A Retrospective, Single-Arm, Observational Study in Patients with Multiple Sclerosis in India Receiving Ocrelizumab Therapy for 1 Year.

Background

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Objectives

Ocrelizumab is an established therapy for multiple sclerosis (MS). However, real-world data from Indian clinical settings remain limited. Hence, the present study was conducted to evaluate the clinical effectiveness, radiological response, and safety profile of ocrelizumab over 12 months of therapy among patients with MS in India.

Methods

This retrospective observational study included data from adults diagnosed with multiple sclerosis (MS) who received ocrelizumab for at least 12 months. Clinical, radiological, and safety data were recorded. Primary outcomes were changes in the Expanded Disability Status Scale (EDSS) score and relapse rate. Secondary outcomes included magnetic resonance imaging (MRI) lesion counts and safety events. Statistical comparisons were performed.

Results

Fifty-five patients were included with a mean age of 38.2 (8.75) years. 61.8% were female. EDSS scores improved significantly from 3.77 (1.71) at baseline to 3.28 (2.05) at 12 months (P < 0.001). The annualized relapse rate decreased from 0.60 to 0.15, and MRI analysis showed significant reductions in both T2 lesions (17.06 [12.94] to 1.09 [2.38]; P < 0.001) and gadolinium-enhancing T1 lesions (1.26 [1.17] to 0.06 [0.23]; P < 0.001). Clinically indicated MS-related hospitalizations (excluding all treatment-administration admissions) decreased from 32.7% before treatment to none during the 12-month follow-up. No serious adverse events were reported, and 96.4% of patients experienced no adverse events. Regression analysis identified baseline EDSS as the only independent predictor of disability at 12 months.

Conclusions

Twelve months of ocrelizumab therapy was associated with significant reductions in relapse activity and MRI lesion burden, as well as improvement/stabilization of disability, with a favorable safety profile.