BACKGROUND Communicating the clinical impact of immunogenicity in labeling is important for safe and effective use of certain prescription products. Current U.S. Food and Drug Administration (FDA) guidance does not provide comprehensive recommendations on the communication of clinical impact of immunogenicity in labeling. To understand current labeling practice, we evaluated the immunogenicity data and clinical impact information in labeling of selected prescription products. METHODS We created a database of 71 therapeutic biologics and drug products that had an immunogenicity assessment initially approved by FDA's Center for Drug Evaluation and Research between 2014 and 2018. We analyzed the content and format of immunogenicity information (e.g., anti-drug antibody incidence and/or immunogenicity impact on pharmacokinetics (PK), safety, and/or effectiveness) in the most recent approved labeling. RESULTS Immunogenicity information was in the ADVERSE REACTIONS section in 98% of the reviewed labeling. Immunogenicity impact on PK was reported in 52% of the labeling, typically within the ADVERSE REACTIONS section, but supportive PK data were often not included in the CLINICAL PHARMACOLOGY section. Additionally, the immunogenicity impact on safety and/or effectiveness was communicated in 70% of the labeling, with 23% clearly communicating the effect as clinically meaningful, and 10% providing actionable recommendations. CONCLUSIONS Most of the reviewed labeling includes immunogenicity information within the ADVERSE REACTIONS section. However, there is inconsistency in providing supportive PK data and high variability in reporting immunogenicity impact on safety and effectiveness in labeling. Development of a communication framework that allows for consistent inclusion of immunogenicity impact statements in labeling could improve how immunogenicity risk is conveyed in prescription drug labeling.

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交流当前美国 FDA 处方药标签中的免疫原性相关风险：系统评价

背景在标签中传达免疫原性的临床影响对于某些处方产品的安全和有效使用很重要。目前的美国食品和药物管理局 (FDA) 指南并未就标签中免疫原性临床影响的交流提供全面的建议。为了了解当前的标签实践，我们评估了选定处方产品标签中的免疫原性数据和临床影响信息。方法 我们创建了一个包含 71 种治疗性生物制剂和药物产品的数据库，这些药物在 2014 年至 2018 年期间获得了 FDA 药物评价和研究中心最初批准的免疫原性评估。我们分析了免疫原性信息的内容和格式（例如，抗药抗体发生率和/ 或免疫原性对药代动力学 (PK)、安全性、和/或有效性）在最近批准的标签中。结果 98% 的审查标签中的免疫原性信息位于不良反应部分。52% 的标签报告了免疫原性对 PK 的影响，通常在不良反应部分，但支持性 PK 数据通常不包括在临床药理学部分。此外，70% 的标签传达了免疫原性对安全性和/或有效性的影响，23% 的人清楚地传达了具有临床意义的效果，10% 的人提供了可操作的建议。结论 大多数审查的标签包括不良反应部分中的免疫原性信息。然而，在提供支持性 PK 数据方面存在不一致，并且在报告免疫原性对标签安全性和有效性的影响方面存在很大差异。开发允许在标签中一致包含免疫原性影响陈述的沟通框架可以改善处方药标签中免疫原性风险的传达方式。