Prospective and Open label study to compare the cardiac safety profile during first-dose monitoring period of two Fingolimod products: (Gilenya vs Generic version) in RRMS patients (P5.381)

Objective: The primary objective is to assess the cardiac safety of the first dose of FTY-Gilenya / FTY-Generic. Method: Prospective and Open Label study from 4 experienced centers who prescribed FTY-Gilenya or FTY-Generic for treating RRMS patients. Data from the baseline first-dose visit was registered from 12-lead ECG, Heart Rate (HR), and blood pressure (BP). All of them were registered prior to 1st dose administration and hourly BP/HR were monitored till 6 hr. Difference between 1–6 hr were analyzed and compared between products. Background: Fingolimod (FTY-Gilenya) and its generic version (FTY-Generic) were the first oral therapies approved in Latin American countries. At treatment initiation, FTY can induce transient bradycardia and atrioventricular conduction delays linked to S1P receptor activation. Design/Methods: ONE WAY ANOVA Results: FTY-Generic (n=62) / FTY-Gilenya (n=47). (n/%) F: 39(62.9) / 23(37.1); M: 23 (37.1) / 16 (34.04) Age(Mean±SD):40.08±11.28 /37.32±9.54 Basal HR (Mean±SD): −2.41±7.06 /−2.79 ± 3.92 (p: 0.742). ≠6h/Basal (Mean±SD): −8.20 ± 7.48 /−8.19 ± 6.85 (p:0.997) ≠Diastolic BP(Mean±SD): 0.56 ± 1.03 /2.26 ± 0.82 ≠Sistolic BP(Mean±SD): −0.73 ± 1.94 /−0.04 ± 0.74 Cardiac safety profile FTY-Gilenya vs FTY Generic: p = 0.503 Baseline Characteristics of MS: no difference Conclusions: This first national study showed a well-tolerated cardiac safety profile for both products, Gilenya and Generic FTY, in RRMS patients. Despite its limitations, the study showed no difference in first dose for evaluated cardiac parameters. Similar results to those published in pivotal studies and open label studies. Further analysis involving a higher number of patients will help to validate these findings Disclosure: Dr. Curbelo has received personal compensation for activities with Biogen, IVAX, Genzyme, Merck and Synthon-Bago. Dr. Steinberg has received personal compensation for activities with Biogen, IVAX, Sanofi Genzyme, Merck, and Synthon-Bago. Dr. Vrech has received personal compensation for traveling from Bayer; Genzyme; Merck; Novartis; and Synthon-Bago. Dr. Garcea has received personal compensation for activities with Bayer, Biogen, Genzyme, Merck, Novartis, Raffo, and Synthon-Bago for traveling. Dr. Alonso has received personal compensation for activities with Biogen, Genzyme, and Synthon-Bago. Dr. Romero has nothing to disclose. Dr. Martinez has received personal compensation for activities with Biogen, IVAX, Merck, and Synthon-Bago. Dr. Zinnerman has received personal compensation for activities with Gador. Dr. Lindembaum has received personal compensation from Bayer, Gador, Gemabiotech, Genzyme, IVAX, Merck-Serono, Synthon-Bago, and Teva for consulting, speaking or traveling.