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Tysabri Shows Long-term Safety and Efficacy in Japanese RRMS Patients

July 3, 2017

A recent study has proven that Tysabri (natalizumab) treatment for two years to be efficient and safe in Japanese patients with relapsing-remitting multiple sclerosis (RRMS). The study, “Safety and Efficacy of Natalizumab in Japanese Patients with Relapsing-Remitting Multiple Sclerosis: Open-Label Extension Study of a Phase 2 Trial,” appeared in the journal Neurology and Therapy. It was a 24 week study among Asian Japanese patients that demonstrated that Tysabri reduces AAR and increases the ration of relapse-free patients compared to placebo. Researchers continued to follow Japanese RRMS patients for two years to evaluate Tysabri’s long-term efficacy and safety. The team found that after two years of Tysabri treatment, ARR remained lower in patients treated with the drug that those who had been on placebo.

However, researchers found no major differences regarding safety and tolerability between patients who were always treated with Tysabri and those who first received placebo and then started Tysabri treatment. Researchers also didn’t find differences between groups in the percentage of patients who had viral anti-JCV antibodies. The risk of developing progressive multifocal leukoencephalopathy (PML) is higher in patient who have anti-JCV antibodies, but no cases of PML were reported during the study.

“The efficacy and safety findings from the double-blind bridging study and the open-label extension study are comparable to and confirm results reported from other clinical trials of natalizumab [Tysabri] conducted in non-Asian patient populations, and provide longer-term evidence of the efficacy and safety of natalizumab treatment in Japanese patients with RRMS,” authors wrote.