Abstract: P1189
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical and MRI outcomes, including the rate of brain volume loss (BVL), vs SC IFNB-1a over 2 years (y) in treatment-naive patients (pts) with active RRMS. Durable efficacy of alemtuzumab was demonstrated over 6 y in a completed extension study (NCT00930553; 2-y core plus 4-y extension) in the absence of continuous treatment. CARE-MS I pts received 2 courses of alemtuzumab 12 mg/day (baseline: 5 days; 12 months later: 3 days). In the extension, pts could receive as-needed alemtuzumab retreatment (12 mg/day on 3 consecutive days; ≥12 months after previous course for relapse or MRI activity) or other disease-modifying therapy (DMT; per investigator discretion). Pts completing at least 48 months of the CARE-MS extension could enrol in the 5-y TOPAZ study (NCT02255656) for further long-term evaluation.
Goal: Evaluate the effect of alemtuzumab on MRI lesion outcomes and BVL over 7 y in pts who received alemtuzumab in CARE-MS I.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment ≥12 months after a previous course or other DMT at any time point (both per investigator discretion; no criteria). Assessments: Annual MRI scored for disease activity (no new Gd-enhancing lesions; no new/enlarging T2 lesions); for new T1 hypointense lesions; and for BVL, derived by relative change in brain parenchymal fraction (BPF).
Results: 321 of 349 (92%) CARE-MS I pts who entered the extension remained on study until the end of Y6 and then entered TOPAZ; 299 (93%) remained on study through Y7. At Y7, 68% of pts each remained free of MRI disease activity and new/enlarging T2 lesions. 91% were free of new Gd-enhancing lesions and 85% were free of new T1 hypointense lesions. Alemtuzumab consistently slowed median yearly BPF change over 2 y, remaining low in Y3-7 (Y1: -0.59%, Y2: -0.25%, Y3: -0.19%, Y4: -0.14%, Y5: -0.20%, Y6: -0.17%, Y7: -0.16%). These results were achieved with 59% of pts receiving no alemtuzumab retreatment or another DMT.
Conclusion: Alemtuzumab durably reduced MRI disease activity and slowed BVL over 7 y in pts who were treatment-naive, despite 59% receiving no additional treatment after the initial 2 courses of alemtuzumab. These findings suggest that alemtuzumab may provide a unique treatment approach for RRMS pts, offering durable efficacy in the absence of continuous treatment.
Disclosure:
DLA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving 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).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
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).
CLG: Consulting fees (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
DP: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Vertex).
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
SS: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
DHM and ND: Employees of Sanofi.
KN: Speaking fees and research support (Sanofi Genzyme, Biogen); royalty fees for licences (Biogen).
AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi Genzyme, and Teva).
Abstract: P1189
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical and MRI outcomes, including the rate of brain volume loss (BVL), vs SC IFNB-1a over 2 years (y) in treatment-naive patients (pts) with active RRMS. Durable efficacy of alemtuzumab was demonstrated over 6 y in a completed extension study (NCT00930553; 2-y core plus 4-y extension) in the absence of continuous treatment. CARE-MS I pts received 2 courses of alemtuzumab 12 mg/day (baseline: 5 days; 12 months later: 3 days). In the extension, pts could receive as-needed alemtuzumab retreatment (12 mg/day on 3 consecutive days; ≥12 months after previous course for relapse or MRI activity) or other disease-modifying therapy (DMT; per investigator discretion). Pts completing at least 48 months of the CARE-MS extension could enrol in the 5-y TOPAZ study (NCT02255656) for further long-term evaluation.
Goal: Evaluate the effect of alemtuzumab on MRI lesion outcomes and BVL over 7 y in pts who received alemtuzumab in CARE-MS I.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment ≥12 months after a previous course or other DMT at any time point (both per investigator discretion; no criteria). Assessments: Annual MRI scored for disease activity (no new Gd-enhancing lesions; no new/enlarging T2 lesions); for new T1 hypointense lesions; and for BVL, derived by relative change in brain parenchymal fraction (BPF).
Results: 321 of 349 (92%) CARE-MS I pts who entered the extension remained on study until the end of Y6 and then entered TOPAZ; 299 (93%) remained on study through Y7. At Y7, 68% of pts each remained free of MRI disease activity and new/enlarging T2 lesions. 91% were free of new Gd-enhancing lesions and 85% were free of new T1 hypointense lesions. Alemtuzumab consistently slowed median yearly BPF change over 2 y, remaining low in Y3-7 (Y1: -0.59%, Y2: -0.25%, Y3: -0.19%, Y4: -0.14%, Y5: -0.20%, Y6: -0.17%, Y7: -0.16%). These results were achieved with 59% of pts receiving no alemtuzumab retreatment or another DMT.
Conclusion: Alemtuzumab durably reduced MRI disease activity and slowed BVL over 7 y in pts who were treatment-naive, despite 59% receiving no additional treatment after the initial 2 courses of alemtuzumab. These findings suggest that alemtuzumab may provide a unique treatment approach for RRMS pts, offering durable efficacy in the absence of continuous treatment.
Disclosure:
DLA: Compensation for serving as a speaker, consulting, and advisory board participant, and receiving 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).
MB: Institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
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).
CLG: Consulting fees (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi Genzyme, Strativa, Teva, and UCB).
DP: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Vertex).
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
SS: Consulting and/or speaking fees and grant/research support (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
DHM and ND: Employees of Sanofi.
KN: Speaking fees and research support (Sanofi Genzyme, Biogen); royalty fees for licences (Biogen).
AT: Consulting and/or speaking fees and grant/research support (Biogen, Chugai, Roche, Sanofi Genzyme, and Teva).