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Peer-reviewedCC BY 4.0Frontiers in Immunology

Clinical characteristics of cadonilimab-associated infusion reactions: a severity-stratified analysis of 52 cases and preliminary management framework

4 affiliations
  1. 1Department of Pharmacy, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
  2. 2Department of Pharmacy, The People’s Hospital of Jianyang City
  3. 3Department of Clinical Pharmacy, Yantai Traditional Chinese Medicine Hospital
  4. 4Department of Gastroenterology and Urology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Abstract

Objective: To describe the clinical characteristics of infusion-related reactions (IRRs) associated with cadonilimab in a real-world cohort and propose preliminary management considerations based on these observations.

Methods: A descriptive retrospective case series was conducted, involving data collection from 52 patients who received cadonilimab and subsequently experienced infusion-related reactions at a tertiary hospital between July 2022 and December 2025. Patients were classified into a common IRR group (n=31) and a severe IRR group (n=21) based on the severity criteria outlined in CTCAE 6.0. We conducted a comparative analysis of baseline characteristics, IRR onset timing, clinical manifestations, management strategies, and outcomes between the two groups.

Results: The median time to IRR onset was 20 minutes post-infusion, with the highest proportion of recorded IRR cases occurring during the second treatment cycle (42.3%). Severe IRR manifested as multi-organ involvement in 61.9% of cases, predominantly affecting the respiratory and cardiovascular systems. Patients with severe IRR more frequently received corticosteroids combined with antihistamines (57.1% vs. 29.0%) and had higher rates of premedication (76.2% vs. 45.2%). Twenty-four patients (46.2%) attempted same-cycle infusion resumption; among these, 15 (62.5%) successfully completed the infusion without symptom recurrence. Among the 10 severe-group patients who attempted same-cycle infusion resumption, 6 (60.0%) experienced recurrent symptoms; among all 21 severe-group patients, the recurrence rate was 28.6% (6/21). The clinically relevant same-cycle recurrence rates were 9/24 overall (37.5%), 3/14 (21.4%) in the common group, and 6/10 (60.0%) in the severe group.

Conclusion: Cadonilimab is associated with early-onset infusion-related reactions frequently involving multiple organ systems. Based on our institutional experience, we propose a preliminary management framework that requires prospective validation before it can be recommended for routine clinical practice.

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BibTeX
@article{li2026clinical,
  title = {{Clinical characteristics of cadonilimab-associated infusion reactions: a severity-stratified analysis of 52 cases and preliminary management framework}},
  author = {Jinlan Li and Rui Qiu and Guisen Yin and Yong Pan and Po Chen},
  journal = {Frontiers in Immunology},
  year = {2026},
  month = oct,
  doi = {10.3389/fimmu.2026.1815365},
  url = {https://www.frontiersin.org/articles/10.3389/fimmu.2026.1815365/full},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Clinical characteristics of cadonilimab-associated infusion reactions: a severity-stratified analysis of 52 cases and preliminary management framework
AU  - Jinlan Li
AU  - Rui Qiu
AU  - Guisen Yin
AU  - Yong Pan
AU  - Po Chen
PY  - 2026
DA  - 2026/10/09
JO  - Frontiers in Immunology
DO  - 10.3389/fimmu.2026.1815365
UR  - https://www.frontiersin.org/articles/10.3389/fimmu.2026.1815365/full
AB  - Objective: To describe the clinical characteristics of infusion-related reactions (IRRs) associated with cadonilimab in a real-world cohort and propose preliminary management considerations based on these observations.  Methods: A descriptive retrospective case series was conducted, involving data collection from 52 patients who received cadonilimab and subsequently experienced infusion-related reactions at a tertiary hospital between July 2022 and December 2025. Patients were classified into a common IRR group (n=31) and a severe IRR group (n=21) based on the severity criteria outlined in CTCAE 6.0. We conducted a comparative analysis of baseline characteristics, IRR onset timing, clinical manifestations, management strategies, and outcomes between the two groups.  Results: The median time to IRR onset was 20 minutes post-infusion, with the highest proportion of recorded IRR cases occurring during the second treatment cycle (42.3%). Severe IRR manifested as multi-organ involvement in 61.9% of cases, predominantly affecting the respiratory and cardiovascular systems. Patients with severe IRR more frequently received corticosteroids combined with antihistamines (57.1% vs. 29.0%) and had higher rates of premedication (76.2% vs. 45.2%). Twenty-four patients (46.2%) attempted same-cycle infusion resumption; among these, 15 (62.5%) successfully completed the infusion without symptom recurrence. Among the 10 severe-group patients who attempted same-cycle infusion resumption, 6 (60.0%) experienced recurrent symptoms; among all 21 severe-group patients, the recurrence rate was 28.6% (6/21). The clinically relevant same-cycle recurrence rates were 9/24 overall (37.5%), 3/14 (21.4%) in the common group, and 6/10 (60.0%) in the severe group.  Conclusion: Cadonilimab is associated with early-onset infusion-related reactions frequently involving multiple organ systems. Based on our institutional experience, we propose a preliminary management framework that requires prospective validation before it can be recommended for routine clinical practice.
SN  - 1664-3224
ER  -