ABSTRACT
Introduction: As a high-efficacy multiple sclerosis (MS) treatment, cladribine necessitates empirical data from diverse populations. Objective(s): To study the efficacy and safety data of cladribine treatment in a real-world setting. Method(s): Patients from eight MS clinics in Turkey were involved in the study. We retrieved the demographic, clinical, MRI, safety, laboratory, COVID-19, and pregnancy records of patients with at least six months of follow-up on cladribine treatment. Result(s): Our study included 210 MS patients (52 males, 158 females;193 relapsing and 17 relapsing-progressive MS). The mean age at MS disease onset was 27.6 years (+/-8.5). Before cladribine treatment, 56.7% of patients used first-line, and 41.9% used both first and second-line therapies. During a mean follow-up period of 13.0 months (+/-4.7) following cladribine treatment, 5.7% of patients experienced a relapse. The shortest duration of relapse following cladribine administration was one week, and the longest duration was 15.3 months. Interestingly, 50% of the relapses occurred within the first three months. Among relapsing patients, five switched from fingolimod, two from dimethylfumarate, and one from ocrelizumab and interferon-beta. The mean annualized relapse rate was 0.41 (+/-0.41) in the two years preceding cladribine and 0.11 (+/-0.55) one year following treatment. At baseline, the mean EDSS score was 2.47 (+/-1.63), and 51.9% of patients ranked below EDSS 3. EDSS progression was observed in 7.6% of patients following cladribine treatment. On cladribine, eight patients (9.4%) exhibited radiological progression. There was no difference in NEDA status between patients switching from first or second-line therapy (p=0.43). COVID was observed in 73 patients, 54 of them had a mild disease course, six had a moderate disease course, and one had a severe disease course. There have been no COVID-related fatalities. There were five pregnancies documented, three of which are currently ongoing. One of the pregnancies ended with healthy childbirth, while the other was terminated in the first trimester with a miscarriage. Conclusion(s): Despite the relatively short duration of follow-up, our study demonstrates that cladribine is effective in providing NEDA. Moreover, switching from fingolimod to cladribine may increase the likelihood of early relapse.
ABSTRACT
BACKGROUND: The pandemic of the new type of corona virus infection 2019 [Covid-19] also affect people with Multiple Sclerosis (pwMS). Currently, the accumulating information on the effects of the infection regarding the demographic and clinical characteristics of the disease, as well as outcomes within different DMTs¸ enable us to have better practices on the management of the Covid-19 infection in pwMS. OBJECTIVE: To investigate the incidence of coronavirus disease 2019 (Covid-19) and to reveal the relationship between the demographic-clinical and therapeutic features and the outcome of Covid-19 infection in a multi-center national cohort of pwMS. METHODS: The Turkish Neurological Society-MS Study Group in association with the Italian MuSC-19 Study Group initiated this study. A web-based electronic Case Report Form (eCRF) of Study-MuSC-19 were used to collect the data. The demographic data and MS histories of the patients were obtained from the file tracking forms of the relevant clinics. RESULTS: 309 MS patients with confirmed Covid-19 infection were included in this study. Two hundred nineteen (219) were females (70.9%). The mean age was 36.9, ranging from 18 to 66, 194 of them (62.8%) were under 40. The clinical phenotype was relapsing-remitting in 277 (89.6%) and progressive in 32 (10.4%). Disease duration ranged from 0.2 years to 31.4 years. The median EDSS was 1.5, ranging from 0 to 8.5. The EDSS score was<= 1 in 134 (43%) of the patients. 91.6% of the patients were on a DMT, Fingolimod was the most frequently used drug (22.0%), followed by Interferon (20.1%). The comorbidity rate is 11.7%. We were not able to detect any significant association of DMTs with Covid-19 severity. CONCLUSION: The Turkish MS-Covid-19 cohort had confirmed that pwMS are not at risk of having a more severe COVID-19 outcome irrespective of the DMT that they are treated. In addition, due to being a younger population with less comorbidities most had a mild disease further highlight that the only associated risk factors for having a moderate to severe COVID-19 course are similar with the general population such as having comorbid conditions and being older.