Clinical Features of Nivolumab-Induced Thyroiditis: A Case Series Study

Yamauchi, Ichiro; Sakane, Yoriko; Fukuda, Yorihide; Fujii, Toshihito; Taura, Daisuke; Hirata, Masakazu; Hirota, Keisho; Ueda, Yohei; Kanai, Yugo; Yamashita, Yui; Kondo, Eri; Sone, Masakatsu; Yasoda, Akihiro; Inagaki, Nobuya

doi:10.1089/thy.2016.0562

Cited by 169Cancer Immunotherapy and BiomarkersThyroid Disorders and TreatmentsAutoimmune Neurological Disorders and Treatments

Clinical Features of Nivolumab-Induced Thyroiditis: A Case Series Study

Yamauchi, Ichiro, Sakane, Yoriko, Fukuda, Yorihide, Fujii, Toshihito, Taura, Daisuke, Hirata, Masakazu, Hirota, Keisho, Ueda, Yohei +6 more·2017·Thyroid

DOI 10.1089/thy.2016.0562

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Abstract

BACKGROUND: The programmed cell death-1 (PD-1) pathway is a novel therapeutic target in immune checkpoint therapy for cancer. It consists of the PD-1 receptor and its two ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Nivolumab is an anti-PD-1 monoclonal antibody approved for malignant melanoma, advanced non-small cell lung cancer, and advanced renal cell carcinoma in Japan. Thyrotoxicosis and hypothyroidism have both been reported in international Phase 3 studies and national post-marketing surveillance of nivolumab in Japan. METHODS: This study analyzed five consecutive cases with thyroid dysfunction associated with nivolumab therapy. Second, it examined the mRNA and protein expressions of PD-L1 and PD-L2 by reverse transcription polymerase chain reaction and Western blotting. RESULTS: All patients were diagnosed with painless thyroiditis. Thyrotoxicosis developed within four weeks from the first administration of nivolumab and normalized within four weeks of onset in three of the five patients. Hypothyroidism after transient thyrotoxicosis developed in two patients, and preexisting hypothyroidism persisted in one patient. The other two patients were treated with glucocorticoids and discontinued nivolumab therapy for comorbid adverse events. One did not develop hypothyroidism, and the other developed mild, transient hypothyroidism. In addition, it was verified that normal thyroid tissue expresses PD-L1 and PD-L2 mRNA and those proteins. CONCLUSIONS: In the present cases, nivolumab-induced thyrotoxicosis seemed to be associated with painless thyroiditis, while no patient with Graves' disease was observed. A transient and rapid course with subsequent hypothyroidism was observed in nivolumab-induced thyroiditis. In addition, it was verified that PD-L1 and PD-L2 are expressed in normal thyroid tissue. This suggests that nivolumab therapy reduces immune tolerance, even in normal thyroid tissue, and leads to the development of thyroiditis. Treating thyrotoxicosis with only supportive care and considering levothyroxine replacement therapy once subsequent hypothyroidism occurs is proposed. Further investigations are required to confirm whether glucocorticoid therapy and discontinuation of nivolumab therapy prevent subsequent hypothyroidism.

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Corticosteroid therapy may influence the course of ICPi-induced thyroid dysfunction.
“Corticosteroid therapy may influence the course of ICPi-induced thyroid dysfunction [57,61].”
From Graves’ Disease during Immune Checkpoint Inhibitor Therapy (A Case Series and Literature Review) (2021) · cites this paper as [61]

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Rapid Evolution of Thyroid Dysfunction in Patients Treated with Nivolumab
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Authors: Yamauchi, I., Sakane, Y., Fukuda, Y., Fujii, T., Taura, D., Hirata, M., Hirota, K., Ueda, Y., Kanai, Y., Yamashita, Y., Kondo, E., Sone, M., Yasoda, A., & Inagaki, N.
Affiliations: Kyoto University (JP)
Corresponding author: Yamauchi, Ichiro
ORCID: Yamauchi, Ichiro
Fujii, Toshihito
Taura, Daisuke
Hirota, Keisho
Ueda, Yohei
Yamashita, Yui
Sone, Masakatsu
Yasoda, Akihiro
Inagaki, Nobuya
Venue: Thyroid
Publisher: SAGE Publications
Published: 2017-07
Volume: 27
Issue: 7
Pages: 894-901
ISSN: 1050-7256 (ISSN-L)
1557-9077
DOI: 10.1089/thy.2016.0562
OpenAlex: W2619530510
Cited by: 169
References: 39
Citations by year: 2026: 9 · 2025: 16 · 2024: 17 · 2023: 17 · 2022: 21 · 2021: 17 · 2020: 22 · 2019: 25 · 2018: 18 · 2017: 7
FWCI: 8.68
Type: journal article
Language: en
Open access: closed
Licence: journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations: Thyroid (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
Health Sciences › Medicine › Neurology › Autoimmune Neurological Disorders and Treatments
Keywords: nivolumab, immune-related adverse events, thyroiditis, thyrotoxicosis, hypothyroidism, painless thyroiditis, PD-1 pathway, PD-L1, PD-L2, immune tolerance, glucocorticoid therapy, levothyroxine replacement
MeSH terms: Nivolumab, Aged, Antibodies, Monoclonal, Antineoplastic Agents, Breast Neoplasms, Female, Humans, Lung Neoplasms, Male, Melanoma, Middle Aged, Skin Neoplasms, Thyroiditis, Thyrotoxicosis, Thyrotropin, Thyroxine, Triiodothyronine, Symptom Assessment

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Clinical Features of Nivolumab-Induced Thyroiditis: A Case Series Study

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