Neurológia pre prax 1/2022

Experience with shortened ocrelizumab infusion – ENSEMBLE PLUS study

Ocrelizumab (OCR) is humanized monoclonal antibody selectively directed against CD20 + B cells that is approved for the treatment of relapsing remitting and primary progressive multiple sclerosis. OCR is administered intravenously for 3.5 hours. With observation and premedication will the patient spend about 5.5 hours in the infusion centre. The primary objective of the ENSEMBLE PLUS study was to compare the frequency and severity of infusion-related reactions (IRRs) between groups of patients with conventional and shorter 2-hours infusions occurring within or within 24 hours after the first randomized dose. In the population of 580 patients, IRR occurred in the conventional group in 23.1% of patients compared to 24.6% in the shorter infusion group. Most IRRs were mild or moderate, only one patient in each infusion group underwent a severe IRR. There were no serious, life-threatening or fatal IRRs. The results demonstrate that the frequency and severity of IRRs were similar when compared conventional and shorter OCR infusions. Conclusion: The intervention study provides evidence that shorter infusion administration of OCR is safe, reduces the time spent in the infusion centre, and reduces the overall patient and site staff burden, especially taking into account the current COVID-19 pandemic.

Keywords: infusion-related reaction, monoclonal antibodies, multiple sclerosis, ocrelizumab