PT - JOURNAL ARTICLE AU - Comi, Giancarlo AU - Vollmer, Timothy AU - Kappos, Ludwig AU - Montalban, Xavier AU - Sasson, Nissim AU - Gorfine, Tali AU - Knappertz, Volker TI - Laquinimod Disability Progression Effects Are Maintained with Increasingly Rigorous Confirmation Time Intervals (P3.069) DP - 2016 Apr 05 TA - Neurology PG - P3.069 VI - 86 IP - 16 Supplement 4099 - http://n.neurology.org/content/86/16_Supplement/P3.069.short 4100 - http://n.neurology.org/content/86/16_Supplement/P3.069.full SO - Neurology2016 Apr 05; 86 AB - BACKGROUND: Oral laquinimod 0.6mg once-daily (QD) demonstrated consistent reductions of 3-month confirmed disability progression (CDP) in the phase III ALLEGRO and BRAVO trials. OBJECTIVES: To explore the durability of laquinimod effect on CDP, additional analyses were performed utilizing increasingly rigorous durations for disability confirmation. METHODS: Using pooled data from the ALLEGRO and BRAVO trials, laquinimod effects on 6-, 9-, and 12-month CDP were analyzed. CDP was defined as an increase in EDSS of >1 point from baseline for subjects with baseline EDSS ≤5.0, or an increase in EDSS of >0.5 point from baseline for subjects with baseline EDSS of 5.5. In order to have a confirmation of disease progression, the increased EDSS value compared to the reference value had to be increased at all the time points. Therefore, all initial progressions for patients with 12-month CDP events had to occur in the first study year. RESULTS: The treatment effect of laquinimod on CDP was maintained over all tested confirmation intervals. The hazard ratios of the treatment effect were 0.66, 0.54, 0.53, and 0.55 for 3, 6, 9, and 12-months CDP, respectively; P<.005, all comparisons. As expected, there was a reduction in the incidence of CDP over time demonstrated for the placebo group: proportions of placebo patients with CDP at 3, 6, 9, and 12 months were 15[percnt], 12[percnt], 9[percnt], and 7[percnt], respectively. No baseline demographic, clinical, or MRI factors were predictive of CDP at the different time points. CONCLUSIONS: Despite increasingly demanding criteria for confirmed disability progression, a profound effect of laquinimod for reducing disability progression was consistently demonstrated.Disclosure: Dr. Comi has received personal compensation for activities with Teva, Novartis, Genzyme, Merck Serono, Biogen, Bayer, Actelion, Almirall, and Serono Symposia International Foundation. Dr. Vollmer has received personal compensation for activities with Acorda Therapeutics, Biogen Idec, Genentech, Inc., Novartis, Ono Pharmaceutical, Teva Neuroscience, and XenoPort as a consultant. Dr. Kappos's institution (University Hospital Basel) has received royalty payments from Neurostatus Systems GmbH. Dr. Montalban has received personal compensation for activities with Actelion, Almirall, Bayer Pharmaceuticals, Biogen Idec, Genzyme Corporation, Merck & Co., Inc., NeuroTex, Novartis, Octopharma, Receptos, and Roche Diagnostics Corporation as a speaker. Dr. Sasson has received personal compensation for activities with Teva Pharmaceutical Industries Ltd. as an employee. Dr. Gorfine has received personal compensation for activities with Teva Pharmaceuticals Inc. Dr. Knappertz has received personal compensation for activities with Teva Neuroscience as an employee.Monday, April 18 2016, 8:30 am-7:00 pm