ArticleThe oncologist2022
Immune Checkpoint Inhibitor-related New-onset Thyroid Dysfunction: A Retrospective Analysis Using the US FDA Adverse Event Reporting System.
Article in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Addition of immune checkpoint inhibitor to standard of care chemoradiotherapy in patients with locally advanced nasopharyngeal carcinoma: a systematic review and meta-analysis.Exploration of targeted anti-tumor therapy · 2026Pooled it
- Across the Social Network of the Gut: Bacterial, Fungal, and Viral Determinants of Checkpoint Inhibitor Efficacy and Toxicity.International journal of molecular sciences · 2026Review
- Sex-specific reporting patterns and onset timing of immune-related adverse events associated with nivolumab and pembrolizumab: a dual-database pharmacovigilance analysis.Frontiers in immunology · 2026Article
- The Real-World Endocrine Toxicity Profile of ICIs, VEGFR-TKIs, and Their Combination: Analysis of the FDA Adverse Event Reporting System (FAERS) Database.Oncology research · 2026Article
- Metabolomics Reveals Potential Biomarkers for Early Detection of irAEs in ICI-Treated Patients.Drug design, development and therapy · 2026Article
- Impact of dermatology targeted immunotherapies on autoimmune thyroid diseases: cytokine-network crosstalk and thyroid safety.Frontiers in immunology · 2026Review
- ICPi-Induced Graves' Disease with Pre-existing Autoimmune Thyroid Disorders: A Case Report and Literature Review.Endocrine, metabolic & immune disorders drug targets · 2026Review
- Immune checkpoint inhibitor-related thyroid dysfunction during treatment of lung cancer: a disproportionality analysis based on the FDA adverse event reporting system.Frontiers in immunology · 2026Article
- Baseline thyroid function and treatment-emergent thyroid dysfunction predict pathological response and survival after neoadjuvant PD-1 inhibitor plus platinum-based chemotherapy in locally advanced gastric and gastroesophageal junction adenocarcinoma: a multicenter cohort study.Frontiers in endocrinology · 2026Article
- Sex differences in the onset and outcomes of immune checkpoint inhibitor-induced overt thyroid dysfunction: a retrospective study.Endocrine · 2025Article
- Risk factors and outcomes of thyroid immune-related adverse events following PD-1/PD-L1 inhibitors treatment in a large tertiary Chinese center.BMC endocrine disorders · 2025Article
- Mapping the genetic-transcriptional landscape of thyroid irAEs in sintilimab therapy: toward biomarker-guided immunotoxicity prediction.Frontiers in immunology · 2025Article
- Thyroid disorders induced by immune checkpoint inhibitors.Endocrine · 2024Review
- Thyroid dysfunction after immune checkpoint inhibitors in a single-centre UK pan-cancer cohort: A retrospective study.European journal of cancer (Oxford, England : 1990) · 2024Article
- Endocrine adverse events in patients with cancer receiving perioperative immune checkpoint blockade: a meta-analysis of randomized controlled trials.Therapeutic advances in medical oncology · 2024Article
- Immune-related thyroid dysfunction as a positive prognostic factor for patients with lung cancer in China: a real-world retrospective study.Frontiers in immunology · 2024Article
- Primary Thyroid Dysfunction Is Prevalent in Hidradenitis Suppurativa and Marked by a Signature of Hypothyroid Graves' Disease: A Case-Control Study.Journal of clinical medicine · 2023Article
- Endocrine Side Effects in Patients Treated with Immune Checkpoint Inhibitors: A Narrative Review.Journal of clinical medicine · 2023Review
- Severe thyrotoxicosis induced by tislelizumab: a case report and literature review.Frontiers in oncology · 2023Article
- Drug Repurposing to Enhance Antitumor Response to PD-1/PD-L1 Immune Checkpoint Inhibitors.Cancers · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe study aimed to investigate the prevalence and demographic characteristics of an immune checkpoint inhibitor (ICI)-related thyroid dysfunction (ICI-TD), and to explore risk factors of poor clinical outcome using data from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS).
methodsThis is a retrospective study. All cases, aged over 18-year olds, of new-onset or new-diagnosed thyroid dysfunction related to FDA-approved ICIs from January 1, 2011 to December 31, 2020 were identified using FAERS. Data of age, gender, other combined endocrinopathies related to ICIs besides ICI-TDs, and the prognosis was analyzed.
resultsIn total, 2.60% (2971/114 121) cases of ICI-TDs were identified. Among them, 1842 (62.0%) developed hypothyroidism, 675 (22.7%) were hyperthyroidism, and 454 (15.3%) presented in thyroiditis without the mention of thyroid function. Patients on anti- programmed cell death protein-1 (PD-1) therapy displayed higher risk of hypothyroidism compared with other 3 regimens, respectively (P < .01 for all). The likelihood of other immune-related endocrinopathies in patients on the combination therapy of anti-cytotoxic T-cell-associated protein-4 (CTLA-4) and anti-PD-1 was significantly elevated than anti-PD-1 (odds ratio [OR] 2.362, 95% confidence interval [CI] [1.925-2.898], P < .001) and anti-programmed death-ligand 1 (PD-L1) regimens (OR 4.857, 95%CI [3.228-7.308], P < .001). The risk of severe cases was positively related to hypothyroidism in individuals on anti-PD-1 therapy (OR 1.587, 95%CI [1.146-2.197], P = .005) and those on anti-CTLA-4 therapy (OR 3.616, 95%CI [1.285-10.171], P = .015). The risk of severe cases was positively associated with the comorbidity with other endocrinopathies (anti-PD-1 group, OR 0.285, 95%CI [0.200-0.467], P < .001; anti-PD-1+anti-CTLA-4 group, OR 0.574, 95%CI [0.371-0.890], P = .013).
conclusionsRegular monitor of thyroid function is indispensable, since ICI-TDs manifested as hypothyroidism or hyperthyroidism, especially those on the combination therapy. Awareness among health care professionals is critical when hypothyroidism occurs, which might indicate poor clinical outcomes.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.