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THUR 173 Longterms: 10-year experience of fingolimod in RRMS patients
  1. Cohen Jeffrey1,
  2. Tenenbaum Nadia2,
  3. Bhatt Alit3,
  4. Pimentel Ron2,
  5. Kappos Ludwig4
  1. 1Neurological Institute, Cleveland Clinic, Cleveland, OH, USA
  2. 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
  3. 3Novartis Healthcare Pvt. Ltd., Hyderabad, India
  4. 4Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomed


Objectives Present results for up to 10 years of fingolimod treatment in RRMS patients.

Methods LONGTERMS is an open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of fingolimod in patients who previously participated in earlier fingolimod studies. Key efficacy measures: annualised relapse rate (ARR), proportion of patients free of 6 month confirmed disability progression (6 m-CDP), annualised rate of new or newly enlarging T2 lesions (ARneT2), and annualised rate of brain atrophy (ARBA). Safety analyses: adverse events (AEs) and serious AEs (SAEs) frequencies.

Results 3168 patients were included in the analysis. ARR decreased with longer exposure from 0.26 (Month [M] 0–12) to 0.20 (M0–60) and 0.19 (M0–120). Most patients remained free from 6 m-CDP at M60 (79.3%) and M120 (68.1%). ARneT2 decreased from 1.31 (M0–12) to 0.90 (M0–60), and 0.71 (M0–120). Change in brain volume was stable throughout the study (−0.37 [M12], −0.33 [M60] and −0.32 [M120]). Long-term exposure did not raise new safety concerns. No increase in frequencies of AEs or SAEs per year was observed over long-term fingolimod treatment.

Conclusions Long-term follow-up confirmed the established safety profile of fingolimod. Treatment was associated with a sustained low level of disease activity as expressed by clinical and MRI outcomes.

Disclaimer Previously presented at ECTRIMS 2017

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