Author Of 1 Presentation
P0150 - REWORD-MS: REal WOrld study to assess the Response to Dimethyl fumarate in patients with Multiple Sclerosis (ID 1813)
Abstract
Background
The response of relapsing-remitting Multiple Sclerosis patients (RRMSp) to disease-modifying drugs (DMDs) is heterogeneous. Tools able to predict response at the beginning of therapy are not available, but early treatment optimization is crucial to prevent disability accumulation. Scoring systems based on combination of relapse rate and new or enlarged T2 lesions (NT2) during the first year of treatment, as the MAGNIMS (Magnetic Resonance Imaging in MS) score, have been validated in RRMSp treated with interferon, to predict the individual response over time. Dimethyl fumarate (DMF) is nowadays the leading treatment prescribed among first line DMDs.
Objectives
The aim of the study is to evaluate the validity of the MAGNIMS score in predicting therapeutic failure in RRMSp treated with DMF.
Methods
Data about clinical relapses and NT2 were collected from 195 RRMSp treated with DMF for at least 12 months and with ≥ 24 months of follow-up. The MAGNIMS score was applied at month 12. Therapeutic failure was defined as EDSS (Expanded Disability Status Scale) worsening or change of therapy for inefficacy and loss of NEDA-3 status (No Evidence of Disease Activity: no relapse, no EDSS worsening, no NT2). The association between score and risk of treatment failure was evaluated by Cox proportional hazard model.
Results
At month 12, 175/195 (89.7%) patients had score=0 (no clinical relapse and <3 NT2) and 20/195 (10.3%) had score≥1 (≥ 1 clinical relapse and/or ≥3 NT2). Patients with score≥1 had a four times greater risk of EDSS worsening or change of therapy compared with patients with score=0 (HR 3.89, 95% CI 1.80-8.43; p=0.001). Similarly, the risk of losing NEDA-3 status was two times greater in patients scored ≥1 (HR 2.19, 95% CI 1.07-4.48; p=0.031). Considering RRMSp treated with DMF as first therapy (naïve, 91), patients with score≥1 had a six times greater risk of EDSS worsening or change of therapy (HR 5.86, 95% CI 2.03-16.92; p=0.001) and a two and a half times greater risk of losing NEDA-3 (HR 2.48, 95% CI 1.01 – 6.11; p=0.048).
Conclusions
Our data show that the MAGNIMS score is a reliable tool to predict response to DMF in a real world setting, even in naïve patients. Early identification of non-responders is crucial to identify candidates for a therapeutic shift to prevent disease progression. Due to the complexity of MS, future studies are needed to assess whether the addiction of other biomarkers (i.e. neurofilaments and brain atrophy) will improve the predictive power of a clinical-radiological score.
Presenter Of 1 Presentation
P0150 - REWORD-MS: REal WOrld study to assess the Response to Dimethyl fumarate in patients with Multiple Sclerosis (ID 1813)
Abstract
Background
The response of relapsing-remitting Multiple Sclerosis patients (RRMSp) to disease-modifying drugs (DMDs) is heterogeneous. Tools able to predict response at the beginning of therapy are not available, but early treatment optimization is crucial to prevent disability accumulation. Scoring systems based on combination of relapse rate and new or enlarged T2 lesions (NT2) during the first year of treatment, as the MAGNIMS (Magnetic Resonance Imaging in MS) score, have been validated in RRMSp treated with interferon, to predict the individual response over time. Dimethyl fumarate (DMF) is nowadays the leading treatment prescribed among first line DMDs.
Objectives
The aim of the study is to evaluate the validity of the MAGNIMS score in predicting therapeutic failure in RRMSp treated with DMF.
Methods
Data about clinical relapses and NT2 were collected from 195 RRMSp treated with DMF for at least 12 months and with ≥ 24 months of follow-up. The MAGNIMS score was applied at month 12. Therapeutic failure was defined as EDSS (Expanded Disability Status Scale) worsening or change of therapy for inefficacy and loss of NEDA-3 status (No Evidence of Disease Activity: no relapse, no EDSS worsening, no NT2). The association between score and risk of treatment failure was evaluated by Cox proportional hazard model.
Results
At month 12, 175/195 (89.7%) patients had score=0 (no clinical relapse and <3 NT2) and 20/195 (10.3%) had score≥1 (≥ 1 clinical relapse and/or ≥3 NT2). Patients with score≥1 had a four times greater risk of EDSS worsening or change of therapy compared with patients with score=0 (HR 3.89, 95% CI 1.80-8.43; p=0.001). Similarly, the risk of losing NEDA-3 status was two times greater in patients scored ≥1 (HR 2.19, 95% CI 1.07-4.48; p=0.031). Considering RRMSp treated with DMF as first therapy (naïve, 91), patients with score≥1 had a six times greater risk of EDSS worsening or change of therapy (HR 5.86, 95% CI 2.03-16.92; p=0.001) and a two and a half times greater risk of losing NEDA-3 (HR 2.48, 95% CI 1.01 – 6.11; p=0.048).
Conclusions
Our data show that the MAGNIMS score is a reliable tool to predict response to DMF in a real world setting, even in naïve patients. Early identification of non-responders is crucial to identify candidates for a therapeutic shift to prevent disease progression. Due to the complexity of MS, future studies are needed to assess whether the addiction of other biomarkers (i.e. neurofilaments and brain atrophy) will improve the predictive power of a clinical-radiological score.