Yaroslavl State Medical University
Neurology

Author Of 1 Presentation

Clinical Outcome Measures Poster Presentation

P0113 - MRI activity as a predictor of suboptimal response to natalizumab treatment: single center prospective cohort trial (ID 850)

Speakers
Presentation Number
P0113
Presentation Topic
Clinical Outcome Measures

Abstract

Background

Second line disease modifying drugs are widely used in clinical practice, the most common is natalizumab. NTZ have usually reduced the annualized rate of relapse and MRI lesion load in clinical trials but sometimes clinical and MRI activity was still present. Defining the predictors of suboptimal response is still needed to decide which second line treatment drug is optimal for patient.

Objectives

To determine the early clinical and MRI predictors of suboptimal treatment responses at one year of natalizumab (NTZ) therapy.

Methods

Clinical assessment (EDSS, relapses) and MRI (T2, T1Gd+) on start, after 6 and 12 months were made. All patients receive NTZ as second line therapy. RRMS patients undergoing treatment with NTZ for at least 12 months were classified as optimal responders if they have no EDSS score increase, no relapses and stable MRI (<3 new T2 and no Gd+(GELs)).Statistical analysis: one-way ANOVA, ROC-curve.

Results

43 patients (34 female) were included in analysis, RRMS, age–35.9-41.6 (95%CI) years, with disease duration of 58-131(95%CI) months;25-31(95%CI) NTZ infusions. On month 12 30.2% have a suboptimal response: 3 patient have a clinical relapse, 4–increasing of EDSS, 13–MRI activity. The comparison of the groups did not reveal statistically significant differences in age, sex, duration of the disease, duration of therapy before starting NTZ, relapse rate on baseline. Patients in suboptimal response group have more severe previous year MRI activity (before NTZ): more severe T2 lesion load (F=6.3,p=0.016) and high number of GELs (F=4.1,p=0.051). Predictors of suboptimal response are: more than 4 new T2 lesions during last year and more than 2 GELs on MRI before NTZ.

Conclusions

High previous year MRI activity is a strong predictor of suboptimal NTZ response. This cohort of patients probably needs more powerful therapy, for example, alemtuzumab or cladribine.

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