Real-world Use of Monoclonal Anti-Tetanus Toxin Antibody for Post-Traumatic Passive Immunization: A Nationwide Survey in China

Purpose To investigate the current status of monoclonal anti-tetanus toxin antibody used for passive immunization in the prevention and management of post-traumatic tetanus in China, and to provide evidence for the selection of passive immunization agents for tetanus prophylaxis. Methods This retrospective, multicenter, real-world survey included patients who received a monoclonal anti-tetanus toxin antibody (siltartoxatug injection) for passive immunization following traumatic injury at participating hospitals across China between March 1 and August 20, 2025. Patients with incomplete registration data or at least 1 missing key variable were excluded. Demographic, clinical, wound-related, payment, and follow-up information was collected. According to the National Clinical Practice Guideline for Non-neonatal Tetanus Prevention and Treatment (2024 Edition), patients were classified into high- and low-risk tetanus exposure groups based on vaccination history, booster interval, wound characteristics, and immune status. Demographic, clinical, and wound-related characteristics were compared between the 2 groups. Statistical analyses were performed using IBM SPSS Statistics, version 26.0 (IBM Corp., Armonk, NY, USA). Categorical variables were presented as frequencies and percentages and compared using the chi-square test or Fisher's exact test, as appropriate. All statistical tests were two-sided, and a p value < 0.05 was considered statistically significant. Results A total of 423 hospitals from 28 provinces, autonomous regions, and municipalities participated in the survey and provided case data. Among 1474 patients who received monoclonal anti-tetanus toxin antibody for passive immunization following trauma, no tetanus cases were documented during the available observation period; however, follow-up duration was not standardized across centers, and the protective efficacy of the monoclonal antibody could not be definitively evaluated. Conclusion Standardized wound assessment and appropriate selection of passive immunization agents are crucial for tetanus prevention. Monoclonal anti-tetanus toxin antibody represents an effective and promising option for passive immunization against tetanus.