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Abstract Details

Alemtuzumab Maintains Efficacy on Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, Over 9 Years in RRMS Patients: CARE-MS II Follow-up (TOPAZ Study)
Multiple Sclerosis
P7 - Poster Session 7 (5:30 PM-6:30 PM)
9-022
Evaluate efficacy and safety of alemtuzumab in CARE-MS II patients over 9 years.
In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes vs subcutaneous interferon beta-1a (SC IFNB-1a) over 2 years in RRMS patients. Efficacy was maintained in a 4-year extension (NCT00930553), wherein patients could receive additional 3-day alemtuzumab (≥12 months apart, as-needed) or other disease-modifying therapy (DMT) per investigator discretion. Further follow-up was available in an additional 5-year extension, TOPAZ (NCT02255656).
Patients in TOPAZ can receive additional alemtuzumab (≥12 months apart; no criteria) or other DMT.
From core study baseline through Y9, 288/435 (66%) CARE-MS II alemtuzumab-treated patients remained on study and 41% received neither additional alemtuzumab nor another DMT. Annualized relapse rate was 0.19 in Y3–9. From baseline to Y9, 68% of patients had stable/improved EDSS scores, mean change in EDSS was +0.32, 60% were free of 6-month confirmed disability worsening, and 49% achieved 6-month confirmed disability improvement. On average, 69% of patients were free of MRI disease activity, 89% were free of new gadolinium-enhancing lesions, and 69% were free of new/enlarging T2 hyperintense lesions per year from Y3–9. Median percent brain volume loss (BVL) was 1.22% cumulatively and ≤0.19% annually over Y3–9. Incidence of overall adverse events (AEs) and infections declined through Y9; cumulative thyroid AE incidence was 44% and immune thrombocytopenia incidence was 3.7% (1 new case in Y9). Efficacy and safety in core study SC IFNB-1a?treated patients who switched to alemtuzumab in the extension were consistent with those treated with alemtuzumab both in the core and extension.
Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 9 years in CARE-MS II patients. Safety in Y9 in this study was consistent with that of previous years.
Authors/Disclosures
Ann D. Bass, MD (Lone Star Neurology - San Antonio)
PRESENTER 		Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen, Alexion, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. The institution of Dr. Bass has received research support from Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics.
Raed Alroughani, MD, FÂ鶹´«Ã½Ó³»­ Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, AstraZeneca, Novartis, Merck, Roche, Sanofi. Dr. Alroughani has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for AstraZeneca, Biogen, Novartis, Merck, Roche, Sanofi.
Simon Broadley, PhD, FRACP (Griffith University School of Medicine) The institution of Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. The institution of Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Dr. Broadley has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Broadley has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sage. The institution of Dr. Broadley has received research support from NHMRC. The institution of Dr. Broadley has received research support from ARC. The institution of Dr. Broadley has received research support from GCH Foundation. The institution of Dr. Broadley has received research support from NHMRC.
No disclosure on file
Yang Mao-Draayer, MD (University of Michigan, Department of Neurology) Dr. Mao-Draayer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen Idec. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme-Sanofi. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme-Sanofi. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizone. Dr. Mao-Draayer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen Idec. The institution of Dr. Mao-Draayer has received research support from NIH .
Hans-Peter Hartung, MD, FÂ鶹´«Ã½Ó³»­ (Heinrich Heine University Medical Faculty) Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS Celgene. Dr. Hartung has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Geneuro. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Hartung has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Hartung has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Frontiers Neurology.
Eva Havrdova, MD (Neurologicka Klinika 1 LF UK) Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havrdova has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi.
Ho Jin Kim, MD (National Cancer Center) Dr. Kim has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Altos Biologics, AstraZeneca, Biogen, Daewoong Pharmaceutical, Kaigene, Kolon Life Science, MDimune, Roche, and Sanofi. Dr. Kim has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion, AstraZeneca, Eisai, GC Pharma, Merck, Mitsubishi Tanabe Pharma, and Roche. Dr. Kim has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Multiple Sclerosis Journal, Journal of Clinical Neurology.
Kunio Nakamura, PhD (Cleveland Clinic) Dr. Nakamura has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for INmune Bio. The institution of Dr. Nakamura has received research support from Biogen. The institution of Dr. Nakamura has received research support from PCORI. The institution of Dr. Nakamura has received research support from NIH. The institution of Dr. Nakamura has received research support from Genzyme. The institution of Dr. Nakamura has received research support from NIH. The institution of Dr. Nakamura has received research support from Genzyme. The institution of Dr. Nakamura has received research support from Novartis. The institution of Dr. Nakamura has received research support from DOD. Dr. Nakamura has received intellectual property interests from a discovery or technology relating to health care.
Carlos A. Navas, MD No disclosure on file
Alex Rovira Alex Rovira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofy. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers. Alex Rovira has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Alex Rovira has stock in Tensor Medical.
Krzysztof W. Selmaj (University of Warmia and Mazury) Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Patrick Vermersch (CHR de Lille) Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS-Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ad Scientiam. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi.
Sibyl E. Wray, MD (Hope Neurology) Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wray 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. Wray 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/Celgene. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Wray has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Wray has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche/Genentech. Dr. Wray 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. Wray has received research support from Biogen. The institution of Dr. Wray has received research support from Atara Biotherapeutics. The institution of Dr. Wray has received research support from Bristol Myers Squibb/Celgene. The institution of Dr. Wray has received research support from Novartis. The institution of Dr. Wray has received research support from Roche/Genentech. The institution of Dr. Wray has received research support from Sanofi/Genzyme. The institution of Dr. Wray has received research support from TG Therapeutics. The institution of Dr. Wray has received research support from EMD Serono. The institution of Dr. Wray has received research support from Pharmaceuticals Corp..
Zia Choudhry No disclosure on file
No disclosure on file
No disclosure on file
Barry A. Singer, MD Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Singer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Singer has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for TG Therapeutics. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb (Celgene). Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for EMD Serono. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Novartis. Dr. Singer has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Singer has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Vanda. An immediate family member of Dr. Singer has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for TG Therapeutics. The institution of Dr. Singer has received research support from Novartis. The institution of Dr. Singer has received research support from Sanofi. The institution of Dr. Singer has received research support from TG Therapeutics. The institution of Dr. Singer has received research support from Bristol Myers Squibb.