Long-term real-world effectiveness and safety of fingolimod over 5 years in Germany.

Objective: To evaluate the 5-year real-world benefit-risk profile of fingolimod in patients with relapsing-remitting MS (RRMS) in Germany.

Methods: Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) is a non-interventional real-world study to prospectively assess the effectiveness and safety of fingolimod in routine clinical practice in Germany. The follow-up period comprised 5 years.

Descriptive Analysis of Real-World Data on Fingolimod Long-Term Treatment of Young Adult RRMS Patients.

Fingolimod (Gilenya®) is approved for adult and pediatric patients with highly active relapsing-remitting multiple sclerosis (RRMS). The objective was to describe the effectiveness of fingolimod in young adults compared to older patients in clinical practice. PANGAEA is the largest prospective, multi-center, non-interventional, long-term study evaluating fingolimod in RRMS.

Long-term real-world evidence for sustained clinical benefits of fingolimod following switch from natalizumab.

Background: The risk of progressive multifocal leukoencephalopathy limits the duration over which patients can receive natalizumab before requiring a switch to other therapies such as fingolimod. To date, no studies have assessed the long-term real-world effectiveness and safety of fingolimod following a switch from natalizumab. We aimed to investigate the benefit-risk profile of fingolimod over 48 months in patients switching from natalizumab, and the impact of washout duration after natalizumab discontinuation on outcomes during fingolimod treatment.

Real-world persistence and benefit-risk profile of fingolimod over 36 months in Germany.

Objective: To assess the long-term real-world benefit-risk profile of fingolimod in patients with relapsing MS in Germany.

Methods: This analysis used data from the noninterventional real-world study, Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA), to assess prospectively the persistence, effectiveness, and safety of fingolimod over 36 months (±90 days) in Germany. For inclusion in the effectiveness analysis (n = 2,537), patients were required to have received fingolimod for the first time in PANGAEA, to have at least 12 months of data, and to have completed each 12-month follow-up period.

Clinical and Demographic Profile of Patients Receiving Fingolimod in Clinical Practice in Germany and the Benefit-Risk Profile of Fingolimod After 1 Year of Treatment: Initial Results From the Observational, Noninterventional Study PANGAEA.

The population with multiple sclerosis receiving treatment in clinical practice differs from that in randomized controlled trials (RCTs). An assessment of the real-world benefit-risk profile of therapies is needed. This analysis used data from the large, noninterventional, observational German study Post-Authorization Non-interventional German sAfety study of GilEnyA (PANGAEA) to assess prospectively baseline characteristics and outcomes after 12 months (± 90 days) of fingolimod treatment.

Acquired pendular nystagmus in multiple sclerosis: an examiner-blind cross-over treatment study of memantine and gabapentin.

A prospective examiner-blind, cross-over study was conducted to compare the efficacy of memantine (40 or 60 mg/day) and gabapentin (1,200 mg/day) as therapy for acquired fixational pendular nystagmus (APN) in 11 patients with multiple sclerosis. APN was documented in 20 eyes by electrooculography (EOG). The primary objective of the study was an at least 50% reduction in amplitude and/or frequency of APN compared with baseline values in EOG.