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Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study).
Neurol Ther. 2019 Dec; 8(2):367-381.NT

Abstract

INTRODUCTION

Multiple sclerosis (MS) patients of African descent have increased risk for disease progression and may be less responsive to disease-modifying therapy.

METHODS

Patients in the CARE-MS studies received alemtuzumab 12 mg/day [initial alemtuzumab treatment (IAT); baseline: 5 days; 12 months later: 3 days] or subcutaneous interferon beta-1a (SC IFNB-1a) 3 ×/week. Core study outcomes were compared between treatment groups. In the extension study CAMMS03409, SC IFNB-1a-treated patients switched to alemtuzumab [delayed alemtuzumab treatment (DAT)]. Data from IAT and DAT arms were pooled to assess outcomes through 6 years post alemtuzumab initiation; IAT patients had an additional 2 years of follow-up in TOPAZ.

RESULTS

Of 1200 CARE-MS patients, 43 (4%) were of African descent (35 IAT; 8 DAT) and received alemtuzumab in the 2-year core and/or 6-year extension; 29 (67%) remained on study at the time of analysis (24 IAT patients completed year 8 post alemtuzumab; 5 DAT patients completed year 6 post alemtuzumab). In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a. Alemtuzumab remained efficacious at year 6 (pooled IAT/DAT) and at year 8 (IAT only) post alemtuzumab (ARR: 0.15 and 0.30; improved EDSS: 17% and 25%; CDI: 47% and 55%; BVL: - 1.14% and - 0.70%, respectively). No safety signals were unique to this population.

CONCLUSIONS

Alemtuzumab was efficacious in a small cohort of relapsing-remitting MS patients of African descent over 8 years. Safety was consistent with the overall CARE-MS population, although the small sample size may have prevented the detection of known low-frequency adverse events. CLINICALTRIALS.

GOV REGISTRATION NUMBERS

CARE-MS I, II, extension, TOPAZ: NCT00530348, NCT00548405, NCT00930553, NCT02255656.

FUNDING

Sanofi (Cambridge, MA, USA) and Bayer HealthCare Pharmaceuticals (Leverkusen, Germany).

Authors+Show Affiliations

Multiple Sclerosis Treatment Center of Dallas, Dallas, TX, USA. afokai@gmail.com.Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.Keck School of Medicine of University of Southern California, Los Angeles, CA, USA. , West Hollywood, CA, USA.San Juan Multiple Sclerosis Center, Guaynabo, PR, USA.MS Center of Northeastern New York, Latham, NY, USA.Fort Lauderdale Multiple Sclerosis Center, Fort Lauderdale, FL, USA.Medical University of South Carolina, Charleston, SC, USA.Sanofi, Cambridge, MA, USA.Sanofi, Cambridge, MA, USA.Multiple Sclerosis Center of Atlanta, Mableton, GA, USA.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31654272

Citation

Okai, Annette F., et al. "Efficacy and Safety of Alemtuzumab in Patients of African Descent With Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study)." Neurology and Therapy, vol. 8, no. 2, 2019, pp. 367-381.
Okai AF, Amezcua L, Berkovich RR, et al. Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurology and therapy. 2019;8(2):367-381.
Okai, A. F., Amezcua, L., Berkovich, R. R., Chinea, A. R., Edwards, K. R., Steingo, B., Walker, A., Jacobs, A. K., Daizadeh, N., & Williams, M. J. (2019). Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurology and Therapy, 8(2), 367-381. https://doi.org/10.1007/s40120-019-00159-2
Okai AF, et al. Efficacy and Safety of Alemtuzumab in Patients of African Descent With Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). Neurology and therapy. 2019;8(2):367-381. PubMed PMID: 31654272.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Alemtuzumab in Patients of African Descent with Relapsing-Remitting Multiple Sclerosis: 8-Year Follow-up of CARE-MS I and II (TOPAZ Study). AU - Okai,Annette F, AU - Amezcua,Lilyana, AU - Berkovich,Regina R, AU - Chinea,Angel R, AU - Edwards,Keith R, AU - Steingo,Brian, AU - Walker,Aljoeson, AU - Jacobs,Alan K, AU - Daizadeh,Nadia, AU - Williams,Mitzi J, AU - ,, Y1 - 2019/10/25/ PY - 2019/07/03/received PY - 2019/10/28/pubmed PY - 2019/10/28/medline PY - 2019/10/27/entrez KW - African descent KW - Alemtuzumab KW - Disease-modifying therapy KW - Multiple sclerosis SP - 367 EP - 381 JF - Neurology and therapy VL - 8 IS - 2 N2 - INTRODUCTION: Multiple sclerosis (MS) patients of African descent have increased risk for disease progression and may be less responsive to disease-modifying therapy. METHODS: Patients in the CARE-MS studies received alemtuzumab 12 mg/day [initial alemtuzumab treatment (IAT); baseline: 5 days; 12 months later: 3 days] or subcutaneous interferon beta-1a (SC IFNB-1a) 3 ×/week. Core study outcomes were compared between treatment groups. In the extension study CAMMS03409, SC IFNB-1a-treated patients switched to alemtuzumab [delayed alemtuzumab treatment (DAT)]. Data from IAT and DAT arms were pooled to assess outcomes through 6 years post alemtuzumab initiation; IAT patients had an additional 2 years of follow-up in TOPAZ. RESULTS: Of 1200 CARE-MS patients, 43 (4%) were of African descent (35 IAT; 8 DAT) and received alemtuzumab in the 2-year core and/or 6-year extension; 29 (67%) remained on study at the time of analysis (24 IAT patients completed year 8 post alemtuzumab; 5 DAT patients completed year 6 post alemtuzumab). In year 2, annualized relapse rate (ARR; 0.09 versus 0.42), percentage of patients with improved Expanded Disability Status Scale (EDSS; 18% versus 11%), 6-month confirmed disability improvement (CDI; 28% versus 13%), no evidence of disease activity (55% versus 13%), and cumulative brain volume loss (BVL; - 0.55% versus - 1.32%) favored alemtuzumab versus SC IFNB-1a. Alemtuzumab remained efficacious at year 6 (pooled IAT/DAT) and at year 8 (IAT only) post alemtuzumab (ARR: 0.15 and 0.30; improved EDSS: 17% and 25%; CDI: 47% and 55%; BVL: - 1.14% and - 0.70%, respectively). No safety signals were unique to this population. CONCLUSIONS: Alemtuzumab was efficacious in a small cohort of relapsing-remitting MS patients of African descent over 8 years. Safety was consistent with the overall CARE-MS population, although the small sample size may have prevented the detection of known low-frequency adverse events. CLINICALTRIALS. GOV REGISTRATION NUMBERS: CARE-MS I, II, extension, TOPAZ: NCT00530348, NCT00548405, NCT00930553, NCT02255656. FUNDING: Sanofi (Cambridge, MA, USA) and Bayer HealthCare Pharmaceuticals (Leverkusen, Germany). SN - 2193-8253 UR - https://www.unboundmedicine.com/medline/citation/31654272/Efficacy_and_Safety_of_Alemtuzumab_in_Patients_of_African_Descent_with_Relapsing_Remitting_Multiple_Sclerosis:_8_Year_Follow_up_of_CARE_MS_I_and_II__TOPAZ_Study__ L2 - https://dx.doi.org/10.1007/s40120-019-00159-2 DB - PRIME DP - Unbound Medicine ER -
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