Contributions
Abstract: P885
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. Patient-reported treatment satisfaction was assessed in both the Phase 3 TENERE study extension (NCT00883337) and in the non-interventional TAURUS-MS I study in Germany.
Objective: To describe treatment satisfaction for patients who switched from other disease modifying therapies (DMTs) to teriflunomide 14 mg in the TENERE extension and TAURUS-MS I.
Methods: In TENERE, patients were randomized (1:1:1) to teriflunomide 7 mg once daily, teriflunomide 14 mg once daily, or subcutaneous interferon β-1a 44 µg 3 times weekly (SC IFNβ-1a); patients completing the core study could enter the extension, during which all patients received teriflunomide 14 mg. In TAURUS-MS I, patients received teriflunomide 14 mg according to local labelling; a subset of patients discontinued another DMT within 6 months prior to initiating teriflunomide. In both studies, treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM; v1.4 in TENERE and v9 in TAURUS-MS I). TSQM was administered at baseline and every 24 weeks thereafter in the TENERE extension, and at baseline, Week (W)12, W24, W48, W72, and W96 in TAURUS-MS I.
Results: In the TENERE extension, 59 patients previously randomized to SC IFNβ-1a entered the extension and received teriflunomide 14 mg. Mean (SD) age at baseline was 38.7 (10.2) years and mean (SD) baseline EDSS score was 1.9 (1.2). In TAURUS-MS I, 593 patients previously treated with another DMT (most commonly glatiramer acetate [11%]) initiated treatment with teriflunomide 14 mg. Mean (SD) age at baseline among all patients in TAURUS-MS I was 44.9 (10.2) years and mean (SD) baseline EDSS score was 2.3 (1.5). Global Satisfaction scores increased from baseline to W96 in the patients switching from another DMT to teriflunomide in both studies: mean (SD) change from baseline, 9.1 (16.4) in TENERE (P=0.0341) and 15.3 (27.4) in TAURUS-MS I (P< 0.001).
Conclusions: Improvements in treatment satisfaction scores were observed among patients switching from other DMTs to teriflunomide 14 mg in the TENERE extension and in TAURUS-MS I. The TENERE study provided evidence of improved treatment satisfaction in a small population in the clinical trial setting. The TAURUS-MS I study confirms these findings in a larger cohort in the real-world setting.
Disclosure: 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. AS: Received remuneration for providing consulting services and lectures from Bayer, Merck-Serono, Biogen, Sanofi, Teva, and Novartis. NG: Received honoraria, travel support and consultancy fees from Bayer, Biogen, Genesis Pharma, Merck Serono, Novartis, Sanofi and Teva; has received research grants from Biogen, Genesis Pharma, Merck Serono, Novartis and Teva. 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. JDS: Provided consulting services and taken part in advisory boards for Sanofi. AB: Received honoraria, travel support and consultancy fees from Novartis, Merck-Serono, Genzyme, Biogen, and Roche. Research grant support from Pfizer, Sanofi and Roche. Advisory boards for Novartis and Merck. 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. AM: Consulting fees from Accordant Health Services, Acorda Therapeutics, Adamas, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme, Mallinckrodt Pharmaceuticals [Questcor], Mapi Pharma, Novartis, contracted research for Biogen, Genentech/Roche, Genzyme/Sanofi, Mallickrodt, MedDay, Novartis; Speaker's Bureau: Biogen Idec, EMD Serono, Genentech/Roche (all for unbranded programs only). KTW: Honoraria for lectures, studies, and consultancy from Almirall, Bayer, Biogen, Genzyme, Ipsen, Merck Serono, Merz Pharma, Novartis, Roche, Sanofi, and Teva. JK: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. AC: Consulting fees, speaker honoraria from Actelion, Almirall, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Sanofi, and Teva all used for university research funds; research support from Genzyme and UCB; served as country lead investigator (Germany) for TEMSO and TENERE trials, both sponsored by Sanofi.
Study supported by Sanofi.
Abstract: P885
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. Patient-reported treatment satisfaction was assessed in both the Phase 3 TENERE study extension (NCT00883337) and in the non-interventional TAURUS-MS I study in Germany.
Objective: To describe treatment satisfaction for patients who switched from other disease modifying therapies (DMTs) to teriflunomide 14 mg in the TENERE extension and TAURUS-MS I.
Methods: In TENERE, patients were randomized (1:1:1) to teriflunomide 7 mg once daily, teriflunomide 14 mg once daily, or subcutaneous interferon β-1a 44 µg 3 times weekly (SC IFNβ-1a); patients completing the core study could enter the extension, during which all patients received teriflunomide 14 mg. In TAURUS-MS I, patients received teriflunomide 14 mg according to local labelling; a subset of patients discontinued another DMT within 6 months prior to initiating teriflunomide. In both studies, treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM; v1.4 in TENERE and v9 in TAURUS-MS I). TSQM was administered at baseline and every 24 weeks thereafter in the TENERE extension, and at baseline, Week (W)12, W24, W48, W72, and W96 in TAURUS-MS I.
Results: In the TENERE extension, 59 patients previously randomized to SC IFNβ-1a entered the extension and received teriflunomide 14 mg. Mean (SD) age at baseline was 38.7 (10.2) years and mean (SD) baseline EDSS score was 1.9 (1.2). In TAURUS-MS I, 593 patients previously treated with another DMT (most commonly glatiramer acetate [11%]) initiated treatment with teriflunomide 14 mg. Mean (SD) age at baseline among all patients in TAURUS-MS I was 44.9 (10.2) years and mean (SD) baseline EDSS score was 2.3 (1.5). Global Satisfaction scores increased from baseline to W96 in the patients switching from another DMT to teriflunomide in both studies: mean (SD) change from baseline, 9.1 (16.4) in TENERE (P=0.0341) and 15.3 (27.4) in TAURUS-MS I (P< 0.001).
Conclusions: Improvements in treatment satisfaction scores were observed among patients switching from other DMTs to teriflunomide 14 mg in the TENERE extension and in TAURUS-MS I. The TENERE study provided evidence of improved treatment satisfaction in a small population in the clinical trial setting. The TAURUS-MS I study confirms these findings in a larger cohort in the real-world setting.
Disclosure: 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. AS: Received remuneration for providing consulting services and lectures from Bayer, Merck-Serono, Biogen, Sanofi, Teva, and Novartis. NG: Received honoraria, travel support and consultancy fees from Bayer, Biogen, Genesis Pharma, Merck Serono, Novartis, Sanofi and Teva; has received research grants from Biogen, Genesis Pharma, Merck Serono, Novartis and Teva. 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. JDS: Provided consulting services and taken part in advisory boards for Sanofi. AB: Received honoraria, travel support and consultancy fees from Novartis, Merck-Serono, Genzyme, Biogen, and Roche. Research grant support from Pfizer, Sanofi and Roche. Advisory boards for Novartis and Merck. 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. AM: Consulting fees from Accordant Health Services, Acorda Therapeutics, Adamas, Alkermes, Biogen, Celgene, EMD Serono, Genentech/Roche, Genzyme, Mallinckrodt Pharmaceuticals [Questcor], Mapi Pharma, Novartis, contracted research for Biogen, Genentech/Roche, Genzyme/Sanofi, Mallickrodt, MedDay, Novartis; Speaker's Bureau: Biogen Idec, EMD Serono, Genentech/Roche (all for unbranded programs only). KTW: Honoraria for lectures, studies, and consultancy from Almirall, Bayer, Biogen, Genzyme, Ipsen, Merck Serono, Merz Pharma, Novartis, Roche, Sanofi, and Teva. JK: Employee of Sanofi with ownership interest. EP: Employee of Sanofi with ownership interest. AC: Consulting fees, speaker honoraria from Actelion, Almirall, Bayer, Biogen, Celgene, Genzyme, Merck, Novartis, Roche, Sanofi, and Teva all used for university research funds; research support from Genzyme and UCB; served as country lead investigator (Germany) for TEMSO and TENERE trials, both sponsored by Sanofi.
Study supported by Sanofi.