Monteiro Beatriz P, Simon Anthony, Knesl Oliver, Mandello Kristen, Nederveld Steven, Olby Natasha J, Innes John F, Lascelles B Duncan X
Global Medical Affairs, Zoetis, Parsippany, NJ, United States.
Veterinary Medicine Research and Development, Global Pharmacovigilance, Zoetis, Parsippany, NJ, United States.
Front Vet Sci. 2025 Apr 24;12:1558222. doi: 10.3389/fvets.2025.1558222. eCollection 2025.
Continuous product monitoring post approval builds on the knowledge gained during clinical studies to aid in understanding a product's safety and efficacy profile. Pharmacovigilance reporting of a medicinal product might be influenced by several factors including duration in the market, geographical region and veterinary practices. The goals of this report are to present the global data accrued for bedinvetmab, the first monoclonal antibody for canine osteoarthritis, and to explore reporting patterns globally and across major markets.
Adverse event reports from the Zoetis Global Pharmacovigilance database (from first introduction on 01 February 2021 through 30 June 2024) were collected irrespective of suspected causality or off-label use. Each adverse event was coded using the Veterinary Dictionary for Drug Related Affairs (VeDDRA) terminology. The top 20 most reported VeDDRA terms were identified. Countries were ranked by number of doses distributed and frequency of adverse events.
Globally, 18,102,535 doses of bedinvetmab were sold during the study period with a total of 17,162 adverse events reported in dogs (9.48 events/10,000 treated animals (doses)). Eight clinical signs were considered rare (1-10 events/10,000 treated animals (doses)) with lack of efficacy having the highest rate (1.70) followed by polydipsia, ataxia, polyuria/pollakiuria, anorexia, lethargy, death, and emesis. All other clinical signs were considered very rare (< 1 event/10,000 treated animals (doses)). Median (interquartile range) of dogs' age and body weight were 12 (10-13) years and 26 (16-34.6) kg, respectively. The top eight countries by market size were United States (US), United Kingdom (UK), Germany, Spain, France, Italy, Canada, and Australia; from these, the top five by frequency of adverse events were Canada, US, UK, Australia and Germany. The most reported adverse events following bedinvetmab are considered rare or very rare.
The reported clinical signs generally aligned with expected adverse events or were anticipated within the population receiving bedinvetmab. Reporting rates and patterns in general and for specific VeDDRA terms greatly varied between countries and were not related to market size. Most dogs for which adverse events were reported were considered older and in fair clinical condition. Reporting to pharmacovigilance contributes to the understanding of the safety profile of a medicinal product.
批准后对产品进行持续监测，是基于临床研究中获得的知识，以帮助了解产品的安全性和有效性概况。药品的药物警戒报告可能受到多种因素的影响，包括上市时间、地理区域和兽医实践。本报告的目的是展示针对首个用于犬骨关节炎的单克隆抗体贝地维单抗积累的全球数据，并探讨全球及主要市场的报告模式。
收集硕腾全球药物警戒数据库（从2021年2月1日首次引入至2024年6月30日）中的不良事件报告，无论是否怀疑因果关系或超适应症使用。每个不良事件均使用兽药相关事务词典（VeDDRA）术语进行编码。确定报告最多的前20个VeDDRA术语。按分发剂量数量和不良事件发生频率对国家进行排名。
在研究期间，全球共售出18,102,535剂贝地维单抗，犬类共报告了17,162起不良事件（每10,000只接受治疗的动物（剂量）中发生9.48起事件）。八种临床症状被认为罕见（每10,000只接受治疗的动物（剂量）中发生1 - 10起事件），其中疗效不佳发生率最高（1.70），其次是烦渴、共济失调、多尿/尿频、厌食、嗜睡、死亡和呕吐。所有其他临床症状被认为非常罕见（每10,000只接受治疗的动物（剂量）中发生少于1起事件）。犬的年龄和体重中位数（四分位间距）分别为12（10 - 13）岁和26（16 - 34.6）千克。按市场规模排名前八位的国家是美国、英国、德国、西班牙、法国、意大利、加拿大和澳大利亚；其中，按不良事件发生频率排名前五的是加拿大、美国、英国、澳大利亚和德国。贝地维单抗之后报告最多的不良事件被认为罕见或非常罕见。
报告的临床症状总体上与预期不良事件相符，或在接受贝地维单抗治疗的人群中可以预见。各国在总体报告率和模式以及特定VeDDRA术语方面差异很大，且与市场规模无关。报告不良事件的大多数犬被认为年龄较大且临床状况一般。向药物警戒部门报告有助于了解药品的安全性概况。
