Contributions
Abstract: EP1622
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Both Teriflunomide (TRF) and Dimethyl-Fumarate (DMF) have been approved as first line treatments for patients with relapsing-remitting multiple sclerosis (RRMS). However, to date, neither randomized controlled nor observational studies have compared their relative efficacy.
Objective: To compare TRF and DMF efficacy on both clinical and MRI outcomes in RRMS patients from the national french OFSEP cohort.
Methods: RRMS Patients were included if aged 18 to 65 with an EDSS score of 0 to 5.5 at baseline and an available brain MRI performed within the year before treatment initiation. Data were collected prospectively for 585 patients treated with TRF and 890 with DMF. The main outcome was the proportion of patients with at least one relapse in the year following TRF or DMF initiation. Three secondary endpoints were studied: the proportion of patients with at least a new T2 lesion, the proportion of patients with at least one gadolinium positive (gado+) lesion and the proportion of patients with an increased EDSS score after one year of treatment. Outcomes were modeled using propensity scores (Inverse Probability Weighting) and logistic regressions by using weighted likelihood maximization and robust variance estimator.
Results: Baseline comparison revealed that patients treated with DMF were significantly younger with shorter disease duration, increased percentage of patients with at least one relapse in the year and the two years preceding treatment initiation and increased percentage of patients with at least one gado+ lesion on baseline MRI scans. However, the confounder-adjusted proportion of patients with at least one relapse within the first year of treatment was similar in TRF-treated patients compared to DMF group (20.1% versus 20.4%). On the same way, analyses of the MRI and EDSS secondary endpoints revealed similar efficacy of the treatments at one year after initiation.
Interpretation: In France neurologists preferentially choose DMF as a first-line treatment for patients with objective clinical and radiological signs of activity. However, after one year of treatment and after correction for confounders, the efficacy of DMF and TRF was similar in terms of prevention of relapse and occurrence of new T2 or gadolinium-positive lesions.
Disclosure:
DA Laplaud: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday
S. Vukusic: consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
P Vermersch: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche, Medday and Almirall. Research supports from Biogen, Bayer, Novartis, Sanofi-Genzyme, Roche and Merck-Serono
O Heinzlef: Honoraria and consulting fees from Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, Medday and Almirall. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Merck-Serono
A Créange: received departmental research grants from Biogen-Idec, CSL-Behring, GE Neuro, Novartis, Octapharma and expert testimony from Novartis, CSL Behring, Genzyme.
L Magy: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Novartis
JP Camdessanché: lectures, consulting, writing of articles, or training courses from Biogen-Idec, CSL-Behring, Genzyme, Laboratoire Français des Biotechnologies, Merck-Serono, Novartis, Teva, Editions Scientifiques L&C, Edimark, Expression Santé, Natus, Scien, SNF-Floerger.
P Labauge: no disclosures
J Ciron: consulting and lecture fees, travel grants from Biogen, Novartis, Genzyme, Teva Pharmaceuticals, Merck Serono and Roche.
O Casez: consulting and lecture fees, travel grants from biogen, genzyme, novartis, almogran.
G Castelnovo: Honoraria and consulting fees from Novartis, Biogen, Teva, Sanofi, Genzyme, Merck-Serono, Merz, Ipsen, Bayer. Research supports from Novartis, Merz, Ipsen
C Lebrun-Frenay: boards for Biogen, Merck, Teva, Medday, Roche, Novartis
G Defer: personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva Pharmaceutical Industries Ltd He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen Idec, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd. His institution received grants supporting research in his department from Merck Serono, Biogen Idec, Sanofi Aventis and Novartis
B Brochet: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen-Idec, Merck, Bayer Schering, Roche, Medday, Bayer, Actelion, Teva and Genzyme Sanofi.
J Pelletier: Consulting fees and travels from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, Medday
B. Bourre: scientific advisory board for Merck Serono and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme and Teva. Unconditional research grants from Biogen, Novartis, Roche and Merck-Serono
T Moreau: consultancy fees, speaker fees, research supports, or honoraria from Novartis, Biogen-Idec, Merck, Roche, Medday, Teva and Genzyme Sanofi
P Clavelou: Honoraria and consulting fees from Almirall, Medday, Merck, Novartis, Roche, Sanofi-Genzyme, Teva .Research supports from Biogen, Merck, Novartis
B. Stankoff: honoraria from Biogen, Teva, Novartis, Genzyme, Roche and research support from Genzyme, Merck-Serono and Roche.
F Rollot: no disclosures
R Casey: no disclosures
J De Sèze: Sanofi-Genzyme and Biogen
S Wiertlewski: honoraria from Biogen, Teva, Novartis, Genzyme, Roche
C Nifle: Honoraria and consulting: none. Research supports from Biogen, Novartis. Congress participation: Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, and Merck-Serono
C. Pottier: Research supports from Novartis
L Barbin: nothing to disclose
Y Foucher: nothing to disclose
E Leray: nothng to disclose
Abstract: EP1622
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Both Teriflunomide (TRF) and Dimethyl-Fumarate (DMF) have been approved as first line treatments for patients with relapsing-remitting multiple sclerosis (RRMS). However, to date, neither randomized controlled nor observational studies have compared their relative efficacy.
Objective: To compare TRF and DMF efficacy on both clinical and MRI outcomes in RRMS patients from the national french OFSEP cohort.
Methods: RRMS Patients were included if aged 18 to 65 with an EDSS score of 0 to 5.5 at baseline and an available brain MRI performed within the year before treatment initiation. Data were collected prospectively for 585 patients treated with TRF and 890 with DMF. The main outcome was the proportion of patients with at least one relapse in the year following TRF or DMF initiation. Three secondary endpoints were studied: the proportion of patients with at least a new T2 lesion, the proportion of patients with at least one gadolinium positive (gado+) lesion and the proportion of patients with an increased EDSS score after one year of treatment. Outcomes were modeled using propensity scores (Inverse Probability Weighting) and logistic regressions by using weighted likelihood maximization and robust variance estimator.
Results: Baseline comparison revealed that patients treated with DMF were significantly younger with shorter disease duration, increased percentage of patients with at least one relapse in the year and the two years preceding treatment initiation and increased percentage of patients with at least one gado+ lesion on baseline MRI scans. However, the confounder-adjusted proportion of patients with at least one relapse within the first year of treatment was similar in TRF-treated patients compared to DMF group (20.1% versus 20.4%). On the same way, analyses of the MRI and EDSS secondary endpoints revealed similar efficacy of the treatments at one year after initiation.
Interpretation: In France neurologists preferentially choose DMF as a first-line treatment for patients with objective clinical and radiological signs of activity. However, after one year of treatment and after correction for confounders, the efficacy of DMF and TRF was similar in terms of prevention of relapse and occurrence of new T2 or gadolinium-positive lesions.
Disclosure:
DA Laplaud: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche and Medday. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Medday
S. Vukusic: consultancy fees, speaker fees, research grants (non-personal) or honoraria from Biogen, Geneuro, Genzyme-Sanofi, Medday, Merck-Serono, Novartis, Roche and Teva.
P Vermersch: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, Merck-Serono, Roche, Medday and Almirall. Research supports from Biogen, Bayer, Novartis, Sanofi-Genzyme, Roche and Merck-Serono
O Heinzlef: Honoraria and consulting fees from Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, Medday and Almirall. Research supports from Biogen, Novartis, Sanofi-Genzyme, Roche and Merck-Serono
A Créange: received departmental research grants from Biogen-Idec, CSL-Behring, GE Neuro, Novartis, Octapharma and expert testimony from Novartis, CSL Behring, Genzyme.
L Magy: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Novartis
JP Camdessanché: lectures, consulting, writing of articles, or training courses from Biogen-Idec, CSL-Behring, Genzyme, Laboratoire Français des Biotechnologies, Merck-Serono, Novartis, Teva, Editions Scientifiques L&C, Edimark, Expression Santé, Natus, Scien, SNF-Floerger.
P Labauge: no disclosures
J Ciron: consulting and lecture fees, travel grants from Biogen, Novartis, Genzyme, Teva Pharmaceuticals, Merck Serono and Roche.
O Casez: consulting and lecture fees, travel grants from biogen, genzyme, novartis, almogran.
G Castelnovo: Honoraria and consulting fees from Novartis, Biogen, Teva, Sanofi, Genzyme, Merck-Serono, Merz, Ipsen, Bayer. Research supports from Novartis, Merz, Ipsen
C Lebrun-Frenay: boards for Biogen, Merck, Teva, Medday, Roche, Novartis
G Defer: personal compensation for serving on scientific advisory boards for Biogen Idec, Merck-Serono, Novartis, Sanofi Aventis, Genzyme and Teva Pharmaceutical Industries Ltd He has received funding for travel and/or speaker honoraria from Merck Serono, Biogen Idec, Guerbet, Sanofi Aventis, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd. His institution received grants supporting research in his department from Merck Serono, Biogen Idec, Sanofi Aventis and Novartis
B Brochet: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen-Idec, Merck, Bayer Schering, Roche, Medday, Bayer, Actelion, Teva and Genzyme Sanofi.
J Pelletier: Consulting fees and travels from Biogen, Sanofi-Genzyme, Novartis, Teva, Merck-Serono, Roche, Medday
B. Bourre: scientific advisory board for Merck Serono and has received funding for travel and honoraria from Biogen Idec, Merck Serono, Novartis, Sanofi-Genzyme and Teva. Unconditional research grants from Biogen, Novartis, Roche and Merck-Serono
T Moreau: consultancy fees, speaker fees, research supports, or honoraria from Novartis, Biogen-Idec, Merck, Roche, Medday, Teva and Genzyme Sanofi
P Clavelou: Honoraria and consulting fees from Almirall, Medday, Merck, Novartis, Roche, Sanofi-Genzyme, Teva .Research supports from Biogen, Merck, Novartis
B. Stankoff: honoraria from Biogen, Teva, Novartis, Genzyme, Roche and research support from Genzyme, Merck-Serono and Roche.
F Rollot: no disclosures
R Casey: no disclosures
J De Sèze: Sanofi-Genzyme and Biogen
S Wiertlewski: honoraria from Biogen, Teva, Novartis, Genzyme, Roche
C Nifle: Honoraria and consulting: none. Research supports from Biogen, Novartis. Congress participation: Biogen, Sanofi-Genzyme, Bayer, Novartis, Teva, and Merck-Serono
C. Pottier: Research supports from Novartis
L Barbin: nothing to disclose
Y Foucher: nothing to disclose
E Leray: nothng to disclose