Contributions
Abstract: 228
Type: Free Communications
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: previous post marketing studies suggested comparable effectiveness between dimethylfumarate(DMF) and fingolimod(FTY), two oral drugs approved for Relapsing-Remitting Multiple Sclerosis(RRMS) patients, that differ in terms of line of treatment and reimbursement policy.
Aims: to assess effectiveness and discontinuation of DMF and FTY in an Italian monocentric cohort of RRMS patients.
Methods: RRMS patients treated with DMF or FTY progressively recruited at the MS Centre of San Raffaele Hospital were included in the study. Propensity score(PS) was built using a multivariable logistic regression model. After PS calculation, patients were matched on their propensity to receive DMF or FTY in a variable ratio of up to 5:1 using nearest neighbor matching. Effectiveness was assessed considering the following outcomes: annualized relapse rate(ARR), time to first relapse(TTFR), time to EDSS progression, MRI activity and NEDA status. Time to treatment discontinuation(TTD) was also assessed and a subgroup analysis comparing naïve and previously treated patients was performed.
Results: 367 FTY-patients and 445 DMF-patients were enrolled. After applying PS-matching, 196 FTY-patients and 350 DMF-patients were included in the analyses. No differences were observed in terms of ARR, TTFR and time to disability progression between the two groups. Higher MRI activity was observed in DMF-treated patients when adjusting for follow-up and new-T2 lesions at baseline(OR:1.73, 95%CI:1.11-2.71). NEDA was observed in 60.4% of FTY-treated patients compared to the 54.3% of DMF-treated. The two years rate of discontinuation was 22.8% (SE:2.4%) for DMT and 17.1%(SE:2.7%) in FTY(HR:2.32,95% CI:1.33-4.07;p:0.003); moreover the time to discontinuation was significantly shorter for DMT compared to FTY treated group (p< 0.005). In the subgroup analysis, for naive patients the DMF treated showed higher MRI activity compared to FTY-treated(p< 0.05); this effect was not observed for previously treated patients. Similarly, the higher frequency discontinuation rate in DMF-treated compared to FTY treated patients(p< 0.05) was more evident in naïve subgroups.
Conclusions: DMT and FTY appear to have comparable effects on clinical outcomes of efficacy, but the TTD that was shorter for the DMT group. However, the effects on MRI activity was larger in FTY patients and this difference was even higher in the naïve-subgroup. The long term impact of these differences need to be assessed
Disclosure: L. Moiola received honoraria from Sanofi-Genzyme, TEVA, Novartis, Merck-Serono and Biogen
F. Esposito received honoraria from Almirall and Genzyme.
M. Di Cristinzi nothing to disclose
L. Ferre': nothing to disclose
G. Sferruzza: nothing to disclose
M. Romeo: nothing to disclose:
M. Radaelli: nothing to disclose
F. Sangalli: nothing to disclose
M. Robotti: nothing to disclose
G. Dalla Costa: nothing to disclose
B. Colombo: nothing to disclose
F. Martinelli Boneschi: received honoraria for consulting, research grant and travel expenses from TEVA neuroscience, Biogen IDEC, Merck Serono, Roche and Sanofi-Genzyme
M.A. Rocca: declared participation in a company sponsored speaker's bureau: Biogen-Idec, Novartis, Teva Neuro Sciences, Genzyme
A. Signori has received teaching honoraria from Novartis
V. Martinelli: reports consultancy, speaking fees and/or travel expenses from Biogen-Dompe` SG, Merck Serono, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme Europe, Teva Pharmaceuticals
M. Filippi: received compensation for consulting services and/or speaking activities from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA).
MP Sormani received consulting fees from TEVA, Biogen, Merck Serono, Genzyme, Roche, GeNeuro, Novartis, Medday.
G.Comi: has received compensation for consulting services and /or for speaking activities from Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Celgene, Forward Pharma, Medday.
This study is supported by the “Fondazione Italiana Sclerosi Multipla”, project 2013/R/13
Abstract: 228
Type: Free Communications
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: previous post marketing studies suggested comparable effectiveness between dimethylfumarate(DMF) and fingolimod(FTY), two oral drugs approved for Relapsing-Remitting Multiple Sclerosis(RRMS) patients, that differ in terms of line of treatment and reimbursement policy.
Aims: to assess effectiveness and discontinuation of DMF and FTY in an Italian monocentric cohort of RRMS patients.
Methods: RRMS patients treated with DMF or FTY progressively recruited at the MS Centre of San Raffaele Hospital were included in the study. Propensity score(PS) was built using a multivariable logistic regression model. After PS calculation, patients were matched on their propensity to receive DMF or FTY in a variable ratio of up to 5:1 using nearest neighbor matching. Effectiveness was assessed considering the following outcomes: annualized relapse rate(ARR), time to first relapse(TTFR), time to EDSS progression, MRI activity and NEDA status. Time to treatment discontinuation(TTD) was also assessed and a subgroup analysis comparing naïve and previously treated patients was performed.
Results: 367 FTY-patients and 445 DMF-patients were enrolled. After applying PS-matching, 196 FTY-patients and 350 DMF-patients were included in the analyses. No differences were observed in terms of ARR, TTFR and time to disability progression between the two groups. Higher MRI activity was observed in DMF-treated patients when adjusting for follow-up and new-T2 lesions at baseline(OR:1.73, 95%CI:1.11-2.71). NEDA was observed in 60.4% of FTY-treated patients compared to the 54.3% of DMF-treated. The two years rate of discontinuation was 22.8% (SE:2.4%) for DMT and 17.1%(SE:2.7%) in FTY(HR:2.32,95% CI:1.33-4.07;p:0.003); moreover the time to discontinuation was significantly shorter for DMT compared to FTY treated group (p< 0.005). In the subgroup analysis, for naive patients the DMF treated showed higher MRI activity compared to FTY-treated(p< 0.05); this effect was not observed for previously treated patients. Similarly, the higher frequency discontinuation rate in DMF-treated compared to FTY treated patients(p< 0.05) was more evident in naïve subgroups.
Conclusions: DMT and FTY appear to have comparable effects on clinical outcomes of efficacy, but the TTD that was shorter for the DMT group. However, the effects on MRI activity was larger in FTY patients and this difference was even higher in the naïve-subgroup. The long term impact of these differences need to be assessed
Disclosure: L. Moiola received honoraria from Sanofi-Genzyme, TEVA, Novartis, Merck-Serono and Biogen
F. Esposito received honoraria from Almirall and Genzyme.
M. Di Cristinzi nothing to disclose
L. Ferre': nothing to disclose
G. Sferruzza: nothing to disclose
M. Romeo: nothing to disclose:
M. Radaelli: nothing to disclose
F. Sangalli: nothing to disclose
M. Robotti: nothing to disclose
G. Dalla Costa: nothing to disclose
B. Colombo: nothing to disclose
F. Martinelli Boneschi: received honoraria for consulting, research grant and travel expenses from TEVA neuroscience, Biogen IDEC, Merck Serono, Roche and Sanofi-Genzyme
M.A. Rocca: declared participation in a company sponsored speaker's bureau: Biogen-Idec, Novartis, Teva Neuro Sciences, Genzyme
A. Signori has received teaching honoraria from Novartis
V. Martinelli: reports consultancy, speaking fees and/or travel expenses from Biogen-Dompe` SG, Merck Serono, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme Europe, Teva Pharmaceuticals
M. Filippi: received compensation for consulting services and/or speaking activities from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries; and receives research support from Biogen Idec, Merck-Serono, Novartis, Teva Pharmaceutical Industries, Roche, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA).
MP Sormani received consulting fees from TEVA, Biogen, Merck Serono, Genzyme, Roche, GeNeuro, Novartis, Medday.
G.Comi: has received compensation for consulting services and /or for speaking activities from Novartis, Teva, Sanofi, Genzyme, Merck, Biogen, Excemed, Roche, Almirall, Celgene, Forward Pharma, Medday.
This study is supported by the “Fondazione Italiana Sclerosi Multipla”, project 2013/R/13