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

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. 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. 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. 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.

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Journal
Journal of Pharmaceutical Health Care and Sciences
Published
2026-02-03
DOI
https://doi.org/10.1186/s40780-026-00546-6
Primary Topic
Adrenal Hormones and Disorders
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article
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article

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

Kanji Tomogane, Tsutomu Mitsuie, Kouhei Yamagiwa, Yoshinori Wakasugi et al.
Journal of Pharmaceutical Health Care and Sciences
Adrenal Hormones and Disorders
article

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

Kanji Tomogane, Tsutomu Mitsuie, Kouhei Yamagiwa, Yoshinori Wakasugi, Tatsuya Ohtsubo, Satoshi Dote, Kazuo Sato, Hiroki Hasegawa, Saori Matumoto, Yuzuka Sasa, Yumi Kitahiro, Kazuhiro Yamamoto, Katuya Makihara, Kosuke Tomishima, Kaori Ito, Nobuhiko Uoshima
article en

Abstract

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. 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. 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. 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.

Journal of Pharmaceutical Health Care and SciencesVol. 12(1)
Fujita Health University (JP), Okayama University (JP), Kobe University Hospital (JP), Shiga University of Medical Science Hospital (JP), Rakuwakai Otowa Hospital (JP), Yodogawa Christian Hospital (JP), Kindai University Sakai Hospital (JP), Osaka Hospital (JP), Kyoto first Red Cross hospital (JP), Otsu Red Cross Hospital (JP), Kyoto Katsura Hospital (JP), Baptist Hospital (US), Japanese Red Cross Society Kyoto Daini Hospital (JP), Saiseikai Shigaken Hospital (JP), Meijo University (JP)
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