Ongoing Safety and Effectiveness: An Interim Analysis of Long-Term Fingolimod Treatment (P3.057)

Objective: To evaluate the long-term safety and effectiveness of fingolimod patients with relapsing-remitting multiple sclerosis (RRMS) derived from a pool of phase 3 clinical trials. Background: LONGTERMS is an ongoing, open-label, single-arm, extension study evaluating the long-term safety and tolerability of fingolimod in patients who previously participated in phase 2/3/3b fingolimod trials. Methods: Two patient cohorts treated with fingolimod 0.5 mg were evaluated: A long-term cohort (LC; n=1655; median exposure: 4.1y) previously enrolled in three core phase 3 trials plus their extensions (including non-participants of LONGTERMS), and a core cohort (CC; n=1212; median exposure: 1.6y) pooled from core phase 3 trials. Incidence rates (IRs) for LC and CC and IR ratios (IRRs; IR for LC/IR for CC) were determined for any adverse events (AEs), serious AEs (SAEs) and AEs of special interest. Effectiveness analysis included patients from FREEDOMS/FREEDOMS II (pooled FREEDOMS: N=982, median exposure: 6.6y) and TRANSFORMS (N=732, median exposure: 7.1y) who received ≥1 fingolimod dose in LONGTERMS. Relapse (ARR and [percnt] relapse-free patients) and disability outcomes (Kaplan-Meier [KM] estimates for patients not reaching EDSS score 4, 6, or 7) were evaluated. Results: IRRs (95[percnt] CI) for AEs and SAEs were 0.74 (0.68-0.79) and 0.73 (0.60-0.91), respectively. IRRs for AEs of special interest were 200 cells/mm 3 in CC. ARR remained low up to 84 months (M): pooled FREEDOMS, 0.14; TRANSFORMS, 0.18. Most patients remained relapse-free (54.2[percnt] and 47.0[percnt]) and did not reach EDSS (KM estimates at M60) ≥4 (76[percnt] and 78[percnt]), ≥6 (90[percnt] and 93[percnt]) and ≥7 (99[percnt] and 99[percnt]). Data from latest cut-off will be presented. Conclusions: In patients continuing follow-up, long-term exposure to fingolimod raised no new safety/tolerability concerns in RRMS patients. Disease remained stable. Funding:Novartis Pharma AG Disclosure: Dr. Cohen received personal compensation for activities with Genentech, Genzyme, Novartis, and Teva as a consultant or speaker. Dr. Cohen has received personal compensation in an editorial capacity for Multiple Sclerosis Journal-Experimental, Translationa Dr. Pradhan has received personal compensation for activities with Novartis as an employee. Dr. Chen has received personal compensation for activities with Novartis as an employee. Dr. Chen has received personal compensation for activities with Novartis as an employee. Dr. Kappos9s institution (University Hospital Basel) has received royalty payments from Neurostatus Systems GmbH.