Abstract
Background: Glatiramer acetate (GA) is an effective treatment for the earliest stages of multiple sclerosis (MS)—clinically isolated syndrome (CIS) or clinically definite MS (CDMS). Objective: This study aims to determine the differences in the lymphocyte population (at baseline and the course of five years) between confirmed sustained progression (CSP) and non-CSP groups and to identify potential biomarkers among these parameters that can predict a positive response to the treatment. Methods: Twelve male and 60 female patients were included in the study. Peripheral blood samples were collected before and five years after treatment with GA. The authors compared lymphocyte parameters between the CSP and non-CSP groups by statistical analyses. Univariate and penalized logistic regression models were fitted to identify the best lymphocyte parameters at baseline and their combination for potential biomarkers. Subsequently, the ROC analysis was used to identify cut-offs for selected parameters. Results: The parameter CD4+/CD45RO+ was identified as the best single potential biomarker, demonstrating the ability to identify patients with CSP. Moreover, a combination of four lymphocyte parameters at baseline, relative lymphocyte counts, CD3+/CD69+, CD4+/CD45RO+, and CD4+/CD45RA+ab, was identified as a potential composite biomarker. This combination explains 23% of the variability in CSP, which is better than the best univariate parameter when compared to CD4+/CD45RO+ at baseline. Conclusions: The results suggest that other biomarkers can help monitor the conditions of patients and predict a favourable outcome.
Highlights
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease affecting the central nervous system
The group of patients treated with Glatiramer acetate (GA) consisted of 72 patients (12 male and 60 female patients)
We validated the ability of identified potential biomarkers and their cut-offs to predict confirmed sustained progression (CSP) on an independent group of patients treated with interferon β-1b (IFN), i.e., with a drug with a different mechanism of action against GA, in order to assess the robustness of these cut-offs
Summary
Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease affecting the central nervous system. Glatiramer acetate (GA) is one of the basic drugs used for the treatment of multiple sclerosis and has shown a persistent and sufficient clinical efficacy by reducing the number of attacks and stabilizing and improving disability [1,2,3,4]. Glatiramer acetate (GA) is an effective treatment for the earliest stages of multiple sclerosis (MS)—clinically isolated syndrome (CIS) or clinically definite MS (CDMS). Objective: This study aims to determine the differences in the lymphocyte population (at baseline and the course of five years) between confirmed sustained progression (CSP) and non-CSP groups and to identify potential biomarkers among these parameters that can predict a positive response to the treatment. Univariate and penalized logistic regression models were fitted to identify the best lymphocyte parameters at baseline and their combination for potential biomarkers. Results: The parameter CD4+/CD45RO+ was identified as the best single potential biomarker, demonstrating the ability to identify patients with
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