Safety assessment of the world's first novel cocktail of two monoclonal antibodies in WHO category-III animal-bite patients

ABSTRACT Background: 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 standardiz...

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Published inJournal of family medicine and primary care Vol. 13; no. 10; pp. 4493 - 4498
Main Authors Agarwal, Anurag, Agarwal, Amita, Mohan, Arvind, Dutta, Trayambak, Mahajan, Manish, Desai, Samir, Kumar, Deepak
Format Journal Article
LanguageEnglish
Published India Wolters Kluwer - Medknow 01.10.2024
Medknow Publications and Media Pvt. Ltd
Wolters Kluwer Medknow Publications
Edition2
Subjects
adverse events
Analysis
Bites and stings
Marketing
Medical research
Medicine, Experimental
Monoclonal antibodies
Original
Original Article
post-exposure prophylaxis
rabies
Safety and security measures
safety assessment
twinrab
Vaccines
Zoonoses
Thailand
India
safety assessment
rabies
Adverse events
TwinRab
post-exposure prophylaxis
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Summary:ABSTRACT Background: 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. Materials and Methods: 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. Results: 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%). Conclusion: 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.
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ISSN:2249-4863
2278-7135
DOI:10.4103/jfmpc.jfmpc_377_24