Novartis’ Gilenya Improves Cognition, Reduces Relapses and MS Lesions, Phase 4 Trial Shows

Novartis’ Gilenya Improves Cognition, Reduces Relapses and MS Lesions, Phase 4 Trial Shows

The team recruited 198 patients with relapsing–remitting MS (RRMS) for the Phase 4 Golden trial (NCT01333501).

They randomized 157 of the patients to receive one of the two treatments. One hundred six received Gilenya and 51 interferon beta-1b. Those in the Gilenya group had a more severe disease at the start of the study than those in the interferon beta-1b group.

Gilenya reduced inflammation associated with loss of myelin, researchers found. Unlike interferons, it can reach the brain by crossing the blood–brain barrier. The barrier prevents invaders such as bacteria from reaching the vain but also prevents many drugs from reaching it as well.

“This mechanism of action [working directly in the brain] might be responsible for the effects of fingolimod on slowing brain atrophy observed in previous studies,” the researchers wrote.

After 18 months of treatment, researchers evaluated patients’ cognitive performance with several tests. They included the Rao’s Brief Repeatable Battery and Delis–Kaplan Executive Function System test, magnetic resonance imaging or MRI, and the expanded disability status scale. The team also recorded the number of patient relapses.

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