Abstract: P1205
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The efficacy and safety of teriflunomide have been established in a clinical trial program including a Phase 2 study (NCT01487096) and the Phase 3 TEMSO (NCT00134563), TOWER (NCT00751881), and TENERE (NCT00883337) studies.
Objective: To investigate the efficacy and safety of teriflunomide in subgroups defined by prior treatment in a pooled post hoc analysis of the Phase 2 study and the Phase 3 TEMSO, TOWER, and TENERE studies.
Methods: In the Phase 2 study and the Phase 3 TEMSO and TOWER studies, patients were randomized 1:1:1 to receive placebo, teriflunomide 7 mg, or teriflunomide 14 mg. In TENERE, patients were randomized 1:1:1 to receive subcutaneous interferon beta-1a (IFN), teriflunomide 7 mg, or teriflunomide 14 mg. Post hoc analysis of ARR was carried out for patients receiving placebo or teriflunomide (IFN-treated patients were not included) according to subgroups defined by prior MS treatment: Group 1, patients whose last prior DMT was discontinued within 6 months prior to randomization; Group 2, patients whose last prior DMT was discontinued 6 months to 2 years prior to randomization; and Group 3, patients who had received no prior DMT. Data reported here are for patients treated with teriflunomide 14 mg.
Results: There were a total of 2643 patients in the pooled population, of whom 348, 412, and 1883 were in Group 1, 2, and 3, respectively. ARR was statistically significantly lower in patients treated with teriflunomide 14 mg compared with placebo, regardless of prior treatment status: Group 1, 0.45 vs 0.81 (45% relative reduction; P=0.0029); Group 2, 0.53 vs 0.79, (34% relative reduction; P=0.0117), and Group 3, 0.33 vs 0.53 (38% relative reduction; P< 0.0001). Safety findings will be reported.
Conclusions: In a pooled analysis of Phase 2 and Phase 3 studies, the treatment effect of teriflunomide was consistent across subgroups of patients defined by prior MS treatment. Notably, treatment efficacy was not lost despite the higher disease activity in the subgroups of patients who had received prior DMTs.
Disclosure: GC: Compensation for consulting services and/or speaking activities from Almirall, Biogen, Celgene, Excemed, Forward Pharma, Genzyme, Merck, Novartis, Receptos, Roche, Sanofi, and Teva; fees for non-CME services from Almirall, Bayer, Biogen, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, SSIF, and Teva. MF: Research/educational grant support from Bayer and Genzyme; honoraria/consulting fees from Bayer, Biogen, EMD Canada, Novartis, Sanofi, and Teva; member of company advisory boards/board of directors/other similar group for Bayer, Biogen, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, and Teva. JML: Consulting fees from Almirall, Biogen, Merck Serono, Novartis, Sanofi, and Teva. PV: Honoraria, consulting fees from Almirall, Bayer, Biogen, Celgene, Genzyme, Sanofi, GSK, Merck Serono, Novartis, Servier, and Teva; research support from Bayer, Biogen, Genzyme, Sanofi, and Merck Serono. BK: Nothing to disclose. AP: Nothing disclosed. KE: Consulting fees from Biogen, Genzyme, EMD Serono; research support from Biogen, Eli Lilly, Genentech, Sanofi, and Hoffmann-La Roche, Novartis. RG: Consulting fees from Bayer, Biogen, Elan, Genzyme, Roche, and Teva; grant/research support from Bayer, Biogen, Genzyme, and Teva. JO: Speakers fees, advisory fees, travel, and hospitality from Roche, Biogen, Novartis, Teva, Merck, Medday, Allergan, Celgene, and Genzyme; Research and departmental funds from Novartis, Biogen, Roche, Genzyme, and Merck. HK: Employee of Sanofi with ownership interest. JC: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. PC: Consulting fees from Accordant, Acorda, Bayer, Biogen, Celgene, Genentech, Roche, Genzyme, Sanofi, Novartis, Serono, and Teva; research support from Actelion, Alkermes, Genentech, Roche, MedDay, NINDS, and Novartis.
Study supported by Sanofi.
Abstract: P1205
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The efficacy and safety of teriflunomide have been established in a clinical trial program including a Phase 2 study (NCT01487096) and the Phase 3 TEMSO (NCT00134563), TOWER (NCT00751881), and TENERE (NCT00883337) studies.
Objective: To investigate the efficacy and safety of teriflunomide in subgroups defined by prior treatment in a pooled post hoc analysis of the Phase 2 study and the Phase 3 TEMSO, TOWER, and TENERE studies.
Methods: In the Phase 2 study and the Phase 3 TEMSO and TOWER studies, patients were randomized 1:1:1 to receive placebo, teriflunomide 7 mg, or teriflunomide 14 mg. In TENERE, patients were randomized 1:1:1 to receive subcutaneous interferon beta-1a (IFN), teriflunomide 7 mg, or teriflunomide 14 mg. Post hoc analysis of ARR was carried out for patients receiving placebo or teriflunomide (IFN-treated patients were not included) according to subgroups defined by prior MS treatment: Group 1, patients whose last prior DMT was discontinued within 6 months prior to randomization; Group 2, patients whose last prior DMT was discontinued 6 months to 2 years prior to randomization; and Group 3, patients who had received no prior DMT. Data reported here are for patients treated with teriflunomide 14 mg.
Results: There were a total of 2643 patients in the pooled population, of whom 348, 412, and 1883 were in Group 1, 2, and 3, respectively. ARR was statistically significantly lower in patients treated with teriflunomide 14 mg compared with placebo, regardless of prior treatment status: Group 1, 0.45 vs 0.81 (45% relative reduction; P=0.0029); Group 2, 0.53 vs 0.79, (34% relative reduction; P=0.0117), and Group 3, 0.33 vs 0.53 (38% relative reduction; P< 0.0001). Safety findings will be reported.
Conclusions: In a pooled analysis of Phase 2 and Phase 3 studies, the treatment effect of teriflunomide was consistent across subgroups of patients defined by prior MS treatment. Notably, treatment efficacy was not lost despite the higher disease activity in the subgroups of patients who had received prior DMTs.
Disclosure: GC: Compensation for consulting services and/or speaking activities from Almirall, Biogen, Celgene, Excemed, Forward Pharma, Genzyme, Merck, Novartis, Receptos, Roche, Sanofi, and Teva; fees for non-CME services from Almirall, Bayer, Biogen, Excemed, Genzyme, Merck Serono, Novartis, Receptos, Sanofi, SSIF, and Teva. MF: Research/educational grant support from Bayer and Genzyme; honoraria/consulting fees from Bayer, Biogen, EMD Canada, Novartis, Sanofi, and Teva; member of company advisory boards/board of directors/other similar group for Bayer, Biogen, Chugai, Merck Serono, Novartis, Opexa Therapeutics, Sanofi, and Teva. JML: Consulting fees from Almirall, Biogen, Merck Serono, Novartis, Sanofi, and Teva. PV: Honoraria, consulting fees from Almirall, Bayer, Biogen, Celgene, Genzyme, Sanofi, GSK, Merck Serono, Novartis, Servier, and Teva; research support from Bayer, Biogen, Genzyme, Sanofi, and Merck Serono. BK: Nothing to disclose. AP: Nothing disclosed. KE: Consulting fees from Biogen, Genzyme, EMD Serono; research support from Biogen, Eli Lilly, Genentech, Sanofi, and Hoffmann-La Roche, Novartis. RG: Consulting fees from Bayer, Biogen, Elan, Genzyme, Roche, and Teva; grant/research support from Bayer, Biogen, Genzyme, and Teva. JO: Speakers fees, advisory fees, travel, and hospitality from Roche, Biogen, Novartis, Teva, Merck, Medday, Allergan, Celgene, and Genzyme; Research and departmental funds from Novartis, Biogen, Roche, Genzyme, and Merck. HK: Employee of Sanofi with ownership interest. JC: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. PC: Consulting fees from Accordant, Acorda, Bayer, Biogen, Celgene, Genentech, Roche, Genzyme, Sanofi, Novartis, Serono, and Teva; research support from Actelion, Alkermes, Genentech, Roche, MedDay, NINDS, and Novartis.
Study supported by Sanofi.