Natalizumab in Multiple Sclerosis: A Single Centre Real-World Study

INTRODUCTION: Natalizumab (NTZ) is an effective immunomodulator therapy (IMT) employed for multiple sclerosis (MS) therapy. This study aimed to investigate the efficacy and safety of NTZ treatment in MS patients.
METHODS: Patients with clinically definite MS who received NTZ treatment were included in the study, and their data were derived from the iMed database. Patient demographics such as age, sex, and disease duration were assessed. The results pertaining to the annual number of attacks, expanded disability status scale (EDSS) results, magnetic resonance data, and no evidence of disease activity-3 (NEDA-3) were obtained.
RESULTS: This study included 153 patients (108 female and 43 male). The patients’ ages ranged from 21.63 to 67.60 years, with a mean age of 44.50 years. Prior to undergoing NTZ treatment, 54.3% of the patients had received at least two other IMTs. The mean annual number of assaults was 1.19, and the number of attacks in the year prior to treatment ranged from 0 to 6. The mean number of attacks in the first year following treatment was 0.07, 0.13 in the second year, and 0.09 in the third year. The baseline EDSS values of the patients varied between 0 and 5.5, and the mean baseline EDSS value was 3.08. During the initial year of treatment, the patient’s mean EDSS value was 2.58, the second year was 2.32, and the third year was 2.34. Recurrence with increased severity of disease activity or rebound development was observed in 14.6% of the patients whose NTZ treatment was terminated for any reason. The NEDA-3 value decreased from 82.8% (n=145) in the first year to 77.3% (n=132) in the second year and 79.0% (n=81) in the third year.
DISCUSSION AND CONCLUSION: Patients received NTZ for three years on average. 14.6% of the patients exhibit a recurrence or rebound of disease activity. Anti-John Cunningham virus antibody was detected in 5% of patients during the course of treatment. Approximately 80% of patient achieved NEDA-3 while receiving NTZ over the three-year period.