Agarwal Anurag, Agarwal Amita, Mohan Arvind, Dutta Trayambak, Mahajan Manish, Desai Samir, Kumar Deepak
Department of Paediatrics, Maulana Azad Medical College, New Delhi, India.
Senior Administrative Grade, Hindu Rao Hospital, Delhi, India.
J Family Med Prim Care. 2024 Oct;13(10):4493-4498. doi: 10.4103/jfmpc.jfmpc_377_24. Epub 2024 Oct 18.
Rabies, a zoonotic disease, poses a significant global public health challenge, and post-exposure prophylaxis (PEP) is crucial for prevention. Monoclonal antibodies (mAbs) have emerged as a promising alternative to rabies immunoglobulins due to their high efficacy and standardized manufacturing process.
A prospective, open-label post-marketing surveillance study was conducted with patients of WHO category-III suspected rabid animal bites. TwinRab™, a novel cocktail of docaravimab and miromavimab, was administered at a dosage of 40 IU/kg in and around the wound, along with the anti-rabies vaccine, which was administered intradermal as per Thai Red Cross regimen.
In this study, 200 subjects received TwinRab™ with a 100% completion rate. Three (1.5%) patients showed solicited local AEs, and two (1%) patients showed solicited systemic AEs, which were resolved after appropriate treatment intervention. The overall tolerability assessment showed positive ratings from doctors (94%) and patients (74%).
The post-marketing surveillance study demonstrated the safety of TwinRab™ in patients who experienced category-III suspected rabid animal bites, thereby supporting its potential as an alternative option for PEP in the management of animal bite for the prevention of rabies.
狂犬病是一种人畜共患疾病，对全球公共卫生构成重大挑战，暴露后预防（PEP）对于预防至关重要。单克隆抗体（mAb）因其高效性和标准化生产工艺，已成为狂犬病免疫球蛋白的一种有前景的替代物。
对世界卫生组织III类疑似狂犬病动物咬伤患者进行了一项前瞻性、开放标签的上市后监测研究。TwinRab™是一种新型的多卡拉维单抗和米罗维单抗鸡尾酒疗法，以40 IU/kg的剂量在伤口及其周围注射，同时按照泰国红十字会方案皮内注射抗狂犬病疫苗。
在本研究中，200名受试者接受了TwinRab™治疗，完成率为100%。三名（1.5%）患者出现了预期的局部不良反应，两名（1%）患者出现了预期的全身不良反应，经适当治疗干预后症状缓解。总体耐受性评估显示医生（94%）和患者（74%）给予了积极评价。
上市后监测研究证明了TwinRab™在III类疑似狂犬病动物咬伤患者中的安全性，从而支持其作为预防狂犬病动物咬伤管理中PEP替代选择的潜力。
