アブストラクト

Japanese

Title 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
Subtitle ノート
Authors 黒松誠1, 梶田貴司1, 樽野麻依1, 西川豊1, 赤坂尚司2, 奥野智之1
Authors (kana)
Organization 1公益財団法人天理よろづ相談所病院薬剤部, 2血液内科
Journal 医療薬学
Volume 47
Number 11
Page 631-638
Year/Month 2021 / 11
Article 報告
Publisher 日本医療薬学会
Abstract 「緒言」非ホジキンリンパ腫のうち, B細胞リンパ腫は細胞表面にCD20を発現しており, これを標的とした抗CD20モノクローナル抗体であるリツキシマブが開発されて以降, B細胞リンパ腫の治療成績は飛躍的に向上した. しかし, リツキシマブ併用化学療法に治療抵抗性を示す症例が病型によらず存在し, リツキシマブを上まわる効果をもつ抗CD20モノクローナル抗体の開発が望まれてきた. 近年, 新規抗体改変技術を用いたFc領域の糖鎖改変により直接的な細胞死の誘導活性, 抗体依存性細胞傷害(antibody dependent cellular cytotoxicity: ADCC)および抗体依存性細胞貪食(antibody dependent cell mediated phagocytosis: ADCP)活性を高めた新規抗CD20モノクローナル抗体であるオビヌツズマブが開発された. 濾胞性リンパ腫患者を対象とした国際共同第III相臨床試験(GALLIUM 試験)において, オビヌツズマブ + 化学療法(G群)とリツキシマブ + 化学療法(R群)の有効性が比較され, R群に対するG群の有意な無増悪生存期間の延長を認めた一方, 有害事象の頻度はR群に比べG群で高かった.
Practice 薬学
Keywords obinutuzumab, infusion reactions, risk factor, soluble interleukin-2 receptor, lactate dehydrogenase

English

Title Search for Risk Factors Influencing the Occurrence of Infusion Reaction after Initial Treatment with Obinutuzumab
Subtitle Notes
Authors Makoto Kuromatsu1, Takashi Kajita1, Mai Taruno1, Yutaka Nishikawa1, Takashi Akasaka2, Tomoyuki Okuno1
Authors (kana)
Organization 1Department of Pharmacy, 2Department of Hematology Tenri Hospital
Journal Japanese Journal of Pharmaceutical Health Care and Sciences
Volume 47
Number 11
Page 631-638
Year/Month 2021 / 11
Article Report
Publisher Japanese Society of Pharmaceutical Health Care and Sciences
Abstract 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.
Practice Pharmaceutical sciences
Keywords obinutuzumab, infusion reactions, risk factor, soluble interleukin-2 receptor, lactate dehydrogenase
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