Abstract Details

Title 18-Month Interim Results of a Registry Study To Establish Long-Term Safety and Pharmaco-Economic Data on Fingolimod (Gilenya®) in Multiple Sclerosis Patients in Germany (PANGAEA)

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 185

Objective

Background BACKGROUND: Fingolimod is the first representative of a new substance class, the S1P-receptor modulators. It is licensed in Germany since April 2011 as escalation therapy for patients with highly active relapsing-remitting multiple sclerosis.

Design/Methods DESIGN/METHODS: The aim of this national registry is the prospective compilation of long-term data on safety and pharmaco-economic aspects of fingolimod. Recruitment is planned until end of 2012 with a 5-year observation. In addition to regular quarterly assessments, cardiac risk profile, compliance and a resource questionnaire, the PRIMUS, EQ5-D, TSQM-9. MSFC and SDMT questionnaires are recorded. PANGAEA also fulfils a quality assurance function as measures of the risk management plan are documented.

Results RESULTS: As of January 2013, more than 2500 patients have been enrolled in 475 participating centers. This data analysis focus on patients whose data were recorded over 18 months.90% of the investigators and 91% of the patients rated the treatment success with either "good" or "very good". The overall safety profile is in line with data of the large phase III study program. Additionally, first insights on wash out phase, post-switch relapse rate and safety parameters could be drawn for patients who switched from natatlizumab to fingolimod.

Conclusions CONCLUSIONS: First annual results are in accordance with the positive known profile of fingolimod. PANGAEA will continue to deliver transparent information for fingolimod under real-life conditions.

Authors/Disclosures
Tjalf Ziemssen, MD, FAAN (University Clinic Dresden) PRESENTER	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.
Maria Diaz Lorente, MD (Novartis Pharma GmbH)	No disclosure on file
Patrick Vollmar (Novartis Pharma)	No disclosure on file
Matthias Meergans	No disclosure on file
Ferenc M. Tracik, MD	No disclosure on file
	No disclosure on file
	No disclosure on file
Tom van Lokven	No disclosure on file

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