Treatment of Multiple Sclerosis With Teriflunomide. Multicenter Study of Real Clinical Practice in the Valencian Community-Spain.

Introduction: We have different treatment alternatives for relapsing-remitting multiple sclerosis-RRMS-within the so-called platform drugs. It would be desirable to know the ideal drug for each patient. Real clinical practice studies provide us with data on drug efficacy in the medium and long term, safety beyond clinical trials, and can help us to know the patient profile appropriate for each therapy. Material and Methods: An observational multicenter study of real clinical practice in patients with RRMS who were treated with teriflunomide in the Valencian Community, since teriflunomide was authorized in Spain. The database created for this study collects retrospectively patients followed prospectively in the MS clinics. Objectives: To analyze the efficacy and safety of teriflunomide treatment in patients with RRMS under the conditions of real clinical practice, and to identify a patient profile responding to the treatment. Results: We obtained data from 340 patients who received at least one dose of 14 mg teriflunomide. The patients were 69.4% female to 30.6% male, had a mean age of 46.4 years, and a mean time of progression of MS of 11.5 years. The mean pre-teriflunomide relapse rate was 0.4 years, the mean EDSS scorewas 1.98, IgG Oligoclonal bands were present in the CSF of 66.2% of the patients, IgM Oligoclonal bands were present in 46.9%, and the mean number of gadolinium-enhancing lesions was 1.07 lesions per patient at the beginning of treatment. The average number of treatments previously received was 1.04, and 28.53% were naïve. After a follow-up of up to 4 years, a reduction in the annualized and cumulative annualized relapse rate was observed in the first year, in the second year, and in the third year, compared to the pre-treatment year. The EDSS scores were stabilized throughout the follow-up. Likewise, there was a reduction in gadolinium-enhancing lesions in the 1st and 2nd years compared to the pre-treatment period. Applying different generalized multiple linear regression models, we identified a profile of a responding patient to teriflunomide as a male without IgM oligoclonal bands in the CSF, a previous EDSS score of <3, and more than 5 years duration of MS.

Clinically isolated syndromes suggestive of multiple sclerosis: an optical coherence tomography study.

BACKGROUND: Optical coherence tomography (OCT) is a simple, high-resolution technique to quantify the thickness of retinal nerve fiber layer (RNFL), which provides an indirect measurement of axonal damage in multiple sclerosis (MS). This study aimed to evaluate RNFL thickness in patients at presentation with clinically isolated syndromes (CIS) suggestive of MS. METHODOLOGY: This was a cross-sectional study. Twenty-four patients with CIS suggestive of MS (8 optic neuritis [ON], 6 spinal cord syndromes, 5 brainstem symptoms and 5 with sensory and other syndromes) were prospectively studied. The main outcome evaluated was RNFL thickness at CIS onset. Secondary objectives were to study the relationship between RNFL thickness and MRI criteria for disease dissemination in space (DIS) as well as the presence of oligoclonal bands in the cerebrospinal fluid. PRINCIPAL FINDINGS: Thirteen patients had decreased RNFL thickness in at least one quadrant. Mean RNFL thickness was 101.67±10.72 µm in retrobulbar ON eyes and 96.93±10.54 in unaffected eyes. Three of the 6 patients with myelitis had at least one abnormal quadrant in one of the two eyes. Eight CIS patients fulfilled DIS MRI criteria. The presence of at least one quadrant of an optic nerve with a RNFL thickness at a P<5% cut-off value had a sensitivity of 75% and a specificity of 56% for predicting DIS MRI. CONCLUSIONS: The findings from this study show that axonal damage measured by OCT is present in any type of CIS; even in myelitis forms, not only in ON as seen up to now. OCT can detect axonal damage in very early stages of disease and seems to have high sensitivity and moderate specificity for predicting DIS MRI. Studies with prospective long-term follow-up would be needed to establish the prognostic value of baseline OCT findings.

Validation of the FOUR Score (Spanish Version) in acute stroke: an interobserver variability study.

BACKGROUND: Methods to assess impaired consciousness in acute stroke typically include the Glasgow Coma Scale (GCS), but the verbal component has limitations in aphasic or intubated patients. The FOUR (Full Outline of UnResponsiveness) score, a new coma scale, evaluates 4 components: eye and motor responses, brainstem reflexes and respiration. We aimed to study the interobserver variability of the FOUR score in acute stroke patients. METHODS: We prospectively enrolled consecutive patients with acute stroke admitted from February to July 2008 to the stroke unit of our Neurology Department. Patients were evaluated by neurology residents and nurses using the FOUR score and the GCS. For both scales, we obtained paired and total weighted kappa values (Kw) and intraclass correlation coefficients (ICC). NIH stroke scale was also recorded on admission. RESULTS: We obtained a total of 75 paired evaluations in 60 patients (41 cerebral infarctions, 15 cerebral hemorrhages and 4 transient ischemic attacks). Thirty-three (55%) patients were alert, 17 (28.3%) drowsy and 10 (16.7%) stuporous or comatose. The overall rater agreement was excellent in the FOUR score (Kw 0.93; 95% CI 0.89-0.97) with an ICC of 0.94 (95% CI 0.91-0.96) and in the GCS (Kw 0.96; 95% CI 0.94-0.98) with an ICC of 0.96 (95% CI 0.93-0.97). A good correlation was found between the FOUR score and the GCS (rho 0.83; p < 0.01) and between the FOUR score and the NIH stroke scale (rho -0.78; p < 0.001). CONCLUSIONS: The FOUR score is a reliable scale for evaluating the level of consciousness in acute stroke patients, showing a good correlation with the GCS and the NIH stroke scale.

Poststroke depression: importance of its detection and treatment.

BACKGROUND: Poststroke depression (PSD) is a complication that occurs in up to 30% of the patients who have had a stroke. Its development is associated with a poor functional prognosis and a negative impact on the patient's quality of life. METHODS: In the present review, we summarize the diagnostic criteria, prevalence, predisposing factors, the lesion site, the impact of PSD on the clinical evolution of the patient, the current therapeutic approaches and even the relationship between depression and cerebrovascular disease. RESULTS: There are differences in relation to prevalence, essentially due to the use of different diagnostic criteria. Also, there have been few studies focusing on the search for factors that are predictive of PSD (age, female sex, single vascular lesion independent of site) and the reluctance to initiate preventive treatments to minimize the effects on the clinical evolution of the patients. There have been several advances with respect to the treatment of PSD. It seems that treatments show improvement trends, but today there is not enough evidence to recommend a preventive therapy for depression in any stroke patient. CONCLUSIONS: We consider that the prevalence of PSD is relevant and that the risk factors as well as the early diagnosis are important for the best management and prognosis of stroke patients. Further studies are needed in this field in order to reduce PSD.