ABSTRACT
Objectives: To study safety and efficacy of Cladribine tablets (Clad T) treatment in RMS patients over 2 years in a real-world clinical setting. Aim(s): To describe the efficacy and safety in Real-world experience in an Arab Population. Method(s): This is a retrospective single-centre observational study in Qatar. Medical records of Relapsing Multiple Sclerosis (RMS) patients who received at least one year treatment of Cladribine treatment between January 2018 through December 2021 were reviewed. Demographic and clinical aspects, EDSS, previous disease-modifying drugs (DMD) and annual relapse rate (ARR) were recorded. MRI data of patients who completed at least first-year course of Cladribine tablets were assessed as well adverse events. Result(s): A total of 49 RMS patients (46 RRMS, 3 SPMS) were included, from those 34 (69%) were females. Mean age at Clad T initiation was 32 (18-59), mean disease duration is 7.6 (1-25) years. 25 patients (51%) were treatment naive, and 24 patients (49%) had one or more disease modifying therapy (DMT) before treatment. The most common reason for treatment with cladribine was disease activity (68 %), pregnancy planning (11%), compliance (10%) and side effects (11%). Prior DMTs included DMF (40%), Fingolimod (16%), Teriflunomide (16%), Natalizumab (12%), Interferon Beta (12%) and Ocrelizumab (5%). By December 2021, 32 patients finished the two courses of the drug. The Median follow-up period of the total cohort was 32 months. 26/32 (81.25%) patients were relapse free post treatment compared to 25% pretreatment. Annualised relapse rate (ARR) was reduced by 92% (0.08 vs 0.97). 75% of patients were free of Gd+ T1 lesions post treatment compared to 37.5% at the baseline. Majority of MRI findings (7/8) were observed in the 1st year of treatment and only one patient experimented radiological activity after the second-year course. 31 patients (96.8%) had no 3 months confirmed EDSS progression. Only mild Adverse events were reported and single case of herpes zoster, urinary tract infection and oral candidiasis. All COVID-19 cases (n=12) were mild and didn't need hospitalization. Grade 3 lymphopenia was recorder for 5 patients (1.5%) and no grade 4 was observed. Conclusion(s): Our real-world experience confirms good efficacy, tolerability, and safety of cladribine tablets in consistency with data from phase 3 clinical trials and other real-life studies. Reported adverse events showed lower frequency of lymphocytopenia.