ENIGM: A French Observational Study about Switching from Natalizumab to Fingolimod in Multiple Sclerosis (S41.002)

OBJECTIVE: To collect prospectively safety and efficacy outcomes in relapsing remitting multiple sclerosis (RRMS) patients switching from natalizumab (NTZ) to fingolimod (FTY) therapy. 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 haven9t 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 didn9t prevent the risk of relapse during WP. No predictive factor of relapse under FTY have been identified yet in this cohort. Supported by: The ENIGM (Enquete Nationale concernant l9Introduction du finGolimod en relais au natalizuMab) study was conducted on behalf the Club Francophone de la Sclerose en Plaques (CFSEP). Disclosure: Dr. Cohen has received personal compensation for activities with Schering, Biogen Idec, Serono, Inc., Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., and Novartis. Dr. Maillart has nothing to disclose. Dr. Papeix has received personal compensation for activities with Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi and Teva Pharma, Almirall, Roche, Genzyme as consultant. Dr. Vukusic has nothing to disclose. Dr. Brassat has received personal compensation from Schering, Biogen Idec, Serono and Sanofi for speaking in symposia. Dr. De Seze has received personal compensation for activities with Allergan, Inc., Almirall, Bayer Schering, Biogen Idec, Genzyme Corporation, LFB, Merck Serono, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Tourbah has received personal compensation for activities with Novartis, Merck Serono, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, and Biogen Idec. Dr. Wiertlewski has nothing to disclose. D. Laplaud has received personal compensation for consulting and lecture fees from Biogen Idec, Genzyme, Novartis and Teva Pharma. Dr. Courtois has nothing to disclose. Dr. Derouiche has nothing to disclose. Dr. Chambaud has nothing to disclose. Dr. Boulay has nothing to disclose. Dr. Brochet has received personal compensation from BayerHealthcare, Novartis Pharma, Merck-Serono and Biogen-Idec. Dr. Brochet received personal compensation for serving as associate editor for a journal published by LEN (publisher). This journal is supported by Biogen-Idec. ....Dr. Brochet has received research support from Merck-Serono, Biogen-Idec and Bayer Healthcare. Dr. Debouverie has received personal compensation for activities with Biogen Idec, Bayer, Merck Serono, Novartis, Sanofi-Aventis Pharmaceutials, and Teva Neuroscience. Dr. Casez has nothing to disclose. Dr. Heinzlef has nothing to disclose. Dr. Ouallet has received personal compensation for activities with Novartis, Biogen Idec, Merck Serono, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Stankoff has received personal compensation for activities with Teva Neuroscience, Biogen Idec, Bayer, Merck Serono, and Novartis. Dr. Castelnovo has nothing to disclose. Dr. Le Page has nothing to disclose. Dr. Defer has received personal compensation for activities with Biogen Idec, Novartis, Teva Pharmaceutical Industries Ltd, Merck Serono, Guerbet, and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Derache has received personal compensation for activities with Merck Serono, Biogen Idec and Novartis as a speaker. Dr. Anne has nothing to disclose. Dr. Berger has nothing to disclose. Dr. Rumbach has nothing to disclose. Dr. Camdessanche has nothing to disclose. Dr. Kopf has nothing to disclose. Dr. Fleury has received personal compensation for activities with Biogen Idec, Bayer Schering, Teva Neuroscience, Merck & Co., Inc., and Sanofi-Aventis Pharmaceuticals, Inc. Dr. Malikova has nothing to disclose. Dr. Pelletier has received personal compensation for activities with Allergan, Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva, and Genzyme. Dr Pelletier has received research support from Bayer Schering, Biogen Idec, BMS, GSK, Merck Serono, Novartis, Peptimmune, Roche, Sanofi, Teva and Wyeth. Dr. Al Khedr has nothing to disclose. Dr. Zaenker has nothing to disclose. Dr. Edan has received personal compensation for activities with Biogen Idec, Teva Neuroscience, BENEFIT, and LFB. Dr. Edan has received research support from Bayer and Serono, Inc. Dr. Moreau has received research support from Biogen Idec, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, Bayer, Merck Serono, and Novartis. Dr. Fromont has nothing to disclose. Dr. Rico has nothing to disclose. Dr. Blanc has received personal compensation for activities with BIOGEN IDEC, NOVARTIS, JANSSENS-CILAG and EISAI, BAYER SCHERING PHARMA, TEVA, MERCK, SANOFI. Dr. Collongues has received personal compensation for activities with Biogen Idec, Bayer Schering, Teva Neuroscience, Merck Serono, Sanofi-Aventis Pharmaceuticals, Inc., and Novartis. Dr. Barth has nothing to disclose. Dr. Louiset has nothing to disclose. Dr. Pittion has nothing to disclose. Dr. Clavelou has received personal compensation for activities with Schering, Biogen Idec, Serono, Inc., and Sanofi-Aventis Pharmaceuticals, Inc. as a speaker. Dr. Taithe has nothing to disclose. Dr. Vermersch has received personal compensation for activities with Biogen Idec, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, Novartis, Merck Serono, GlaxoSmithKline, Inc., and Almirall. Dr. Vermersch has received research support from Biogen Idec, Sanofi-Aventis Pharmaceuticals, Inc., Bayer, and Merck Serono. Dr. Zephir has received personal compensation for activities with Biogen Idec, Bayer Pharmaceuticals Corporation, Merck Serono, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc. and Novartis as a consultant. Dr. Creange has nothing to disclose. Dr. Gout has received personal compensation for activities with Teva Pharma, Biogen Idec, Bayer-Schering Pharma, Merk-Serono and Novartis. Dr. Guennoc has nothing to disclose. Dr. Coustans has nothing to disclose. Dr. Taurin has nothing to disclose. Dr. Lallement has nothing to disclose. Dr. Rouhart has nothing to disclose. Dr. Camu has nothing to disclose. Dr. Thouvenot has nothing to disclose. Dr. Labauge has nothing to disclose. Dr. Dive has nothing to disclose. Dr. Seeldrayers has nothing to disclose. Dr. Lebrun has received personal compensation for activities with Bayer Pharmaceuticals Corporation, Schering, Biogen Idec, Merck Serono, Genzyme, Almirall, Allergan, Inc., Novartis, and Sanofi as a speaker. Dr. Lebrun has received personal compensation in an editorial capacity from Elsevier.