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Abstract Details

Improved Clinical and MRI Disease Activity Outcomes, Including Slowing of Brain Volume Loss, in Alemtuzumab-Treated RRMS Patients: 8-Year Follow-up of CARE-MS II (TOPAZ Study)
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-058
Evaluate efficacy/safety of alemtuzumab over 8 years (y) in CARE-MS II patients.
In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 y in relapsing-remitting MS (RRMS) patients with inadequate response to prior therapy. Efficacy was maintained in a 4-y extension (NCT00930553), in which patients could receive additional, as-needed alemtuzumab (12 mg/day on 3 days; ≥12 months apart) for disease activity or other disease-modifying therapy (DMT) per investigator discretion. Following the initial 4-y extension, patients could continue in TOPAZ (NCT02255656), an additional 5-y extension.
Patients in TOPAZ can receive additional alemtuzumab (≥12 months apart) or other DMT (at any time), both per investigator’s discretion.
300/435 patients (69%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 44% received neither additional alemtuzumab nor another DMT through Y8. At Y8, annualized relapse rate was 0.18; 85% were relapse-free. From core study baseline to Y8, 70% of patients had stable/improved EDSS scores; mean EDSS score change was +0.17. Through Y8, 64% of patients were free of 6-month confirmed disability worsening; 47% attained 6-month confirmed disability improvement. In Y8, 58% of patients achieved no evidence of disease activity, 70% were free of MRI disease activity, 89% were free of new Gd-enhancing lesions, and 70% were free of new/enlarging T2 hyperintense lesions. Median cumulative brain volume loss (BVL) from baseline through Y8 was −1.06%; annual BVL was ≤0.19% in Y3–8. Incidence of overall adverse events (AEs) and infections decreased through Y8. Thyroid AE incidence peaked at 17% in Y3, declining thereafter.
Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y without continuous treatment in CARE-MS II patients, with a consistent and manageable safety profile.
Authors/Disclosures
Barry A. Singer, MD
PRESENTER 		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.
Raed Alroughani, MD, FAAN 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.
Sara Eichau Madueno Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Sara Eichau Madueno has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Sara Eichau Madueno has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis. Sara Eichau Madueno has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Sara Eichau Madueno has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck.
Hans-Peter Hartung, MD, FAAN (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
Carlo Pozzilli Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Carlo Pozzilli has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion.
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.
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..
Luke Chung (Sanofi Genzyme) Luke Chung has received personal compensation for serving as an employee of Sanofi Genzyme. Luke Chung has received stock or an ownership interest from Sanofi Genzyme.
No disclosure on file
No disclosure on file
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.