Ocrelizumab (OCR) is a humanized monoclonal antibody that targets CD20 positive lymphocytes, resulting in preferential B cell depletion. It is FDA approved for relapsing-remitting, primary progressive and secondary progressive multiple sclerosis (RRMS, PPMS and SPMS).Ocrelizumab (OCR) is a humanized monoclonal antibody that targets CD20 positive lymphocytes, resulting in preferential B cell depletion. It is FDA approved for relapsing-remitting, primary progressive and secondary progressive multiple sclerosis (RRMS, PPMS and SPMS).
We present a real-world safety and efficacy analysis of ocrelizumab therapy in a comprehensive multiple sclerosis center.
A query to Genentech’s MyPatientSolutions for patients prescribed and treated with OCR through the University of Florida’s MS Center between March 2017 and June 2020 produced a sample of 163 patients. Data was captured through electronic chart review, stored in REDCap, and exported to SPSS for statistical analysis.
Patients had a mean age of 48.1 years (range 22-73), were predominantly female (68.7%). Of the 163 patients, 66.2% had RRMS, 20.9% SPMS, and 12.9% PPMS. Infusion reactions (IR) were reported in 41 patients (25.1%), 11 of whom had recurrent IRs. At least one infection occurred in 42 patients (25.8%), with 20 (12.2%) experiencing recurrent infections. Urinary tract infection (UTI) was most commonly reported, followed by respiratory tract infection with women being more likely to have an infection (73.1%, p=0.016). Malignancies were reported in 4 patients (2.5%), 2 breast cancer, 1 pancreatic carcinoma, and 1 renal cell carcinoma. Eight patients (4.9%) discontinued OCR due to IR, infection risk and patient preference. Six patients (3.7%) had gadolinium enhancing MRI lesions. Five patients (3.1%) received intravenous corticosteroids for a clinical relapse. There were 7 deaths reported, 5 of whom were on OCR at time of death. The mean age at death was 69 years. Deaths were associated with malignancy (pancreatic and renal cell carcinoma), sepsis, sudden cardiac arrest (1 patient) and unclear cause in 2 patients.
At least one occurrence of lymphopenia was reported in 39 patients (23.9%), however, persistent grade III lymphopenia was only reported in 6 patients and 2 of these patients reported recurrent infections. Similarly, persistent hypogammaglobulinemia was reported in 6 patients and persistently suppressed IgM levels in 13 patients.
OCR was effective at reducing clinical and radiographic progression. Some safety concerns were found, a larger sample and longer-term follow-up is needed to corroborate findings.