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Abstract Details

Two-Year Interim Analysis of the TREAT-MS Alemtuzumab Study in Germany Differentiated by Direct Pretreatment
Multiple Sclerosis
P9 - Poster Session 9 (5:30 PM-6:30 PM)
12-006

Alemtuzumab is approved in >70 countries for patients with highly active relapsing remitting multiple sclerosis (RRMS). The TREAT-MS study (Paul-Ehrlich-Institute registry: 281) investigates the real-world effectiveness and safety of alemtuzumab in RRMS patients in Germany.

To provide 2-year interim results for alemtuzumab in German real-world setting.

TREAT-MS is an ongoing 5-year, noninterventional, multicenter study of alemtuzumab-treated patients. This interim analysis (cut-off 02 FEB 2021) included patients who had completed two years of follow-up. Data were analyzed exploratively according to the last previous therapy.

For this interim analysis 494 of 907 patients were considered. Hereof, 17.0% (n=84) were treatment-naïve and 83% received the following last previous therapy prior to alemtuzumab: fingolimod (28.5%, n=141), natalizumab (21.1%, n=104), basic injectables (glatiramer acetate or interferon-beta; 20.6%, n=102), or basic orals (dimethyl fumarate or teriflunomide; 12.8%, n=63). For 87.6% of patients no clinical disease progression (CDP) which could be confirmed over 6 months was documented. During a median observation period of 2.1 years after alemtuzumab initiation, 71.6% of all evaluable patients were relapse-free. However, this rate was lower in patients treated with fingolimod (61.2%). Percentage of patients relapse-free and without EDSS-based CDP was 55.9% for all evaluable and 48.2% of fingolimod-pretreated patients. For 28.4% of patients, at least one relapse was documented resulting in an annualized relapse rate of 0.2065 for all patients which was lowest for patients pretreated with basic injectables (0.1283) and highest for fingolimod-pretreated patients (0.3100). Adverse events related to alemtuzumab were documented for 60.3% of patients. Most frequently reported adverse events related to alemtuzumab included headache, rash, and nasopharyngitis.

These interim results indicate that alemtuzumab shows good real-world effectiveness and safety across patient subgroups with different pretreatment history but less pronounced effects after fingolimod pretreatment.

Authors/Disclosures
Angeliki Konstantinidou (Sanofi)
PRESENTER
Miss Konstantinidou has received personal compensation for serving as an employee of Sanofi-Aventis Deutschland GmbH.
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 Biogen. 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 $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Ziemssen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 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 BMS Celgene. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Ziemssen has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for TEVA. The institution of Dr. Ziemssen has received research support from Biogen. 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 Celgene.
Stephan Richter The institution of Stephan Richter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Stephan Richter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. The institution of Stephan Richter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Darmstadt. The institution of Stephan Richter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Stephan Richter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme.
Frank Hoffmann, MD (Staedt KH Martha-Maria Halle) Dr. Hoffmann 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. Hoffmann 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. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Dr. Hoffmann 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. Hoffmann 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. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Dr. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Talecris. Dr. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi.
Laura Quint Laura Quint has received personal compensation for serving as an employee of Sanofi-Aventis Deutschland GmbH.