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.
ABSTRACT
Objective: This study evaluates the generalizability of data from Ocrelizumab phase 3 clinical trials and its effectiveness in a real-world setting of an Arab population With in a rapidly developing country such as Qatar. Background: Ocrelizumab was FDA approved in 2017 as the newest drug for the treatment of both relapsing-remitting (RRMS) and primary progressive multiple sclerosis (PPMS). OPERA I/II, the major clinical trials, for RRMS shows it is highly efficacious in controlling clinical and radiological activity with a good safety profile and generalizability. Design/Methods: In this retrospective longitudinal cohort study patients were between 18-75 years old;had a confirmed MS;started Ocrelizumab after physician approval;received minimum 3 infusions and 24 months follow up. Primary outcomes: Clinical relapses, baseline and monitoring imaging and adverse events. Secondary outcomes: Demographics, disability outcomes and prior disease-modifying therapies. Results: Of 83 patients, 65 met inclusion criteria. Mean age was 38.7, 58.5% were male, 31.7% were treatment-naive, 52 had RRMS, 5 had PPMS and 3 had SPMS. Average duration of disease and number of infusions was 7.75 years and 3.2 respectively. Average number of gadolinium-enhancing lesions on baseline MRI was 1.27 and 0.07 after treatment. 11 patients had mild adverse events (infusion-related reactions), 13 had URTIs with 1 patient having COVID pneumonia, and 1 patient had UTI. Two patients developed cancer while on treatment. Compared to OPERA I/II, patients in Qatar were older (mean age of 38.7 vs. 37.1 and 37.2), mostly male (58.5% vs. 65.9% and 65.0%), had similar mean EDSS score (2.57±2.67 vs 2.86±1.24 and 2.78±1.30) but longer duration of disease (7.75±6.72 vs. 6.7±6.4 and 6.7±6.1). Conclusions: Ocrelizumab is highly effective for the treatment of MS, especially in this Arab population with a long follow-up period. Compared to previous clinical trials, patients in Qatar had different demographic characteristics, with longer disease durations and fewer enhancing lesions at baseline.