
Contributions
Abstract: P909
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: MS patients of African descent are known to be at a higher risk for rapid progression of disability and may be less responsive to current disease-modifying therapy. Over 2 years (y) in the CARE-MS core studies, 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical/MRI outcomes vs SC IFNB-1a in RRMS patients who were either treatment-naive (CARE-MS I; NCT00530348) or had an inadequate response to prior therapy at baseline (CARE-MS II; NCT00548405). Efficacy was maintained in a 4-y extension (NCT00930553), wherein patients could receive additional courses of alemtuzumab as needed for relapse/MRI activity or receive other DMTs per investigator's discretion. Patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study for further evaluation.
Aims: To evaluate the efficacy/safety of alemtuzumab over 7 y in patients of African descent who received alemtuzumab 12 mg in the CARE-MS core studies.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart) or another DMT.
Results: In the pooled CARE-MS core studies, 46 patients (4%) were of African descent (alemtuzumab, n=35; SC IFNB-1a, n=11), of which 76% were female. Baseline EDSS scores (mean±SD) were 2.2±1.4 (alemtuzumab) and 2.5±1.3 (SC IFNB-1a). Of the 35 alemtuzumab-treated core study patients, 27 (77%) completed Y7; 34% received neither alemtuzumab nor another DMT in the extension through Y7. Annualized relapse rate for core study Y2 was 0.09 with alemtuzumab (vs 0.42 with SC IFNB-1a), and was 0.19 at Y7. 60% of patients had stable/improved EDSS scores from baseline to Y7. In Y7, 63% were free of MRI disease activity; 94% were free of new Gd-enhancing lesions and 63% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline over 7 y was -0.75%; median yearly BVL in Y7 was 0.28%. There were no serious thyroid AEs or malignancies through Y7; no new cases of immune thrombocytopenia or nephropathy were seen. The safety profile was consistent with the overall alemtuzumab study population.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 7 y in this higher-risk RRMS population of African descent. The study had a high retention rate (77%) from core study baseline. Alemtuzumab had a consistent and manageable safety profile through Y7.
Disclosure: MW: Speaker/consulting fees (Biogen Idec, EMD Serono, Genentech, Novartis, Sanofi, and Teva Neuroscience). LA: Consulting fees (Celgene and Genzyme) and research support (Biogen and Novartis). RB: Compensation for serving as a consultant and an advisory board participant (Acorda, Avanir, Bayer, Biogen, Novartis, Questcor, Sanofi, and Teva). AC: Speaker/consultant (Allergan, Biogen, Genentech, Novartis, Sanofi, and Teva Neuroscience) and research support (Novartis). KE: Consulting fees (Biogen and Genzyme); speaker bureaus (Biogen and Genzyme); and research support (Biogen, Genentech, Hoffmann-La Roche, and Sanofi). MG: Consulting fees, speaker bureaus, scientific advisory board, and/or other activities (ADAMAS, EMD Serono, Novartis Pharmaceuticals, Sanofi, and Teva Neuroscience) and research support (Biogen Idec, National MS Society, NIH, and Novartis Pharmaceuticals). BS: Consulting fees, speaker bureaus and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi, and Teva). AW: Consulting and advisory board participant fees (Bayer, Biogen Idec, EMD Serono, Genentech, and Sanofi). AJ and ND: Employees of Sanofi. AO: Speaking and consulting fees (Biogen, Genentech, Novartis, Sanofi, Teva Neuroscience, and TG Therapeutics) and research support (Alexion, Novartis, Sanofi, and Sun Pharma). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals
Abstract: P909
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: MS patients of African descent are known to be at a higher risk for rapid progression of disability and may be less responsive to current disease-modifying therapy. Over 2 years (y) in the CARE-MS core studies, 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical/MRI outcomes vs SC IFNB-1a in RRMS patients who were either treatment-naive (CARE-MS I; NCT00530348) or had an inadequate response to prior therapy at baseline (CARE-MS II; NCT00548405). Efficacy was maintained in a 4-y extension (NCT00930553), wherein patients could receive additional courses of alemtuzumab as needed for relapse/MRI activity or receive other DMTs per investigator's discretion. Patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study for further evaluation.
Aims: To evaluate the efficacy/safety of alemtuzumab over 7 y in patients of African descent who received alemtuzumab 12 mg in the CARE-MS core studies.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart) or another DMT.
Results: In the pooled CARE-MS core studies, 46 patients (4%) were of African descent (alemtuzumab, n=35; SC IFNB-1a, n=11), of which 76% were female. Baseline EDSS scores (mean±SD) were 2.2±1.4 (alemtuzumab) and 2.5±1.3 (SC IFNB-1a). Of the 35 alemtuzumab-treated core study patients, 27 (77%) completed Y7; 34% received neither alemtuzumab nor another DMT in the extension through Y7. Annualized relapse rate for core study Y2 was 0.09 with alemtuzumab (vs 0.42 with SC IFNB-1a), and was 0.19 at Y7. 60% of patients had stable/improved EDSS scores from baseline to Y7. In Y7, 63% were free of MRI disease activity; 94% were free of new Gd-enhancing lesions and 63% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline over 7 y was -0.75%; median yearly BVL in Y7 was 0.28%. There were no serious thyroid AEs or malignancies through Y7; no new cases of immune thrombocytopenia or nephropathy were seen. The safety profile was consistent with the overall alemtuzumab study population.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 7 y in this higher-risk RRMS population of African descent. The study had a high retention rate (77%) from core study baseline. Alemtuzumab had a consistent and manageable safety profile through Y7.
Disclosure: MW: Speaker/consulting fees (Biogen Idec, EMD Serono, Genentech, Novartis, Sanofi, and Teva Neuroscience). LA: Consulting fees (Celgene and Genzyme) and research support (Biogen and Novartis). RB: Compensation for serving as a consultant and an advisory board participant (Acorda, Avanir, Bayer, Biogen, Novartis, Questcor, Sanofi, and Teva). AC: Speaker/consultant (Allergan, Biogen, Genentech, Novartis, Sanofi, and Teva Neuroscience) and research support (Novartis). KE: Consulting fees (Biogen and Genzyme); speaker bureaus (Biogen and Genzyme); and research support (Biogen, Genentech, Hoffmann-La Roche, and Sanofi). MG: Consulting fees, speaker bureaus, scientific advisory board, and/or other activities (ADAMAS, EMD Serono, Novartis Pharmaceuticals, Sanofi, and Teva Neuroscience) and research support (Biogen Idec, National MS Society, NIH, and Novartis Pharmaceuticals). BS: Consulting fees, speaker bureaus and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi, and Teva). AW: Consulting and advisory board participant fees (Bayer, Biogen Idec, EMD Serono, Genentech, and Sanofi). AJ and ND: Employees of Sanofi. AO: Speaking and consulting fees (Biogen, Genentech, Novartis, Sanofi, Teva Neuroscience, and TG Therapeutics) and research support (Alexion, Novartis, Sanofi, and Sun Pharma). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals