Bedinvetmab (Librela/Beransa) in dogs raises safety concerns, including rapidly progressive osteoarthritis, and warrants vigilant adverse event reporting.

IF 2.3 2区 农林科学 Q2 VETERINARY SCIENCES
Dirsko J F von Pfeil, Robert J Adams, Louise Clark, Curtis W Dewey, Matthew W Brunke, Michael Garner, Otto I Lanz, Nate Miller, Lee Breshears, Loïc M Déjardin, Andrew Armitage, Kei Hayashi, Aldo Vezzoni
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引用次数: 0

Abstract

Bedinvetmab (Librela/Beransa) is a canine anti-nerve growth factor monoclonal antibody (aNGFmAb) approved for the management of osteoarthritis pain. By neutralizing NGF, it reduces nociceptive signaling and improves comfort. However, NGF plays critical roles in neural, bone, and cartilage homeostasis across species. Multiple studies indicate that NGF contributes to bone remodeling and cartilage repair by modulating osteoblast, osteoclast, and chondrocyte activity, processes that are highly active in osteoarthritic joints. In humans, rodents, and rabbits, inhibition of NGF is associated with rapidly progressive osteoarthritis, a serious adverse event characterized by accelerated joint destruction and collapse, which ultimately prevented regulatory approval of human aNGFmAbs-yet the canine aNGFmAb, bedinvetmab, received marketing authorization. Emerging clinical signals in canine patients raise concern that NGF blockade may similarly mask early structural deterioration, potentially accelerating osteolysis and chondrolysis in both index joints and nonindex joints. Although purportedly rare, those adverse drug events are irreversible and often catastrophic, resulting in rapid joint degeneration, progressive osseous collapse, and fractures, which can occur within months. This stands in contrast to high reported clinician satisfaction rates and underscores the need for careful postmarketing vigilance. Given NGF's integral role in joint biology, objective monitoring strategies are warranted. These strategies should include thorough baseline and follow-up examinations, standardized imaging protocols, diligent adverse event reporting, and, where appropriate, histopathological assessment. Transparent communication of potential risks, along with documented informed consent, is essential to support balanced, clinical decision-making by veterinarians and pet owners.

Bedinvetmab (Librela/Beransa)在狗身上引起了安全性问题,包括快速进行性骨关节炎,需要警惕不良事件报告。
Bedinvetmab (Librela/Beransa)是一种犬抗神经生长因子单克隆抗体(aNGFmAb),被批准用于治疗骨关节炎疼痛。通过中和NGF,它减少了伤害性信号,提高了舒适度。然而,NGF在跨物种的神经、骨和软骨稳态中起着关键作用。多项研究表明,NGF通过调节成骨细胞、破骨细胞和软骨细胞活性来促进骨重塑和软骨修复,这些过程在骨关节炎关节中高度活跃。在人类、啮齿动物和家兔中,抑制NGF与快速进行性骨关节炎相关,这是一种以加速关节破坏和崩溃为特征的严重不良事件,最终阻碍了人类aNGFmAb的监管批准,但犬aNGFmAb bedinvetmab获得了上市许可。在犬患者中出现的新临床信号引起了人们的关注,NGF阻断可能同样会掩盖早期结构恶化,潜在地加速指数关节和非指数关节的骨溶解和软骨溶解。尽管据称罕见,但这些药物不良事件是不可逆转的,往往是灾难性的,导致快速关节变性,进行性骨塌陷和骨折,可在几个月内发生。这与高报告的临床医生满意度形成对比,并强调了上市后谨慎警惕的必要性。鉴于NGF在联合生物学中不可或缺的作用,客观的监测策略是必要的。这些策略应包括彻底的基线和随访检查,标准化的成像方案,勤奋的不良事件报告,并在适当的情况下进行组织病理学评估。潜在风险的透明沟通,以及书面的知情同意,对于支持兽医和宠物主人做出平衡的临床决策至关重要。
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来源期刊
CiteScore
1.60
自引率
15.80%
发文量
539
审稿时长
6-16 weeks
期刊介绍: Published twice monthly, this peer-reviewed, general scientific journal provides reports of clinical research, feature articles and regular columns of interest to veterinarians in private and public practice. The News and Classified Ad sections are posted online 10 days to two weeks before they are delivered in print.
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