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

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Authors: Tatsuya Ohtsubo, Kazuhiro Yamamoto, Saori Matumoto, Kaori Ito, Yuzuka Sasa, Kosuke Tomishima, Satoshi Dote, Katsuya Makihara, Yoshinori Wakasugi, Tsutomu Mitsuie, Kouhei Yamagiwa, Kazuo Sato
+4 more Hiroki Hasegawa, Nobuhiko Uoshima, Yumi Kitahiro, Kanji Tomogane
Cited by: 0
References: 17

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: The incidence rates of IRR in the high-dose and low-dose corticosteroid groups were investigated and compared using Student’s t-test.Univariable and multivariable logistic regression analyses were performed on patients to explore the risk of developing IRRs with obinutuzumab. 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 (OR = 3.31, 95% CI: 1.16–9.47; reference: second-generation histamine 1 receptor antagonist), hydrocortisone (OR = 7.21, 95% CI: 1.57–33.15; reference: dexamethasone), and methylprednisolone (OR = 3.99, 95% CI :1.13–14.10; reference: dexamethasone), although no association was found with the lower dose of corticosteroids. CONCLUSIONS: Although no association was found between corticosteroid dosage and IRR when considering multiple factors, dexamethasone may be a better option than hydrocortisone or methylprednisolone for preventing IRR. Additionally, second-generation H1-receptor antagonists may be a better option than first-generation drugs. Certain combinations of premedications may influence infusion reaction incidence.

Fields of Study & Subjects

Chronic Lymphocytic Leukemia Research Drug-Induced Adverse Reactions Pharmacovigilance and Adverse Drug Reactions

Publication details

Journal / source
Journal of Pharmaceutical Health Care and Sciences
Volume
12
Issue
1
Publication date
3 February 2026
Language
EN