Abstract: P1190
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical outcomes 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 efficacy and safety 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); MRI scans were annual. Assessments: annualised relapse rate (ARR); 6-month confirmed disability worsening (CDW); 6-month confirmed disability improvement (CDI); no evidence of disease activity (NEDA); adverse events.
Results: Of 173 SC IFNB-1a-treated pts completing CARE-MS I, 139 (80%) received alemtuzumab in the extension study; 122 (88%) of these completed Y4 of post-alemtuzumab follow-up and entered TOPAZ, and 118 (97%) completed Y5 post-alemtuzumab. ARR decreased from 0.39 with SC IFNB-1a (Y0-2) to 0.11 with alemtuzumab (Y0-2) and remained low through Y5 (0.09). Percentage relapse-free increased from 79% in Y2 of SC IFNB-1a to 87% in Y2 post-alemtuzumab and was 92% in Y5. Percentages achieving annual NEDA increased from 47% in Y2 of SC IFNB-1a to 71%, 59%, 54%, and 56% in Y2, Y3, Y4, and Y5 post-alemtuzumab, respectively. Through Y5 of alemtuzumab follow-up, 75% were free of 6-month CDW; 28% had 6-month CDI. 71% received no further treatment after the initial 2 alemtuzumab courses. Safety was consistent with that of core study alemtuzumab-treated pts.
Conclusion: In pts with prior SC IFNB-1a treatment, clinical outcomes with alemtuzumab were improved over 5 y. 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, offering durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
RA: Honoria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi Genzyme).
DB: Compensation for advisory board participant, lecture, and travel fees (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva).
ANB: Consulting fees/participated in clinical trials (Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva Pharmaceuticals).
PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi Aventis, and Teva Pharmaceuticals).
BS: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva).
BVW: Research and travel grants, honoraria for MS expert advice and speakers fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
DHM, ND, and CER: Employees of Sanofi.
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
Abstract: P1190
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical outcomes 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 efficacy and safety 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); MRI scans were annual. Assessments: annualised relapse rate (ARR); 6-month confirmed disability worsening (CDW); 6-month confirmed disability improvement (CDI); no evidence of disease activity (NEDA); adverse events.
Results: Of 173 SC IFNB-1a-treated pts completing CARE-MS I, 139 (80%) received alemtuzumab in the extension study; 122 (88%) of these completed Y4 of post-alemtuzumab follow-up and entered TOPAZ, and 118 (97%) completed Y5 post-alemtuzumab. ARR decreased from 0.39 with SC IFNB-1a (Y0-2) to 0.11 with alemtuzumab (Y0-2) and remained low through Y5 (0.09). Percentage relapse-free increased from 79% in Y2 of SC IFNB-1a to 87% in Y2 post-alemtuzumab and was 92% in Y5. Percentages achieving annual NEDA increased from 47% in Y2 of SC IFNB-1a to 71%, 59%, 54%, and 56% in Y2, Y3, Y4, and Y5 post-alemtuzumab, respectively. Through Y5 of alemtuzumab follow-up, 75% were free of 6-month CDW; 28% had 6-month CDI. 71% received no further treatment after the initial 2 alemtuzumab courses. Safety was consistent with that of core study alemtuzumab-treated pts.
Conclusion: In pts with prior SC IFNB-1a treatment, clinical outcomes with alemtuzumab were improved over 5 y. 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, offering durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
CO-G: Speaking and/or consultancy (Bayer, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
RA: Honoria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi Genzyme).
DB: Compensation for advisory board participant, lecture, and travel fees (Bayer, Biogen, Merck, Sanofi Genzyme, and Teva).
ANB: Consulting fees/participated in clinical trials (Bayer HealthCare, Biogen, Merck Serono, Novartis, Sanofi Aventis, Sanofi Genzyme, and Teva Pharmaceuticals).
PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi Aventis, and Teva Pharmaceuticals).
BS: Consulting, speaking fees and/or grant/research support (Acorda, Biogen, EMD Serono, Mallinckrodt, Novartis, Sanofi Genzyme, and Teva).
BVW: Research and travel grants, honoraria for MS expert advice and speakers fees (Bayer-Schering, Biogen, Merck-Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
DHM, ND, and CER: Employees of Sanofi.
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).