Contributions
Abstract: P907
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in CARE-MS I (NCT00530348), 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved efficacy outcomes vs SC IFNB-1a in treatment-naive RRMS patients. SC IFNB-1a patients enrolling in a 4-y extension (NCT00930553) received alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days), with additional courses of alemtuzumab (12 mg/day; 3 days; ≥12 months apart) as needed for disease activity or another disease-modifying therapy (DMT) per investigator discretion. Significant improvements in efficacy outcomes were observed at Y2 of alemtuzumab vs Y2 of SC IFNB-1a in CARE-MS I, and alemtuzumab remained efficacious through the extension, with 75% receiving no additional alemtuzumab or DMT. After this extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension.
Aims: Evaluate efficacy and safety of alemtuzumab over 6 y in patients who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS I.
Methods: At investigator discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria), or receive another DMT (at any time). MRI disease activity was defined as new gadolinium (Gd)-enhancing or new/enlarging T2 hyperintense lesions.
Results: Of 139 patients initiating alemtuzumab in the extension, 117 (84%) completed Y2 of TOPAZ (Y6 after initiating alemtuzumab); 67% received neither additional courses of alemtuzumab nor another DMT. At Y6, the annualised relapse rate was 0.19, and 70% of patients had stable/improved EDSS scores from CARE-MS I baseline. After initiating alemtuzumab, 69% were free from 6-month confirmed disability worsening and 28% had 6-month confirmed disability improvement. At Y6, 62% were free of MRI disease activity, 82% were free of new Gd-enhancing lesions, and 62% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from CARE-MS I baseline was -1.99% over 8 total study y; -1.49% occurred over Y0-2 with SC IFNB-1a, and -0.23% occurred over 6 y with alemtuzumab. Safety was consistent with the alemtuzumab arm of the core and extension studies.
Conclusions: Alemtuzumab improved clinical, MRI, and BVL outcomes in patients who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS I. These improved outcomes were maintained over 6 y in the absence of continuous treatment, with a consistent safety profile that is manageable and acceptable.
Disclosure: BVW: Received research and travel grants, honoraria for MS-expert advice, and speaking fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DB: Consulting and speaking honoraria with travel support (Bayer, Biogen, EMD Serono, Sanofi, and Teva). SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); speaker honoraria (Biogen and Sanofi); and unencumbered research grant (Biogen). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). RMMH: Research grants, speaking fees, and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi, and Teva). 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). LM: Consulting and/or speaking fees, research grants or conference travel sponsorship (Biogen, Merck-Serono, Mylan, Novartis, Roche, and Sanofi). XM: Consulting and/or speaking fees (Actelion, Biogen, Celgene, Merck, Novartis, Orzyon, Roche, Sanofi, and Teva). RTN: Compensation for consulting (Acorda, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, Novartis, and Teva). KP: Consulting and/or speaking fees (Biogen, Genentech, Sanofi, and Teva). SS: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Sanofi, and Teva). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, Merck Serono, Novartis, Sanofi, Servier, and Teva). LC, ND, and CER: Employees of Sanofi. 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). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals
Abstract: P907
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in CARE-MS I (NCT00530348), 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved efficacy outcomes vs SC IFNB-1a in treatment-naive RRMS patients. SC IFNB-1a patients enrolling in a 4-y extension (NCT00930553) received alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days), with additional courses of alemtuzumab (12 mg/day; 3 days; ≥12 months apart) as needed for disease activity or another disease-modifying therapy (DMT) per investigator discretion. Significant improvements in efficacy outcomes were observed at Y2 of alemtuzumab vs Y2 of SC IFNB-1a in CARE-MS I, and alemtuzumab remained efficacious through the extension, with 75% receiving no additional alemtuzumab or DMT. After this extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension.
Aims: Evaluate efficacy and safety of alemtuzumab over 6 y in patients who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS I.
Methods: At investigator discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria), or receive another DMT (at any time). MRI disease activity was defined as new gadolinium (Gd)-enhancing or new/enlarging T2 hyperintense lesions.
Results: Of 139 patients initiating alemtuzumab in the extension, 117 (84%) completed Y2 of TOPAZ (Y6 after initiating alemtuzumab); 67% received neither additional courses of alemtuzumab nor another DMT. At Y6, the annualised relapse rate was 0.19, and 70% of patients had stable/improved EDSS scores from CARE-MS I baseline. After initiating alemtuzumab, 69% were free from 6-month confirmed disability worsening and 28% had 6-month confirmed disability improvement. At Y6, 62% were free of MRI disease activity, 82% were free of new Gd-enhancing lesions, and 62% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from CARE-MS I baseline was -1.99% over 8 total study y; -1.49% occurred over Y0-2 with SC IFNB-1a, and -0.23% occurred over 6 y with alemtuzumab. Safety was consistent with the alemtuzumab arm of the core and extension studies.
Conclusions: Alemtuzumab improved clinical, MRI, and BVL outcomes in patients who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS I. These improved outcomes were maintained over 6 y in the absence of continuous treatment, with a consistent safety profile that is manageable and acceptable.
Disclosure: BVW: Received research and travel grants, honoraria for MS-expert advice, and speaking fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DB: Consulting and speaking honoraria with travel support (Bayer, Biogen, EMD Serono, Sanofi, and Teva). SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); speaker honoraria (Biogen and Sanofi); and unencumbered research grant (Biogen). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). RMMH: Research grants, speaking fees, and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi, and Teva). 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). LM: Consulting and/or speaking fees, research grants or conference travel sponsorship (Biogen, Merck-Serono, Mylan, Novartis, Roche, and Sanofi). XM: Consulting and/or speaking fees (Actelion, Biogen, Celgene, Merck, Novartis, Orzyon, Roche, Sanofi, and Teva). RTN: Compensation for consulting (Acorda, Alkermes, Biogen, EMD Serono, Genentech, Genzyme, Novartis, and Teva). KP: Consulting and/or speaking fees (Biogen, Genentech, Sanofi, and Teva). SS: Consulting and/or speaking fees, and grant/research support (Biogen, Merck Serono, Novartis, Sanofi, and Teva). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, Celgene, Merck Serono, Novartis, Sanofi, Servier, and Teva). LC, ND, and CER: Employees of Sanofi. 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). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals