Contributions
Abstract: P680
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In CARE-MS II (NCT00548405), alemtuzumab significantly reduced the annualised relapse rate (ARR) versus SC IFNB-1a over 2 years in patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline (BL). Patients completing CARE-MS II could enter an extension study (NCT00930553), in which SC IFNB-1a-treated patients switched to alemtuzumab.
Goals: To evaluate 4-year efficacy and safety of alemtuzumab in patients who switched from SC IFNB-1a in CARE-MS II.
Methods: Following SC IFNB-1a discontinuation, patients received 2 courses of alemtuzumab 12 mg (Month 0: 5 days; Month 12: 3 days), followed by as-needed alemtuzumab for relapse or MRI activity or DMT per investigator discretion. Assessments: ARR, 6-month confirmed disability worsening (CDW; ≥1-point EDSS increase [≥1.5-point if BL EDSS=0]) and confirmed disability improvement (CDI; ≥1-point EDSS decrease [BL score ≥2.0]), EDSS stability (≤0.5-point change) or improvement (≥1.0-point decrease), no evidence of disease activity (NEDA), and adverse events (AEs).
Results: 125/146 (86%) CARE-MS II SC IFNB-1a-treated patients who enrolled in the extension remained on study 4 years later. ARR decreased from 0.52 during SC IFNB-1a treatment to 0.15 over the first 2 years after switching to alemtuzumab. Proportions of patients with no evidence of relapse increased from 48% after SC IFNB-1a treatment to 80% over 2 years after switching to alemtuzumab; the proportion achieving NEDA increased from 14% to 41%. In Year 4, ARR remained low (0.17), and proportions with no evidence of relapse (85%) and achieving NEDA (60%) remained high. 70% of patients had improved/stable EDSS after switching. Over 4 years after switching, 80% had no evidence of 6-month CDW; 18% had 6-month CDI. These results were achieved with 71% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab. The 4-year AE profile of alemtuzumab after switching was consistent with alemtuzumab-treated patients in the core study.
Conclusion: Improvements in clinical outcomes were observed in the first 2 years after switching from SC IFNB-1a to alemtuzumab and were durable over the following 2 years, with most patients receiving no additional treatment. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS patients who switched from SC IFNB-1a.
Disclosure: Study support: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
ANB: Consulting fees/participated in clinical trials (Bayer, Biogen, Sanofi Genzyme, Merck Serono, Novartis, Sanofi Aventis, and Teva).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme), and research consultant (Medical Safety Systems).
DB: Advisory board participant, lecture and travel (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva).
DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Novartis, Merck-Serono, Sanofi Genzyme, and Teva).
RMMH: Research grants, speaker´s fees, and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); scientific advisory boards for (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); editorial board of Acta Neurologica Scandinavica; and unconditional research grants (Biogen, Novartis, and Teva).
XM: Consulting and/or speaking fees (Almirall, Bayer, Biogen, EMD Serono, Genentech, Geneuro, Merck, Neurotec, Novartis, Roche, Sanofi, Sanofi Genzyme, and Teva).
BS: Nothing to disclose.
SW: Consultant, principal investigator, and speaker (Bayer, Biogen, EMD Serono, Novartis,); consultant and principal investigator (Genentech and Roche); principal investigator (Alkermes); and principal investigator and speaker (Teva).
DHM, KT, and MC: Employees of Sanofi Genzyme.
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).
Abstract: P680
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In CARE-MS II (NCT00548405), alemtuzumab significantly reduced the annualised relapse rate (ARR) versus SC IFNB-1a over 2 years in patients with active relapsing-remitting multiple sclerosis (RRMS) and an inadequate response (≥1 relapse) to prior therapy at baseline (BL). Patients completing CARE-MS II could enter an extension study (NCT00930553), in which SC IFNB-1a-treated patients switched to alemtuzumab.
Goals: To evaluate 4-year efficacy and safety of alemtuzumab in patients who switched from SC IFNB-1a in CARE-MS II.
Methods: Following SC IFNB-1a discontinuation, patients received 2 courses of alemtuzumab 12 mg (Month 0: 5 days; Month 12: 3 days), followed by as-needed alemtuzumab for relapse or MRI activity or DMT per investigator discretion. Assessments: ARR, 6-month confirmed disability worsening (CDW; ≥1-point EDSS increase [≥1.5-point if BL EDSS=0]) and confirmed disability improvement (CDI; ≥1-point EDSS decrease [BL score ≥2.0]), EDSS stability (≤0.5-point change) or improvement (≥1.0-point decrease), no evidence of disease activity (NEDA), and adverse events (AEs).
Results: 125/146 (86%) CARE-MS II SC IFNB-1a-treated patients who enrolled in the extension remained on study 4 years later. ARR decreased from 0.52 during SC IFNB-1a treatment to 0.15 over the first 2 years after switching to alemtuzumab. Proportions of patients with no evidence of relapse increased from 48% after SC IFNB-1a treatment to 80% over 2 years after switching to alemtuzumab; the proportion achieving NEDA increased from 14% to 41%. In Year 4, ARR remained low (0.17), and proportions with no evidence of relapse (85%) and achieving NEDA (60%) remained high. 70% of patients had improved/stable EDSS after switching. Over 4 years after switching, 80% had no evidence of 6-month CDW; 18% had 6-month CDI. These results were achieved with 71% of patients receiving no additional treatment after their initial 2 courses of alemtuzumab. The 4-year AE profile of alemtuzumab after switching was consistent with alemtuzumab-treated patients in the core study.
Conclusion: Improvements in clinical outcomes were observed in the first 2 years after switching from SC IFNB-1a to alemtuzumab and were durable over the following 2 years, with most patients receiving no additional treatment. Based on these findings, alemtuzumab may provide a unique treatment approach with durable efficacy in the absence of continuous treatment for RRMS patients who switched from SC IFNB-1a.
Disclosure: Study support: Sanofi Genzyme and Bayer HealthCare Pharmaceuticals.
ANB: Consulting fees/participated in clinical trials (Bayer, Biogen, Sanofi Genzyme, Merck Serono, Novartis, Sanofi Aventis, and Teva).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme), and research consultant (Medical Safety Systems).
DB: Advisory board participant, lecture and travel (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva).
DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Novartis, Merck-Serono, Sanofi Genzyme, and Teva).
RMMH: Research grants, speaker´s fees, and honoraria for advisory boards (Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi Genzyme, and Teva); scientific advisory boards for (Almirall, Biogen, Novartis, Sanofi Genzyme, and Teva); editorial board of Acta Neurologica Scandinavica; and unconditional research grants (Biogen, Novartis, and Teva).
XM: Consulting and/or speaking fees (Almirall, Bayer, Biogen, EMD Serono, Genentech, Geneuro, Merck, Neurotec, Novartis, Roche, Sanofi, Sanofi Genzyme, and Teva).
BS: Nothing to disclose.
SW: Consultant, principal investigator, and speaker (Bayer, Biogen, EMD Serono, Novartis,); consultant and principal investigator (Genentech and Roche); principal investigator (Alkermes); and principal investigator and speaker (Teva).
DHM, KT, and MC: Employees of Sanofi Genzyme.
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).