Abstract Details

Title Tolerability and Efficacy of Fingolimod in Clinical Practice

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 183

Objective

Background BACKGROUND: Fingolimod is approved by the U.S. Food and Drug Administration to reduce relapses and disability progression in relapsing forms of MS.

Design/Methods DESIGN/METHODS: Patients prescribed fingolimod from December 2010 to August 2011 were identified through the electronic medical record and followed for 12 months after fingolimod initiation. Adverse effects (AE), clinical measures, patient reported outcomes, and MRI data were collected.

Results RESULTS: Three hundred seventeen patients started fingolimod. Follow-up data was available for 306 patients with 11 lost to follow-up. Mean follow-up time was 332 days (SD:129). Fingolimod was discontinued in 76 patients (23.9%) and occurred on average 248 days (SD:151) after fingolimod start. Discontinuation was mostly due to AEs (n=40) and break-through disease (n=23) and 3.8% switched to natalizumab. Half of the patients who discontinued fingolimod due to breakthrough disease had been on cyclophosphamide or natalizumab previously. The most frequent AEs leading to discontinuation included infection (n=8), headache (n=4), and pulmonary side effects (n=4). 230 patients (72.6%) remained on fingolimod in follow-up, of which 203 (64%) remained relapse-free and 188 (59.3%) had no relapses or MRI activity. 36 relapses on fingolimod were observed in 34 patients (10.7%). Relapses occurred on average 282 days (SD: 171) after starting fingolimod. Cardiac adverse effects were observed in 3.2% and included hypertension (n=3), bradycardia (n=3), chest pain (n=2), and troponin elevation (n=1). MS performance scale, PHQ9, and EQ5D remained stable at 12 month follow-up (p>0.2 for all). Timed 25 foot walk was significantly slower at 12 months compared with baseline (difference=1.16 seconds, paired t-test p = 0.013).

Conclusions CONCLUSIONS: Fingolimod in clinical practice was discontinued at a higher rate than in clinical trials. Discontinuation was primarily due to adverse events and breakthrough disease. Disease activity was adequately controlled in most patients who continued fingolimod.

Authors/Disclosures
Carrie M. Hersh, DO, MSc, FAAN (Cleveland Clinic Lou Ruvo Center for Brain Health) PRESENTER	Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech_GN41791. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol-Myers Squibb . Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon Therapeutics. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Genzyme. Dr. Hersh has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. The institution of Dr. Hersh has received research support from Biogen. The institution of Dr. Hersh has received research support from Novartis. The institution of Dr. Hersh has received research support from Genentech_GN41791. The institution of Dr. Hersh has received research support from PCORI. The institution of Dr. Hersh has received research support from Bristol Myers Squibb.
	No disclosure on file
David Rog, MBBS	Dr. Rog 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. Rog 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. Dr. Rog has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck. Dr. Rog has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Rog has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Teva. The institution of Dr. Rog has received research support from Merck. The institution of Dr. Rog has received research support from Novartis. The institution of Dr. Rog has received research support from TG Therapeutics. Dr. Rog has received research support from Janssen-Cilag.
Richard A. Rudick, MD, FAAN (Optimal Brain Health Consultants)	Dr. Rudick has received personal compensation for serving as an employee of Biogen. Dr. Rudick has received stock or an ownership interest from Biogen. Dr. Rudick has received publishing royalties from a publication relating to health care.
	No disclosure on file
Jeffrey A. Cohen, MD (Cleveland Clinic)	Dr. Cohen has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Convelo. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astoria. Dr. Cohen has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Viatris. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for PSI. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Cohen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celltrion.
Robert A. Bermel, MD, FAAN (Cleveland Clinic)	Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/Roche. Dr. Bermel has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Bermel has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Bermel has received research support from Biogen. The institution of Dr. Bermel has received research support from Roche. The institution of Dr. Bermel has received research support from Novartis. Dr. Bermel has received intellectual property interests from a discovery or technology relating to health care.
Daniel Ontaneda, MD, PhD, FAAN (Cleveland Clinic)	Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech/Roche. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen Idec. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Ontaneda has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. The institution of Dr. Ontaneda has received research support from NIH. The institution of Dr. Ontaneda has received research support from PCORI. The institution of Dr. Ontaneda has received research support from NMSS. The institution of Dr. Ontaneda has received research support from Genetech.

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