Abstract Details

Title ENIGM: A French Observational Study about Switching from Natalizumab to Fingolimod in Multiple Sclerosis

Topic MS and Related Diseases

Presentation(s) S41 - (-)

Poster/Presentation
Number 002

Objective

Background Switching from NTZ to FTY can be considered as an option regarding tolerance, efficacy, or risk of developing progressive multifocal leukoencephalopathy (PML) under NTZ. Depending on patients or neurologists, a switch can be proposed either after two years of NTZ infusions or earlier in case of adverse events. However, safety of such strategies haven't been evaluated.

Design/Methods This is a French observational multicentric study. Patients for which a switching strategy from NTZ to FTY was planned were prospectively included. Demographical data, clinical data about NTZ treatment period, duration and management of washout period (WP), relapses during WP and after initiation of FTY were anonymously collected.

Results 36 centers treating 4500 patients with NTZ participated. 177 patients switched to FTY after an average of 36 infusions (F/M sex ratio: 2.5; age 40y; EDSS 3.6). 72% were seropositive for JC virus and 50% were classified in the highest risk category for developing PML. EDSS score remained stable under treatment. During the WP, 55% patients did not receive any treatment and 45% received sequential methylprednisolone infusions. 65% presented a relapse. The only predictive factor was the duration of the WP (p=0.002). At the initiation of FTY, EDSS had slightly but significantly worsened (3.7; p=0.004). 33% of patients who received FTY for more than 6 months presented at least one relapse. 3.3% stopped FTY for efficacy or tolerance issues.

Conclusions In this study, switching from NTZ to FTY is not safe enough to be considered as a routine option in treatment strategy. Use of immunomodulatory drugs didn't prevent the risk of relapse during WP. No predictive factor of relapse under FTY have been identified yet in this cohort.

Authors/Disclosures
Mikael Cohen (Hopital Pasteur) PRESENTER	Mikael Cohen has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen, Roche, Merck, Ad scientiam, Novartis, Alexion, BMS.
Elisabeth Maillart	No disclosure on file
Caroline Papeix (GH Pitie Salpetriere)	Caroline Papeix has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIOGEN . Caroline Papeix has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ROCHE . Caroline Papeix has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MERCK. Caroline Papeix has received personal compensation in the range of $0-$499 for serving as a Consultant for NOVARTIS .
Maria Pia Sormani (University of Genoa)	Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Geneuro. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic. Maria Pia Sormani has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medday. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer)	The institution of Dr. Vukusic has received research support from Biogen. The institution of Dr. Vukusic has received research support from Janssen. The institution of Dr. Vukusic has received research support from Merck. The institution of Dr. Vukusic has received research support from Novartis. The institution of Dr. Vukusic has received research support from Roche.
	No disclosure on file
	No disclosure on file
Ayman P. Tourbah (Department of Neurology University Hospital Raymond Poincaré)	No disclosure on file
Sandrine Wiertlewski (Hop Guillaume Et Rene Laennec)	No disclosure on file
David Laplaud	No disclosure on file
Sylvie Courtois, MD (Hopital Emile Muller)	Sylvie Courtois, MD has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for BIOGEN. Sylvie Courtois, MD has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for SANOFI.
Faycal Derouiche, MD (Hopital Emile Muller)	No disclosure on file
Loic Chambaud, MD	No disclosure on file
Clotilde Boulay (Hopital Emile Muller)	No disclosure on file
Bruno Brochet, MD, FEAN (University of Bordeaux)	Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for celgene. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for jansen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biogen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for novartis. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for biogen. Prof. Brochet has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for celgene.
Marc Debouverie, MD (Hospital Central)	Dr. Debouverie has nothing to disclose.
Olivier Casez, MD (CHU De Grenoble)	Dr. Casez has nothing to disclose.
Olivier Heinzlef, MD (Hospital De Poissy)	Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Heinzlef has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Edimark.
Jean C. Ouallet (Dept of Neurology S258)	Jean C. Ouallet has nothing to disclose.
Bruno Stankoff, MD, PhD (Hopital De La Pitie Salpetriere)	The institution of Bruno Stankoff, MD, PhD has received research support from Roche, Sanofi, Serono . The institution of Bruno Stankoff, MD, PhD has received research support from Novartis.
Giovanni Castelnovo	No disclosure on file
Emmanuelle Le Page (CHR Pontchaillou)	Emmanuelle Le Page has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for MERCK. Emmanuelle Le Page has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis.
Gilles Defer, MD (Hopital Cote De Nacre)	Dr. Defer has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Defer 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. Defer 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. Defer has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Nathalie Derache (Hopital Cote De Nacre)	Nathalie Derache has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MERCK. Nathalie Derache has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MERCK. Nathalie Derache has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS.
Olivier Anne	No disclosure on file
	No disclosure on file
Lucien Rumbach, MD (Hopital Jean Minjoz)	No disclosure on file
Jean-Phillippe Camdessanche	Jean-Phillippe Camdessanche has nothing to disclose.
Audrey Kopf (Hopital De La Pitie Salpetriere)	No disclosure on file
Marie Fleury	No disclosure on file
Irina Malikova (CHU Timone)	No disclosure on file
Jean Pelletier, MD, PhD (Dpt of Neurology, CHU Timone)	Dr. Pelletier has nothing to disclose.
Abdullatif Al Khedr (CHRU Amiens Nord)	No disclosure on file
	No disclosure on file
Gilles Edan, MD	No disclosure on file
	No disclosure on file
Agnes Fromont	No disclosure on file
	No disclosure on file
Frederic Blanc (Hopital Service de Neurologie)	No disclosure on file
Nicolas Collongues, MD (Hopital Civil)	Nicolas Collongues, MD has nothing to disclose.
	No disclosure on file
	No disclosure on file
Sophie Pittion (Hopital Central/ Service Du Pr Vespignani)	Sophie Pittion has nothing to disclose.
Pierre Clavelou, MD, PhD (Hopital Gabriel Montpied)	Dr. Clavelou 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. Clavelou has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Dr. Clavelou has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck.
Frederic Taithe (CHU Gabriel Montpied)	No disclosure on file
Patrick Vermersch (CHR de Lille)	Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AB Science. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS-Celgene. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Ad Scientiam. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Teva. Patrick Vermersch has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for La revue des microbiotes. The institution of Patrick Vermersch has received research support from Roche. The institution of Patrick Vermersch has received research support from Sanofi.
Helene Zephir (Hospital Roger Salengro)	Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for BIogen Idec. Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for novartis. Helene Zephir has received personal compensation in the range of $0-$499 for serving as a Consultant for BMS. Helene Zephir has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion.
Alain Creange (Hopital Henri Mondor)	No disclosure on file
Olivier F. Gout, MD (Hôpital Fondation A de Rothschild)	Dr. Gout has nothing to disclose.
	No disclosure on file
Marc Coustans	No disclosure on file
Gregory Taurin	No disclosure on file
Francois Lallement (Hopital Yves Le Foll)	No disclosure on file
Francois Rouhart (Hopital La Cavale Blanche)	No disclosure on file
William Camu, MD (Centre Gui de Chauliac)	No disclosure on file
	No disclosure on file
Pierre Labauge, MD	Dr. Labauge has nothing to disclose.
Dominique L. Dive, MD (Chu of Liege)	No disclosure on file
Pierrette A. Seeldrayers, MD	No disclosure on file
Christine Lebrun Frenay, MD, FAAN (CRCSEP Neurologie)	Dr. Lebrun Frenay has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Revue Neurologique.

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