1177/17562864211057661
language
English
LU publication?
yes
id
25a41f76-c7a9-4029-be33-c650474f4ca1
date added to LUP
2022-01-18 17:17:23
date last changed
2024-04-06 16:36:06
@article{25a41f76-c7a9-4029-be33-c650474f4ca1,
  abstract     = {{<p>Objective: To report on safety and effectiveness of subcutaneous cladribine (Litak<sup>®</sup>) in multiple sclerosis (MS) patients. Methods: Litak<sup>®</sup> was offered to MS-patients irrespective of disease course. Litak<sup>®</sup> 10 mg was administered for 3–4 days during week 1. Based on lymphocyte count at week 4, patients received another 0–3 doses at week 5. A second course was administered 11 months later. Follow-up included adverse events, relapses, expanded disability status scale (EDSS), 9-hole-peg and Timed-25-foot-walking tests, no-evidence-of-disease-activity (NEDA), no-evidence-of-progression-or-active-disease (NEPAD), MRI, cerebrospinal fluid (CSF) neurofilament light chain (NfL), and lymphocyte counts. Results: In all, 208 patients received at least one course of treatment. Age at baseline was 44 (17–72) years and EDSS 0–8.5. Cladribine was generally well tolerated. One myocardial infarction, one breast cancer, and three severe skin reactions occurred without long-term sequelae. Two patients died (one pneumonia, one encephalitis). Lymphopenia grade 3 occurred in 5% and grade 4 in 0.5%. In 94 out of 116 pwMS with baseline and follow-up (BaFU) data after two treatment courses, EDSS remained stable or improved. At 18 months, 64% of patients with relapsing MS and BaFU data (n = 39) had NEDA. At 19 months, 62% of patients with progressive MS and BaFU data (n = 13) had NEPAD. Of n = 13 patients whose CSF-NfL at baseline was elevated, 77% were normalised within 12 months. Conclusions: Litak<sup>®</sup> was well tolerated. Effectiveness in relapsing MS appeared similar to cladribine tablets and was encouraging in progressive MS. Our data suggest cladribine may be safe and effective in MS-patients irrespective of their disease stage.</p>}},
  author       = {{Allen-Philbey, Kimberley and De Trane, Stefania and Mao, Zhifeng and Álvarez-González, Cesar and Mathews, Joela and MacDougall, Amy and Stennett, Andrea and Zhou, Xia and Yildiz, Ozlem and Adams, Ashok and Bianchi, Lucia and Blain, Camilla and Chapman, Christine and Chung, Karen and Constantinescu, Cris S. and Dalton, Catherine and Farrell, Rachel A. and Fisniku, Leonora and Ford, Helen and Gran, Bruno and Hobart, Jeremy and Khaleeli, Zhaleh and Mattoscio, Miriam and Pavitt, Sue and Pearson, Owen and Peruzzotti-Jametti, Luca and Scalfari, Antonio and Sharrack, Basil and Silber, Eli and Tallantyre, Emma C. and Webb, Stewart and Turner, Benjamin P. and Marta, Monica and Gnanapavan, Sharmilee and Juliusson, Gunnar and Giovannoni, Gavin and Baker, David and Schmierer, Klaus}},
  issn         = {{1756-2856}},
  keywords     = {{cladribine; disease-modifying treatment; multiple sclerosis; NEDA; NEPAD; treatment access}},
  language     = {{eng}},
  publisher    = {{SAGE Publications}},
  series       = {{Therapeutic Advances in Neurological Disorders}},
  title        = {{Subcutaneous cladribine to treat multiple sclerosis : experience in 208 patients}},
  url          = {{http://dx.doi.org/10.1177/17562864211057661}},
  doi          = {{10.1177/17562864211057661}},
  volume       = {{14}},
  year         = {{2021}},
}