Evidence map›Paper›PMID 41087308›Full record

ArticleRenal failure2025

Immune checkpoint inhibitor-induced nephrotic syndrome: a pharmacovigilance analysis of 404 FAERS cases and literature case series.

Jingjing Ye, Jiangfeng Huang, Leping Shao, Zhi Wang

Abstract read
In one paragraph

Article in Renal failure, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Review
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

4 authors.

Jingjing YeThe First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.
Jiangfeng HuangThe First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.
Leping ShaoDepartment of Nephrology, (Fujian Provincial Clinical Research Center for Glomerular Nephritis) The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.
Zhi WangDepartment of Nephrology, (Fujian Provincial Clinical Research Center for Glomerular Nephritis) The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Immune checkpoint inhibitor (ICI)-related nephrotic syndrome is a rare but increasingly reported adverse event, where early-onset severe cases warrant heightened vigilance. This pharmacovigilance study assessed this correlation by analyzing the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) database from Q1 2011 to Q1 2025. A total of 404 cases of ICI-related nephrotic syndrome were identified in the FAERS database, with 84.1% of cases related to programmed cell death protein 1 (58.9%) or programmed death-ligand 1 (25.2%) inhibitors. Disproportionality signals were observed for six ICI monotherapies and one combination therapy: atezolizumab (ROR 6.84; 95% CI: 5.58-8.40), avelumab (ROR 5.54; 95% CI: 2.64-11.63), nivolumab (ROR 4.37; 95% CI: 3.64-5.25), pembrolizumab (ROR 3.44; 95% CI: 2.88-4.10), durvalumab (ROR 2.03; 95% CI: 1.12-3.66), ipilimumab (ROR 2.05; 95% CI: 1.07-3.94), and the combination therapy of nivolumab and ipilimumab (ROR 4.56; 95% CI: 3.56-5.83). Firth multivariate logistic regression analysis identified several independent risk factors, including advanced age (>65 years), malignant renal neoplasm, malignant mesothelioma, and the concomitant use of bevacizumab or lenvatinib. The median onset time was significantly shorter for severe cases than for non-severe cases (22.5 vs. 96.5 days, respectively;

Indexed as

Immune Checkpoint InhibitorsNephrotic SyndromeAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overAntibodies, Monoclonal, HumanizedDatabases, FactualFemaleHumansMaleMiddle AgedNivolumabPharmacovigilanceUnited StatesUnited States Food and Drug AdministrationAntibodies, Monoclonal, HumanizedatezolizumabImmune Checkpoint InhibitorsNivolumabFAERS databaseImmune checkpoint inhibitorimmune-related adverse eventsnephrotic syndromeoncologypharmacovigilance

Identifiers

PMID41087308
PMCPMC12523462

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Registered trials

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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.