Abstract: P728
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved MRI outcomes, including brain volume loss (BVL), versus SC IFNB-1a over 2 years (y) in treatment-naive patients (pts) with active RRMS. In a completed extension study (NCT00930553), SC IFNB-1a-treated pts discontinued that therapy and initiated alemtuzumab 12 mg (2 courses: baseline, 5 days; 12 months later, 3 days), which demonstrated durable efficacy in the absence of continuous treatment. In the extension, pts could receive as-needed alemtuzumab retreatment (12 mg/day on 3 consecutive days, ≥12 months after previous course for relapse/MRI activity) or other disease-modifying therapy (DMT; per investigator discretion). Pts completing ≥48 months of the extension could enrol in TOPAZ, a 5-y, phase 3b/4 study (NCT02255656) for further evaluation.
Goal: Evaluate alemtuzumab MRI efficacy 5 y after switching from SC IFNB-1a.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment (≥12 months apart) or other DMT at any time point (both per investigator discretion, no criteria). Assessments: annual MRI scored for disease activity (gadolinium [Gd]-enhancing T1 lesions or new/enlarging T2 hyperintense lesions) and brain parenchymal fraction (BPF) change.
Results: Of 173 SC IFNB-1a-treated pts completing CARE-MS I, 139 (80%) were treated with alemtuzumab in the extension; 122 (88%) of these completed Y4 of post-alemtuzumab follow-up and entered TOPAZ, and 118 (97%) completed Y5 post-alemtuzumab. Percentages free of Gd-enhancing T1 lesions were 81% in SC IFNB-1a Y2, increasing to 96% in post-alemtuzumab Y2, and 92%-89% in Y3-5. Percentages free of new/enlarging T2 hyperintense lesions were 60% in SC IFNB-1a Y2, 82% in post-alemtuzumab Y2, and 72%-67% in Y3-5. Percentages free of MRI disease activity increased from 59% in SC IFNB-1a Y2 to 82% in post-alemtuzumab Y2, and were 72%-67% in Y3-5. Median yearly BPF percent change decreased post-alemtuzumab (SC IFNB-1a Y2: -0.50%; alemtuzumab Y1-Y5: -0.07%, -0.15%, -0.05%, 0.01%, -0.13%). 71% of pts received no further treatment after the initial 2 alemtuzumab courses.
Conclusion: In pts with prior SC IFNB-1a treatment, switching to alemtuzumab improved MRI lesion and BVL outcomes over 5 years. These findings are consistent with core study conclusions, and suggest that alemtuzumab may provide a unique treatment approach for RRMS pts treated previously with SC IFNB-1a, with durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
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, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva).
KN: Consulting (NeuroRx); research support (Biogen and Sanofi Genzyme); royalty on licenses (Biogen).
DP: Consulting and/or speaking fees (Biogen, Novartis, Roche, Sanofi Genzyme, and Vertex); grant/research support (Biogen).
SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Novartis, Sanofi Genzyme).
AT: Consulting fees (Biogen, Novartis, Roche, Sanofi Genzyme, Serono, and Teva); grant/research support (Roche and Sanofi Genzyme).
DHM and ND: Employees of Sanofi.
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 Pharmaceuticals).
Abstract: P728
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved MRI outcomes, including brain volume loss (BVL), versus SC IFNB-1a over 2 years (y) in treatment-naive patients (pts) with active RRMS. In a completed extension study (NCT00930553), SC IFNB-1a-treated pts discontinued that therapy and initiated alemtuzumab 12 mg (2 courses: baseline, 5 days; 12 months later, 3 days), which demonstrated durable efficacy in the absence of continuous treatment. In the extension, pts could receive as-needed alemtuzumab retreatment (12 mg/day on 3 consecutive days, ≥12 months after previous course for relapse/MRI activity) or other disease-modifying therapy (DMT; per investigator discretion). Pts completing ≥48 months of the extension could enrol in TOPAZ, a 5-y, phase 3b/4 study (NCT02255656) for further evaluation.
Goal: Evaluate alemtuzumab MRI efficacy 5 y after switching from SC IFNB-1a.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment (≥12 months apart) or other DMT at any time point (both per investigator discretion, no criteria). Assessments: annual MRI scored for disease activity (gadolinium [Gd]-enhancing T1 lesions or new/enlarging T2 hyperintense lesions) and brain parenchymal fraction (BPF) change.
Results: Of 173 SC IFNB-1a-treated pts completing CARE-MS I, 139 (80%) were treated with alemtuzumab in the extension; 122 (88%) of these completed Y4 of post-alemtuzumab follow-up and entered TOPAZ, and 118 (97%) completed Y5 post-alemtuzumab. Percentages free of Gd-enhancing T1 lesions were 81% in SC IFNB-1a Y2, increasing to 96% in post-alemtuzumab Y2, and 92%-89% in Y3-5. Percentages free of new/enlarging T2 hyperintense lesions were 60% in SC IFNB-1a Y2, 82% in post-alemtuzumab Y2, and 72%-67% in Y3-5. Percentages free of MRI disease activity increased from 59% in SC IFNB-1a Y2 to 82% in post-alemtuzumab Y2, and were 72%-67% in Y3-5. Median yearly BPF percent change decreased post-alemtuzumab (SC IFNB-1a Y2: -0.50%; alemtuzumab Y1-Y5: -0.07%, -0.15%, -0.05%, 0.01%, -0.13%). 71% of pts received no further treatment after the initial 2 alemtuzumab courses.
Conclusion: In pts with prior SC IFNB-1a treatment, switching to alemtuzumab improved MRI lesion and BVL outcomes over 5 years. These findings are consistent with core study conclusions, and suggest that alemtuzumab may provide a unique treatment approach for RRMS pts treated previously with SC IFNB-1a, with durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal).
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, Merck Serono, Novartis, Sanofi Genzyme, and Teva); lecture fees (Bayer, Biogen Dompé, Merck Serono, Novartis, Sanofi Genzyme, Serono Symposia International Foundation, and Teva).
KN: Consulting (NeuroRx); research support (Biogen and Sanofi Genzyme); royalty on licenses (Biogen).
DP: Consulting and/or speaking fees (Biogen, Novartis, Roche, Sanofi Genzyme, and Vertex); grant/research support (Biogen).
SS: Consulting and/or speaking fees (Biogen, Merck Serono, Novartis, Sanofi Genzyme, and Teva); grant/research support (Novartis, Sanofi Genzyme).
AT: Consulting fees (Biogen, Novartis, Roche, Sanofi Genzyme, Serono, and Teva); grant/research support (Roche and Sanofi Genzyme).
DHM and ND: Employees of Sanofi.
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 Pharmaceuticals).