Abstract Details

Title Real-World Effectiveness of Alemtuzumab in Relapsing-Remitting MS Patients in Germany: Interim Results of the TREAT-MS Study

Topic Multiple Sclerosis

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

Poster/Presentation
Number 15-057

Objective Report interim results from the TREAT-MS study (Paul-Ehrlich-Institut registry: 281) assessing real-world effectiveness of alemtuzumab in an RRMS cohort in Germany.

Background In the CARE-MS studies (NCT00530348; NCT00548405), alemtuzumab 12 mg/day (baseline, 5 days; 12 months later, 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a in RRMS patients over 2 years. Efficacy was maintained over 8 years in 2 consecutive extension studies (NCT00930553; NCT02255656); safety was consistent and manageable.

Design/Methods TREAT-MS is a 5-year, observational, longitudinal, retrospective/prospective study of alemtuzumab-treated patients (max: 1600), with a 4-year follow-up after the last treatment course (C).

Results As of October 1, 2018, 779 patients were enrolled. At baseline, 70.6% of patients were female, with mean (SD) time since first MS symptoms/diagnosis of 8.0 (6.6)/7.3 (6.3) years. Mean (SD) numbers of relapses in 12/24 months pre-enrollment were 1.6 (1.2)/2.2 (1.8). Mean (SD) baseline EDSS score was 2.9 (1.7); 60.8% had EDSS score ≤3. 18.6%, 21.4%, 31.1%, 18.0%, and 10.9% of patients received 0, 1, 2, 3, or ≥4 prior DMTs, respectively. Treatments immediately prior to enrollment included fingolimod (21.6%), natalizumab (14.9%), IFNB preparations (9.0%), glatiramer acetate (5.8%), other/unknown (34.0%), or none (14.8%). Mean (SD) observational time: 1.9 (1.2) years after initiating alemtuzumab; 99.2% of patients received alemtuzumab C1 and 69.2% received C2. Annualized relapse rate post-alemtuzumab initiation was 0.21; 87.2% were relapse-free between C1 and C2, and 84.8% were relapse-free post-C2. Mean (SD) change from baseline in EDSS score was 0 (1.1); changes in mean (SD) Clinical Global Impression (CGI) scores were -0.1 (1.7; physician), and -0.1 (1.6; patient). Safety was similar to registration trials.

Conclusions Results from these interim analyses show reduced relapses and stable EDSS and CGI scores with alemtuzumab, supporting registration study findings. TREAT-MS will provide further understanding of safety monitoring and sequencing to/from alemtuzumab in a real-world setting.

Authors/Disclosures
Katja Akgün PRESENTER	Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Katja Akgün has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi. Katja Akgün has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS.
Robin White	No disclosure on file
	No disclosure on file
Ulrich Engelmann	No disclosure on file
	No disclosure on file
	No disclosure on file
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.

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