Objectives: To study the 30-month safety and effectiveness of Cladribine tablets (CladT) in relapsing multiple sclerosis (RMS) months in a real-world setting.
Methods: Retrospective single-centre observational study in Qatar (January 2018-Feb 2023). Clinical and MRI data, lymphocyte counts and adverse events (AE) were recorded for patients with RMS who received at least one course of CladT.
Results: Forty-six patients were included (mean follow-up 22 months); 34 (74 %) were female, 22 (48 %) were disease-modifying therapy (DMT) naïve, 16 (35 %) had switched from platform DMT and 8 (17 %) from high efficacy (HE) DMD. Mean age was 26.7±7.2 y, mean disease duration was 7.2±6.0 y. Common reasons for treatment with CladT were MS activity (91 %), pregnancy planning (17 %), AE (20 %), compliance (9 %). 44/46 ( 96 %) received the year 2 course of CladT. Annualised relapse rate (ARR) fell from 1.02 (baseline) to 0.1, 0, 0.1, 0.1 and 0.1 for years 1-5 post-treatment, respectively; 87.5-100 % were free of relapses at these times, vs. 21 % at baseline. There were no relapses in year 2; 78 %, 100 %, 84 %, 80 % and 100 %, respectively, were free of GD+ MRI lesions at years 1-5, vs. 31 % at baseline. Most clinical AE were mild (1 moderate, no severe AE); 12 contracted Covid-19 (no hospitalisations). Grade 3 lymphopenia occurred in 5 patients.
Conclusions: CladT appeared to be effective and safe in our retrospective study, irrespective of prior treatments, consistent with other real world data that support the early use of CladT in the management of RRMS.
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| http://dx.doi.org/10.1016/j.clineuro.2024.108615 | DOI Listing |
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