News 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 by Patricia Inacio, PhD | December 8, 2017 Share this article: Share article via email Copy article link 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 āEfficacy of fingolimod and interferon beta-1b on cognitive, MRI, and clinical outcomes in relapsingāremitting multiple sclerosis: an 18-month, open-label, rater-blinded, randomised, multicentre study (the GOLDEN study).ā āCognitive 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 relapsingāremitting 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 bloodābrain barrier. The barrier prevents invaders such as bacteria from reaching the vain but also prevents many drugs from reaching it as well. āThis 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 Raoās Brief Repeatable Battery and DelisāKaplan 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 ādespite 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. Print This Page About the Author Patricia Inacio, PhD Patricia holds her PhD in cell biology from the University Nova de Lisboa, Portugal, and has served as an author on several research projects and fellowships, as well as major grant applications for European agencies. She also served as a PhD student research assistant in the Department of Microbiology & Immunology, Columbia University, New York, for which she was awarded a Luso-American Development Foundation (FLAD) fellowship. Tags BETASERON, clinical trials, cognition, Fingolimod, Gilenya, interferon beta-1b, lesions, Novartis, relapse
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