Subcutaneous cladribine to treat multiple sclerosis: experience in 208 patients

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 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.

Real-Life Experience of the Effects of Cladribine Tablets on Lymphocyte Subsets and Serum Neurofilament Light Chain Levels in Relapsing Multiple Sclerosis Patients

“…The sNfL levels in the subgroup of 18 patients showed a statistically significant decrease at W24 compared to baseline ( p = 0.01). These data replicate the results reported in a previous work where 77% of the patients who were treated with subcutaneous CLAD and had high CSF levels of neurofilament light chain at baseline showed normalised values within 12 months [ 45 ]. The measurement of sNfL levels represents an important opportunity to verify the effects of this DMT on axonal integrity and evaluate its future potential as an index of treatment outcome.…”

Safety and efficacy of cladribine in multiple sclerosis: a systematic review and meta-analysis

“…After duplicate removal, the title and abstract of 1570 studies were screened and 1494 papers were excluded. Finally, after a full-text review, 23 studies were included in our qualitative and quantitative synthesis [ 12 , 22 – 43 ]. A total of 15 clinical trials and eight observational studies involving 7244 MS patients were included in our study (Table 1 ).…”

Disease activity 4.5 years after starting cladribine: experience in 264 patients with multiple sclerosis

“…From the cohort of pwMS using the MS service (BartsMS) at our centre, we identified pwMS treated with SClad between 1 October 2014 and 31 May 2022 using a previously reported dosing schedule (Figure 1). 9–12…”