Contributions
Abstract: P707
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS (RRMS). Teri-PRO (NCT01895335), a global phase 4 study, previously demonstrated high levels of treatment satisfaction with teriflunomide together with improvements on other patient-reported outcomes (PROs). TAURUS-MS I and II (Germany), TACO (Switzerland), Teri-LIFE (Nordics), AURELIO (Greece), and Teri-CARE (Spain) are regional studies evaluating quality of life (QoL) and treatment satisfaction in patients with RRMS treated with teriflunomide in a real-world clinical setting.
Objective(s): To evaluate patient-reported QoL and treatment satisfaction from several separate regional studies throughout Europe in patients with RRMS treated with teriflunomide.
Methods: TAURUS-MS I and II, TACO, Teri-LIFE, AURELIO, and Teri-CARE are multicentre, prospective, non-interventional, ≤2-year studies in patients with RRMS receiving teriflunomide 14 mg, as per local labelling. These studies will evaluate a range of PROs to assess the impact of teriflunomide on QoL, fatigue, disease and disability progression, safety and overall treatment satisfaction. Target enrolment: n=1115 for TAURUS-MS I, n=1080 for TAURUS-MS II, n=120 for TACO, n=200 for Teri-LIFE, n=350 for AURELIO, and n=323 for Teri-CARE. Visits are scheduled at baseline, and at Month (M)1 (AURELIO only), M3 (TAURUS-MS I and II), M6, M12, and M18 until M24 (end of study) after start of teriflunomide treatment.
Results: The majority of these regional studies are currently ongoing, and a full update will be presented. The most advanced of these studies, TAURUS-MS I, has completed enrolment. Out of the 1115 patients enrolled in TAURUS-MS I, data from 733 patients who received teriflunomide treatment for 1 year (≥9 months) are available. Mean (SD) TSQM-9 scores at baseline/M12 were: Global Satisfaction 64.7 (24.1)/74.6 (22.3); Convenience 74.8 (24.2)/91.0 (11.2); and Effectiveness 62.1 (23.6)/69.0 (23.8).
Conclusions: PROs provide valuable additional insights into the effect of MS therapies on QoL and disease progression, and may help inform decisions regarding patient treatment and care. These non-interventional studies will evaluate the impact of teriflunomide on PROs in different countries. As many of the PROs included are identical across the studies, data will ultimately be integrated to further characterise the real-world effectiveness of teriflunomide.
Disclosure: Study supported by Sanofi Genzyme
AC: Consulting fees, speaker honoraria (Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva); research support (Biogen Idec, Genzyme, Novartis); has served as country lead investigator (Germany) for TEMSO and TENERE trials (sponsored by Sanofi).
CB: Speaker bureaus (Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Teva).
MM: Honoraria for lectures (Bayer HealthCare, Biogen Idec, Boehringer Ingelheim, Genzyme, Merck Serono, Novartis, Sanofi, Talecris, Teva)
PR, EP: Employees of Sanofi Genzyme.
JML: Consulting fees (Almirall, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva).
Abstract: P707
Type: Poster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Teriflunomide is a once-daily oral immunomodulator approved for the treatment of relapsing-remitting MS (RRMS). Teri-PRO (NCT01895335), a global phase 4 study, previously demonstrated high levels of treatment satisfaction with teriflunomide together with improvements on other patient-reported outcomes (PROs). TAURUS-MS I and II (Germany), TACO (Switzerland), Teri-LIFE (Nordics), AURELIO (Greece), and Teri-CARE (Spain) are regional studies evaluating quality of life (QoL) and treatment satisfaction in patients with RRMS treated with teriflunomide in a real-world clinical setting.
Objective(s): To evaluate patient-reported QoL and treatment satisfaction from several separate regional studies throughout Europe in patients with RRMS treated with teriflunomide.
Methods: TAURUS-MS I and II, TACO, Teri-LIFE, AURELIO, and Teri-CARE are multicentre, prospective, non-interventional, ≤2-year studies in patients with RRMS receiving teriflunomide 14 mg, as per local labelling. These studies will evaluate a range of PROs to assess the impact of teriflunomide on QoL, fatigue, disease and disability progression, safety and overall treatment satisfaction. Target enrolment: n=1115 for TAURUS-MS I, n=1080 for TAURUS-MS II, n=120 for TACO, n=200 for Teri-LIFE, n=350 for AURELIO, and n=323 for Teri-CARE. Visits are scheduled at baseline, and at Month (M)1 (AURELIO only), M3 (TAURUS-MS I and II), M6, M12, and M18 until M24 (end of study) after start of teriflunomide treatment.
Results: The majority of these regional studies are currently ongoing, and a full update will be presented. The most advanced of these studies, TAURUS-MS I, has completed enrolment. Out of the 1115 patients enrolled in TAURUS-MS I, data from 733 patients who received teriflunomide treatment for 1 year (≥9 months) are available. Mean (SD) TSQM-9 scores at baseline/M12 were: Global Satisfaction 64.7 (24.1)/74.6 (22.3); Convenience 74.8 (24.2)/91.0 (11.2); and Effectiveness 62.1 (23.6)/69.0 (23.8).
Conclusions: PROs provide valuable additional insights into the effect of MS therapies on QoL and disease progression, and may help inform decisions regarding patient treatment and care. These non-interventional studies will evaluate the impact of teriflunomide on PROs in different countries. As many of the PROs included are identical across the studies, data will ultimately be integrated to further characterise the real-world effectiveness of teriflunomide.
Disclosure: Study supported by Sanofi Genzyme
AC: Consulting fees, speaker honoraria (Almirall, Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi, Teva); research support (Biogen Idec, Genzyme, Novartis); has served as country lead investigator (Germany) for TEMSO and TENERE trials (sponsored by Sanofi).
CB: Speaker bureaus (Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Teva).
MM: Honoraria for lectures (Bayer HealthCare, Biogen Idec, Boehringer Ingelheim, Genzyme, Merck Serono, Novartis, Sanofi, Talecris, Teva)
PR, EP: Employees of Sanofi Genzyme.
JML: Consulting fees (Almirall, Biogen Idec, Merck Serono, Novartis, Sanofi, Teva).