OBJECTIVES: To describe the Annualized Relapse Rate (ARR) (primary objective) and the proportion of patients with No Evidence of Disease Activity (relapses, disability progression and MRI activity, NEDA-3) (secondary objective) in a cohort of MS Italian patients after 1 and 2 years of fingolimod treatment.

METHODS: GENIUS is an observational, retrospective cohort study on MS patients who started fingolimod in the years 2013-2014. ARR and the proportion of NEDA-3 patients after 1 and 2 years of treatment were calculated.

RESULTS

: Data of 391 patients were analysed: 270 (69%) were females; mean (SD) age was 38.7 (9.8) years; mean (SD) duration of fingolimod treatment was 22.8 (4.2) months. Mean (SD) number of relapses in the year before treatment start was 1.0 (0.8). The one- and two-year ARR (95% CI) were 0.19 (0.15-0.23) and 0.18 (0.14-0.22), respectively.

Relapsing patients were 53 (13.6%) in the first year of treatment, 47 (12.0%) in the second year and 85 (21.7%) after two years of treatment.

At 1 and 2 years after fingolimod start, 81 (20.7%) and 60 (15.3%) patients had MRI disease activity, respectively; 114 (29.2%) patients had MRI disease activity during the 2 years after treatment start.

At fingolimod start, 77 (19.7%) patients showed NEDA-3, whereas after 1 and 2 years of treatment there were 278 (71.1%) and 299 (76.5%) NEDA-3 patients respectively; 229 (58.6%) patients showed NEDA-3 after two years of treatment.

CONCLUSIONS

:

• GENIUS study results confirmed the effectiveness of fingolimod in the Italian RW setting;
• patients were analyzed
• was (0.35 in NTZ+, 0.13 in NTZ-);
• ARR was 0.18 (0.30 in NTZ+, 0.16 in NTZ-);
• % of patients was NEDA-3 at 1 year and 77% at 2 years;
• RWD is becoming more and more important for assessing drug effectiveness