Biology and Life Sciences Forum (Jul 2023)
A Clinical Review of a Polyvalent F(ab’)<sub>2</sub> Antivenom (Inoserp<sup>TM</sup> PAN-AFRICA) in the Management of Snakebite Envenomation in Sub-Saharan Africa: Clinical Studies and Actual Use since Its Introduction in 2012
Abstract
InoserpTM PAN-AFRICA is a polyvalent F(ab’)2 antivenom that has been specifically developed for the management of snakebite envenomation in sub-Saharan Africa. The antivenom provides a very large coverage of medically important species in sub-Saharan Africa, with at least 24 species covered. This review presents all clinical data available on the use of InoserpTM PAN-AFRICA in sub-Saharan Africa since it was introduced in 2012. The antivenom has been used in more than 20 countries from west to east Africa, with approximately 200,000 vials distributed through marketing approvals, special import permits, and organizations such as armies or NGOs. Four clinical studies have been performed in five countries of West and Central Africa, encompassing 22 clinical sites and involving 676 patients exposed to InoserpTM PAN-AFRICA. Patients were rather young, with a median age ranging from 18 to 38 years, and a great majority were males, with a sex ratio (M/F) ranging from 2.7 to 4.5, according to the study. Snakebite envenomation was representative of the sub-Saharan African region with mostly hemorrhagic and cytotoxic but also neurotoxic syndromes. Overall, patients received an average dose of two to three vials, which was enough to obtain a rapid control of symptoms in the great majority of cases. The observed lethality rate was 0% to 4.4%, depending on the study. Adverse events were mostly of mild or moderate intensity and have been reported in 5 to 11% of patients. Other available data, such as published reports of patient cases, as well as the most updated pharmacovigilance surveillance report in 2022, have been used to complete this review. Overall, InoserpTM PAN-AFRICA benefits from a large experience in sub-Saharan Africa. Clinical data available consistently show a very good efficacy and safety profile of the antivenom.
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