Immune Checkpoint Inhibitors and Hypothyroidism: An Emerging Public Health Challenge Identified Through a Systematic Review of ClinicalTrials.gov.
- 1Independent Research, Belmont High School, Belmont, USA.
- 2Psychological and Brain Sciences, Microbiology, University of Massachusetts Amherst, Amherst, USA.
- 3Internal Medicine, Virginia Mason Medical Center, Federal Way, USA.
Abstract
Immune checkpoint inhibitors (ICIs) have transformed cancer treatment, but their growing use has exposed a class of immune-related side effects with lasting consequences, most notably hypothyroidism. Unlike many other drug-related toxicities, ICI-associated hypothyroidism is frequently permanent, requiring lifelong thyroid hormone replacement. As the number of long-term cancer survivors continues to rise, this condition is an underrepresented public health problem. This study aimed to characterize how often hypothyroidism is reported as an adverse event (AE) across ICI clinical trials using publicly available data from ClinicalTrials.gov and to examine the public health implications of these findings. We expected hypothyroidism to be common, particularly with programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and combination regimens, and that registry-reported frequencies would be high enough to justify wider surveillance beyond individual clinical care. Using a PRISMA 2020-aligned registry-based systematic review, we screened interventional oncology trials with posted results and extracted thyroid-related AE data for descriptive analysis. Across eligible trials, hypothyroidism was consistently reported, with trial-reported proportions ranging from low single digits to over 30%, with the highest frequencies seen in combination ICI regimens. These findings demonstrate that ICI-associated hypothyroidism is frequently reported across clinical trials and support the need for standardized thyroid monitoring, long-term endocrine follow-up, and integration of thyroid toxicity surveillance into survivorship care and health system planning.
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BibTeX
@article{wu2026immune,
title = {{Immune Checkpoint Inhibitors and Hypothyroidism: An Emerging Public Health Challenge Identified Through a Systematic Review of ClinicalTrials.gov.}},
author = {Jeffrey Wu and Xuetao Wu and Hong Ren},
journal = {Cureus},
year = {2026},
month = sep,
doi = {10.7759/cureus.117019},
url = {https://europepmc.org/article/MED/42948510},
note = {CC BY},
}
RIS
TY - JOUR
TI - Immune Checkpoint Inhibitors and Hypothyroidism: An Emerging Public Health Challenge Identified Through a Systematic Review of ClinicalTrials.gov.
AU - Jeffrey Wu
AU - Xuetao Wu
AU - Hong Ren
PY - 2026
DA - 2026/09/27
JO - Cureus
DO - 10.7759/cureus.117019
UR - https://europepmc.org/article/MED/42948510
AB - Immune checkpoint inhibitors (ICIs) have transformed cancer treatment, but their growing use has exposed a class of immune-related side effects with lasting consequences, most notably hypothyroidism. Unlike many other drug-related toxicities, ICI-associated hypothyroidism is frequently permanent, requiring lifelong thyroid hormone replacement. As the number of long-term cancer survivors continues to rise, this condition is an underrepresented public health problem. This study aimed to characterize how often hypothyroidism is reported as an adverse event (AE) across ICI clinical trials using publicly available data from ClinicalTrials.gov and to examine the public health implications of these findings. We expected hypothyroidism to be common, particularly with programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and combination regimens, and that registry-reported frequencies would be high enough to justify wider surveillance beyond individual clinical care. Using a PRISMA 2020-aligned registry-based systematic review, we screened interventional oncology trials with posted results and extracted thyroid-related AE data for descriptive analysis. Across eligible trials, hypothyroidism was consistently reported, with trial-reported proportions ranging from low single digits to over 30%, with the highest frequencies seen in combination ICI regimens. These findings demonstrate that ICI-associated hypothyroidism is frequently reported across clinical trials and support the need for standardized thyroid monitoring, long-term endocrine follow-up, and integration of thyroid toxicity surveillance into survivorship care and health system planning.
SN - 2168-8184
ER -