Abstract Details

Title Relapse Outcomes in Fingolimod-Treated Patients Previously Exposed to Natalizumab: Post-Hoc Analysis from the 4-Month, Open-Label FIRST Study

Topic MS and Related Diseases

Presentation(s) P07 - (-)

Poster/Presentation
Number 103

Objective

Background BACKGROUND: The FIRST study was the first investigation in the fingolimod trial program to include patients who had been exposed to natalizumab up to 3 months prior to the study baseline.

Design/Methods DESIGN/METHODS: 254 of 2417 enrolled relapsing MS patients had been previously exposed to natalizumab; 240 (94.5%) completed the study. Assessments included number, duration, severity and treatment of relapses. 135 patients received natalizumab more than 6 months before baseline (>6m group) and 119 patients received natalizumab between 3 and 6 months prior to baseline (3-6m group). 2163 patients had not been exposed to natalizumab (no natalizumab).

Results RESULTS: In the first month of fingolimod treatment the proportion of patients with relapses was higher in the 3-6m group compared to the no natalizumab group (16.8% vs 4.9%) with an intermediate value for the >6m group (9.0%). In the second month of fingolimod treatment the proportion of patients with attacks decreased in all groups, with a larger reduction in the 3-6m group (16.8% to 5.9%) and remained low until the end of the study (month 4): 1.7% in 3-6m group, 3.8% in the >6m group and 1.6% in the no natalizumab group. Most relapses resulted in partial or complete recovery in both natalizumab-exposed groups (81.6% in >6m and 90.7% in 3-6m group) as well as in the no natalizumab group (85.3%). In the natalizumab-exposed groups there were no relapse-related study-drug discontinuations or study-drug interruptions.

Conclusions CONCLUSIONS: Patients with recent discontinuation of natalizumab had a higher risk of relapse which was in most cases improved with ongoing fingolimod treatment. No notably severe relapses were observed in this short term interventional safety study.

Authors/Disclosures
Giancarlo Comi, MD (University Vita-Salute) PRESENTER	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.
Ralf Gold, MD (Neurologische Universitaetsklinik)	Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold 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. Gold 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. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.
Frank Dahlke, MD, PhD	Dr. Dahlke has received personal compensation for serving as an employee of Novartis.
	No disclosure on file
	No disclosure on file
Davorka Tomic-Wallis, PhD (Biogen Idec)	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.
Frank Bennett, PhD	No disclosure on file

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