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Efficacy and Safety of Infliximab for Management of Immune-Related Adverse Events: A Retrospective Analysis

Year: 2026

Type: article

Abstract: BACKGROUND: Immune-related adverse events (irAEs) are common complications of immune checkpoint inhibitor (ICI) therapy and frequently require immunosuppressive treatment. Infliximab is commonly used for steroid-refractory irAEs; however, the optimal dosing strategy remains unclear. OBJECTIVE: The study objective is to evaluate the efficacy and safety of infliximab and assess the impact of dosing strategies across diverse irAEs. PATIENTS AND METHODS: We retrospectively analyzed patients treated at our institution who developed irAEs requiring infliximab. Patients were grouped according to infliximab starting dose and total number of doses received. Treatment outcomes and infliximab-related adverse events were assessed. RESULTS: The study included 457 patients with irAEs treated with infliximab. Among 443 patients receiving 5 mg/kg infliximab, 342 received 1-2 doses and 101 received ≥ 3 doses. Patients receiving ≥ 3 doses had higher 8-week remission rates than those receiving 1-2 doses (75 versus 49%, p < 0.01) despite a longer time to response (19 versus 6 days, p = 0.01). Univariate analysis identified baseline Common Terminology Criteria for Adverse Events (CTCAE) grade, combination immunotherapy, lower gastrointestinal toxicity, and receipt of ≥ 3 doses as predictors of response. Dose escalation to 10 mg/kg was rare, and no increase in adverse events was observed. CONCLUSIONS: Infliximab 5 mg/kg appears to be a safe and effective treatment for diverse steroid-refractory irAEs. Receipt of ≥ 3 doses was associated with higher remission rates without increased toxicity. Prospective studies are needed to define optimal dosing strategies.

Source: Targeted Oncology

DOI: 10.1007/s11523-026-01264-7