Contributions
Abstract: P1188
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical outcomes vs SC IFNB-1a over 2 years in treatment-naive patients (pts) with active RRMS. Durable efficacy of alemtuzumab was demonstrated over 6 years in a completed extension study (NCT00930553; 2 years core study plus 4 years 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 CARE-MS extension could enrol in the 5-year TOPAZ study (NCT02255656) for further long-term evaluation.
Goal: Evaluate 7-year efficacy/safety of alemtuzumab in CARE-MS I pts who received alemtuzumab.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment ≥12 months after previous course or other DMT at any time point (both per investigator discretion; no criteria); MRI scans were done annually. 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 (AEs).
Results: 321/349 (92%) CARE-MS I pts who entered the extension remained on study until the end of Year 6 and then entered TOPAZ; 299 (93%) remained on study through Year 7. ARR remained low (0.13 at Year 7); proportion of pts with stable or improved EDSS remained high (Year 7: 78%). Through 7 years, 74% of pts were free from 6-month CDW, 37% achieved 6-month CDI, and the majority achieved NEDA each year. These effects were achieved with 59% of pts receiving no additional treatment (alemtuzumab or other DMT) after their initial 2 courses of alemtuzumab. Incidences of overall AEs, infusion-associated reactions, and infections decreased over time and were reduced vs the 2-year core study. Thyroid AE incidence peaked at Year 3 and then declined.
Conclusion: Clinical efficacy of alemtuzumab was maintained for 7 years in treatment-naive pts, despite 59% receiving no additional treatment since the initial 2 courses of alemtuzumab. 37% of pts also showed improvement in disability. These findings suggest that alemtuzumab may provide a unique treatment approach for RRMS pts, offering durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
AJC: Consulting fees, lecture fees, and institutional grant support (Sanofi Genzyme).
ANB: Consulting fees/participated in clinical trials (Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, Sanofi Genzyme, and Teva Pharmaceuticals).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi Genzyme).
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva) and is supported by Ministry of Education of Czech Republic.
JSI: Nothing to disclose.
PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi-Aventis, and Teva Pharmaceuticals).
XM: Consulting and/or speaking fees (Almirall, Bayer, Biogen, EMD, Genentech, Geneuro, Merck, Neurotec, Novartis, Roche, Sanofi, Sanofi Genzyme, and Teva Pharmaceuticals).
CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Synthon).
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
DHM, ND, and CER: Employees of Sanofi.
BVW: Received research and travel grants, honoraria for MS-expert advice, and speaker's fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).
Abstract: P1188
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: In CARE-MS I (NCT00530348), alemtuzumab significantly improved clinical outcomes vs SC IFNB-1a over 2 years in treatment-naive patients (pts) with active RRMS. Durable efficacy of alemtuzumab was demonstrated over 6 years in a completed extension study (NCT00930553; 2 years core study plus 4 years 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 CARE-MS extension could enrol in the 5-year TOPAZ study (NCT02255656) for further long-term evaluation.
Goal: Evaluate 7-year efficacy/safety of alemtuzumab in CARE-MS I pts who received alemtuzumab.
Methods: In TOPAZ, pts can receive alemtuzumab retreatment ≥12 months after previous course or other DMT at any time point (both per investigator discretion; no criteria); MRI scans were done annually. 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 (AEs).
Results: 321/349 (92%) CARE-MS I pts who entered the extension remained on study until the end of Year 6 and then entered TOPAZ; 299 (93%) remained on study through Year 7. ARR remained low (0.13 at Year 7); proportion of pts with stable or improved EDSS remained high (Year 7: 78%). Through 7 years, 74% of pts were free from 6-month CDW, 37% achieved 6-month CDI, and the majority achieved NEDA each year. These effects were achieved with 59% of pts receiving no additional treatment (alemtuzumab or other DMT) after their initial 2 courses of alemtuzumab. Incidences of overall AEs, infusion-associated reactions, and infections decreased over time and were reduced vs the 2-year core study. Thyroid AE incidence peaked at Year 3 and then declined.
Conclusion: Clinical efficacy of alemtuzumab was maintained for 7 years in treatment-naive pts, despite 59% receiving no additional treatment since the initial 2 courses of alemtuzumab. 37% of pts also showed improvement in disability. These findings suggest that alemtuzumab may provide a unique treatment approach for RRMS pts, offering durable efficacy in the absence of continuous treatment.
Study support: Sanofi and Bayer HealthCare Pharmaceuticals.
Disclosure:
AJC: Consulting fees, lecture fees, and institutional grant support (Sanofi Genzyme).
ANB: Consulting fees/participated in clinical trials (Bayer, Biogen, Merck Serono, Novartis, Sanofi-Aventis, Sanofi Genzyme, and Teva Pharmaceuticals).
JDS: Consulting and/or speaking fees, advisory board, and grant/research support (Sanofi Genzyme).
H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi Genzyme).
EH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi Genzyme, and Teva) and is supported by Ministry of Education of Czech Republic.
JSI: Nothing to disclose.
PM: Consulting and/or speaking fees (Biogen, Novartis, Sanofi-Aventis, and Teva Pharmaceuticals).
XM: Consulting and/or speaking fees (Almirall, Bayer, Biogen, EMD, Genentech, Geneuro, Merck, Neurotec, Novartis, Roche, Sanofi, Sanofi Genzyme, and Teva Pharmaceuticals).
CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi Genzyme, and Teva).
KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi Genzyme, and Synthon).
PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi Genzyme, and Teva).
DHM, ND, and CER: Employees of Sanofi.
BVW: Received research and travel grants, honoraria for MS-expert advice, and speaker's fees (Bayer-Schering, Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, and Teva).