Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies.
Mult Scler. 2020 Nov; 26(13):1719-1728.MS

Abstract

BACKGROUND

Alemtuzumab is administered as two annual courses for relapsing-remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen.

OBJECTIVE

The objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers).

METHODS

Post hoc analysis of patients from the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) studies who enrolled in the extension.

RESULTS

Early relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1-2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: -0.67% (CARE-MS I); -0.47% (CARE-MS II)) declined after Course 2 (Year 6: -0.24%; -0.13%).

CONCLUSION

Early relapsers' outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit.

CLINICALTRIALS.GOV REGISTRATION NUMBERS

CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553.

Links

Publisher Full Text

ncbi.nlm.nih.gov

journals.sagepub.com

PMC Free PDF

Authors+Show Affiliations

Van Wijmeersch B

Rehabilitation and MS Center Overpelt; BIOMED, Hasselt University, Hasselt, Belgium.

Singer BA

The MS Center for Innovations in Care, Missouri Baptist Medical Center, St Louis, MO, USA.

Boster A

OhioHealth Neurological Physicians, Columbus, OH, USA.

Broadley S

School of Medicine, Griffith University, Southport, QLD, Australia.

Fernández Ó

Fundación IMABIS, Hospital Universitario Carlos Haya, Málaga, Spain.

Freedman MS

University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, ON, Canada.

Izquierdo G

Virgen Macarena University Hospital, Seville, Spain.

Lycke J

Institution of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.

Pozzilli C

Sapienza University of Rome, Rome, Italy.

Sharrack B

NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospitals, University of Sheffield, Sheffield, UK.

Steingo B

Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA.

Wiendl H

University of Münster, Münster, Germany.

Wray S

Hope Neurology PLLC, Knoxville, TN, USA.

Ziemssen T

Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany.

Chung L

Sanofi, Cambridge, MA, USA.

Margolin DH

Sanofi, Cambridge, MA, USA; Cerevance, Boston, MA, USA.

Thangavelu K

Sanofi, Cambridge, MA, USA; EMD Serono, Billerica, MA, USA.

Vermersch P

University of Lille, INSERM U995, CHU Lille, FHU Imminent, Lille, France.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31675266

Clinical Trial Links

Clinical trial which this article describes [1]

Clinical trial which this article describes [2]

Clinical trial which this article describes [3]

Citation

Van Wijmeersch, Bart, et al. "Efficacy of Alemtuzumab Over 6 Years in Relapsing-remitting Multiple Sclerosis Patients Who Relapsed Between Courses 1 and 2: Post Hoc Analysis of the CARE-MS Studies." Multiple Sclerosis (Houndmills, Basingstoke, England), vol. 26, no. 13, 2020, pp. 1719-1728.

Van Wijmeersch B, Singer BA, Boster A, et al. Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Mult Scler. 2020;26(13):1719-1728.

Van Wijmeersch, B., Singer, B. A., Boster, A., Broadley, S., Fernández, Ó., Freedman, M. S., Izquierdo, G., Lycke, J., Pozzilli, C., Sharrack, B., Steingo, B., Wiendl, H., Wray, S., Ziemssen, T., Chung, L., Margolin, D. H., Thangavelu, K., & Vermersch, P. (2020). Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. Multiple Sclerosis (Houndmills, Basingstoke, England), 26(13), 1719-1728. https://doi.org/10.1177/1352458519881759

Van Wijmeersch B, et al. Efficacy of Alemtuzumab Over 6 Years in Relapsing-remitting Multiple Sclerosis Patients Who Relapsed Between Courses 1 and 2: Post Hoc Analysis of the CARE-MS Studies. Mult Scler. 2020;26(13):1719-1728. PubMed PMID: 31675266.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies. AU - Van Wijmeersch,Bart, AU - Singer,Barry A, AU - Boster,Aaron, AU - Broadley,Simon, AU - Fernández,Óscar, AU - Freedman,Mark S, AU - Izquierdo,Guillermo, AU - Lycke,Jan, AU - Pozzilli,Carlo, AU - Sharrack,Basil, AU - Steingo,Brian, AU - Wiendl,Heinz, AU - Wray,Sibyl, AU - Ziemssen,Tjalf, AU - Chung,Luke, AU - Margolin,David H, AU - Thangavelu,Karthinathan, AU - Vermersch,Patrick, Y1 - 2019/11/01/ PY - 2019/11/2/pubmed PY - 2019/11/2/medline PY - 2019/11/2/entrez KW - Alemtuzumab KW - disability KW - disease-modifying therapy KW - efficacy KW - magnetic resonance imaging (MRI) KW - relapsing–remitting multiple sclerosis (MS) SP - 1719 EP - 1728 JF - Multiple sclerosis (Houndmills, Basingstoke, England) JO - Mult Scler VL - 26 IS - 13 N2 - BACKGROUND: Alemtuzumab is administered as two annual courses for relapsing-remitting multiple sclerosis (MS). Patients may relapse before completing the two-course regimen. OBJECTIVE: The objective was to evaluate 6-year outcomes in patients who relapsed between alemtuzumab Courses 1 and 2 (early relapsers). METHODS: Post hoc analysis of patients from the Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis (CARE-MS) studies who enrolled in the extension. RESULTS: Early relapsers (CARE-MS I: 15%; CARE-MS II: 24%) had more relapses in 1-2 years pre-alemtuzumab and higher mean baseline Expanded Disability Status Scale score than patients without relapse. Their annualized relapse rate declined from Year 1 (CARE-MS I: 1.3; CARE-MS II: 1.2) to Year 2 following Course 2 (0.3; 0.5) and remained low thereafter. Over 6 years, 60% remained free of 6-month confirmed disability worsening; 24% (CARE-MS I) and 34% (CARE-MS II) achieved 6-month confirmed disability improvement. During Year 6, 69% (CARE-MS I) and 68% (CARE-MS II) were free of magnetic resonance imaging (MRI) disease activity. Median percent yearly brain volume loss (Year 1: -0.67% (CARE-MS I); -0.47% (CARE-MS II)) declined after Course 2 (Year 6: -0.24%; -0.13%). CONCLUSION: Early relapsers' outcomes improved after completing the second alemtuzumab course. These findings support administering the approved two-course regimen to maximize clinical benefit. CLINICALTRIALS.GOV REGISTRATION NUMBERS: CARE-MS I, II, extension: NCT00530348, NCT00548405, NCT00930553. SN - 1477-0970 UR - https://www.unboundmedicine.com/medline/citation/31675266/Efficacy_of_alemtuzumab_over_6_years_in_relapsing_remitting_multiple_sclerosis_patients_who_relapsed_between_courses_1_and_2:_Post_hoc_analysis_of_the_CARE_MS_studies_ L2 - https://journals.sagepub.com/doi/10.1177/1352458519881759?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -

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Efficacy of alemtuzumab over 6 years in relapsing-remitting multiple sclerosis patients who relapsed between courses 1 and 2: Post hoc analysis of the CARE-MS studies.Mult Scler. 2020 Nov; 26(13):1719-1728.MS