Abstract: P1232
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate (ARR) versus SC IFNB-1a over 2 years in treatment-naive patients with active relapsing-remitting multiple sclerosis (RRMS). Patients completing CARE-MS I could enter an extension study (NCT00930553), in which SC IFNB-1a-treated patients switched to alemtuzumab.
Goal: To evaluate 4-year efficacy and safety of alemtuzumab in patients who switched from SC IFNB-1a in CARE-MS I.
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 other DMT per investigator discretion. Assessments: ARR, 6-month confirmed disability worsening (CDW; ≥1-point EDSS increase [≥1.5-point if baseline EDSS=0]) and confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline 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: 144/173 (83%) CARE-MS I SC IFNB-1a-treated patients enrolled in the extension; 125 (87%) remained on study 4 years later. ARR decreased from 0.39 during SC IFNB-1a treatment to 0.11 over the first 2 years after switching to alemtuzumab. Over 2 years after switching to alemtuzumab, the proportions of patients with no evidence of relapse increased from 60% after SC IFNB-1a treatment to 80% and the proportion achieving NEDA increased from 27% to 54%. In Year 4 after switching, ARR remained low (0.15), and the proportions with no evidence of relapse (86%) and achieving NEDA (54%) remained high. 86% of patients had improved/stable EDSS since switching to alemtuzumab. Over the 4 years since switching, 81% had no evidence of 6-month CDW; 24% had 6-month CDI. These results were achieved with most patients (75%) receiving no additional treatment after their initial 2 courses of alemtuzumab. The 4-year AE profile of alemtuzumab after switching was consistent with that of alemtuzumab-treated patients in the core study.
Conclusion: Alemtuzumab improved clinical outcomes in the first 2 years after switching from SC IFNB-1a; these improvements 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.
CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva). RA: Honoria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, Novartis, GSK, Lundbeck, Merck Serono, Sanofi Genzyme). DB: Compensation for advisory board participant, lecture and travel (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva). ANB: Consulting fees/participated in clinical trials (Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva Pharmaceuticals). PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi Aventis, and Teva Pharmaceuticals). BS: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva). BVW: Research and travel grants, honoraria for MS expert advice and speakers fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva). DHM, KT and CER: Employees of Sanofi Genzyme. PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
Abstract: P1232
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly reduced the annualised relapse rate (ARR) versus SC IFNB-1a over 2 years in treatment-naive patients with active relapsing-remitting multiple sclerosis (RRMS). Patients completing CARE-MS I could enter an extension study (NCT00930553), in which SC IFNB-1a-treated patients switched to alemtuzumab.
Goal: To evaluate 4-year efficacy and safety of alemtuzumab in patients who switched from SC IFNB-1a in CARE-MS I.
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 other DMT per investigator discretion. Assessments: ARR, 6-month confirmed disability worsening (CDW; ≥1-point EDSS increase [≥1.5-point if baseline EDSS=0]) and confirmed disability improvement (CDI; ≥1-point EDSS decrease [baseline 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: 144/173 (83%) CARE-MS I SC IFNB-1a-treated patients enrolled in the extension; 125 (87%) remained on study 4 years later. ARR decreased from 0.39 during SC IFNB-1a treatment to 0.11 over the first 2 years after switching to alemtuzumab. Over 2 years after switching to alemtuzumab, the proportions of patients with no evidence of relapse increased from 60% after SC IFNB-1a treatment to 80% and the proportion achieving NEDA increased from 27% to 54%. In Year 4 after switching, ARR remained low (0.15), and the proportions with no evidence of relapse (86%) and achieving NEDA (54%) remained high. 86% of patients had improved/stable EDSS since switching to alemtuzumab. Over the 4 years since switching, 81% had no evidence of 6-month CDW; 24% had 6-month CDI. These results were achieved with most patients (75%) receiving no additional treatment after their initial 2 courses of alemtuzumab. The 4-year AE profile of alemtuzumab after switching was consistent with that of alemtuzumab-treated patients in the core study.
Conclusion: Alemtuzumab improved clinical outcomes in the first 2 years after switching from SC IFNB-1a; these improvements 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.
CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva). RA: Honoria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, Novartis, GSK, Lundbeck, Merck Serono, Sanofi Genzyme). DB: Compensation for advisory board participant, lecture and travel (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva). ANB: Consulting fees/participated in clinical trials (Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva Pharmaceuticals). PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi Aventis, and Teva Pharmaceuticals). BS: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva). BVW: Research and travel grants, honoraria for MS expert advice and speakers fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva). DHM, KT and CER: Employees of Sanofi Genzyme. PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).