Supervised automatic procedure to identify new lesions in brain MR longitudinal studies of patients with multiple sclerosis

Purpose. Identification of new enhancing lesions is a major endpoint of longitudinal brain magnetic resonance (MR) studies of multiple sclerosis (MS). To date, this is a visual, time-consuming procedure. We present here a supervised automated procedure (SAP) aimed at reducing the time needed to identify new MS enhancing lesions. Materials and methods. The SAP uses an algorithm including Cartesian coordinates of the lesions to be compared, their area and a constant (k). The procedure was validated for enhancing lesions on T1-weighted spin-echo images after intravenous administration of 0.1 mmol/kg, of paramagnetic contrast agent, randomly selected from a dataset of a longitudinal MR study on ten relapsing-remitting MS patients followed for 2-5 years. During the validation session, two readers decided by consensus whether two lesions, present on the same slice of two examinations performed on subsequent dates, were the same or not. In this way, k was calibrated to obtain the same result from both visual inspection and automatic algorithm output. . Results. After evaluating of 25 +/- 5 (mean standard deviation) lesions in each of ten different sessions with correction of k value, the k value became a stable value (0.45 +/- 0.05). Conclusions. Once the suitable value of k was found, SAP was able to identify new enhancing lesions, avoiding visual inspection, which is usually a lengthy procedure

The Italian Natalizumab Registry: a 1-year follow-up

Background: Natalizumab is labelled by EMEA (A) as second line in relapsing remitting multiple sclerosis (RRMS) in non-responders to -interferon, and (B) as first line in more aggressive RRMS. Italian Medicines Agency (AIFA), accordingly to a neurological expert panel, established more restrictive criteria to dispense and reimburse natalizumab, and organised a national registry for monitoring its safety. Objectives: To assess risks associated with natalizumab after 1 year since its marketing in Italy, and to compare the Italian Registry data with the characteristics of RCT AFFIRM patients. Methods: Patients under treatment with natalizumab were enrolled into a web-based registry available on AIFA website. It contains electronic forms on: patient eligibility, follow-up during the therapy (to fill every 3 months), drug withdrawal, ADR report, and follow-up after drug withdrawal (to fill every 6 months). It has been active since January 2007. Data up to January 2008 were collected and analysed. Results: Ninety-six MS Centres have enrolled at least one patient. Overall, 696 pts (67% females) were treated: 91% as non-responders to -interferon (A), and 9% with aggressive RRMS (B). Patient baseline disease was more serious compared to AFFIRM: annual relapses were 2.31.0 (average SD) in A pts and 3.51.3 in B pts vs 1.50.9 in AFFIRM pts; EDSS disability was 3.71.5 in A pts and 3.71.4 in B pts vs 2.31.2 in AFFIRM pts. Main pts (53%) received 1\u20134 drug doses. For 371 pts, at least 1 follow-up was recorded and 78 pts had at least 1 ADR. Hundred ADRs were recorded and 29% were infections. Drug effectiveness in terms of EDSS on 270 pts with 4 to 9 months therapy showed improvements in 49% of cases. Conclusions: Data on ADRs were consistent with available evidences. The national registry appears a useful tool to closely monitor a drug with critical safety profile