Association between the incidence of infusion-related reactions by obinutuzumab and the dose of corticosteroid as premedication: A multicenter retrospective cohort study

Abstract

Background Premedication with corticosteroids is recommended for prophylaxis against infusion-related reactions (IRRs) caused by obinutuzumab despite a lack of solid evidence regarding the dose of corticosteroids. Methods We investigated the incidence of IRRs in the high-dose (patients who received 100 mg or higher of prednisolone, 80 mg or higher of methylprednisolone, or 16.5 mg or higher of dexamethasone) and low-dose (patients who received a dose lower than that in those groups or those who take hydrocortisone) corticosteroid groups. Results The incidence of IRRs in the high-dose and low-dose corticosteroid groups at the initial administration of obinutuzumab was 27.0% (41/152) and 48.4% (31/64), respectively, indicating that the high-dose group had a lower incidence of IRRs (p = 0.002). The incidence of IRRs at the initial administration of obinutuzumab was significantly associated with the administration of first-generation histamine 1 receptor antagonist (odds ratio = 3.70, 95% confidence interval: 1.47–9.28; reference: second-generation histamine 1 receptor antagonist), hydrocortisone (odds ratio = 6.49, 95% confidence interval: 1.53–27.46; reference: dexamethasone), and methylprednisolone (odds ratio = 1.38, 95% confidence interval:1.10–12.16; reference: dexamethasone), although no association was found with the lower dose of corticosteroids. Conclusions Higher doses of corticosteroids as premedication can reduce the incidence of IRRs by obinutuzumab than lower doses. Dexamethasone may be a better choice for IRRs prophylaxis rather than hydrocortisone or methylprednisolone, and second-generation histamine 1 receptor antagonists may be a better choice rather than first-generation drugs.