Contributions
Abstract: 226
Type: Free Communications
Abstract Category: Therapy - 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 on both clinical and MRI outcomes in RRMS patients from 34 MS centers participating to the French prospective national cohort of MS patients OFSEP.
Methods: The 1770 RRMS patients (713 in TRF group and 1057 in DMF group) included in the study were aged from 18 to 65 with an EDSS score of 0 to 5.5 and an available brain MRI performed within six months before treatment initiation. The outcomes studied were the proportion of patients with at least one relapse in the year and the two years following TRF or DMF initiation, proportion of patients with at least a new T2 lesion at one and two years, patients with an increased EDSS score at one and two years and reasons for treatment stop at one and two years. For statistical analyses the outcomes were modeled using propensity scores (Inverse Probability Weighting) and logistic regressions by using weighted likelihood maximization and robust variance estimator.
Results: Confounder-adjusted proportion of patients with at least one relapse at one and two years of treatment was similar in TRF-treated patients compared to DMF group (21.6% versus 20.2% for first year, 30.4% versus 29.5% at two years). On the same way, a similar percentage of patients has an increase of EDSS score at one and two years in TRF (27.4% and 41.6% respectively) and DMF (27.1% and 40.6% respectively) groups. However, MRI comparisons reveal that the confounder-adjusted proportion of patients with at least one new T2 lesion at two years was significantly lower in patients treated by DMF compared to TRF (60.8% versus 72.2%, OR: 0.6 [CI95%:0.43-0.82]). Reason for treatment withdrawal supports the superiority of DMF at two years as lack of efficacy was reported for 8.5% of DMF-treated patients versus 14.5% of TRF-treated patients (OR:0.54 [CI95%:0.41-0.74]).
Interpretation: After one and two years of treatment and after correction for confounders, the efficacy of DMF and TRF is similar in terms of risk of relapse and worsening of EDSS. However, significantly more patients experience new T2 lesions after 2 years under TRF as compared to DMF which is supported by an increased treatment withdrawal for lack of efficacy in the TRF group.
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
T Debroucker : scientific advisory boards for Novartis, Sanofi Aventis, speaker honoraria from Merck Serono, Biogen Idec, Novartis
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
JP Camdessanché: lectures, consulting, writing of articles, or training courses from Biogen-Idec, CSL-Behring, Genzyme, Laboratoire Français des Biotechnologies, Merck-Serono, Novartis, Pfizer, Pharmalliance, Teva, Editions Scientifiques L&C, Edimark, Expression Santé, Natus, Scien, SNF-Floerger.
P LABAUGE: 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
O Casez: consulting and lecture fees, travel grants from biogen, genzyme, novartis, Roche, Merck.
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
Bruno 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
F Rollot: no disclosures
R Casey: no disclosures
J De Seze: Sanofi-Genzyme and Biogen
O Heinzlef: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen-Idec, Merck, Bayer Schering, Roche, Medday, Almirall, Teva and Genzyme Sanofi.
M Debouverie: no disclosures
I Patry: Honoraria and consulting fees from Novartis and Roche, research supports from Biogen and Novartis, travel grants from Novartis and Roche. Affiliation: Centre Hospitalier Sud Francilien (Corbeil Essonnes)
P Clavelou: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen, Merck, Roche, Medday, Actelion, Teva and Genzyme Sanofi.
G Edan: grants and personal fees from Biogen, Mercks, Sanofi, Novartis, Teva,
Y Foucher: no disclosure
S Wiertlewski: consultancy fees, speaker fees, honoraria and clinical research grants (non-personal) from Biogen-Idec, Genzyme, Novartis, Merck, Roche, Sanofi-Aventis and Teva.
Créange: Consulting fees and travels Biogen,CSL Behring, Genzyme, Roche. Research supports from Biogen, CSL Behring, GE Neuro, Medday.
L Magy: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Medday, Merck-Serono, Novartis, Teva,
Abstract: 226
Type: Free Communications
Abstract Category: Therapy - 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 on both clinical and MRI outcomes in RRMS patients from 34 MS centers participating to the French prospective national cohort of MS patients OFSEP.
Methods: The 1770 RRMS patients (713 in TRF group and 1057 in DMF group) included in the study were aged from 18 to 65 with an EDSS score of 0 to 5.5 and an available brain MRI performed within six months before treatment initiation. The outcomes studied were the proportion of patients with at least one relapse in the year and the two years following TRF or DMF initiation, proportion of patients with at least a new T2 lesion at one and two years, patients with an increased EDSS score at one and two years and reasons for treatment stop at one and two years. For statistical analyses the outcomes were modeled using propensity scores (Inverse Probability Weighting) and logistic regressions by using weighted likelihood maximization and robust variance estimator.
Results: Confounder-adjusted proportion of patients with at least one relapse at one and two years of treatment was similar in TRF-treated patients compared to DMF group (21.6% versus 20.2% for first year, 30.4% versus 29.5% at two years). On the same way, a similar percentage of patients has an increase of EDSS score at one and two years in TRF (27.4% and 41.6% respectively) and DMF (27.1% and 40.6% respectively) groups. However, MRI comparisons reveal that the confounder-adjusted proportion of patients with at least one new T2 lesion at two years was significantly lower in patients treated by DMF compared to TRF (60.8% versus 72.2%, OR: 0.6 [CI95%:0.43-0.82]). Reason for treatment withdrawal supports the superiority of DMF at two years as lack of efficacy was reported for 8.5% of DMF-treated patients versus 14.5% of TRF-treated patients (OR:0.54 [CI95%:0.41-0.74]).
Interpretation: After one and two years of treatment and after correction for confounders, the efficacy of DMF and TRF is similar in terms of risk of relapse and worsening of EDSS. However, significantly more patients experience new T2 lesions after 2 years under TRF as compared to DMF which is supported by an increased treatment withdrawal for lack of efficacy in the TRF group.
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
T Debroucker : scientific advisory boards for Novartis, Sanofi Aventis, speaker honoraria from Merck Serono, Biogen Idec, Novartis
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
JP Camdessanché: lectures, consulting, writing of articles, or training courses from Biogen-Idec, CSL-Behring, Genzyme, Laboratoire Français des Biotechnologies, Merck-Serono, Novartis, Pfizer, Pharmalliance, Teva, Editions Scientifiques L&C, Edimark, Expression Santé, Natus, Scien, SNF-Floerger.
P LABAUGE: 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
O Casez: consulting and lecture fees, travel grants from biogen, genzyme, novartis, Roche, Merck.
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
Bruno 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
F Rollot: no disclosures
R Casey: no disclosures
J De Seze: Sanofi-Genzyme and Biogen
O Heinzlef: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen-Idec, Merck, Bayer Schering, Roche, Medday, Almirall, Teva and Genzyme Sanofi.
M Debouverie: no disclosures
I Patry: Honoraria and consulting fees from Novartis and Roche, research supports from Biogen and Novartis, travel grants from Novartis and Roche. Affiliation: Centre Hospitalier Sud Francilien (Corbeil Essonnes)
P Clavelou: consultancy fees, speaker fees, research grants (non-personal), or honoraria from Novartis, Biogen, Merck, Roche, Medday, Actelion, Teva and Genzyme Sanofi.
G Edan: grants and personal fees from Biogen, Mercks, Sanofi, Novartis, Teva,
Y Foucher: no disclosure
S Wiertlewski: consultancy fees, speaker fees, honoraria and clinical research grants (non-personal) from Biogen-Idec, Genzyme, Novartis, Merck, Roche, Sanofi-Aventis and Teva.
Créange: Consulting fees and travels Biogen,CSL Behring, Genzyme, Roche. Research supports from Biogen, CSL Behring, GE Neuro, Medday.
L Magy: Honoraria and consulting fees from Biogen, Sanofi-Genzyme, Medday, Merck-Serono, Novartis, Teva,