Abstract Details

Title TREAT-MS Study of Real-World Effectiveness of Alemtuzumab in RRMS Patients in Germany: Subgroup Analysis by Timing of Treatment Initiation

Topic Multiple Sclerosis

Presentation(s) P12 - Poster Session 12 (12:00 PM-1:00 PM)

Poster/Presentation
Number 9-010

Objective To investigate changes in the profile of patients selected for alemtuzumab therapy over time, and their treatment responses.

Background The TREAT-MS study (Paul-Ehrlich-Institut registry: 281) is assessing real-world effectiveness of alemtuzumab in RRMS patients in Germany.

Design/Methods TREAT-MS is a 5-year, observational, longitudinal, noninterventional, open-label, multicenter, retrospective/prospective study of alemtuzumab-treated patients. Patients were stratified by alemtuzumab initiation prior to 2016 (pre-2016) versus in 2016 or later (post-2016; study midpoint to analyze potential changes in treatment behavior in Germany).

Results As of October 2018, 778 patients were enrolled (pre-2016: n=298; post-2016: n=480). At baseline, pre-2016 patients had a trend for more advanced disease than post-2016 patients (mean time since first MS symptoms, 8.6 vs 7.7 years; time since diagnosis, 7.8 vs 7.0 years; EDSS score, 3.0 vs 2.8; all P=not significant), and pre-2016 experienced significantly more relapses in the year prior to baseline (1.8 vs 1.5; P=0.003) and 2 years prior to baseline (2.5 vs 2.0; P=0.001) compared with post-2016 patients. After alemtuzumab treatment, mean follow-up time was 2.8 years for pre-2016 and 1.3 years for post-2016 patients. Annualized relapse rate was higher in pre-2016 compared with post-2016 patients (0.24 vs 0.17; P=0.005) and the proportion of relapse-free patients after the second alemtuzumab course was significantly lower (76.3% over 2 years vs 92.9% over 0.7 year; P<0.001). Incidence of adverse events during total follow-up was higher in pre-2016 compared with post-2016 patients (68.8% vs 54.2%); incidence of serious adverse events was also higher (29.2% vs 12.9%).

Conclusions Interim analyses of the TREAT-MS study show that while treatment was effective regardless of timing of treatment initiation, annualized relapse rate was higher in pre-2016 versus post-2016 patients. The profile of patients selected for alemtuzumab treatment in Germany may be shifting to those earlier in the disease course, coinciding with improving treatment outcomes.

Authors/Disclosures
Robin White PRESENTER	No disclosure on file
Tjalf Ziemssen, MD, F�鶹��ýӳ�� (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.
	No disclosure on file
Ulrich Engelmann	No disclosure on file
	No disclosure on file
Ben Guikema, PhD (Sanofi Genzyme)	No disclosure on file
Katja Akgün	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.

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