Highlights
- •Multiple sclerosis involves immune-mediated demyelination of nerve fibers and neurons leading to permanent nerve damage.
- •Role of MS-associated retrovirus envelope protein (MSRV-Env) is suggested in the pathogenesis of MS.
- •Temelimab is a humanized IgG4 monoclonal antibody (mAb) that targets the MSRV-Env protein.
- •Clinical trials demonstrate that the drug is safe as well as favourable for use in MS patients.
Abstract
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.
Keywords
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Article info
Publication history
Published online: March 14, 2022
Accepted:
March 11,
2022
Received in revised form:
January 30,
2022
Received:
December 25,
2021
Identification
Copyright
© 2022 Elsevier B.V. All rights reserved.
