Safety and Efficacy of Teriflunomide in Patients Switching from Subcutaneous Interferon Beta-1a (P7.275)

OBJECTIVE: To report the safety and efficacy results from the open-label extension of the TENERE study (NCT00883337). BACKGROUND: Teriflunomide is a once-daily oral immunomodulator approved for relapsing forms of MS (RMS). TENERE, a rater-blinded phase 3 study, compared the effectiveness of teriflunomide with subcutaneous interferon beta-1a (sc IFNβ-1a) in patients with RMS. Effects on time to failure were comparable between teriflunomide and IFNβ-1a. teriflunomide safety and tolerability profile was consistent with previous studies. DESIGN/METHODS: Patients completing TENERE were offered to enroll in an open-label extension. All patients in the extension received teriflunomide 14 mg, regardless of treatment in the core study (teriflunomide 14 mg, teriflunomide 7 mg, or IFNβ-1a), without a washout RESULTS: Of 249 patients who completed the core study, 237 entered the extension, 59 patients switched from IFNβ-1a (IFN/14), 88 continued teriflunomide 14 mg (14/14), and 90 switched from teriflunomide 7 mg (7/14). Median duration of treatment ranged from 1003-1009 days. Relapse rates were low in all groups: 0.239 (IFN/14), 0.181 (14/14), and 0.223 (7/14). No statistically significant differences were seen between any groups. Incidence of treatment-emergent adverse events (AEs) was similar in all groups. Serious AEs were reported in 12.2[percnt] patients. AEs leading to treatment discontinuation were reported in 5.9[percnt] patients. type and frequency of AEs were consistent with previous studies; there were no new or unexpected AE signals associated with switching to or long-term treatment with teriflunomide. CONCLUSIONS: The extension of TENERE is the first study in which patients switched from sc IFNβ-1a to teriflunomide without a washout interval. These data demonstrate potential for teriflunomide as a safe and effective option for managing disease activity in patients switching from IFN. Study Supported by: Genzyme, a Sanofi company. Disclosure: Dr. De Seze has nothing to disclose. Dr. Olsson has received personal compensation for activities with Biogen Idec. Dr. Czlonkowska has nothing to disclose. Dr. Benamor has received personal compensation for activities with Sanofi as an employee. Dr. Truffinet has received personal compensation for activities with Genzyme Corporation as an employee. Dr. Dukovic has received personal compensation for activities with Sanofi. Dr. Patrick has received personal compensation for activities with Biogen Idec.