Abstract Details

Title 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 I (TOPAZ Study)

Topic Multiple Sclerosis

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

Poster/Presentation
Number 15-037

Objective Evaluate efficacy/safety of alemtuzumab over 8 years (y) in relapsing-remitting MS (RRMS) patients from CARE-MS I.

Background In CARE-MS I (NCT00530348), 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 treatment-naive patients. Efficacy was maintained in a 4-y extension (NCT00930553), in which patients could receive additional alemtuzumab (12 mg/day on 3 days; ≥12 months apart) as needed for disease activity or other disease-modifying therapy (DMT) per investigator discretion. Patients completing the initial 4-y extension could enroll in TOPAZ (NCT02255656), an additional 5-y extension.

Design/Methods Patients in TOPAZ can receive additional alemtuzumab (≥12 months apart) or other DMT (at any time), both per investigator’s discretion.

Results 290/376 patients (77%) completed Y2 of TOPAZ (Y8 after initiating alemtuzumab). 56% of patients received neither additional alemtuzumab nor other DMT through Y8. At Y8, annualized relapse rate was 0.14; 88% were relapse-free. From core study baseline through Y8, 78% of patients had stable/improved EDSS scores, and mean EDSS score change was +0.07. Through Y8, 71% of patients were free of 6-month confirmed disability worsening; 41% experienced 6-month confirmed disability improvement. In Y8, 60% of patients achieved no evidence of disease activity, 67% were free of MRI disease activity, 87% were free of new Gd-enhancing lesions, and 67% were free of new/enlarging T2 hyperintense lesions. Median cumulative brain volume loss (BVL) from baseline through Y8 was –1.83%; BVL was ≤0.22% annually in Y3–8. Incidence of overall adverse events (AEs) and infections decreased over time. Thyroid AE incidence peaked at 15% in Y3, declining thereafter.

Conclusions Efficacy of alemtuzumab on clinical, MRI, and BVL outcomes was maintained over 8 y in the absence of continuous treatment in CARE-MS I patients, with a consistent and manageable safety profile.

Authors/Disclosures
Daniel Pelletier, MD (Keck School of Medicine of USC) PRESENTER	Dr. Pelletier has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Pelletier has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Pelletier has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. Dr. Pelletier has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Polpharma Biologics.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ)	Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.
Alexey Boyko, MD, PhD (FCCPSMS Center At Usupov's Hospital)	No disclosure on file
Giancarlo Comi, MD (University Vita-Salute)	Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aspen Healthcare. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Sanofi. Dr. Comi has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Rewind.
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.
Jihad S. Inshasi, MD, MBBS, FAAN (Rashid Hospital)	Dr. Inshasi has nothing to disclose.
Pamela A. McCombe, MD (Dr PA McCombe Medical Pty Ltd)	Dr. McCombe 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. McCombe 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. McCombe has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme. The institution of Dr. McCombe has received research support from Motor Neurone Disease Resaerch Institute of Australia.
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.
	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.
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.
Thomas F. Scott, MD (AHN Neurology)	Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme-Sanofi. Dr. Scott has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Serono. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Scott has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Scott has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genzyme.
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
Bart Van Wijmeersch, MD, PhD (Rehabilitation & MS-Centre Overpelt)	Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/Bristol Myers Group. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen Pharmaceutics. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Prof. Van Wijmeersch has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. The institution of Prof. Van Wijmeersch has received research support from Merck. The institution of Prof. Van Wijmeersch has received research support from Roche.

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