Alemtuzumab improves disability and quality of life outcomes over 8 years in patients with RRMS
ECTRIMS Online Library. Wiendl H. 09/13/19; 278382; P1180
Heinz Wiendl
Heinz Wiendl

Abstract: P1180

Type: Poster Sessions

Abstract Category: Clinical aspects of MS - Patient reported outcomes

H. Wiendl1, R.A. Aburashed2, R. Alroughani3, A. Boster4, A. Chan5, D. Dive6, S. Eichau7, D. Kantor8, H.J. Kim9, C. LaGanke10, J. Lycke11, R.A.L. Macdonell12, C. Pozzilli13, T.F. Scott14, P. Vermersch15, Z. Choudhry16, N. Daizadeh16, D.P. Baker16, S. Hunter17

1University of Münster, Münster, Germany, 2Institute for Neurosciences and Multiple Sclerosis, Owosso, MI, United States, 3Amiri Hospital, Sharq, Kuwait, 4OhioHealth Neurological Physicians, Columbus, OH, United States, 5Bern University Hospital and University of Bern, Bern, Switzerland, 6University Hospital Centre of Liège, Liège, Belgium, 7Hospital Universitario Virgen Marcarena, Seville, Spain, 8Florida Atlantic University, Boca Raton, FL, United States, 9Research Institute and Hospital of National Cancer Center, Goyang, Republic of Korea, 10North Central Neurology Associates, Cullman, AL, United States, 11Sahlgrenska University Hospital, Gothenburg, Sweden, 12Austin Health and Florey Institute of Neuroscience and Mental Health, Melbourne, VIC, Australia, 13University of Rome, Rome, Italy, 14Allegheny General Hospital, Pittsburgh, PA, United States, 15University of Lille, INSERM U995, CHU Lille, Lille, France, 16Sanofi, Cambridge, MA, 17Advanced Neurosciences Institute, Franklin, TN, United States

Introduction: In the CARE-MS I/II (NCT00530348; NCT00548405) trials, alemtuzumab significantly improved clinical/MRI outcomes and quality of life (QoL) measures, including 6-month confirmed disability improvement (CDI) in CARE-MS II, versus SC IFNB-1a over 2 years (y). Efficacy was maintained in 2 consecutive extensions (NCT00930553; NCT02255656 [TOPAZ]).
Aims: To assess EDSS and QoL improvements over 8 y in pooled CARE-MS patients who achieved 6-month CDI.
Methods: Patients received 2 alemtuzumab courses (12mg/day; baseline: 5 days; 12 months later: 3 days) in the core studies, with additional courses (12mg/day; ≥12 months apart) as needed in the extensions. CDI, defined as ≥1-point EDSS decrease confirmed over 6 months, was assessed in eligible patients (baseline EDSS≥2.0). Patients with CDI were stratified by baseline EDSS and assessed for EDSS improvement/stability from baseline through Y8, and 6-month confirmed disability worsening (CDW) post-CDI; improvements from baseline on Functional Assessment of MS (FAMS); Short-Form 36-Item (SF-36) survey mental component summary (MCS), and physical component summary (PCS); and EuroQol 5-dimensions visual analogue scale (EQ-5D VAS) were assessed in patients with CDI.
Results: Of the 375 patients eligible for CDI and with Y8 data, 176 (47%) achieved 6-month CDI. 56% of patients with CDI had improved EDSS from baseline at Y8 versus 4% of those without CDI. Patients with CDI showed improved EDSS at Y8, regardless of baseline EDSS score (EDSS 2.0-2.5: 63% [42/67]; 3.0-3.5: 49% [37/75]; 4.0-4.5: 54% [14/26]; and 5.0-5.5: 75% [6/8]). Across all baseline EDSS levels, ≤14% of patients had 6-month CDW after achieving CDI (2.0-2.5: 7%; 3.0-3.5: 9%; 4.0-4.5: 14%; and 5.0-5.5: 11%). Patients with CDI showed significant improvements from baseline in each y (P< 0.05) through Y8 on FAMS (least squares means, Y1-8: 9.6-12.3), SF-36 (MCS: 2.0-3.1; PCS: 3.3-4.7), and EQ-5D VAS (5.4-9.4). At Y8, most patients with CDI had improved/stable scores on SF-36 (MCS: 75.9%; PCS: 85.6%). Rates of AEs, infections, and thyroid AEs (peaked in Y3) declined through Y8; additional safety will be presented.
Conclusions: Alemtuzumab-treated patients who achieved 6-month CDI showed a high rate of improvement on EDSS at Y8 versus baseline, regardless of baseline EDSS, and had improvements in QoL outcomes which were maintained over 8 y. These results support the use of CDI as a meaningful endpoint for assessing long-term outcomes in RRMS patients.
Disclosure: HW: Consulting and/or speaking fees (Bayer, Behring, Biogen, EMD Serono, Fresnius Medical Care, Merck Serono, Novartis, Roche, Sanofi, and Teva). RAA: Consulting and/or speaker honoraria and scientific advisory boards (Bayer, Biogen, Genentech, Novartis, Sanofi, and Teva) and research grants (Novartis). RA: Speaker honoraria, scientific advisory boards, and research grants (Bayer, Biogen, Biologix, Genpharm, GlaxoSmithKline, Lundbeck, Merck Serono, Novartis, and Sanofi). AB: Consulting fees and/or fees for non-CME services (Biogen, Mallinckrodt, Medtronic, Novartis, Sanofi, and Teva). AC: Honoraria for presentations or advisory boards to support university research funds (Actelion, Almirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, and Teva) and research support (Biogen, Sanofi, and UCB). DD: Institutional honoraria for advisory board participation and travel grants (Bayer, Biogen, Merck Serono, Novartis, Sanofi, and Teva). SE: Speaking and/or consulting (Biogen, Merck Serono, Novartis, Roche, Sanofi, and Teva). DK: Consulting fees and/or fees for non-CME services (AbbVie, Actelion, Bayer, Biogen, Celgene, EMD Serono, Genentech, Mylan, Novartis, and Sanofi) and research grants (Actelion and Sanofi). HJK: Consultant 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); and co-editor/associate editor (MS Journal - Experimental, Translational and Clinical; and Journal of Clinical Neurology). CL: Compensation for consulting (Acorda Therapeutics, Bayer, Biogen, Cephalon, EMD Serono, Novartis, Pfizer, Questcor, Sanofi, Strativa, Teva, and UCB). JL: Travel support and/or lecture honoraria (Biogen, Novartis, Sanofi, and Teva); scientific advisory boards (Almirall, Biogen, Novartis, Sanofi, and Teva); editorial board (Acta Neurologica Scandinavica); and unconditional research grants (Biogen, Novartis, and Teva). RALM: Travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). CP: Consulting and/or speaking fees, research, and travel grants (Actelion, Biogen, Merck, Novartis, Sanofi, and Teva). TS: Consulting and/or speaking fees (Biogen, Genentech, Genzyme, and Novartis). PV: Consulting fees and/or speaking fees and research support (Almirall, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Servier, and Teva). ZC, ND, and DPB: Employees of Sanofi. SH: Consulting agreements, speaker honoraria, and grant/research financial support (AbbVie, Acorda, Avanir, Bayer, Biogen, Genzyme, Novartis, Osmotica, Questcor, Roche, Synthon, and Teva). STUDY SUPPORT: Sanofi and Bayer HealthCare Pharmaceuticals.

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