Contributions
Abstract: P913
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in the CARE-MS II phase 3 trials (NCT00548405), 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical and MRI outcomes versus SC IFNB-1a in RRMS patients with inadequate response to prior therapy at baseline. In a 4-y extension (NCT00930553), patients could receive additional courses of alemtuzumab (12 mg/day on 3 consecutive days; ≥12 months apart) as needed for disease activity or receive other disease-modifying therapy (DMT) per investigator discretion; efficacy on clinical/MRI outcomes was maintained in the extension, with 50% receiving no additional alemtuzumab or other DMTs over 6 y after the initial 2 courses. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, for further evaluation.
Aims: To evaluate the efficacy and safety of alemtuzumab over 8 y in CARE-MS II patients.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria) or receive other DMT (at any time).
Results: Of the 435 patients who received alemtuzumab in CARE-MS II, 300 (69%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 44% received neither additional courses of alemtuzumab nor another DMT through Y8. Annualized relapse rate at Y8 was 0.18; 85% were relapse-free in Y8. 70% of patients had stable/improved EDSS scores from core study baseline through Y8; mean change in EDSS score from core study baseline to Y8 was 0.17. Through Y8, 64% of patients were free from 6-month confirmed disability worsening, and 47% achieved 6-month confirmed disability improvement. In Y8, 58% of patients achieved no evidence of disease activity, 70% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 70% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline through Y8 was -1.06%; reduction in BVL was 0.19% or less annually in Y3-8. The safety profile in Y8 was consistent with the previous years. The incidence of AEs, infections, and thyroid AEs continued to decline through Y8; no new cases of immune thrombocytopenia or nephropathy were seen.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y in the absence of continuous treatment in CARE-MS II patients, with a consistent and manageable safety profile.
Disclosure: BAS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Pfizer, Novartis, Sanofi, and Teva), and research support (Acorda, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi). RA: Speaker honoraria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi). SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); speaker honoraria (Biogen and Genzyme); and unencumbered research grant (Biogen). SE: Honoraria as consultant and speaker (Biogen, Merck Serono, Novartis, Roche, Sanofi and Teva). H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi). EKH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi, and Teva), and supported by Ministry of Education of Czech Republic (PROGRES Q27/LF1). HJK: Consulting and speaking fees (Bayer-Schering Pharma, Biogen, Celltrion, Eisai, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Merck Serono, Ministry of Science and ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor/associate editor (MS Journal-Experimental, Translational and Clinical; and Journal of Clinical Neurology). CN: Consulting and speaking fees (Bayer-Schering Pharma, Genzyme, Merck Serono, Novartis, Roche, and Stendhal); research support (Merck Serono, Novartis, and Roche). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, and Teva). SW: Consulting, principal investigator, and/or speaking fees (Alkermes, Bayer, Biogen, EMD Serono, Genentech/Roche, Novartis, Sanofi, and Teva). LC, ND, and SA: Employees of Sanofi. KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi, and Synthon). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals
Abstract: P913
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Over 2 years (y) in the CARE-MS II phase 3 trials (NCT00548405), 2 courses of alemtuzumab (12 mg/day; baseline: 5 consecutive days; 12 months later: 3 consecutive days) significantly improved clinical and MRI outcomes versus SC IFNB-1a in RRMS patients with inadequate response to prior therapy at baseline. In a 4-y extension (NCT00930553), patients could receive additional courses of alemtuzumab (12 mg/day on 3 consecutive days; ≥12 months apart) as needed for disease activity or receive other disease-modifying therapy (DMT) per investigator discretion; efficacy on clinical/MRI outcomes was maintained in the extension, with 50% receiving no additional alemtuzumab or other DMTs over 6 y after the initial 2 courses. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension study, for further evaluation.
Aims: To evaluate the efficacy and safety of alemtuzumab over 8 y in CARE-MS II patients.
Methods: At the investigator's discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart; no criteria) or receive other DMT (at any time).
Results: Of the 435 patients who received alemtuzumab in CARE-MS II, 300 (69%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 44% received neither additional courses of alemtuzumab nor another DMT through Y8. Annualized relapse rate at Y8 was 0.18; 85% were relapse-free in Y8. 70% of patients had stable/improved EDSS scores from core study baseline through Y8; mean change in EDSS score from core study baseline to Y8 was 0.17. Through Y8, 64% of patients were free from 6-month confirmed disability worsening, and 47% achieved 6-month confirmed disability improvement. In Y8, 58% of patients achieved no evidence of disease activity, 70% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 70% were free of new/enlarging T2 hyperintense lesions. Median percent cumulative brain volume loss (BVL) from baseline through Y8 was -1.06%; reduction in BVL was 0.19% or less annually in Y3-8. The safety profile in Y8 was consistent with the previous years. The incidence of AEs, infections, and thyroid AEs continued to decline through Y8; no new cases of immune thrombocytopenia or nephropathy were seen.
Conclusion: Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y in the absence of continuous treatment in CARE-MS II patients, with a consistent and manageable safety profile.
Disclosure: BAS: Speaking and/or consulting (Acorda, Bayer, Biogen, EMD Serono, Genentech, Pfizer, Novartis, Sanofi, and Teva), and research support (Acorda, Alkermes, Biogen, MedImmune, Novartis, Roche, and Sanofi). RA: Speaker honoraria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GSK, Lundbeck, Merck Serono, Novartis, and Sanofi). SB: Honoraria for participation in advisory boards (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); conference travel sponsorship (Bayer-Schering, Biogen, Merck Serono, Novartis, and Sanofi); speaker honoraria (Biogen and Genzyme); and unencumbered research grant (Biogen). SE: Honoraria as consultant and speaker (Biogen, Merck Serono, Novartis, Roche, Sanofi and Teva). H-PH: Consulting and/or speaking fees (Bayer, Biogen, CSL Behring, Grifols, Merck Serono, Novartis, Roche, and Sanofi). EKH: Honoraria and grant support (Actelion, Biogen, Merck Serono, Novartis, Receptos, Roche, Sanofi, and Teva), and supported by Ministry of Education of Czech Republic (PROGRES Q27/LF1). HJK: Consulting and speaking fees (Bayer-Schering Pharma, Biogen, Celltrion, Eisai, Genzyme, HanAll BioPharma, MedImmune, Merck Serono, Novartis, Teva-Handok, and UCB); research support (Genzyme, Merck Serono, Ministry of Science and ICT, Teva-Handok, and UCB); steering committee member (MedImmune); co-editor/associate editor (MS Journal-Experimental, Translational and Clinical; and Journal of Clinical Neurology). CN: Consulting and speaking fees (Bayer-Schering Pharma, Genzyme, Merck Serono, Novartis, Roche, and Stendhal); research support (Merck Serono, Novartis, and Roche). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). AR: Consulting and/or speaking fees (Bayer, Biogen, Bracco, Novartis, Sanofi Genzyme, and Stendhal). PV: Consulting and/or speaking fees, and research support (Almirall, Bayer, Biogen, GlaxoSmithKline, Merck Serono, Novartis, Sanofi, and Teva). SW: Consulting, principal investigator, and/or speaking fees (Alkermes, Bayer, Biogen, EMD Serono, Genentech/Roche, Novartis, Sanofi, and Teva). LC, ND, and SA: Employees of Sanofi. KWS: Consulting and/or speaking fees (Biogen, Merck, Novartis, Roche, Sanofi, and Synthon). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals