Contributions
Abstract: P1233
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The efficacy of teriflunomide has been demonstrated in Phase 2 (NCT01487096) and Phase 3 (TEMSO [NCT00134563; NCT00803049], TOWER [NCT00751881], TENERE [NCT00883337]) studies. Available evidence suggests that teriflunomide does not significantly impact protective immunity.
Objective: To report long-term (up to 12.8 years) efficacy and safety data from a pooled analysis of the Phase 2 and Phase 3 TEMSO, TOWER, and TENERE core and extension studies.
Methods: In the Phase 2 study, TEMSO, and TOWER, patients were randomized 1:1:1 to receive placebo or teriflunomide 7 mg or 14 mg. In TENERE, patients were randomized 1:1:1 to receive subcutaneous interferon beta-1a 44 µg (IFN) or teriflunomide 7 mg or 14 mg. In the extensions, teriflunomide-treated patients either continued on their original dose of teriflunomide (Phase 2, TEMSO) or received teriflunomide 14 mg regardless of original dose (TOWER, TENERE), while placebo- or IFN-treated patients were reassigned 1:1 to teriflunomide 7 mg or 14 mg (Phase 2, TEMSO) or received teriflunomide 14 mg (TOWER, TENERE). Efficacy and safety data were pooled from the Phase 2, TEMSO, TOWER, and TENERE core and extension studies (teriflunomide and placebo groups only). Annualised relapse rates (ARRs) and overall AE rates for patients treated with teriflunomide 14 mg in the core studies are presented; extension data will be available for presentation.
Results: There were 812 and 896 patients in the pooled placebo and teriflunomide 14 mg intention-to-treat groups, respectively. The cumulative treatment exposure for teriflunomide 14 mg was 1357 patient years. Adjusted ARRs (95% CI) were significantly lower among patients treated with teriflunomide 14 mg (0.38 [0.33, 0.43]) compared with placebo (0.59 [0.52, 0.67]), representing a relative reduction of 35% (P< 0.0001). In the placebo and teriflunomide 14 mg groups, the percentage of patients with AEs was 86.4% and 89.7%, respectively; the percentage of patients with serious AEs was 12.4% and 12.8%, respectively; and the percentage of patients who discontinued treatment due to AEs was 6.9% and 13.1%, respectively. Detailed data on AEs will be presented.
Conclusions: ARRs were significantly lower among patients treated with teriflunomide 14 mg vs placebo. No new safety signals were reported.
Disclosure: 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. LRT: Received honoraria for serving on advisory boards and as a speaker, and educational support from Biogen, Sanofi, Genzyme, Merck, Novartis, Teva, Mylan and Almirall. MZ: Received honoraria for speaking or for serving in advisory boards and received funding for traveling from Almirall, Biogen, Genzyme, Merck Serono, and Novartis. JDS: Provided consulting services and taken part in advisory boards for Sanofi. SA: Nothing disclosed. RM: Consulting/speaker fees from Bayer, Biogen, Genzyme, Merck, Sanofi, Serono, Novartis, Roche. AM: Consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Roche, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, and Teva; contracted research for Biogen, Genentech, Novartis, Questcor, Roche, and Sanofi. BK: Received honoraria for serving on advisory boards and as a speaker from Biogen, Sanofi, Genzyme, Merck Serono, Novartis, and Teva. DR: Consulting fees from Bayer, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva; research support from Biogen, Genzyme, GW Pharma, Merck Serono, Mitsubishi, Novartis, and Teva. MB: Employee of Sanofi with ownership interest. PT: Employee of Sanofi, with ownership interest. JC: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. CLF: Consulting fees, honoraria, or scientific committee support from Biogen, Genzyme, MedDay, Merck Serono, Novartis, Roche, and Teva.
Study supported by Sanofi
Abstract: P1233
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing forms of MS. The efficacy of teriflunomide has been demonstrated in Phase 2 (NCT01487096) and Phase 3 (TEMSO [NCT00134563; NCT00803049], TOWER [NCT00751881], TENERE [NCT00883337]) studies. Available evidence suggests that teriflunomide does not significantly impact protective immunity.
Objective: To report long-term (up to 12.8 years) efficacy and safety data from a pooled analysis of the Phase 2 and Phase 3 TEMSO, TOWER, and TENERE core and extension studies.
Methods: In the Phase 2 study, TEMSO, and TOWER, patients were randomized 1:1:1 to receive placebo or teriflunomide 7 mg or 14 mg. In TENERE, patients were randomized 1:1:1 to receive subcutaneous interferon beta-1a 44 µg (IFN) or teriflunomide 7 mg or 14 mg. In the extensions, teriflunomide-treated patients either continued on their original dose of teriflunomide (Phase 2, TEMSO) or received teriflunomide 14 mg regardless of original dose (TOWER, TENERE), while placebo- or IFN-treated patients were reassigned 1:1 to teriflunomide 7 mg or 14 mg (Phase 2, TEMSO) or received teriflunomide 14 mg (TOWER, TENERE). Efficacy and safety data were pooled from the Phase 2, TEMSO, TOWER, and TENERE core and extension studies (teriflunomide and placebo groups only). Annualised relapse rates (ARRs) and overall AE rates for patients treated with teriflunomide 14 mg in the core studies are presented; extension data will be available for presentation.
Results: There were 812 and 896 patients in the pooled placebo and teriflunomide 14 mg intention-to-treat groups, respectively. The cumulative treatment exposure for teriflunomide 14 mg was 1357 patient years. Adjusted ARRs (95% CI) were significantly lower among patients treated with teriflunomide 14 mg (0.38 [0.33, 0.43]) compared with placebo (0.59 [0.52, 0.67]), representing a relative reduction of 35% (P< 0.0001). In the placebo and teriflunomide 14 mg groups, the percentage of patients with AEs was 86.4% and 89.7%, respectively; the percentage of patients with serious AEs was 12.4% and 12.8%, respectively; and the percentage of patients who discontinued treatment due to AEs was 6.9% and 13.1%, respectively. Detailed data on AEs will be presented.
Conclusions: ARRs were significantly lower among patients treated with teriflunomide 14 mg vs placebo. No new safety signals were reported.
Disclosure: 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. LRT: Received honoraria for serving on advisory boards and as a speaker, and educational support from Biogen, Sanofi, Genzyme, Merck, Novartis, Teva, Mylan and Almirall. MZ: Received honoraria for speaking or for serving in advisory boards and received funding for traveling from Almirall, Biogen, Genzyme, Merck Serono, and Novartis. JDS: Provided consulting services and taken part in advisory boards for Sanofi. SA: Nothing disclosed. RM: Consulting/speaker fees from Bayer, Biogen, Genzyme, Merck, Sanofi, Serono, Novartis, Roche. AM: Consulting fees from Accordant Health Services, Acorda Therapeutics, Alkermes, Biogen, EMD Serono, Genentech, Roche, Genzyme, GSK, Mallinckrodt Pharmaceuticals [Questcor], Novartis, Roche, and Teva; contracted research for Biogen, Genentech, Novartis, Questcor, Roche, and Sanofi. BK: Received honoraria for serving on advisory boards and as a speaker from Biogen, Sanofi, Genzyme, Merck Serono, Novartis, and Teva. DR: Consulting fees from Bayer, Biogen, MedDay, Merck Serono, Novartis, Roche, Sanofi, and Teva; research support from Biogen, Genzyme, GW Pharma, Merck Serono, Mitsubishi, Novartis, and Teva. MB: Employee of Sanofi with ownership interest. PT: Employee of Sanofi, with ownership interest. JC: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. CLF: Consulting fees, honoraria, or scientific committee support from Biogen, Genzyme, MedDay, Merck Serono, Novartis, Roche, and Teva.
Study supported by Sanofi