Abstract Details

Title 7-Year Outcomes in MS Patients of African Descent Treated With Alemtuzumab: Follow-up of CARE-MS I and II (TOPAZ study)

Topic Multiple Sclerosis

Presentation(s) P3 - Poster Session 3 (5:30 PM-6:30 PM)

Poster/Presentation
Number 15-067

Objective Evaluate alemtuzumab efficacy/safety over 7 years (y) in RRMS patients of African descent.

Background MS patients of African descent are at increased risk for more rapid disability progression and may be less responsive to disease-modifying therapy (DMT) than white patients. Alemtuzumab significantly improved clinical/MRI outcomes over 2 y versus SC IFNB-1a in RRMS patients who were treatment-naive (CARE-MS I; NCT00530348) or had inadequate response to prior therapy (CARE-MS II; NCT00548405). Efficacy was maintained in a 4-y extension (NCT00930553), wherein patients could receive as-needed alemtuzumab or other DMTs per investigator discretion. Patients could continue in another 5-y extension (TOPAZ; NCT02255656).

Design/Methods At investigator discretion, patients in TOPAZ can receive additional as-needed alemtuzumab (≥12 months apart) or another DMT.

Results In the pooled CARE-MS studies, 46 patients (4%) were of African descent (alemtuzumab, n=35; SC IFNB-1a, n=11), of whom 76% were female. Baseline EDSS scores (mean±SD) were 2.2±1.4 (alemtuzumab) and 2.5±1.3 (SC IFNB-1a). 27/35 (77%) alemtuzumab-treated patients completed Y7; 34% received neither additional alemtuzumab nor another DMT through Y7. Annualized relapse rate was 0.09 at Y2 with alemtuzumab (vs 0.42 with SC IFNB-1a) and 0.19 at Y7. 60% of patients had stable/improved EDSS from baseline to Y7. In Y7, 63% were MRI disease activity-free (no new Gd-enhancing T1 or new/enlarging T2 lesions); 94% were new Gd-enhancing lesion-free and 63% were new/enlarging T2 lesion-free. Median cumulative brain volume loss over 7 y was –0.75%; median yearly change in brain volume in Y7 was +0.28%. There were 2 cases of immune thrombocytopenia and 1 case of nephropathy over 7 y. The safety profile was consistent with the overall alemtuzumab population.

Conclusions Retention from core study baseline was high (77%). Alemtuzumab efficacy on clinical/MRI outcomes was maintained over 7 y in patients of African descent with a consistent and manageable safety profile through Y7.

Authors/Disclosures
Mitzi J. Williams, MD, FAAN (Joi Life Wellness Group) PRESENTER	Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen Idec. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis Pharmaceuticals. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Williams has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Williams has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi. Dr. Williams has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Amgen. Dr. Williams has received publishing royalties from a publication relating to health care. Dr. Williams has received publishing royalties from a publication relating to health care. Dr. Williams has a non-compensated relationship as a National Board Member with National MS Society that is relevant to AAN interests or activities. Dr. Williams has a non-compensated relationship as a Board Trustee with Consortium of MS Centers that is relevant to AAN interests or activities. Dr. Williams has a non-compensated relationship as a Board Chair with Joi Life Foundation that is relevant to AAN interests or activities.
Lilyana M. Amezcua, MD, FAAN (USC)	Dr. Amezcua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD serono. Dr. Amezcua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Amezcua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Amezcua has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for genentech. The institution of Dr. Amezcua has received research support from National MS Society. The institution of Dr. Amezcua has received research support from Genentech. The institution of Dr. Amezcua has received research support from Bristol Myers Squibb Foundation. The institution of Dr. Amezcua has received research support from NIH NINDS. The institution of Dr. Amezcua has received research support from Sanofi/Genzyme. The institution of Dr. Amezcua has received research support from Alexion.
Regina Berkovich, MD, PhD (Regina Berkovich MD PhD Inc)	The institution of Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alexion, Biogen, Genentec, Mallincrodt, Sanofi, Novartis, . Dr. Berkovich has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Genentec, Sanofi, Merck . Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion, Biogen, Sanofi, Merck, Mallincrodt . The institution of Dr. Berkovich has received research support from Biogen, Sanofi, Merck.
Angel R. Chinea, MD	Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for biogen. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for emd serono. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Chinea has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for allergan.
Keith R. Edwards, MD, FAAN (MS Center of Northeastern New York)	No disclosure on file
Brian Steingo, MD (Sunrise Medical Group)	Dr. Steingo has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen, EMD Serono, Bristol Myers, Sanofi, Janssen. Dr. Steingo has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen, EMD Serono, Bristol Myers, Sanofi, Janssen. The institution of Dr. Steingo has received research support from Infinity Clinical Research.
Aljoeson Walker, MD	No disclosure on file
Alan K. Jacobs, MD, FAAN (Satellos Biosciences)	Dr. Jacobs has received personal compensation for serving as an employee of Immunovant, Inc. Dr. Jacobs has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Galler Consulting.
	No disclosure on file
Annette Okai, MD, FAAN (North Texas Institute of Neurology and Headache)	Dr. Okai has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Genentech. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Okai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Okai has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme . The institution of Dr. Okai has received research support from Sanofi Genzyme. The institution of Dr. Okai has received research support from Roche Genetech. The institution of Dr. Okai has received research support from Novartis. The institution of Dr. Okai has received research support from EMD Serono. The institution of Dr. Okai has received research support from TG Therapeutics.

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