rome and Drug-Hypersensitivity

We reported a post-marketing experience of 190 patients affected by relapsing multiple sclerosis on treatment with natalizumab. Clinical findings during pre-treatment period and throughout the study were documented. Magnetic resonance imaging (MRI) scans were performed at baseline and at 6, 12, and 24 months of therapy. Cumulative proportions of patients disease activity free (i.e. absence of relapses, disability progression, MRI activity) were measured as efficacy endpoints. Despite that the baseline characteristics suggested a more severe course of disease in our sample than that of the AFFIRM trial, data on effectiveness of natalizumab were comparable. At 1 year of treatment we found 80 and 70% patients free from relapses and MRI activity, respectively, that is similar to 75 and 62% detected in the AFFIRM trial. Moreover, only 5% of our patients showed a progression of disability after a mean follow-up time of 15 months. Finally, the presence of antibodies anti-Natalizumab was strongly related to the occurrence of relapses (p = 0.002) and MRI activity (p < 0.001) even in the post-marketing experience.

Topics: Adult; Antibodies, Monoclonal, Humanized; Drug Hypersensitivity; Female; Follow-Up Studies; Humans; Magnetic Resonance Imaging; Male; Multiple Sclerosis; Natalizumab; Product Surveillance, Postmarketing; Prospective Studies; Rome; Treatment Outcome