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Abstract Details

Treatment With Additional Courses of Alemtuzumab Improves Clinical and MRI Outcomes in RRMS Patients With Disease Activity After Three Courses: Analysis of CARE-MS Patients Who Received =4 Courses
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-055
Evaluate 7-year (y) efficacy and safety of alemtuzumab Course 4 (C4) in pooled CARE-MS patients.
In the CARE-MS studies (NCT00530348; NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months [M] later: 3 days) significantly improved outcomes versus SC IFNB-1a over 2 y in RRMS patients. Efficacy was maintained in a 4-y extension (NCT00930553), wherein patients could receive additional alemtuzumab courses (12 mg/day; 3 days; ≥12M apart) as needed for disease activity, or receive another disease-modifying therapy (DMT). After the initial extension, patients could continue in another 5-y extension (TOPAZ; NCT02255656).
Inclusion criteria: ≥4 courses by M72 to allow ≥12M follow-up post-C4; no other DMT. Data were censored at C5.
742/811 (91%) CARE-MS patients entered the 4-y extension; 129/742 (17%) received ≥4 courses (mean interval from C3: 1.9 y). C4 was given in Y4 (6.1%), Y5 (4.6%), Y6 (3.5%), or Y7 (3.2%). 103/129 (80%) patients receiving ≥4 courses met inclusion criteria. Annualized relapse rate was 1.59 12M pre-study, 0.77 12M pre-C4, 0.24 12M post-C4 (P<0.0001), and 0.27 36M post-C4. At 36M post-C4, mean change in EDSS score was -0.37 from C4, 95% of patients were free of 6-M confirmed disability worsening, and 31% had 6-M confirmed disability improvement. 50% of patients were free of MRI disease activity at 12M pre-C4 versus 65% at 12M post-C4 (P<0.01) and 74% at 36M post-C4. Incidence of AEs, including autoimmune AEs and infections, was similar in patients receiving additional courses, the overall CARE-MS population, and those receiving 2 courses over 7 y.
In the small percentage of patients with disease activity after C3, a fourth course of alemtuzumab (mean interval of 1.9 y after C3) improved clinical and MRI outcomes through 36M. Safety was similar to the overall CARE-MS population and those receiving 2 courses over 7 y.
Authors/Disclosures
Regina Berkovich, MD, PhD (Regina Berkovich MD PhD Inc)
PRESENTER 		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.
Ann D. Bass, MD (Lone Star Neurology - San Antonio) 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.
Aaron L. Boster, MD (Ohiohealth) Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
No disclosure on file
No disclosure on file
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.
Volker Limmroth, MD, PhD (City of Cologne / Cologne General Hospital (Merheim)) No disclosure on file
Jan N. Lycke, MD Dr. Lycke 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. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Lycke 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. Lycke 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. Lycke 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. Dr. Lycke has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GeNeuro. The institution of Dr. Lycke has received research support from Sanofi.
Richard A. Macdonell, MD, FAAN (Austin Health) Dr. Macdonell has nothing to disclose.
Sven Schippling (University of Neurology) 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.
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.
Heinz Wiendl, MD, FAAN (University of Freiburg) Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunovant. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Johnson&Johnson / Janssen. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Idorsia. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Argenx. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Lundbeck. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for LTS. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Samsung. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sangamo. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dianthus. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for INmune Bio_Syneos Health. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Muna Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Myrobalan Therapeutics. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSL Group. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Red Nucleus. Dr. Wiendl has received personal compensation in the range of $0-$499 for serving as a Consultant for Swiss Multiple Sclerosis Society. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Teladoc Health. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Toleranzia . Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Wiendl 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. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Wiendl has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz-Hexal. Dr. Wiendl has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cellerys. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Uniqure. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biocryst. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Galapagos. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Idorsia. Dr. Wiendl has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biontech. The institution of Dr. Wiendl has received research support from Biogen. The institution of Dr. Wiendl has received research support from Roche. The institution of Dr. Wiendl has received research support from Deutsche Forschungsgemeinschaft. The institution of Dr. Wiendl has received research support from European Union. The institution of Dr. Wiendl has received research support from Argenx. The institution of Dr. Wiendl has received research support from CSL Behring. The institution of Dr. Wiendl has received research support from Merck. The institution of Dr. Wiendl has received research support from UCB. Dr. Wiendl has received research support from Alexion Syneos Health iVH UK Ltd.. The institution of Dr. Wiendl has received research support from Deutsche Myasthenie-Gesellschaft. The institution of Dr. Wiendl has received research support from Winicker Norimed GmbH. The institution of Dr. Wiendl has received research support from Novartis. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care. Dr. Wiendl has received publishing royalties from a publication relating to health care.
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden) Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS . Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Sanofi. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as an officer or member of the Board of Directors for Dresden Internation University. The institution of Dr. Ziemssen has received research support from Novartis. The institution of Dr. Ziemssen has received research support from Merck. The institution of Dr. Ziemssen has received research support from Sanofi. The institution of Dr. Ziemssen has received research support from BMS. The institution of Dr. Ziemssen has received research support from Roche.
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
Claudio E. Rodriguez, MD (Sunovion Pharmaceuticals) No disclosure on file
Anthony Traboulsee, MD (University of British Columbia) Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Traboulsee 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. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee 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. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.