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

Novartis‘ Gilenya and interferon beta-1b-based therapies stop multiple sclerosis patients’ cognitive decline, a Phase 4 clinical trial shows.

Gilenya (fingolimod) also reduces patients’ relapses and the number of their brain lesions — areas where a protein coating that protects nerve cells has deteriorated, researchers found.

The study, published in the Journal of Neurology, is titled “Efficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsing–remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study).”

“Cognitive dysfunction is a common clinical problem in MS and is associated with functional impairment leading to deterioration in patients’ quality of life,” the researchers wrote.

The team wanted to see what effect Gilenya and interferon beta-1b therapies would have on MS patients’ cognitive impairment. Gilenya is an approved therapy for relapsing forms of MS.  Interferon beta-1b therapies include Bayer‘s Betaseron.

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.

Thirty patients discontinued the study. A lot more were in the interferon beta-1b group than in  the Gilenya  group — 41 percent versus 8 percent.

Both therapies improved patients’ cognition, the trial showed. But patients in the interferon beta-1b group had more relapses and brain lesions than the Gilenya-treated patients.

Overall, the results supported the notion that both therapies can improve MS patients’ cognition. But “despite a disadvantage in terms of baseline characteristics [severity of the disease] and drop-out patterns, fingolimod treatment demonstrated significantly better effects than interferon beta-1 on MRI parameters and relapse rate,” the team concluded.