
Contributions
Abstract: P1203
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS in 70 countries, with more than 71,000 patients currently being treated worldwide. In the phase 2 extension study, disease activity, as measured by MRI and clinical outcomes, remained low in patients who continued to receive teriflunomide for up to 14 years.
Objective: To report long-term outcomes, including patient-level data, for patients who continued in the teriflunomide phase 2 extension study (NCT00228163) until final study termination.
Methods: In the 36-week placebo-controlled phase of the study (NCT01487096), patients with relapsing MS were randomized (1:1:1) to once-daily placebo, teriflunomide 7 mg, or 14 mg; in the extension, patients previously treated with placebo were randomized to teriflunomide 7 mg or 14 mg, and teriflunomide-treated patients continued on active treatment. Evaluation using the Expanded Disability Status Scale (EDSS) was scheduled to occur at baseline, then every 12 weeks until the end of the core study and every 24 weeks throughout the extension and at unscheduled visits. For patients ever exposed to teriflunomide, the overall EDSS outcome was categorized as improved, stable, or worsened at the last available EDSS compared with baseline.
Results: A total of 172 patients received either teriflunomide 7 mg or 14 mg for up to 14 years (core + extension), with a cumulative duration of exposure of 1136 patient-years. Mean EDSS scores remained consistently low in patients who received teriflunomide 14 mg throughout the placebo-controlled and extension phases of the study (2.28 [n=40] at baseline, 2.33 at Year 5 [n=24] and 2.26 at Year 10 [n=21]). After Year 10, although patient numbers were small, EDSS scores remained stable. For the majority of patients, EDSS scores remained stable or improved (combined total of 63% of patients) compared with baseline at the last EDSS evaluation. Individual EDSS changes for each patient remaining in the study at termination will be presented.
Conclusions: EDSS scores remained stable or improved through to the last assessment visit for the majority of patients receiving teriflunomide treatment.
Disclosure: Study supported by Sanofi Genzyme
MSF: Honoraria/consulting fees (Bayer HealthCare, Biogen Idec, EMD Canada,
Novartis, Sanofi, Teva Canada Innovation); member of company advisory boards/board of directors/other similar group (Bayer HealthCare, Biogen Idec, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, Teva Canada Innovation); research/educational grant support (Bayer HealthCare, Genzyme).
AB-O: Speaking, consultancy fees, and/or grant support (Amplimmune, Biogen Idec, Diogenix, Genentech, Genzyme/Sanofi, GSK, Merck/EMD Serono, Novartis, Ono Pharma, Receptos, Roche, Teva Neuroscience).
MB, EP and MM: Employees of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
MK: Research support from Canadian Institute of Health Research [CIHR] and Chapman Chair in MS clinical research at LHSC, and grants for clinical trials from (Biogen, Sanofi, Genzyme, Novartis).
Abstract: P1203
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS in 70 countries, with more than 71,000 patients currently being treated worldwide. In the phase 2 extension study, disease activity, as measured by MRI and clinical outcomes, remained low in patients who continued to receive teriflunomide for up to 14 years.
Objective: To report long-term outcomes, including patient-level data, for patients who continued in the teriflunomide phase 2 extension study (NCT00228163) until final study termination.
Methods: In the 36-week placebo-controlled phase of the study (NCT01487096), patients with relapsing MS were randomized (1:1:1) to once-daily placebo, teriflunomide 7 mg, or 14 mg; in the extension, patients previously treated with placebo were randomized to teriflunomide 7 mg or 14 mg, and teriflunomide-treated patients continued on active treatment. Evaluation using the Expanded Disability Status Scale (EDSS) was scheduled to occur at baseline, then every 12 weeks until the end of the core study and every 24 weeks throughout the extension and at unscheduled visits. For patients ever exposed to teriflunomide, the overall EDSS outcome was categorized as improved, stable, or worsened at the last available EDSS compared with baseline.
Results: A total of 172 patients received either teriflunomide 7 mg or 14 mg for up to 14 years (core + extension), with a cumulative duration of exposure of 1136 patient-years. Mean EDSS scores remained consistently low in patients who received teriflunomide 14 mg throughout the placebo-controlled and extension phases of the study (2.28 [n=40] at baseline, 2.33 at Year 5 [n=24] and 2.26 at Year 10 [n=21]). After Year 10, although patient numbers were small, EDSS scores remained stable. For the majority of patients, EDSS scores remained stable or improved (combined total of 63% of patients) compared with baseline at the last EDSS evaluation. Individual EDSS changes for each patient remaining in the study at termination will be presented.
Conclusions: EDSS scores remained stable or improved through to the last assessment visit for the majority of patients receiving teriflunomide treatment.
Disclosure: Study supported by Sanofi Genzyme
MSF: Honoraria/consulting fees (Bayer HealthCare, Biogen Idec, EMD Canada,
Novartis, Sanofi, Teva Canada Innovation); member of company advisory boards/board of directors/other similar group (Bayer HealthCare, Biogen Idec, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, Teva Canada Innovation); research/educational grant support (Bayer HealthCare, Genzyme).
AB-O: Speaking, consultancy fees, and/or grant support (Amplimmune, Biogen Idec, Diogenix, Genentech, Genzyme/Sanofi, GSK, Merck/EMD Serono, Novartis, Ono Pharma, Receptos, Roche, Teva Neuroscience).
MB, EP and MM: Employees of Sanofi Genzyme.
PT: Employee of Sanofi Genzyme, with ownership interest.
MK: Research support from Canadian Institute of Health Research [CIHR] and Chapman Chair in MS clinical research at LHSC, and grants for clinical trials from (Biogen, Sanofi, Genzyme, Novartis).