Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study

Giancarlo Comi, Carlo Pozzilli, Vincenzo Brescia Morra, Antonio Bertolotto, Francesca Sangalli, Luca Prosperini, Antonio Carotenuto, Pietro Iaffaldano, Marco Capobianco, Delia Colombo, Mihaela Nica, Sara Rizzoli, Maria Trojano

Research output: Contribution to journalArticlepeer-review


Background: Fingolimod is the first oral agent approved for treatment of relapsing-remitting multiple sclerosis (RRMS). We aimed to evaluate fingolimod effectiveness in a real-world sample of RRMS patients. Methods: A retrospective, multicentre study in patients treated with fingolimod, whom clinical and radiological data were collected in the 2 years preceding and following the initiation of fingolimod. Results: Out of 414 patients, 56.8% received prior first-line injectable disease-modifying therapies, 25.4% were previously treated with natalizumab, 1.2% with immunosuppressant agents, and 16.7% were treatment naive. The annualized relapse rate decreased by 65% in the first year and by 70% after two years of treatment. Age ≤ 40 years, ≥ 1 relapse in the 24 months before fingolimod initiation and previous treatment with natalizumab were risk factors for relapses. Overall, 67.9% patients had no evidence of disease activity (NEDA-3) after 1 year and 54.6% after 2 years of treatment. A higher proportion of naïve (81.2% in 1 year and 66.7% after 2 years) or first-line injected patients (70.2% and 56.6%) achieved NEDA-3 than those previously treated with natalizumab (54.3% and 42.9%). Conclusions: Fingolimod appeared to be effective in naive patients and after first-line treatment failure in reducing risk of relapse and disease activity throughout the 2-year follow-up.

Original languageEnglish
Pages (from-to)2843-2851
Number of pages9
JournalNeurological Sciences
Issue number10
Publication statusPublished - Oct 1 2020


  • Annualized relapse rate
  • Fingolimod
  • NEDA-3
  • Relapsing-remitting multiple sclerosis

ASJC Scopus subject areas

  • Dermatology
  • Clinical Neurology
  • Psychiatry and Mental health


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