Abstract: P1235
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in the CARE-MS I phase 3 trial (NCT00530348), 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical and MRI outcomes vs SC IFNB-1a in treatment-naive RRMS patients. In a 4-y extension (NCT00930553), patients could receive additional courses of alemtuzumab (12 mg/day on 3 consecutive days; ≥12 months apart) as needed for disease activity or receive other disease-modifying therapy (DMT) per investigator discretion; efficacy on clinical/MRI outcomes was maintained in the extension, with 63% of patients receiving no additional alemtuzumab or other DMTs over 6 y after the initial 2 courses. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, for further evaluation.
Aims: To evaluate the efficacy and safety of alemtuzumab over 8 y in CARE-MS I patients.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria) or receive other DMT (at any time).
Results: Of the 376 patients who entered CARE-MS I, 290 (77%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 56% of patients received neither additional courses of alemtuzumab nor another DMT through Y8. Annualized relapse rate at Y8 was 0.14; 88% were relapse-free in Y8. 78% of patients had stable/improved EDSS scores from core study baseline through Y8; mean change in EDSS score from core study baseline to Y8 was 0.07. Through Y8, 71% of patients were free from 6-month confirmed disability worsening, and 41% achieved 6-month confirmed disability improvement. In Y8, 60% of patients achieved no evidence of disease activity, 67% were free of MRI disease activity, 87% were free of new Gd-enhancing lesions, and 67% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline through Y8 was -1.83%; reduction in BVL was 0.22% or less annually in Y3-8. The safety profile in Y8 was consistent with the previous years. The incidence of AEs, infections, and thyroid AEs continued to decline through Y8; no new cases of immune thrombocytopenia or nephropathy were seen.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y in the absence of continuous treatment in CARE-MS I patients, with a consistent and manageable safety profile.
Disclosure: GC: Consulting fees (Actelion, Bayer-Schering, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer-Schering, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva). DLA: Compensation for speaking, consulting, advisory board participation, and research support (Acorda, Bayer, Biogen, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Sanofi Genzyme, and Teva). ANB: Consulting fees/participation in clinical trials (Bayer, Biogen, Merck Serono, Novartis, Sanofi, and Teva). H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi). EKH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi, and Teva, and supported by Ministry of Education of Czech Republic). JSI: Nothing to disclose. PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi, and Teva Pharmaceuticals). CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DP: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Roche, and Sanofi). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi, and Synthon). TFS: Consulting and/or speaking fees (Biogen, Genentech, Genzyme, and Novartis). LC, ND, and SA: Employees of Sanofi. BVW: Research and travel grants, honoraria for MS-expert advice, and speaker fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals
Abstract: P1235
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in the CARE-MS I phase 3 trial (NCT00530348), 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical and MRI outcomes vs SC IFNB-1a in treatment-naive RRMS patients. In a 4-y extension (NCT00930553), patients could receive additional courses of alemtuzumab (12 mg/day on 3 consecutive days; ≥12 months apart) as needed for disease activity or receive other disease-modifying therapy (DMT) per investigator discretion; efficacy on clinical/MRI outcomes was maintained in the extension, with 63% of patients receiving no additional alemtuzumab or other DMTs over 6 y after the initial 2 courses. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, for further evaluation.
Aims: To evaluate the efficacy and safety of alemtuzumab over 8 y in CARE-MS I patients.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria) or receive other DMT (at any time).
Results: Of the 376 patients who entered CARE-MS I, 290 (77%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 56% of patients received neither additional courses of alemtuzumab nor another DMT through Y8. Annualized relapse rate at Y8 was 0.14; 88% were relapse-free in Y8. 78% of patients had stable/improved EDSS scores from core study baseline through Y8; mean change in EDSS score from core study baseline to Y8 was 0.07. Through Y8, 71% of patients were free from 6-month confirmed disability worsening, and 41% achieved 6-month confirmed disability improvement. In Y8, 60% of patients achieved no evidence of disease activity, 67% were free of MRI disease activity, 87% were free of new Gd-enhancing lesions, and 67% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline through Y8 was -1.83%; reduction in BVL was 0.22% or less annually in Y3-8. The safety profile in Y8 was consistent with the previous years. The incidence of AEs, infections, and thyroid AEs continued to decline through Y8; no new cases of immune thrombocytopenia or nephropathy were seen.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y in the absence of continuous treatment in CARE-MS I patients, with a consistent and manageable safety profile.
Disclosure: GC: Consulting fees (Actelion, Bayer-Schering, Merck Serono, Novartis, Sanofi, and Teva); lecture fees (Bayer-Schering, Biogen Dompé, Merck Serono, Novartis, Sanofi, Serono Symposia International Foundation, and Teva). DLA: Compensation for speaking, consulting, advisory board participation, and research support (Acorda, Bayer, Biogen, Canadian Institutes of Health Research, Eli Lilly, EMD Serono, Genentech, GlaxoSmithKline, MedImmune, Merck Serono, MS Society of Canada, NeuroRx Research, Novartis, Opexa Therapeutics, Receptos, Roche, Sanofi, Sanofi Genzyme, and Teva). ANB: Consulting fees/participation in clinical trials (Bayer, Biogen, Merck Serono, Novartis, Sanofi, and Teva). H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi). EKH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi, and Teva, and supported by Ministry of Education of Czech Republic). JSI: Nothing to disclose. PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi, and Teva Pharmaceuticals). CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DP: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Roche, and Sanofi). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi, and Synthon). TFS: Consulting and/or speaking fees (Biogen, Genentech, Genzyme, and Novartis). LC, ND, and SA: Employees of Sanofi. BVW: Research and travel grants, honoraria for MS-expert advice, and speaker fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals