Abstract Details

Title Early Initiation of Fingolimod Treatment Reduces the Recurrence of Disease Activity after Natalizumab Discontinuation in Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 199

Objective

Background BACKGROUND: Natalizumab (NAT, Tysabri®) is an effective therapy for relapsing-remitting multiple sclerosis (RRMS), but it carries the risk of progressive multifocal leukoencephalopathy (PML). Accordingly, fear of PML is the leading cause for discontinuation of NAT treatment. Because disease activity is likely to recur in highly active RRMS within 4-7 months after stopping NAT, early substitution of an alternative treatment is recommended. An obvious option is fingolimod (FTY, Gilenya®).

Design/Methods DESIGN/METHODS: Retrospective analysis of disease activity (Annualized relapse rate (ARR) and (Gd+) lesions on magnetic resonance imaging) before, during, and after discontinuation of NAT in patients, who switched to FTY ?24 weeks after cessation of NAT (FTY group, n=32) compared to patients who remained without therapy for at least 24 weeks (therapy free group=TFG; n=11).

Results RESULTS: 15 patients (47%) in the FTY group and 8 patients (73%) in the TFG had ?1 relapses after cessation of NAT (ARR 0.8 vs. 1.8, p=0.03). 3/15 (20%) FTY patients and 7/10 (70%) patients in the TFG showed Gd+ lesions on MRI after stopping NAT (p<0.05). Patients who switched to FTY ?12 weeks after NAT discontinuation (n=10) had a lower post-NAT ARR (0.4) compared to patients (n=22) who started FTY therapy ?12 weeks after NAT (ARR 0.9; not significant). Most relapses in the FTY group occurred just before or within 8 weeks after starting FTY.

Conclusions CONCLUSIONS: Our observation suggests that initiation of FTY treatment after NAT discontinuation reduces the recurrence of disease activity compared to patients who remain without immunomodulatory treatment. In the FTY group the ARR tended to depend on the time interval between discontinuation of NAT and initiation of FTY.

Authors/Disclosures
Joachim Havla, MD (Univ Klinikum Grosshadern) PRESENTER	Dr. Havla has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Havla 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. Havla 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. Havla 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. Havla 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. Havla 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. Havla has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Havla has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck. Dr. Havla has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Havla has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Havla has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Havla has received research support from Merck.
Björn Tackenberg, MD, FAAN (F. Hoffmann-La Roche AG)	Dr. Tackenberg has received personal compensation for serving as an employee of F. Hoffmann-La Roche AG. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck Serono. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GILEAD. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Celgene. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Tackenberg has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene. Dr. Tackenberg has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Roche. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Merck Serono. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Tackenberg has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Tackenberg has received stock or an ownership interest from F. Hoffmann-La Roche AG. The institution of Dr. Tackenberg has received research support from Biogen. The institution of Dr. Tackenberg has received research support from Novartis. The institution of Dr. Tackenberg has received research support from Roche.
Kerstin Hellwig (St. Josef Hospital Bochum)	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from BMS .
Markus Krumbholz	Markus Krumbholz has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme, Merck, Novartis, Roche. The institution of Markus Krumbholz has received research support from Merck.
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
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.
Reinhard Hohlfeld, MD (Neurologic Klinik & Inst for Clinic Neuroimmun)	Dr. Hohlfeld has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis .
Ingo Kleiter (Neurologische Universitaetsklinik Regensburg)	No disclosure on file
Tania Kuempfel, MD (Institut for Klinische Neuroimmunologie)	Dr. Kuempfel 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. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB Pharma. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Dr. Kuempfel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Amgen/Horizon.

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