Abstract

Introduction: In relapsing Multiple Sclerosis (RMS) patients treated with disease modifying drugs (DMDs), few data are available regarding the biomarkers of treatment response. We aimed to assess the predictive value of lymphocyte count (LC) and Body Mass Index (BMI) for treatment response in a real life setting of dimethyl fumarate (DMF) treated patients.Materials and Methods: We included in our observational analysis 338 patients who were prescribed DMF in an Italian MS Center. We collected clinical and demographic data at the beginning of DMF (T0), and assessed White Blood Cells (WBC) and LC at T0 and at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months. Gadolinium enhancing (Gd+), new T2 lesions and relapses within the first year of treatment (T12) were recorded in order to evaluate clinical activity at 12 months. Analysis of correlation was performed to correlate WBC, LC and BMI with clinical and radiological responses. We evaluated whether BMI or LC can predict treatment response by using multivariate logistic regression models at each follow-up.Results: Our cohort was followed up for a mean period of 19.8 ± 6.8 months. The mean BMI at baseline was 24.19 ± 4.48. The multivariate models gave as predictive factors for Gd+ lesions at T12, LC at T3 (OR = 1.003, 95% CI = 1.00-1.07; p = 0.046) and baseline BMI (OR = 0.71, 95% CI = 0.52–0.98; p = 0.037). Predictive factors for new T2 lesions at T12 were LC at T3 (OR = 1.01 95%CI = 1.00–1.95; p = 0.005) and baseline BMI (OR = 0.99, 95% CI = 0.98–1.00; p = 0.026).Conclusions: In our real life-experience, BMI and LC may be early biomarkers to predict treatment response during DMF.

Highlights

  • In relapsing Multiple Sclerosis (RMS) patients treated with disease modifying drugs (DMDs), few data are available regarding the biomarkers of treatment response

  • The multivariate models gave as predictive factors for Gd+ lesions at T12, lymphocyte count (LC) at T0 and at 3 (T3) (OR = 1.003, 95% confidence intervals (95% CI) = 1.00-1.07; p = 0.046) and baseline Body Mass Index (BMI) (OR = 0.71, 95% CI = 0.52–0.98; p = 0.037)

  • After 1 year of therapy, dimethyl fumarate (DMF) was effective in reducing both clinical and Magnetic Resonance Imaging (MRI) disease activity, as shown by the multivariate models used that take into account the absence of exact date of both clinical and MRI relapses

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Summary

Introduction

In relapsing Multiple Sclerosis (RMS) patients treated with disease modifying drugs (DMDs), few data are available regarding the biomarkers of treatment response. Interferon-β (IFNβ) and glatiramer acetate (GA) are well-established MS therapies which have well-characterized safety profiles and have shown a reduction of relapse rate by approximately one third. These DMDs are administered through weekly or daily injections and patients may experience breakthrough disease activity and tolerability may be suboptimal [2, 3]. These drawbacks have prompted the search for drugs that could reduce the burden of medication administration and be somehow more efficacious. All newer DMDs have the aim of regulating or suppressing the immune system through specific pathways, and in many cases this has resulted in foreseeable adverse effects (lymphopenia)

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