オビヌツズマブ投与時におけるinfusion reaction発現に影響を与える因子の探索

抄録

Obinutuzumab, a novel glyco-engineered anti-CD20 monoclonal antibody, has been developed to have superior efficacy to rituximab. Although obinutuzumab frequently causes infusion reactions (IR) during initial administration, there have been few reports about the frequency and risk factors for IR. In this study, we investigated the frequency of clinically relevant IR during obinutuzumab administration and explored the risk factors associated with obinutuzumab-induced IR. We included patients who were administered obinutuzumab for CD20⁺ B-cell non-Hodgkin lymphoma treatment at the Department of Hematology in Tenri Hospital from September 2018 to September 2020. Twenty-five patients were included (13 men and 12 women) and their median age was 68 (49 - 81 years). Nine (36％) of these patients developed IR (grade ≧ 2). Comparison of patient characteristics between IR and non-IR groups showed that the incidence of IR during obinutuzumab administration was related to soluble interleukin-2 receptor (sIL-2R) and lactate dehydrogenase (LDH) levels. The results of ROC curve analysis revealed the cut-off values of sIL-2R and LDH were 3,201 U/mL and 260 U/L, respectively, and AUC of ROC curve for sIL-2R and LDH were estimated at 0.75 and 0.72, respectively. The higher IR incidence was detected when sIL-2R levels exceeded 3,201 U/mL. In addition, the number of patients who developed IR at sIL-2R ≧ 3,201 U/mL and/or LDH ≧ 260 U/L was larger than that at sIL-2R ≧ 3,201 U/mL. The combined biomarker, sIL-2R and LDH may be useful for prediction of the occurrence of IR after the initial administration of obinutuzumab.