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

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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Gilenya's benefits

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 ā€” areas where a protein coating that protects nerve cells has deteriorated, researchers found.

The study,Ā published in the Journal ofĀ Neurology,Ā is titled ā€œEfficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsingā€“remitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study).ā€

ā€œCognitive dysfunction is a common clinical problem in MS and is associated with functional impairment leading to deterioration in patientsā€™ quality of life,ā€ 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. Ā Interferon beta-1b therapies include Bayer‘s Betaseron.

The team recruited 198 patients with relapsingā€“remitting MS (RRMS) forĀ the Phase 4 Golden trial (NCT01333501).

They randomizedĀ 157 of the patients to receive one of the two treatments. One hundred six received Gilenya and 51 interferon beta-1b. ThoseĀ 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 bloodā€“brain barrier. The barrier prevents invaders such as bacteria from reaching the vain but also prevents many drugs from reaching it as well.

ā€œThis mechanism of action [working directly in the brain] might be responsible for the effects of fingolimod on slowing brain atrophy observed in previous studies,ā€ the researchers wrote.

After 18 months of treatment, researchers evaluated patients’ cognitive performance with several tests. They included the Raoā€™s Brief Repeatable Battery and Delisā€“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 Ā the Gilenya Ā group ā€” 41 percent versus 8 percent.

Both therapies improved patientsā€™ 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. ButĀ ā€œdespite 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,ā€ the team concluded.