BACKGROUND: It is unclear whether natalizumab and fingolimod have analogous efficacy for relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: To compare the outcome of RRMS patients treated with either therapy. METHODS: RRMS patients treated with natalizumab or fingolimod at Verona Hospital, Italy, were included. The study design was retrospective, based on prospectively collected clinical and MRI data. As efficacy outcomes, time to relapse, relapse rate, expanded disability status scale (EDSS) score change, and new T2/gadolinium-enhancing lesions on brain MRI were compared over treatment period between the two groups. Multivariate Cox and logistic regression models were used to control for potential confounders. RESULTS: Fifty-seven subjects receiving natalizumab and 30 receiving fingolimod for a median duration of 23 (1-63) and 22 (2-35) months, respectively (p = 0.22) were included. Patients treated with natalizumab had a more active pre-treatment disease course compared to those treated with fingolimod. In multivariate analysis, the relapse risk was reduced in patients on natalizumab (Hazard Ratio = 0.33; 95% CI = 0.11-1.03; p = 0.056) compared to those on fingolimod. There was no significant difference in EDSS and MRI outcomes. No relevant unexpected adverse events occurred. One patient discontinued natalizumab for progressive multifocal leukoencephalopathy. CONCLUSIONS: RRMS patients receiving natalizumab had higher baseline disease activity and lower relapse risk over 20 months of treatment compared to those receiving fingolimod. Head-to-head randomized clinical trials are needed.
BACKGROUND: It is unclear whether natalizumab and fingolimod have analogous efficacy for relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: To compare the outcome of RRMS patients treated with either therapy. METHODS: RRMS patients treated with natalizumab or fingolimod at Verona Hospital, Italy, were included. The study design was retrospective, based on prospectively collected clinical and MRI data. As efficacy outcomes, time to relapse, relapse rate, expanded disability status scale (EDSS) score change, and new T2/gadolinium-enhancing lesions on brain MRI were compared over treatment period between the two groups. Multivariate Cox and logistic regression models were used to control for potential confounders. RESULTS: Fifty-seven subjects receiving natalizumab and 30 receiving fingolimod for a median duration of 23 (1-63) and 22 (2-35) months, respectively (p = 0.22) were included. Patients treated with natalizumab had a more active pre-treatment disease course compared to those treated with fingolimod. In multivariate analysis, the relapse risk was reduced in patients on natalizumab (Hazard Ratio = 0.33; 95% CI = 0.11-1.03; p = 0.056) compared to those on fingolimod. There was no significant difference in EDSS and MRI outcomes. No relevant unexpected adverse events occurred. One patient discontinued natalizumab for progressive multifocal leukoencephalopathy. CONCLUSIONS: RRMS patients receiving natalizumab had higher baseline disease activity and lower relapse risk over 20 months of treatment compared to those receiving fingolimod. Head-to-head randomized clinical trials are needed.
Authors: Roderick P P W M Maas; Annemarie H G Muller-Hansma; Rianne A J Esselink; Jean-Luc Murk; Clemens Warnke; Joep Killestein; Mike P Wattjes Journal: J Neurol Date: 2016-07-11 Impact factor: 4.849
Authors: Thomas Roux; Elisabeth Maillart; Jean-Sébastien Vidal; Sophie Tezenas du Montcel; Catherine Lubetzki; Caroline Papeix Journal: Front Neurol Date: 2017-05-05 Impact factor: 4.003
Authors: Lisa Lohmann; Claudia Janoschka; Andreas Schulte-Mecklenbeck; Svenja Klinsing; Lucienne Kirstein; Uta Hanning; Timo Wirth; Tilman Schneider-Hohendorf; Nicholas Schwab; Catharina C Gross; Maria Eveslage; Sven G Meuth; Heinz Wiendl; Luisa Klotz Journal: Front Immunol Date: 2018-07-09 Impact factor: 7.561
Authors: Laetitia Barbin; Chloe Rousseau; Natacha Jousset; Romain Casey; Marc Debouverie; Sandra Vukusic; Jerome De Sèze; David Brassat; Sandrine Wiertlewski; Bruno Brochet; Jean Pelletier; Patrick Vermersch; Gilles Edan; Christine Lebrun-Frenay; Pierre Clavelou; Eric Thouvenot; Jean-Philippe Camdessanché; Ayman Tourbah; Bruno Stankoff; Abdullatif Al Khedr; Philippe Cabre; Caroline Papeix; Eric Berger; Olivier Heinzlef; Thomas Debroucker; Thibault Moreau; Olivier Gout; Bertrand Bourre; Alain Créange; Pierre Labauge; Laurent Magy; Gilles Defer; Yohann Foucher; David A Laplaud Journal: Neurology Date: 2016-01-29 Impact factor: 9.910