Contributions
Abstract: P1204
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab (an anti-CD52 antibody approved for treatment of RRMS) is administered as 2 annual courses (baseline: 5 consecutive days; 12 months later: 3 consecutive days). In CARE-MS I (NCT00530348), alemtuzumab significantly improved efficacy outcomes vs SC IFNB-1a over 2 years in treatment-naive patients with active RRMS. Durable efficacy was demonstrated over 6 years in an extension study (NCT00930553; 2 years core study plus 4 years extension) in the absence of continuous treatment; over one-third had confirmed disability improvement (CDI).
Goal: Evaluate the long-term efficacy of alemtuzumab in CARE-MS I patients who relapsed between Courses 1 and 2.
Methods: Assessments: annualised relapse rate (ARR); freedom from 6-month confirmed disability worsening (CDW) and 6-month CDI; MRI disease activity (gadolinium [Gd]-enhancing and new/enlarging T2 lesions); new T1 hypointense lesions; brain volume loss (BVL).
Results: 56/376 (15%) alemtuzumab-treated CARE-MS I patients relapsed in the year after Course 1. Of these, 52/56 (93%) enrolled in extension; 45/52 (87%) remained through Year 6. In patients who relapsed, ARR in Year 1 (1.3) declined in the year after Course 2 (0.3); 73% of patients did not relapse in Year 2. ARR remained low (0.3-0.5) over Years 3-6. Despite relapse between Courses 1 and 2, 87% of these patients were free of 6-month CDW in Year 1 and 60% were CDW-free at Year 6. Patients in this subgroup were also able to achieve improvements in disability; 12% achieved CDI in Year 1, increasing to 24% in Year 6. Most patients were free of Gd-enhancing lesions (84%), new/enlarging T2 lesions (71%), MRI disease activity (69%), and new T1 hypointense lesions (90%) in Year 6. Median percent yearly BVL declined over time (Years 1-6: -0.67%, -0.17%, -0.20%, -0.11%, -0.21%, -0.24%). These effects were achieved with 48% of patients receiving no additional treatment (alemtuzumab or other disease-modifying therapy [DMT]) after Course 2.
Conclusion: Although relapse is not uncommon in the first year with any DMT, 85% of alemtuzumab-treated patients in CARE-MS I were relapse-free between Courses 1 and 2. In the 15% of patients who relapsed, long-term outcomes were favourable, and nearly one-quarter achieved CDI. These data indicate that relapse between Courses 1 and 2 is not indicative of subsequent limited treatment response and support administering alemtuzumab according to approved labelling (2 courses) to achieve optimal clinical benefit.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
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).
SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi Genzyme); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi Genzyme); speaker honoraria (Biogen and Sanofi Genzyme); and unencumbered research grant (Biogen).
OF: Speaking and/or consulting (Allergan, Almirall, Bayer-Schering, Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple); and research support (Hospital Foundation FIMABIS).
MSF: Honoraria/consulting fees (Actelion, Bayer, Biogen, Canada Innovation, Chugai, EMD Canada, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva); member of advisory board, board of directors, or other similar group (Actelion, Bayer, Biogen, Merck Serono, Novartis, Opexa, Roche, and Sanofi-Aventis); participation in speaker's bureau (Sanofi Genzyme).
GI: Speaking and advisory fees (Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); editorial board (Acta Neurologica Scandinavica); and unconditional research grants (Biogen, Novartis, and Teva).
CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
BSharrack: Nothing to disclose.
BSinger: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Pfizer, Sanofi Genzyme, and Teva), and research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme).
BSteingo: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva).
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
SW: Consultant, principal investigator, and/or speaker (Alkermes, Asclepios, Biogen, EMD Serono, Novartis, Roche, Sanofi, TG Therapeutics).
BvW: Received research and travel grants, honoraria for MS-expert advice, and speakers fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi.
SS: Provided statistical support as a paid consultant for Sanofi Genzyme.
AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi Genzyme, and Teva)
Abstract: P1204
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Alemtuzumab (an anti-CD52 antibody approved for treatment of RRMS) is administered as 2 annual courses (baseline: 5 consecutive days; 12 months later: 3 consecutive days). In CARE-MS I (NCT00530348), alemtuzumab significantly improved efficacy outcomes vs SC IFNB-1a over 2 years in treatment-naive patients with active RRMS. Durable efficacy was demonstrated over 6 years in an extension study (NCT00930553; 2 years core study plus 4 years extension) in the absence of continuous treatment; over one-third had confirmed disability improvement (CDI).
Goal: Evaluate the long-term efficacy of alemtuzumab in CARE-MS I patients who relapsed between Courses 1 and 2.
Methods: Assessments: annualised relapse rate (ARR); freedom from 6-month confirmed disability worsening (CDW) and 6-month CDI; MRI disease activity (gadolinium [Gd]-enhancing and new/enlarging T2 lesions); new T1 hypointense lesions; brain volume loss (BVL).
Results: 56/376 (15%) alemtuzumab-treated CARE-MS I patients relapsed in the year after Course 1. Of these, 52/56 (93%) enrolled in extension; 45/52 (87%) remained through Year 6. In patients who relapsed, ARR in Year 1 (1.3) declined in the year after Course 2 (0.3); 73% of patients did not relapse in Year 2. ARR remained low (0.3-0.5) over Years 3-6. Despite relapse between Courses 1 and 2, 87% of these patients were free of 6-month CDW in Year 1 and 60% were CDW-free at Year 6. Patients in this subgroup were also able to achieve improvements in disability; 12% achieved CDI in Year 1, increasing to 24% in Year 6. Most patients were free of Gd-enhancing lesions (84%), new/enlarging T2 lesions (71%), MRI disease activity (69%), and new T1 hypointense lesions (90%) in Year 6. Median percent yearly BVL declined over time (Years 1-6: -0.67%, -0.17%, -0.20%, -0.11%, -0.21%, -0.24%). These effects were achieved with 48% of patients receiving no additional treatment (alemtuzumab or other disease-modifying therapy [DMT]) after Course 2.
Conclusion: Although relapse is not uncommon in the first year with any DMT, 85% of alemtuzumab-treated patients in CARE-MS I were relapse-free between Courses 1 and 2. In the 15% of patients who relapsed, long-term outcomes were favourable, and nearly one-quarter achieved CDI. These data indicate that relapse between Courses 1 and 2 is not indicative of subsequent limited treatment response and support administering alemtuzumab according to approved labelling (2 courses) to achieve optimal clinical benefit.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
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).
SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi Genzyme); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi Genzyme); speaker honoraria (Biogen and Sanofi Genzyme); and unencumbered research grant (Biogen).
OF: Speaking and/or consulting (Allergan, Almirall, Bayer-Schering, Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); compensation for serving as a journal editor, associate editor, or member of an editorial advisory board (Revista Española de Esclerosis Múltiple); and research support (Hospital Foundation FIMABIS).
MSF: Honoraria/consulting fees (Actelion, Bayer, Biogen, Canada Innovation, Chugai, EMD Canada, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva); member of advisory board, board of directors, or other similar group (Actelion, Bayer, Biogen, Merck Serono, Novartis, Opexa, Roche, and Sanofi-Aventis); participation in speaker's bureau (Sanofi Genzyme).
GI: Speaking and advisory fees (Almirall, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); editorial board (Acta Neurologica Scandinavica); and unconditional research grants (Biogen, Novartis, and Teva).
CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
BSharrack: Nothing to disclose.
BSinger: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Novartis, Pfizer, Sanofi Genzyme, and Teva), and research support (Acorda, Biogen, MedImmune, Novartis, Roche, and Sanofi Genzyme).
BSteingo: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva).
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
SW: Consultant, principal investigator, and/or speaker (Alkermes, Asclepios, Biogen, EMD Serono, Novartis, Roche, Sanofi, TG Therapeutics).
BvW: Received research and travel grants, honoraria for MS-expert advice, and speakers fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
TZ: Consulting and/or speaking fees (Almirall, Bayer, Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Teva); grant/research support (Biogen, Novartis, Sanofi Genzyme, and Teva).
DHM and KT: Employees of Sanofi.
SS: Provided statistical support as a paid consultant for Sanofi Genzyme.
AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi Genzyme, and Teva)