Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (8): 892-897.
DOI: 10.19803/j.1672-8629.20260414

Previous Articles     Next Articles

Multicenter case analysis of thyroid dysfunction associated with immune checkpoint inhibitors

Lyu Xinge1,2, Liu Aijia3, Wu Yi1, Pan Chen1, Wang Yuting1,2, Cui Xiangli1,*   

  1. 1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China;
    2School of Pharmaceutical Sciences, Capital Medical University, Beijing 100069, China;
    3School of Basic Medical Sciences, Capital Medical University, Beijing 100069, China
  • Received:2026-05-22 Online:2026-08-15 Published:2026-08-17

Abstract: Objective To analyze cases of immune checkpoint inhibitors-related thyroid dysfunction (ICIs-TD) from both multicenter and literature sources in order to provide a reference for early clinical identification and optimization of management strategies. Methods Patients with malignancies who developed thyroid dysfunction following ICIs therapy were retrospectively enrolled from six hospitals between August 2024 and July 2025. CNKI, Wanfang, VIP, PubMed, Web of Science, Scopus, Embase, and Cochrane Library were searched for literature related to ICIs-TD that was published as of October 2025. Clinical characteristics were summarized and statistically analyzed. Results A total of 70 patients with ICIs-TD were enrolled from six hospitals, including 47 cases of hypothyroidism, 17 cases of hyperthyroidism, and 6 cases of thyroiditis. A total of 238 articles involving 265 cases of ICIs-TD were included in literature review, comprising 127 cases of hypothyroidism, 53 cases of hyperthyroidism, and 85 cases of thyroiditis. Hypothyroidism was the dominating condition, and most patients received programmed cell death-1 (PD-1) inhibitors. More than 60% of the patients developed ICIs-TD within 4 months of ICIs therapy. The median time to onset was 97 (66.5, 133.5) days in the multicenter cohort and 63 (42, 105) days in literature, respectively. The symptoms were generally mild, with more than half of the patients continuing ICIs. Management strategies included thyroid hormone replacement or symptomatic treatment with β-blockers, and the overall prognosis was favorable. Conclusion Regular monitoring of thyroid function and antibodies during ICIs therapy is recommended, especially in high-risk populations, in order to facilitate early detection of thyroid injury. Frequent interruption of immunotherapy should be avoided to support individualized precision management.

Key words: Thyroid Dysfunction, Immune Checkpoint Inhibitors, Immune Related Adverse Events, Case Analysis, Adverse Drug Reaction

CLC Number: