Long-term Impact of Early MS Treatment with Interferon Beta-1b (IFNB-1b): Clinical, MRI, Employment, and Patient-Reported Outcomes (PROs) at the 11-Year Follow-up of BENEFIT (BENEFIT 11) (P7.012)

Abstract

International audienceOBJECTIVE:To study long-term outcomes in patients treated with IFNB-1b after clinically isolated syndrome (CIS). BACKGROUND:In BENEFIT, patients with CIS were randomized to IFNB-1b or placebo (PL) treatment. After the second clinical event or after 2 years, all patients were treated with IFNB-1b. Mean delay of IFNB-1b in PL was 1.33 years. Comprehensive clinical, MRI, and PROs at 11 years post-randomization are reported. DESIGN/METHODS:All originally randomized patients were asked to undergo clinical, MRI, laboratory, and PRO assessments 11 years after randomization. RESULTS:281 patients were identified (60[percnt] of originally randomized, 72.6[percnt] of eligible patients at participating sites); 278 enrolled. Baseline characteristics were similar to the original BENEFIT population. At Year 11, patients randomized to IFNB-1b still had lower overall annualized relapse rate (p=0.0018) and longer time to first relapse (p=0.0005) and clinically definite MS (p=0.0012). Median EDSS score was 2.0 (change from baseline 0.5) in both groups. PASAT scores remained high (overall median 56 [IQR 10]). Of the 81.3[percnt] working at CIS start, 73.4[percnt] were still employed (64.4[percnt] fulltime). 12.2[percnt] retired early or were on long-term disability (2.9[percnt] at baseline). 64.0[percnt] did not report any sick leave during the past 12 months. Health-related quality of life remained stable (median [IQR] change from baseline EQ-5D: 0.000 [0.209], FAMS TOI: -7.54 [27.17]. Median (IQR) fatigue (FSMC) score: 45.00 (40.00), 46[percnt] of patients without fatigue (cut-off score\textless43), median (IQR) depression (CES-D) score: 9.00 (15.00). MRI findings were similar across groups: 86.4[percnt] had no gadolinium-enhancing lesions; median (IQR) number of new T2 lesions since 5-year MRI: 2.0 (6.0), T2 volume: 1760.0mm³ (3963.0mm³), cortical lesions: 2.0 (5.0), brain volume 1519.0cm³ (152.0mm³), mean cortical thickness 2.64mm³ (0.56mm³). CONCLUSIONS:Results from BENEFIT11 support a long-term impact of early treatment with IFNB-1b on clinical measures, including cognition and fatigue, and health economic and MRI outcomes. Study Supported by:Bayer HealthCare Pharmaceuticals Disclosure: Dr. Edan has received personal compensation for activities with LFB, Biogenidec, speaking from Serono, Inc., Sanofi, Teva, and Bayer Pharmaceuticals Corporation as a consultant and/or scientific advisory board member. Dr. Freedman has received personal compensation for activities with Bayer Healthcare, Biogen Idec, Chugai, EMD Canada, Genzyme, Novartis, Sanofi-Aventis, and Teva Canada Innovation. Dr. Montalban has received personal compensation for activities with Bayer, Biogen Idec, EMD, Genentech, Genzyme, Merck Serono, Neurotec, Novartis, Sanofi-Aventis, Teva Pharmaceuticals, and Almirall. Dr. Miller has received personal compensation for activities with UCL Institute of Neurology, Biogen Idec, GlaxoSmithKline Inc., Novartis, Merck & Co. Inc., Chugai, and Mitsubishi Pharma. Dr. Miller has received personal compensation in an editorial capac Dr. Hartung has holds stock and/or stock options from Opexa Therapeutics. Dr. Hemmer has received personal compensation for activities with Roche, Novartis, Bayer Schering, Merck Serono, Biogen Idec, GlaxoSmithKline, Chugai Pharmaceutical, Micromet, and Genzyme as a scientific advisory board member. Dr. Fox has received personal compensation for activities Acorda Therapeutics, Bayer Pharmaceuticals Corporation, Biogen Idec, Eli Lilly & Company, EMD Serono, Genzyme Corporation, GlaxoSmithKline, and Novartis. Dr. Barkhof has received personal compensation for activities with Bayer Schering Pharma, Sanofi, Genzyme, Biogen Idec, Teva, Merck Serono, Novartis, Roche, Synthon BV, and Janssen Research as a consultant. Dr. Schippling has received personal compensation for activities with Novartis. Dr. Schippling has received research support from Bayer Schering and Biogen Idec. Dr. Schulze has received personal compensation for activities with PAREXEL International as an employee. Dr. Pleimes has received personal compensation for activities with Myelo Therapeutics GmbH as an employee, and with Bayer Pharmaceuticals Corp. as an employee and consultant. Dr. Pohl has received personal compensation for activities with Bayer Pharmaceuticals Corporation as an employee. Dr. Pohl owns stock and/or stock options in Bayer Pharmaceuticals Corporation. Dr. Sandbrink has received personal compensation for activities with Bayer Pharmaceuticals Corporation as an employee. Dr. Sandbrink holds stock and/or stock options in Bayer Pharmaceuticals Corporation. Dr. Suarez has received personal compensation for activities with Bayer Pharmaceuticals Corporation as an employee. Dr. Wicklein has received personal compensation for activities with Bayer Pharmaceuticals Corporation as an employee. Dr. Kappos has received personal compensation for activities with Actelion Pharmaceutical