Evidence map›Paper›PMID 40775786›Full record

ArticleJournal of pharmaceutical health care and sciences2025

Association between antibody-dependent cellular cytotoxicity activity of antitumor antibodies and infusion reactions: a pharmacovigilance analysis using the Japanese adverse drug event report database.

Yusuke Tabuchi, Masayuki Tsujimoto, Yuna Kise, Tomomi Sakamoto, Miyu Matsuda, Tadashi Kosaka, Kohshi Nishiguchi

Abstract read
In one paragraph

Article in Journal of pharmaceutical health care and sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Yusuke TabuchiLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan.
Masayuki TsujimotoLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan.
Yuna KiseLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan.
Tomomi SakamotoLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan.
Miyu MatsudaLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan.
Tadashi KosakaDepartment of Pharmacy, University Hospital, Kyoto Prefectural University of Medicine, 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan.
Kohshi NishiguchiLaboratory of Clinical Pharmacy, Kyoto Pharmaceutical University, 5 Misasagi-Nakauchi-cho, Yamashina-ku, Kyoto, Japan. kohshi@mb.kyoto-phu.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInfusion reactions (IRs) are common adverse events associated with biologics, often triggered by cytokine release from immune and tumor cells. Antibody-dependent cellular cytotoxicity (ADCC) is a key immune mechanism in which therapeutic antibodies recruit immune effector cells, such as natural killer cells, to induce target cell lysis. This study aimed to clarify the association between activated ADCC and IRs in antitumor antibodies using the Japanese Adverse Drug Event Report (JADER) database.

methodsData from the JADER database (April 2004 to February 2022) were analyzed to identify IRs related to 25 antitumor antibodies. The reporting odds ratio (ROR) was calculated to assess the association between IRs and antitumor antibodies, and statistical analyses were conducted using Fisher's exact test.

resultsAvelumab was the only anti-PD-1/PD-L1 antibody with a significant association with IRs (ROR: 5.44, 95% confidence interval [CI]: 3.59-8.22). Antibodies with ADCC activity detected significantly more IR signals (9/14, 64.3%) than those without ADCC activity (1/11, 9.1%; p = 0.0119).

conclusionsThis study suggests an association between ADCC and the occurrence of IRs in antitumor antibodies based on JADER database analysis. These findings provide valuable insights for the prevention and management of IRs.

Indexed as

Antibody-dependent cellular cytotoxicityAntitumor antibodiesCytokine releaseInfusion reactions

Identifiers

PMID40775786
PMCPMC12333062

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.