Clinical Data Associated With the Therapeutic Response to Glatiramer Acetate in Multiple Sclerosis Patients
Journal Title: Neuro – Open Journal - Year 2016, Vol 3, Issue 1
Abstract
Background: The increasing appearance of new drugs is making more difficult the choice of treatment in multiple sclerosis. According to different criteria, between 20 to 50% of the patients with multiple sclerosis (MS) treated with the classical disease modify treatments (DMT) will have an incomplete response and will need a change for more aggressive therapies. For this reason it is of great importance to improve the selection process in these patients to avoid treatment failures, side-effects and unnecessary risks. The utility of clinical and epidemiological data for the prediction of the therapeutic response to the different MS treatments, and particularly to glatiramer acetate (GA), is insufficient and contradictory. Objective: To develop a predictive model of clinical data associated with the clinical response to GA. Methods: Observational retrospective study by reviewing medical charts from October/2002 to February/2012. Data analysis was conducted from February/2014 to February/2015. Inclusion criteria: Relapsing-remitting multiple sclerosis (RRMS McDonald 2010) with ≥1 relapses in the previous 2 years, and ≥2 years of treatment with GA. All the patients included in this study were treated with GA 20 mg injected subcutaneously once daily as the newer formulation of GA 40 mg 3 times weekly was not approved at the time of the study. Definitions: Responders: ≤1 relapse and no disability progression; Non-responders: ≥2 relapses and/or disability progression. Disability progression: EDSS increase ≥1.5 points if basal EDSS=0; increase ≥1 if basal EDSS=1-5; increase ≥0.5 if basal EDSS ≥5.5. Statistical analysis: logistic regression. Association variable: odds ratio. Results: Two hundred and four subjects included. Responders: 137 (67.5%). Number of relapses in the 2 years before GA onset was associated with a worse clinical response (odds ratio (OR): 1.4; IC 95%: 1.12-1.74%). Accuracy of this model (AUC: 63.5%; IC 95%: 56.2- 70.7%); Diagnostic parameters: Sensitivity: 40%; specificity: 79.8%, positive predictive value: 78.6; negative predictive value: 41.7. Conclusions: GA was associated with a better response in Relapsing-remitting multiple sclerosis (RRMS) patients with low-moderate disease activity. This model could be improved incorporating serological, genetic and imaging data.
Authors and Affiliations
Luis Ignacio Casanova Peño
Keywords
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- EP ID EP552542
- DOI 10.17140/NOJ-3-121
- Views 128
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