Treatment well-tolerated over two years, but adverse events reported more frequently after NTZ
MONDAY, Oct. 10 (HealthDay News) -- Natalizumab (NTZ) is well tolerated and reduces relapses and disability at two years in patients with relapsing-remitting multiple sclerosis (RRMS), according to a review published online Oct. 5 in the Cochrane Database of Systematic Reviews.
Eugenio Pucci, Ph.D., from Ospedale di Macerata in Italy, and colleagues reviewed available literature through Feb. 19, 2010, to evaluate the efficacy, tolerability, and safety of NTZ in the treatment of patients with RRMS. Three randomized trials were included: one placebo-controlled and two add-on placebo-controlled studies, involving a total of 2,223 participants.
The investigators found conclusive data for efficacy and tolerability, but not for safety. There was statistically significant evidence showing that NTZ was efficacious for both primary and secondary outcomes. Compared to a control group, NTZ reduced the risks of experiencing at least one new exacerbation and of experiencing progression at two years by approximately 40 and 25 percent, respectively. Statistical evidence from MRI parameters favored the use of NTZ. During the two-year follow-up NTZ was well tolerated, and there was no difference between NTZ-treated patients and controls regarding the number of patients experiencing at least one adverse event (AE). Progressive multifocal leukoencephalopathy (PML) was identified in two patients: one had received 29 doses and the other 37 doses of NTZ. The risk of rare and long-term AEs, including PML, cancers, and other opportunistic infections, could not be sufficiently evaluated by this protocol.
"We found robust evidence in favor of a reduction in relapses and disability at two years in RRMS patients treated with NTZ," the authors write.
Two authors disclosed financial ties to the pharmaceutical and biotechnology industries. The studies included in this review were funded by the pharmaceutical industry.
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