Jérôme de Sèze1, Richard Devy2, Evelyne Planque3, Jean Philippe Delabrousse-Mayoux4, Olivier Vandhuick5, Marmar Kabir6, Amel Gherib7. 1. Strasbourg University, Hôpital Civil, Strasbourg, France. Electronic address: Jerome.DESEZE@chru-strasbourg.fr. 2. Polyclinique Bordeaux Caudéran, France. 3. SCP Doctors, Épinal, France. 4. Neurology Practice, Bergerac, France. 5. Meridian Center, Rouen, France. 6. Sanofi, Chilly-Mazarin, France. 7. Sanofi, Gentilly, France.
Abstract
BACKGROUND: Fatigue is a frequent and disabling symptom of multiple sclerosis (MS) often associated with impaired quality of life (QoL) in patients. Teriflunomide is a once-daily oral immunomodulator used for the treatment of relapsing remitting forms of MS. However, its effect on fatigue is not well known in real life practice. We evaluated the impact of teriflunomide on fatigue in patients with relapsing remitting MS (RRMS) after 2 years of treatment in the real-world Teri-FAST study. METHODS: Teri-FAST was a 2-year, prospective, observational study conducted in France in RRMS patients treated with teriflunomide 14 mg. Fatigue was assessed using the French version of the modified fatigue impact scale (EMIF-SEP). The primary endpoint was the change from baseline in EMIF-SEP score after 2 years of treatment. Secondary endpoints included evaluation of depression (Beck Depression Inventory [BDI]), health-related QoL (Two-Life Scale TLS-QoL 10), self-reported physical activity, and adverse events. RESULTS: 210 eligible patients were included in the study with a mean age of 45.4 years and a mean ± SD Expanded Disability Status Scale score of 1.76 ± 1.43 at baseline. About half (52.4%) of patients had no previous treatment for MS. In the 163 patients who completed at least 1 follow-up visit, the mean change in EMIF-SEP score at Year 2 was -1.54 (95% CI: -4.02, 0.94) indicating that fatigue remained stable. Similarly, there were no changes in depression level and QoL after 2 years of treatment. Physical activity slightly improved with 57% of patients reporting being physically active after 2 years as compared to 46% at baseline. The safety profile of teriflunomide was consistent with that seen during clinical development, and compliance with treatment was high. CONCLUSION: Fatigue scores remained stable in RRMS patients treated with teriflunomide 14 mg over 2 years in real-life setting. Teriflunomide did not negatively impact depression or QoL.
BACKGROUND:Fatigue is a frequent and disabling symptom of multiple sclerosis (MS) often associated with impaired quality of life (QoL) in patients. Teriflunomide is a once-daily oral immunomodulator used for the treatment of relapsing remitting forms of MS. However, its effect on fatigue is not well known in real life practice. We evaluated the impact of teriflunomide on fatigue in patients with relapsing remitting MS (RRMS) after 2 years of treatment in the real-world Teri-FAST study. METHODS: Teri-FAST was a 2-year, prospective, observational study conducted in France in RRMS patients treated with teriflunomide 14 mg. Fatigue was assessed using the French version of the modified fatigue impact scale (EMIF-SEP). The primary endpoint was the change from baseline in EMIF-SEP score after 2 years of treatment. Secondary endpoints included evaluation of depression (Beck Depression Inventory [BDI]), health-related QoL (Two-Life Scale TLS-QoL 10), self-reported physical activity, and adverse events. RESULTS: 210 eligible patients were included in the study with a mean age of 45.4 years and a mean ± SD Expanded Disability Status Scale score of 1.76 ± 1.43 at baseline. About half (52.4%) of patients had no previous treatment for MS. In the 163 patients who completed at least 1 follow-up visit, the mean change in EMIF-SEP score at Year 2 was -1.54 (95% CI: -4.02, 0.94) indicating that fatigue remained stable. Similarly, there were no changes in depression level and QoL after 2 years of treatment. Physical activity slightly improved with 57% of patients reporting being physically active after 2 years as compared to 46% at baseline. The safety profile of teriflunomide was consistent with that seen during clinical development, and compliance with treatment was high. CONCLUSION:Fatigue scores remained stable in RRMS patients treated with teriflunomide 14 mg over 2 years in real-life setting. Teriflunomide did not negatively impact depression or QoL.