Contributions
Abstract: P1258
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: In CARE-MS studies (NCT00530348; NCT00548405), alemtuzumab showed significant improvement vs SC IFNB-1a in clinical/MRI outcomes over 2 years in patients with RRMS, including higher rates of confirmed disability improvement (CDI). Efficacy was maintained in a 4-year extension (NCT00930553). In CARE-MS II, 71% of patients with CDI achieved improvements in >1 EDSS functional system (FS) score, and improvements were seen across all FS.
Aims: To assess CDI occurring early or late after alemtuzumab initiation in pooled CARE-MS I and II patients over 6 years, including maintenance of effect and pattern of improvement across FS scores.
Methods: Patients received 2 annual courses of alemtuzumab 12 mg/day (baseline: 5 consecutive days; 12 months later: 3 consecutive days) in the core CARE-MS studies, with as-needed alemtuzumab retreatment or other disease-modifying therapies in the extension. CDI was defined as ≥1-point EDSS decrease confirmed over 6 months, assessed in eligible patients (baseline EDSS ≥2). Analyses: percentage of patients with improved (≥1-point) or stable EDSS scores from baseline to Year 6 by achievement of any CDI, early CDI (occurring between baseline and Month 24), or late CDI (Month 25 to Month 72); percentage of patients with stable/improved FS scores at 6 months post-CDI onset; number of improved FS at 6 months post-CDI onset.
Results: Of 427 patients eligible for CDI assessment and with Year 6 data, 171 (40%) achieved CDI. 60% of patients achieving CDI had EDSS scores that remained improved at Year 6, whereas 67% of patients without CDI had stable EDSS scores from baseline to Year 6. EDSS improvement/stability at Year 6 vs baseline was apparent in patients with early CDI (61% improved, 34% stable) and with late CDI (57% improved, 37% stable). At 6 months post-CDI onset, improvement/stability in each FS was observed in 90%-100% of patients with early or late CDI; improvement was most frequently in sensory, pyramidal, and cerebellar FS. 74% of patients with early CDI and 67% with late CDI achieved improvements in >1 FS; 18% and 13%, respectively, achieved improvements in ≥4 FS.
Conclusion: CDI, whether it occurred within the first 2 years or later, was maintained at Year 6 in absence of continuous treatment and was associated with improvements across multiple FS. These results indicate a broad and prolonged effect of alemtuzumab on disability improvement, potentially changing the MS disease course.
Disclosure: PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, Servier, and Teva). RAA: Consulting and/or speaker honoraria, and scientific advisory boards (Bayer, Biogen, Genentech, Novartis, Sanofi, and Teva) and research grants (Novartis). RA: Speaker honoraria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi). AC: Honoraria for presentations or advisory boards to support university research funds (Actelion, Allmirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi Genzyme, and Teva) and research support (Sanofi Genzyme and UCB). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). GI: Speaking and advisory fees (Almirall, Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DK: Consulting fees and/or fees for non-CME services (AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech, Mylan, Novartis, and Sanofi) and research grants (Actelion and Sanofi). HJK: Consulting and/or speaking fees (Bayer, Biogen, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Kael-GemVax, Merck Serono, Ministry of Science and ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor (Multiple Sclerosis Journal - Experimental, Translational, and Clinical); and associate editor (Journal of Clinical Neurology). JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi, and Teva); editorial board (Acta Neurologica Scandinavica); and unconditional research grants (Biogen, Novartis, and Teva). RALM: Advisory boards (Biogen, Merck, Novartis, Roche, Sanofi, and Teva).CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). HW: Consulting and/or speaking fees, and grant/research support (Bayer, Bayer Schering Pharma, Biogen, Elan Corporation, Lilly, Lundbeck, Merck Serono, Novartis, Novo Nordisk, Sanofi, and Teva Neuroscience). LC and ND: Employees of Sanofi. SFH: Consulting agreements, speaker honoraria, and grant/research financial support (AbbVie, Acorda, Avanir, Bayer, Biogen Idec, Genzyme, Novartis, Osmotica, Questcor, Roche, Synthon, and Teva).STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.
Abstract: P1258
Type: Poster Sessions
Abstract Category: Therapy - Tools for detecting therapeutic response
Introduction: In CARE-MS studies (NCT00530348; NCT00548405), alemtuzumab showed significant improvement vs SC IFNB-1a in clinical/MRI outcomes over 2 years in patients with RRMS, including higher rates of confirmed disability improvement (CDI). Efficacy was maintained in a 4-year extension (NCT00930553). In CARE-MS II, 71% of patients with CDI achieved improvements in >1 EDSS functional system (FS) score, and improvements were seen across all FS.
Aims: To assess CDI occurring early or late after alemtuzumab initiation in pooled CARE-MS I and II patients over 6 years, including maintenance of effect and pattern of improvement across FS scores.
Methods: Patients received 2 annual courses of alemtuzumab 12 mg/day (baseline: 5 consecutive days; 12 months later: 3 consecutive days) in the core CARE-MS studies, with as-needed alemtuzumab retreatment or other disease-modifying therapies in the extension. CDI was defined as ≥1-point EDSS decrease confirmed over 6 months, assessed in eligible patients (baseline EDSS ≥2). Analyses: percentage of patients with improved (≥1-point) or stable EDSS scores from baseline to Year 6 by achievement of any CDI, early CDI (occurring between baseline and Month 24), or late CDI (Month 25 to Month 72); percentage of patients with stable/improved FS scores at 6 months post-CDI onset; number of improved FS at 6 months post-CDI onset.
Results: Of 427 patients eligible for CDI assessment and with Year 6 data, 171 (40%) achieved CDI. 60% of patients achieving CDI had EDSS scores that remained improved at Year 6, whereas 67% of patients without CDI had stable EDSS scores from baseline to Year 6. EDSS improvement/stability at Year 6 vs baseline was apparent in patients with early CDI (61% improved, 34% stable) and with late CDI (57% improved, 37% stable). At 6 months post-CDI onset, improvement/stability in each FS was observed in 90%-100% of patients with early or late CDI; improvement was most frequently in sensory, pyramidal, and cerebellar FS. 74% of patients with early CDI and 67% with late CDI achieved improvements in >1 FS; 18% and 13%, respectively, achieved improvements in ≥4 FS.
Conclusion: CDI, whether it occurred within the first 2 years or later, was maintained at Year 6 in absence of continuous treatment and was associated with improvements across multiple FS. These results indicate a broad and prolonged effect of alemtuzumab on disability improvement, potentially changing the MS disease course.
Disclosure: PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, Servier, and Teva). RAA: Consulting and/or speaker honoraria, and scientific advisory boards (Bayer, Biogen, Genentech, Novartis, Sanofi, and Teva) and research grants (Novartis). RA: Speaker honoraria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi). AC: Honoraria for presentations or advisory boards to support university research funds (Actelion, Allmirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi Genzyme, and Teva) and research support (Sanofi Genzyme and UCB). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). GI: Speaking and advisory fees (Almirall, Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DK: Consulting fees and/or fees for non-CME services (AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech, Mylan, Novartis, and Sanofi) and research grants (Actelion and Sanofi). HJK: Consulting and/or speaking fees (Bayer, Biogen, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Kael-GemVax, Merck Serono, Ministry of Science and ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor (Multiple Sclerosis Journal - Experimental, Translational, and Clinical); and associate editor (Journal of Clinical Neurology). JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi, and Teva); editorial board (Acta Neurologica Scandinavica); and unconditional research grants (Biogen, Novartis, and Teva). RALM: Advisory boards (Biogen, Merck, Novartis, Roche, Sanofi, and Teva).CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). HW: Consulting and/or speaking fees, and grant/research support (Bayer, Bayer Schering Pharma, Biogen, Elan Corporation, Lilly, Lundbeck, Merck Serono, Novartis, Novo Nordisk, Sanofi, and Teva Neuroscience). LC and ND: Employees of Sanofi. SFH: Consulting agreements, speaker honoraria, and grant/research financial support (AbbVie, Acorda, Avanir, Bayer, Biogen Idec, Genzyme, Novartis, Osmotica, Questcor, Roche, Synthon, and Teva).STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.