LAUSR

BACKGROUND Multiple Sclerosis (MS) is a chronic debilitating neurological disease affecting young adults. The disease involves immune-mediated demyelination of nerve fibers and neurons that leads to disruption of brain-body communication, leading to permanent nerve damage. MS-associated retrovirus envelope protein (MSRV-Env) has been detected in the blood and lesions of MS patients, and its role is suggested in the pathogenesis of MS. Temelimab is a humanized IgG4 monoclonal antibody (mAb) that targets the MSRV-Env protein and neutralizes its action. Several clinical trials have been conducted to evaluate the effectiveness of the drug in MS. MATERIALS AND METHODS A systemic search was conducted from electronic databases (PubMed/Medline, Cochrane Library, and Google Scholar) from inception to 11th sept 2021. All statistical analysis was conducted in Review Manager 5.4.1. Studies meeting inclusion criteria were selected. Those studies were selected which compared Temelimab therapy to inactive control. The primary outcome of interest was drug safety and efficacy; information about immunogenicity was also included. Random-effect model was used to pool the studies, and the result was reported in the risk ratio (RR) with corresponding 95% Confidence interval (CI). RESULTS Phase I, Phase II-a and Phase II-b trials demonstrate the safety and effectiveness of Temelimab. Our analysis showed statistically non-significant Risk Ratio (RR) of Adverse events in Temelimab group than that in placebo group (1.01 [0.70,1.46]; p-value = 0.94; I2 = 0%) . Considering the effect of Temelimab on brain lesions, pooled result showed statistically significant Risk Ratio (RR) of brain lesions in placebo group than that in Temelimab group (0.75 [0.69,0.81), p-value < 0.00001, I2 = 0% CONCLUSION: Qualitative and quantitative analysis of the trials assessing the safety and efficacy of Temelimab demonstrate that the drug is safe as well as favourable for use in MS patients.