Abstract: P1239
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in CARE-MS II (NCT00548405), 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved efficacy outcomes vs SC IFNB-1a in RRMS patients (pts) with inadequate response to prior therapy. SC IFNB-1a pts 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 II. Alemtuzumab remained efficacious through the extension, with 71% receiving no additional alemtuzumab or DMT. After this extension, pts could continue in TOPAZ (NCT02255656), an additional 5-y extension.
Aims: Evaluate efficacy and safety of alemtuzumab over 6 y in pts who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS II.
Methods: At investigator discretion, pts 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 143 pts initiating alemtuzumab in the extension, 117 (82%) completed Y2 of TOPAZ (Y6 after initiating alemtuzumab); 57% received neither additional courses of alemtuzumab nor another DMT through Y6. At Y6, the annualised relapse rate was 0.19, and 68% of pts had stable/improved EDSS scores from CARE-MS II baseline. After initiating alemtuzumab, 69% were free from 6-month confirmed disability worsening and 23% had 6-month confirmed disability improvement. At Y6, 69% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 69% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from CARE-MS II baseline was -1.34% over 8 total study y; -0.81% occurred over Y0-2 with SC IFNB-1a, and -0.47% occurred over 6 y with alemtuzumab. Safety was consistent with the alemtuzumab arm of the core and extension studies.
Conclusion: Alemtuzumab improved clinical, MRI, and BVL outcomes in pts who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS II. 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: CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). MPA: Institutional support for research (Biogen, Byer, Italian MS Society, Novartis, Sanofi, and Teva) and honoraria for advisory board participation (Biogen, Byer, Merck, Roche, Sanofi, and Teva). MB: Institutional support for research, speaking, and/or participation in advisory boards (Biogen, Novartis, and Sanofi) and research consultant (Medical Safety Systems). AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi, and Teva). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). DG: Compensation for advisory board and/or speaking fees (Acorda, EMD Serono, and Genzyme). WDH: Honoraria for speaking, consultancy fees, and/or research support (Actelion, Alkermes, Biogen-Idec, Celgene, EMD Serono, Mallinckrodt, MedImmune, Novartis, Roche, Sanofi, and Teva). CL: Compensation for consulting (Accorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi, Strativa, Teva, and UCB). CI: Compensation for advisory board participation (Sanofi) and research support (Biogen, Roche, and Sanofi). RALM: Compensation for advisory board and/or speaking fees (Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and research support (Biogen, Merck, Novartis, Sanofi, and Teva). XM: Consulting and/or speaking fees (Actelion, Biogen, Celgene, Merck, Novartis, Orzyon, Roche, Sanofi, and Teva). DR: Consulting fees (Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience) and research support (Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience). BMJU: Consulting fees (Biogen-Idec, Genzyme, Merck Serono, Novartis, Roche, and Teva). LC, ND, and CER: Employees of Sanofi. AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi, and Teva). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.
Abstract: P1239
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in CARE-MS II (NCT00548405), 2 courses of alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved efficacy outcomes vs SC IFNB-1a in RRMS patients (pts) with inadequate response to prior therapy. SC IFNB-1a pts 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 II. Alemtuzumab remained efficacious through the extension, with 71% receiving no additional alemtuzumab or DMT. After this extension, pts could continue in TOPAZ (NCT02255656), an additional 5-y extension.
Aims: Evaluate efficacy and safety of alemtuzumab over 6 y in pts who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS II.
Methods: At investigator discretion, pts 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 143 pts initiating alemtuzumab in the extension, 117 (82%) completed Y2 of TOPAZ (Y6 after initiating alemtuzumab); 57% received neither additional courses of alemtuzumab nor another DMT through Y6. At Y6, the annualised relapse rate was 0.19, and 68% of pts had stable/improved EDSS scores from CARE-MS II baseline. After initiating alemtuzumab, 69% were free from 6-month confirmed disability worsening and 23% had 6-month confirmed disability improvement. At Y6, 69% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 69% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from CARE-MS II baseline was -1.34% over 8 total study y; -0.81% occurred over Y0-2 with SC IFNB-1a, and -0.47% occurred over 6 y with alemtuzumab. Safety was consistent with the alemtuzumab arm of the core and extension studies.
Conclusion: Alemtuzumab improved clinical, MRI, and BVL outcomes in pts who initiated alemtuzumab after receiving SC IFNB-1a in CARE-MS II. 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: CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). MPA: Institutional support for research (Biogen, Byer, Italian MS Society, Novartis, Sanofi, and Teva) and honoraria for advisory board participation (Biogen, Byer, Merck, Roche, Sanofi, and Teva). MB: Institutional support for research, speaking, and/or participation in advisory boards (Biogen, Novartis, and Sanofi) and research consultant (Medical Safety Systems). AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi, and Teva). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Merck Serono, Novartis, Sanofi, and Teva). DG: Compensation for advisory board and/or speaking fees (Acorda, EMD Serono, and Genzyme). WDH: Honoraria for speaking, consultancy fees, and/or research support (Actelion, Alkermes, Biogen-Idec, Celgene, EMD Serono, Mallinckrodt, MedImmune, Novartis, Roche, Sanofi, and Teva). CL: Compensation for consulting (Accorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi, Strativa, Teva, and UCB). CI: Compensation for advisory board participation (Sanofi) and research support (Biogen, Roche, and Sanofi). RALM: Compensation for advisory board and/or speaking fees (Bayer, Biogen, Merck, Novartis, Roche, Sanofi, and Teva) and research support (Biogen, Merck, Novartis, Sanofi, and Teva). XM: Consulting and/or speaking fees (Actelion, Biogen, Celgene, Merck, Novartis, Orzyon, Roche, Sanofi, and Teva). DR: Consulting fees (Bayer Schering, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva Neuroscience) and research support (Biogen, GW Pharma, Merck Serono, Mitsubishi, Novartis, Sanofi, and Teva Neuroscience). BMJU: Consulting fees (Biogen-Idec, Genzyme, Merck Serono, Novartis, Roche, and Teva). LC, ND, and CER: Employees of Sanofi. AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi, and Teva). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.