OP69 – 2651: Safety and effect of fingolimod on no evidence of disease activity (NEDA-4) in young adult patients with relapsing-remitting multiple sclerosis

Abstract

Objective To evaluate the safety and effect of fingolimod 0.5 mg on NEDA-4 in young adult RRMS patients. NEDA-4 is a combined 4-part measure (no new/enlarging T2 lesions; no confirmed relapses; no 6-month confirmed disability progression; annualized rate of brain atrophy Methods Post-hoc analysis of NEDA-4 was conducted in the combined FREEDOMS/FREEDOMS II (2-year studies versus placebo), and in TRANSFORMS (1-year study versus intramuscular interferon-beta-1a, IFN). NEDA-4 was analyzed by logistic regression model (adjusted for treatment, age at baseline, treatment-by-age interaction). Proportion of patients with NEDA-4 and odds ratios (OR) versus controls were estimated for ages ≤30 years and >30 years. Safety in patients ≤30 years was evaluated from AEs reported on fingolimod (N=1364) and placebo (N=966) using combined data from all fingolimod phase II/III RRMS studies. Results In young adults (≤30 years) from FREEDOMS/FREEDOMS II, 24/153 (15.7%) had NEDA-4 on fingolimod versus 4/141 (2.8%) on placebo (OR=6.37, p 30 years. The fingolimod AE profile in young adults was consistent with the known profile of fingolimod in the overall population. Conclusion Young adults were approximately 3–6 times more likely to achieve NEDA-4 on fingolimod versus controls. Efficacy and safety of fingolimod in young patients will be further investigated in the PARADIGMS study (fingolimod versus IFN in pediatric MS), currently recruiting worldwide.