Contributions
Abstract: P1177
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Brain volume loss (BVL) derived from relative change in brain parenchymal fraction (BPF) is a measure of evolving brain atrophy in patients with multiple sclerosis (MS). Patients with active relapsing-remitting MS (RRMS) who were treatment-naive (CARE-MS I; NCT00530348) or who had an inadequate response (≥1 relapse) to prior therapy at baseline (BL) (CARE-MS II; NCT00548405) demonstrated significantly greater reductions in the rate of BVL with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) over 2 years. Patients who completed CARE-MS I and II could enter an extension study (NCT00930553); patients treated with SC IFNB-1a in the core studies were crossed-over to alemtuzumab treatment in the extension and experienced marked improvements in clinical and MRI outcomes.
Goal: To evaluate the effect of alemtuzumab on BVL over 4 years in patients switched from SC IFNB-1a.
Methods: Following SC IFNB-1a discontinuation, patients were infused with 2 courses of alemtuzumab 12 mg (Month 0 of extension: 5 days; Month 12 of extension: 3 days), followed by as-needed retreatment for relapse or MRI activity at any time 12 months following the last infusion. Another disease-modifying therapy could be provided at the investigator"s discretion. MRI scans were assessed at BL and annually thereafter. BVL was derived from relative change in BPF.
Results: The extension study enrolled 144 (83%) and 146 (83%) SC IFNB-1a-treated patients from CARE-MS I and II, respectively; of these, 125 (87%) and 125 (86%) patients remained on study 4 years later. In CARE-MS I, median yearly BPF change was reduced in Years 1, 2, 3, and 4 after switching to alemtuzumab (Year 1: -0.07%; Year 2: -0.15%; Year 3: -0.05%; Year 4: 0.01%) compared with the 2 years before alemtuzumab, during SC IFNB-1a treatment (-0.94% and -0.50%). Similar results were observed in CARE-MS II (median yearly BPF change was 0.02%, -0.04%, -0.15%, and -0.08% in Years 1, 2, 3, and 4 after switching to alemtuzumab) compared with the 2 years before alemtuzumab during SC IFNB-1a treatment (-0.54% and -0.33%). These results were achieved with most patients (CARE-MS I: 75%; CARE-MS II: 71%) receiving no additional treatment after their initial 2 courses of alemtuzumab following their switch from SC IFNB-1a.
Conclusion: Discontinuing SC IFNB-1a and switching to alemtuzumab markedly slowed BVL over 4 years, despite most patients receiving no additional treatment since the initial 2 courses of alemtuzumab.
Disclosure: STUDY SUPPORT: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
AT: Consulting fees (Biogen, Novartis, Roche, Sanofi Genzyme, Serono, and Teva); grant/research support (Roche and Sanofi Genzyme). DA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving research support (Acorda, Bayer, Biogen Idec, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Teva Pharmaceuticals). DP: Consulting and/or speaking fees (Genzyme, Vertex, Novartis, Roche, Biogen.) Grant/Research Support (Biogen). DHM and KT: Employees of Sanofi Genzyme. GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva). AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal). SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Novartis, Sanofi Genzyme). KN: Consultant (NeuroRx Research); research support (Biogen, Sanofi Genzyme).
Abstract: P1177
Type: Poster
Abstract Category: Therapy - disease modifying - Immunomodulation/Immunosuppression
Background: Brain volume loss (BVL) derived from relative change in brain parenchymal fraction (BPF) is a measure of evolving brain atrophy in patients with multiple sclerosis (MS). Patients with active relapsing-remitting MS (RRMS) who were treatment-naive (CARE-MS I; NCT00530348) or who had an inadequate response (≥1 relapse) to prior therapy at baseline (BL) (CARE-MS II; NCT00548405) demonstrated significantly greater reductions in the rate of BVL with alemtuzumab versus subcutaneous interferon beta-1a (SC IFNB-1a) over 2 years. Patients who completed CARE-MS I and II could enter an extension study (NCT00930553); patients treated with SC IFNB-1a in the core studies were crossed-over to alemtuzumab treatment in the extension and experienced marked improvements in clinical and MRI outcomes.
Goal: To evaluate the effect of alemtuzumab on BVL over 4 years in patients switched from SC IFNB-1a.
Methods: Following SC IFNB-1a discontinuation, patients were infused with 2 courses of alemtuzumab 12 mg (Month 0 of extension: 5 days; Month 12 of extension: 3 days), followed by as-needed retreatment for relapse or MRI activity at any time 12 months following the last infusion. Another disease-modifying therapy could be provided at the investigator"s discretion. MRI scans were assessed at BL and annually thereafter. BVL was derived from relative change in BPF.
Results: The extension study enrolled 144 (83%) and 146 (83%) SC IFNB-1a-treated patients from CARE-MS I and II, respectively; of these, 125 (87%) and 125 (86%) patients remained on study 4 years later. In CARE-MS I, median yearly BPF change was reduced in Years 1, 2, 3, and 4 after switching to alemtuzumab (Year 1: -0.07%; Year 2: -0.15%; Year 3: -0.05%; Year 4: 0.01%) compared with the 2 years before alemtuzumab, during SC IFNB-1a treatment (-0.94% and -0.50%). Similar results were observed in CARE-MS II (median yearly BPF change was 0.02%, -0.04%, -0.15%, and -0.08% in Years 1, 2, 3, and 4 after switching to alemtuzumab) compared with the 2 years before alemtuzumab during SC IFNB-1a treatment (-0.54% and -0.33%). These results were achieved with most patients (CARE-MS I: 75%; CARE-MS II: 71%) receiving no additional treatment after their initial 2 courses of alemtuzumab following their switch from SC IFNB-1a.
Conclusion: Discontinuing SC IFNB-1a and switching to alemtuzumab markedly slowed BVL over 4 years, despite most patients receiving no additional treatment since the initial 2 courses of alemtuzumab.
Disclosure: STUDY SUPPORT: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
AT: Consulting fees (Biogen, Novartis, Roche, Sanofi Genzyme, Serono, and Teva); grant/research support (Roche and Sanofi Genzyme). DA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving research support (Acorda, Bayer, Biogen Idec, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, Genzyme, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Teva Pharmaceuticals). DP: Consulting and/or speaking fees (Genzyme, Vertex, Novartis, Roche, Biogen.) Grant/Research Support (Biogen). DHM and KT: Employees of Sanofi Genzyme. GC: Consulting fees (Actelion, Bayer, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva). AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal). SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Novartis, Sanofi Genzyme). KN: Consultant (NeuroRx Research); research support (Biogen, Sanofi Genzyme).