Biernacki-et-al.Real-world-data-on-the-efficacy-and-long-term-use-of-fingolimod-in-Hungary.xlsx

Background: Fingolimod was approved and reimbursed by the healthcare provider in
Hungary for the treatment of highly active relapsing-remitting multiple
sclerosis (RRMS) in 2012. The present study aimed to assess the effectiveness,
safety profile, and persistence to fingolimod in a real-life setting in Hungary
in RRMS patients who were either therapy naïve before enrollment or have changed to fingolimod from another
disease-modifying therapy (DMT) for any reason.

Methods: This cross-sectional, observational study with prospective data
collection was performed nationwide at 21 sites across Hungary. To avoid
selection bias, sites were asked to document eligible patients in consecutive
chronological order. Demographic, clinical, safety and efficacy data were analysed
for up to 5 years from 570 consenting adult patients with RRMS who had received
treatment with fingolimod for at least one year.

Results: 69.6% of patients remained free from relapses for the whole study
duration; in the first year, 85.1% of patients did not experience a relapse,
which rose to 94.6% seen in the 5th year. Compared to baseline at study end,
62.7% of the patients had stable, 28.2% had higher, and 9.1% had lower EDSS
scores. Overall, the annualized relapse rate decreased from 0.804 observed at
baseline to 0.185, 0.149, 0.122, 0.091, and 0.097 (77.0%, 82.1%, 85.2%, 89.7%,
and 89.0% relative reduction, respectively) after 1, 2, 3, 4, and 5 years of
treatment. The greatest reduction rate was seen in the group of therapy naïve patients. Treatment persistence on fingolimod
after 60 months was 73.4%.

Conclusion: In
this nationwide Hungarian cohort, most patients under fingolimod treatment were
free from relapses and disability progression. In addition, fingolimod has
proven to be a well-tolerated DMT that has sustained its manageable safety
profile, high efficacy, and positive benefit/risk ratio for up to 5 years in a
real-life setting.