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

卷:8

the CARE-MS I, CARE-MS II, CAMMS03409, and TOPAZ Investigators¹  Brian Steingo²  Regina R. Berkovich³  Lilyana Amezcua³  Keith R. Edwards⁴  Aljoeson Walker⁵  Mitzi J. Williams⁶  Annette F. Okai⁷  Angel R. Chinea⁸  Nadia Daizadeh⁹  Alan K. Jacobs⁹ 

[1] ;

[2] Fort Lauderdale Multiple Sclerosis Center;

[3] Keck School of Medicine of University of Southern California;

[4] MS Center of Northeastern New York;

[5] Medical University of South Carolina;

[6] Multiple Sclerosis Center of Atlanta;

[7] Multiple Sclerosis Treatment Center of Dallas;

[8] San Juan Multiple Sclerosis Center;

[9] Sanofi;

关键词: African descent;    Alemtuzumab;    Disease-modifying therapy;    Multiple sclerosis;   

DOI  :  10.1007/s40120-019-00159-2

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown