A Cochrane review [Abstract] 1 included 3 RCTs with 2223 patients diagnosed with relapsing remitting multiple sclerosis. The natalizumab (NTZ) trials included one placebo-controlled trial (n=942) and two add-on placebo-controlled trials, i.e. one plus glatiramer acetate (n=110) and the second plus interferon beta-1a (n=1171). The results showed statistically significant evidence in favour of NTZ for all the primary outcomes and for the secondary ones fo data available. NTZ reduced the risk of experiencing at least one new exacerbation at 2 years by about 40% ( RR 0.57, 95% CI 0.47 to 0.69; 2 trials, n=2113) and of experiencing progression at 2 years by about 25% (RR 0.74, 95% CI 0.62 to 0.89; 2 trials, n=2113), as compared to a control group. MRI parameters showed statistical evidence in favour of participants receiving NTZ. NTZ (with or without IFNß-1a) reduces the risk of developing at least one Gadolinium-enhancing lesion at 2 years by 87% (RR 0.12, 95% CI 0.09 to 0.17; 2 trials, n=2113). Infusion reactions, anxiety, sinus congestion, lower limb swelling, rigors, vaginitis and menstrual disorders were reported as adverse events (AEs) more frequently after NTZ treatment. The number of patients experiencing at least one AE did not differ between NTZ-treated patients and controls. Two cases of progressive multifocal leucoencephalopathy (PML) were encountered, both after two years of continuous NTZ treatment.
Primary/Secondary Keywords