A prospective observational post-marketing study of natalizumab-treated multiple sclerosis patients: clinical, radiological and biological features and adverse events. The BIONAT cohort.

BACKGROUND AND PURPOSE: BIONAT is a French multicentric phase IV study of natalizumab (NTZ)-treated relapsing-remitting multiple sclerosis (MS) patients. The purpose of this study was to collect clinical, radiological and biological data on 1204 patients starting NTZ, and to evaluate the clinical/radiological response to NTZ after 2 years of treatment. METHODS: Patients starting NTZ at 18 French MS centres since June 2007 were included. Good response to NTZ was defined by the absence of clinical and radiological activity. Data analysed in this first report on the BIONAT study focus on patients who started NTZ at least 2 years ago (n = 793; BIONAT2Y ). RESULTS: NTZ was discontinued in 17.78% of BIONAT2Y. The proportion of patients without combined disease activity was 45.59% during the first two successive years of treatment. Systematic dosage of anti-NTZantibodies (Abs) detected only two supplementary patients with anti-NTZ Abs compared with strict application of recommendations. A significant decrease of IgG,M concentrations at 2 years of treatment was found. CONCLUSIONS: The efficacy of NTZ therapy on relapsing-remitting MS in a real life setting is confirmed in the BIONAT cohort. The next step will be the identification of biomarkers predicting response to NTZ therapy and adverse events.

Automated analgesic drugs delivery guided by vagal tone evaluation: interest of the Analgesia Nociception Index (ANI).

Analgesic drugs delivery optimization constitutes one of the main objectives of modern anesthesia. Indeed, their over or under determination constitutes a risk for anesthetized patient in terms of hemodynamic reactivity or post-operative hyperalgesia. Nowadays, new physiological indexes allow anesthesiologists to evaluate the balance between the analgesia level and the noxious stimulus importance. ANI is an index related to the autonomic nervous system activity based on heart rate variability analysis. Its ability for the analgesia / nociception balance evaluation has been established bringing evidences about its helpfulness for analgesic drug delivery. In this article, we describe a device for automatic analgesic drugs administration based on the ANI evolution during surgical procedures under general anesthesia. We hypothesized that such a device could improve the quality and safety of anesthesia by reducing adverse cardiovascular events and delivered analgesic drugs doses.