Reduction in ocrelizumab-induced infusion reactions by a modified premedication protocol.

Abstract

BACKGROUND\nOcrelizumab is a monoclonal antibody directed against CD20+\u202fB cells that is approved for MS. The most common side effect is infusion-associated reactions (IARs). This study examines whether a modified premedication protocol reduces incidence of IARs and further examines predictors of IARs.\n\n\nMETHODS\nPatients took cetirizine 10\u202fmg, ranitidine 75\u202fmg, and increased hydration the night before the ocrelizumab infusion. This regimen was repeated the next day prior to arrival. Just prior to the infusion, patients were pretreated with IV diphenhydramine 50\u202fmg, IV methylprednisolone 125\u202fmg, and oral acetaminophen 650\u202fmg. Rates of IARs with this modified protocol were compared to patients who had received only pretreatment medications.\n\n\nRESULTS\n207 patients received ocrelizumab. With the modified premedication protocol, we found significant decreased odds of IARs (OR 0.40, p\u202f=\u202f0.024, 95% CI (0.18, 0.88). Among the baseline characteristics, there was a significant reduction of IARs with increasing age (OR 0.94, p\u202f=\u202f0.001) and male sex (OR 0.34, p\u202f=\u202f0.034). Body mass index (BMI) increased the odds of IARs (OR 1.07, p\u202f=\u202f0.029). Race and smoking status did not affect IARs.\n\n\nCONCLUSION\nThe modified premedication protocol described herein significantly decreases rates of IARs by 60% and suggests that the additional premedication regimen is beneficial. Age and male sex are protective for IARs while BMI is a risk factor for IARs.