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Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years.
Mult Scler J Exp Transl Clin. 2020 Oct-Dec; 6(4):2055217320972137.MS

Abstract

Background

Few data exist concerning conversion to secondary progressive MS in patients treated with disease-modifying therapies.

Objective

Determine the proportion of alemtuzumab-treated patients converting from relapsing-remitting to secondary progressive MS during the CARE-MS core and extension studies.

Methods

Patients (N = 811) were analyzed post hoc for secondary progressive MS conversion. Optimal conversion definition: Expanded Disability Status Scale (EDSS) score ≥4, pyramidal functional system score ≥2, and confirmed progression over ≥3 months including confirmation within the functional system leading to progression, independent of relapse.

Results

Over 6.2 years median follow-up, 20 alemtuzumab-treated patients converted (Kaplan-Meier estimate, 2.7%; 95% confidence interval, 1.8%-4.2%). Sensitivity analysis accounting for dropouts showed similar results (3%), as did analyses using alternative definitions with different EDSS thresholds and/or confirmation periods, and analysis of core study subcutaneous interferon beta-1a-treated patients who received alemtuzumab in the extension. Patients converting to secondary progressive MS were older, and had higher EDSS scores and greater brain lesion volumes at baseline, but did not need additional alemtuzumab or other therapies.

Conclusions

The 6-year conversion rate to secondary progressive MS was low for alemtuzumab-treated patients, supporting further study of the role alemtuzumab may play in reducing risk of secondary progression.ClinicalTrials.gov identifiers: NCT00530348, NCT00548405, NCT00930553.

Authors+Show Affiliations

Department of Neurology and Center of Clinical Neuroscience, First Faculty of Medicine, Charles University and General University Hospital, Prague, Czech Republic.The Boster Center for Multiple Sclerosis, Columbus, USA.AOU San Luigi, Orbassano, Torino, Italy.University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, Canada.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableSanofi, Cambridge, USA.Center of Clinical Neuroscience, Carl Gustav Carus University Hospital, Dresden, Germany Employees of Sanofi during study conduct and analysis.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33414927

Citation

Horáková, Dana, et al. "Proportion of Alemtuzumab-treated Patients Converting From Relapsing-remitting Multiple Sclerosis to Secondary Progressive Multiple Sclerosis Over 6 Years." Multiple Sclerosis Journal - Experimental, Translational and Clinical, vol. 6, no. 4, 2020, p. 2055217320972137.
Horáková D, Boster A, Bertolotto A, et al. Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Mult Scler J Exp Transl Clin. 2020;6(4):2055217320972137.
Horáková, D., Boster, A., Bertolotto, A., Freedman, M. S., Firmino, I., Cavalier, S. J., Jacobs, A. K., Thangavelu, K., Daizadeh, N., Poole, E. M., Baker, D. P., Margolin, D. H., & Ziemssen, T. (2020). Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. Multiple Sclerosis Journal - Experimental, Translational and Clinical, 6(4), 2055217320972137. https://doi.org/10.1177/2055217320972137
Horáková D, et al. Proportion of Alemtuzumab-treated Patients Converting From Relapsing-remitting Multiple Sclerosis to Secondary Progressive Multiple Sclerosis Over 6 Years. Mult Scler J Exp Transl Clin. 2020 Oct-Dec;6(4):2055217320972137. PubMed PMID: 33414927.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Proportion of alemtuzumab-treated patients converting from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis over 6 years. AU - Horáková,Dana, AU - Boster,Aaron, AU - Bertolotto,Antonio, AU - Freedman,Mark S, AU - Firmino,Isabel, AU - Cavalier,Steven J, AU - Jacobs,Alan K, AU - Thangavelu,Karthinathan, AU - Daizadeh,Nadia, AU - Poole,Elizabeth M, AU - Baker,Darren P, AU - Margolin,David H, AU - Ziemssen,Tjalf, AU - ,, Y1 - 2020/12/18/ PY - 2020/04/20/received PY - 2020/10/19/accepted PY - 2021/1/8/entrez PY - 2021/1/9/pubmed PY - 2021/1/9/medline KW - Relapsing-remitting multiple sclerosis KW - alemtuzumab KW - disease progression KW - secondary progressive multiple sclerosis SP - 2055217320972137 EP - 2055217320972137 JF - Multiple sclerosis journal - experimental, translational and clinical JO - Mult Scler J Exp Transl Clin VL - 6 IS - 4 N2 - Background: Few data exist concerning conversion to secondary progressive MS in patients treated with disease-modifying therapies. Objective: Determine the proportion of alemtuzumab-treated patients converting from relapsing-remitting to secondary progressive MS during the CARE-MS core and extension studies. Methods: Patients (N = 811) were analyzed post hoc for secondary progressive MS conversion. Optimal conversion definition: Expanded Disability Status Scale (EDSS) score ≥4, pyramidal functional system score ≥2, and confirmed progression over ≥3 months including confirmation within the functional system leading to progression, independent of relapse. Results: Over 6.2 years median follow-up, 20 alemtuzumab-treated patients converted (Kaplan-Meier estimate, 2.7%; 95% confidence interval, 1.8%-4.2%). Sensitivity analysis accounting for dropouts showed similar results (3%), as did analyses using alternative definitions with different EDSS thresholds and/or confirmation periods, and analysis of core study subcutaneous interferon beta-1a-treated patients who received alemtuzumab in the extension. Patients converting to secondary progressive MS were older, and had higher EDSS scores and greater brain lesion volumes at baseline, but did not need additional alemtuzumab or other therapies. Conclusions: The 6-year conversion rate to secondary progressive MS was low for alemtuzumab-treated patients, supporting further study of the role alemtuzumab may play in reducing risk of secondary progression.ClinicalTrials.gov identifiers: NCT00530348, NCT00548405, NCT00930553. SN - 2055-2173 UR - https://www.unboundmedicine.com/medline/citation/33414927/Proportion_of_alemtuzumab_treated_patients_converting_from_relapsing_remitting_multiple_sclerosis_to_secondary_progressive_multiple_sclerosis_over_6_years_ L2 - https://journals.sagepub.com/doi/10.1177/2055217320972137?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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