[S21.001] Oral Teriflunomide or Placebo Added to Glatiramer Acetate for 6 Months in Patients with Relapsing Multiple Sclerosis: Safety and Efficacy Results

Mark Freedman, Ottawa, ON, Canada, Jerry S. Wolinsky, Houston, TX, Gérald A. Frangin, Montpellier Cedex 4, France, Christian Confavreux, Lyon, France, Giancarlo Comi, Milan, Italy, William J. Byrnes, Malvern, PA, Ludwig Kappos, Basel, Switzerland, Tomas Olsson, Stockholm, Sweden, Aaron Miller, New York, NY, Paul O'Connor, Toronto, ON, Canada

OBJECTIVE: To evaluate the safety and efficacy of teriflunomide added to ongoing glatiramer acetate (GA) treatment for 24-weeks. BACKGROUND: Teriflunomide has anti-proliferative and immunomodulatory properties. In RRMS studies, oral teriflunomide 7 or 14mg/day was well tolerated and reduced MRI activity relative to placebo in monotherapy for 36-weeks (both doses>61%) and when added to interferon-beta for 24-weeks (7mg: 56% and 14mg: 81%). DESIGN/METHODS: RRMS patients on GA were randomized to placebo (n=41), 7mg (n=42) or 14mg (n=40) teriflunomide daily for 24-weeks. Safety was evaluated from Treatment Emergent Adverse Event (TEAE), physical examination, laboratory data, ECG and pancreatic ultrasound (24-weeks). Relapses were recorded. Brain MRI and EDSS were performed every 8 weeks. RESULTS: Baseline characteristics were similar among groups: mean age 41 years, 79% female, mean EDSS 2.5, 41% had no relapse in previous year. The number of patients with baseline T1-Gd-lesions was higher in 7mg (28.6%) as compared to placebo (14.6%) and 14mg (12.8%). Safety: Seven TEAEs led to treatment discontinuation 7mg: 3 (7.1%); 14mg: 4 (10%). There were 6 patients with TEAEs due to increased ALT (2 per group) and 2 with ALT above 3xULN (one placebo, one 14mg) without concomitant increase in bilirubin. The proportion of patients with TEAE potentially related to immunosuppression (including white blood cell counts, infections) was balanced among groups (placebo: 44%, 7mg: 43%, 14mg: 38%); none leading to treatment discontinuation. Efficacy: Compared to placebo T1-Gd lesions number was reduced in 7mg (p=0.011) and T1-Gd lesions volume in 14mg (p=0.039). CONCLUSIONS/RELEVANCE: Adding teriflunomide 7 and 14mg daily to patients on GA showed acceptable safety and improved disease control as evaluated by MRI activity over 24-weeks compared to GA alone. Further data are required to establish clinical benefit and safety. Supported by: Sanofi-aventis.
Category - MS and Related Diseases - Clinical Science

Wednesday, April 14, 2010 2:00 PM

Scientific Sessions: Multiple Sclerosis: Clinical Trials II (2:00 PM-4:00 PM)