Study in Czech Republic followed 392 patients for approximately four years.
Novartis’ Gilenya (fingolimod) was effective for patients with multiple sclerosis (MS) and had a manageable safety profile under real-world conditions over 48 months, according to new research.
In Europe, Gilenya is approved for people with MS with highly active disease despite a full and adequate course of treatment with at least one disease-modifying therapy or patients with rapidly evolving severe relapsing–remitting MS (RRMS).The FDA approved Gilenya in the US in 2016.
A research team led by Veronika Tichá at the MS Center in the Department of Neurology and Center of Clinical Neuroscience at the First Faculty of Medicine at Charles University in Prague, Czech Republic, noted that three large phase 3 clinical trials of Gilenya — FREEDOMS, FREEDOMS II, and TRANSFORMS — showed a significant reduction in relapse rate, magnetic resonance imaging-related lesion counts, disability progression, and brain volume loss when compared with placebo and intramuscular interferon β-1a in patients with RRMS.
The effects were shown to continue in extension studies, which demonstrated decreased MS disease activity and disability progression. In addition, a long-term observational study — LONGTERMS — confirmed the safety and efficacy associated with the Gilenya for up to 14 years in patients with relapsing MS.
Tichá and her colleagues conducted GOLEMS, a national, multicenter, observational, non-nterventional, single-arm study, between November 2012 and March 2018 in the Czech Republic.
Overall, patients in the study were observed for four years. The researchers evaluated 237 patients in the efficacy set and 155 in the completed set, which encompassed patients with a minimum of a 12-month observation period in the core study who continued with Gilenya treatment.
Based on their analysis of 48-month period of Gilenya treatment, 40% in the efficacy set and 34.8% in the completed set were free of relapses. In addition, the majority of relapses were moderate in intensity.
The participants also did not have changes in work capability assessment or number of missed days of work. Of 240 enrolled patients, 61.3% had greater than one treatment-emergent adverse event (AE), and 8.3% reported serious adverse events.
Nearly 19% of patients permanently discontinued treatment because of AEs. No deaths were reported.
“Long-term treatment with fingolimod showed sustained efficacy on disease activity, measured by presence and severity of relapses and progression in neurological disability and confirmed a favorable safety profile by the low incidence of SAEs under real-world conditions in the Czech Republic,” Tichá and her colleagues concluded.
The results were published in BMC Neurology.