1. Effectiveness of fingolimod in real-world relapsing-remitting multiple sclerosis Italian patients: the GENIUS study
- Author
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Antonio Bertolotto, M Nica, Antonio Carotenuto, Maria Trojano, Francesca Sangalli, Luca Prosperini, Carlo Pozzilli, Delia Colombo, Sara Rizzoli, Marco Capobianco, Giancarlo Comi, Pietro Iaffaldano, and Vincenzo Brescia Morra more...
- Subjects
Adult ,medicine.medical_specialty ,Multiple Sclerosis ,Dermatology ,Immunosuppressant Agents ,Therapy naive ,Multiple Sclerosis, Relapsing-Remitting ,Natalizumab ,Internal medicine ,medicine ,Humans ,In patient ,Retrospective Studies ,Annualized relapse rate ,Fingolimod ,NEDA-3 ,Relapsing-remitting multiple sclerosis ,Fingolimod Hydrochloride ,business.industry ,Multiple sclerosis ,General Medicine ,medicine.disease ,Psychiatry and Mental health ,Italy ,Relapsing remitting ,Original Article ,Neurology (clinical) ,Previously treated ,business ,Immunosuppressive Agents ,medicine.drug - Abstract
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. more...
- Published
- 2020