Abstract: EP1783
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: A significant unmet need exists in the treatment of patients with progressive forms of MS. The phase 3 teriflunomide studies, TEMSO (NCT00134563) and TOWER (NCT00751881), both showed a significant decrease in risk of confirmed disability progression (~31% with teriflunomide 14 mg). These studies included a small number of patients with progressive forms of relapsing MS (PfRMS; secondary progressive MS [SPMS] with relapses and progressive relapsing MS [PRMS]).
Objectives: To analyse individual long-term disability outcomes in patients with PfRMS using data from ≤9 years' follow-up of TEMSO and TOWER, and to present observational real-world experience from patients with PfRMS treated with teriflunomide.
Methods: Patients with relapsing forms of MS were randomized 1:1:1 to receive placebo or teriflunomide 7 mg or 14 mg for 108 weeks in TEMSO or, in TOWER, for a study duration that was variable, ending 48 weeks after the last patient was randomized. Patients completing the core studies were eligible to enter extensions. In the TEMSO extension (NCT00803049), teriflunomide-treated patients continued as randomized; placebo-treated patients were re-randomized to teriflunomide 7 mg or 14 mg. In TOWER, all patients received teriflunomide 14 mg in the extension. In a post-hoc analysis, individual long-term Expanded Disability Status Scale (EDSS) outcomes were analysed and listed descriptively. For patients receiving teriflunomide in the real-world setting, a chart review of patients with SPMS or PRMS receiving treatment for ≥3 years was performed and their long-term EDSS scores tabulated.
Results: TEMSO and TOWER included 122 patients with PfRMS at randomization (SPMS, n=60; PRMS, n=62); 72 (59.0%) completed the core studies and 66 entered the extensions, of which 41 (62.1%) completed at least 5 years. Baseline median EDSS score for patients with PfRMS was 4; at last follow-up (≤9 years), median change from baseline was 0. Over periods of up to 5 years, EDSS scores in patients in the real-world setting (SPMS, n=9; PRMS, n=1) also remained stable; longer-term follow-up of these patients will be presented.
Conclusions: These data from a small number of patients with PfRMS and a good initial response to treatment provide preliminary evidence that teriflunomide 14 mg may be associated with long-term stabilization of disease activity and lack of disability progression in patients with PfRMS. These findings need to be confirmed in larger patient cohorts.
Disclosure: Study supported by Sanofi Genzyme.
FN: Consulting agreements and/or honoraria (Acorda, Bayer, CMSC, Genentech, Mylan, Novartis, Sanofi Genzyme, Teva Neuroscience); research support (Alkermes, National MS Society, Novartis).
CL-F: Consulting fees, honoraria or scientific committee support (Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Teva).
WC: Honoraria and/or consulting fees (Biogen Idec, Novartis Pharma, Roche, Sanofi.
AB: Consulting fees as member of advisory boards; participation in clinical trials (sponsored by Biogen Idec, Genzyme, Novartis, Teva, Sanofi, Schering).
KT and PR: Employees of Sanofi Genzyme.
SC and PT: Employees of Sanofi Genzyme, with ownership interest.
JL: Employee of Sanofi.
Abstract: EP1783
Type: ePoster
Abstract Category: Therapy - disease modifying - 31 Treatment of progressive MS
Background: A significant unmet need exists in the treatment of patients with progressive forms of MS. The phase 3 teriflunomide studies, TEMSO (NCT00134563) and TOWER (NCT00751881), both showed a significant decrease in risk of confirmed disability progression (~31% with teriflunomide 14 mg). These studies included a small number of patients with progressive forms of relapsing MS (PfRMS; secondary progressive MS [SPMS] with relapses and progressive relapsing MS [PRMS]).
Objectives: To analyse individual long-term disability outcomes in patients with PfRMS using data from ≤9 years' follow-up of TEMSO and TOWER, and to present observational real-world experience from patients with PfRMS treated with teriflunomide.
Methods: Patients with relapsing forms of MS were randomized 1:1:1 to receive placebo or teriflunomide 7 mg or 14 mg for 108 weeks in TEMSO or, in TOWER, for a study duration that was variable, ending 48 weeks after the last patient was randomized. Patients completing the core studies were eligible to enter extensions. In the TEMSO extension (NCT00803049), teriflunomide-treated patients continued as randomized; placebo-treated patients were re-randomized to teriflunomide 7 mg or 14 mg. In TOWER, all patients received teriflunomide 14 mg in the extension. In a post-hoc analysis, individual long-term Expanded Disability Status Scale (EDSS) outcomes were analysed and listed descriptively. For patients receiving teriflunomide in the real-world setting, a chart review of patients with SPMS or PRMS receiving treatment for ≥3 years was performed and their long-term EDSS scores tabulated.
Results: TEMSO and TOWER included 122 patients with PfRMS at randomization (SPMS, n=60; PRMS, n=62); 72 (59.0%) completed the core studies and 66 entered the extensions, of which 41 (62.1%) completed at least 5 years. Baseline median EDSS score for patients with PfRMS was 4; at last follow-up (≤9 years), median change from baseline was 0. Over periods of up to 5 years, EDSS scores in patients in the real-world setting (SPMS, n=9; PRMS, n=1) also remained stable; longer-term follow-up of these patients will be presented.
Conclusions: These data from a small number of patients with PfRMS and a good initial response to treatment provide preliminary evidence that teriflunomide 14 mg may be associated with long-term stabilization of disease activity and lack of disability progression in patients with PfRMS. These findings need to be confirmed in larger patient cohorts.
Disclosure: Study supported by Sanofi Genzyme.
FN: Consulting agreements and/or honoraria (Acorda, Bayer, CMSC, Genentech, Mylan, Novartis, Sanofi Genzyme, Teva Neuroscience); research support (Alkermes, National MS Society, Novartis).
CL-F: Consulting fees, honoraria or scientific committee support (Bayer Schering, Biogen, Genzyme, Merck Serono, Novartis, Teva).
WC: Honoraria and/or consulting fees (Biogen Idec, Novartis Pharma, Roche, Sanofi.
AB: Consulting fees as member of advisory boards; participation in clinical trials (sponsored by Biogen Idec, Genzyme, Novartis, Teva, Sanofi, Schering).
KT and PR: Employees of Sanofi Genzyme.
SC and PT: Employees of Sanofi Genzyme, with ownership interest.
JL: Employee of Sanofi.