A Case Report of a Multisystemic Immune-Related Adverse Event Caused by Sintilimab in Combination With Thymosin Alpha-1.

This case report describes a nasopharyngeal carcinoma patient who developed severe multisystem immune-related adverse events (irAEs) following combination treatment with sintilimab (a PD-1 immune checkpoint inhibitor) and thymosin alpha-1 (Tα1), an immunomodulatory peptide. The patient reportedly experienced high fever, skin rash, interstitial pulmonary edema, and multiple organ failure. The authors trace the clinical course from symptom onset through regression and use this case to discuss the potential risks of combining immune checkpoint inhibitors (ICIs) with immunomodulatory agents, suggesting that such combinations may trigger immune overactivation beyond what either agent causes alone. The paper reviews relevant literature to contextualize the case and proposes management strategies for clinicians encountering similar presentations. Key limitations include the inherent constraints of single-patient case reports: causality cannot be firmly established, findings are not generalizable, and confounding factors (e.g., underlying disease burden, other medications) cannot be fully excluded. The authors emphasize the need for heightened clinical vigilance when combining ICIs with immunomodulators like Tα1.

Why this grade: A single case report in one human patient provides only limited, anecdotal evidence; no control group or systematic data collection was possible, precluding causal conclusions.