Contributions
Abstract: P918
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Teriflunomide, a once-daily oral immunomodulator approved in 80 countries for treatment of relapsing forms of MS, shows well-characterised efficacy and long-term safety in clinical studies.
Objective: To evaluate the effectiveness, safety, tolerability and patient satisfaction of teriflunomide treatment in real-world clinical practice in Germany.
Methods: TAURUS-MS I was conducted from January 2014-April 2017. Patients were ≥18 years of age, had relapsing remitting MS (RRMS), and received teriflunomide 14 mg once daily. Patients were followed per routine clinical practice for 24 months. The primary endpoint was frequency of steroid-dependent MS relapses. Secondary endpoints included fatigue, patient satisfaction and tolerability.
Results: There were 1128 patients in the per-protocol population (67.5% female; mean [SD] age 44.9 [10.2] years; mean [SD] time since diagnosis 8.9 [7.6] years). Three-quarters (848/1128, 75.2%) of patients previously received MS-specific immune therapy and 24.8% (280/1128) were treatment-naïve. Prior therapy was discontinued due to adverse reactions in 59.0% (500/848) of patients and for lack of efficacy in 24.2% (205/848). Mean [SD] number of MS relapses over the 24 months of teriflunomide treatment was 0.4 [0.7] compared with 0.9 [1.1] in the 24 months before starting teriflunomide (P≤0.001). The fatigue severity scale score decreased by -0.2 [1.7] points from baseline to 24 months (P=0.06). Treatment Satisfaction Questionnaire for Medication-9 scores for effectiveness, convenience and global satisfaction increased significantly (reflecting improved satisfaction) during treatment with teriflunomide (mean [SD] change from baseline to 24 months: 7.6 [27.9], 14.0 [25.9], and 12.8 [26.7] points, respectively; all P≤0.001 vs baseline). Mean Expanded Disability Status Scale (EDSS) score was stable over 24 months (baseline, 2.3; 24 months, 2.4). Teriflunomide was generally well tolerated. A total of 408/1139 patients in the safety analysis set experienced an adverse event (AE) (35.8%), most commonly diarrhoea (4.8%), MS relapse (4.2%) and hair thinning (3.3%). The rate of serious AEs was 13.0%.
Conclusions: Teriflunomide demonstrated sustained effectiveness over 24 months in a diverse population of RRMS patients in the real-world setting, of which a quarter had discontinued prior therapy due to a lack of efficacy. The benefit-risk ratio of teriflunomide was favourable and consistent with that in clinical trials.
Disclosure: TR: Received personal compensation from Abbvie, Bayer, Biogen, Genzyme, Merck, Novartis, Pfizer, Roche, Sanofi, and Teva. UE: Employee of Sanofi. JK: Employee of Sanofi. AC: Received research support and personal compensation from Bayer, Biogen, Sanofi, Genzyme, Merck, Novartis, Roche, Teva, and UCB. Study supported by Sanofi.
Abstract: P918
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Background: Teriflunomide, a once-daily oral immunomodulator approved in 80 countries for treatment of relapsing forms of MS, shows well-characterised efficacy and long-term safety in clinical studies.
Objective: To evaluate the effectiveness, safety, tolerability and patient satisfaction of teriflunomide treatment in real-world clinical practice in Germany.
Methods: TAURUS-MS I was conducted from January 2014-April 2017. Patients were ≥18 years of age, had relapsing remitting MS (RRMS), and received teriflunomide 14 mg once daily. Patients were followed per routine clinical practice for 24 months. The primary endpoint was frequency of steroid-dependent MS relapses. Secondary endpoints included fatigue, patient satisfaction and tolerability.
Results: There were 1128 patients in the per-protocol population (67.5% female; mean [SD] age 44.9 [10.2] years; mean [SD] time since diagnosis 8.9 [7.6] years). Three-quarters (848/1128, 75.2%) of patients previously received MS-specific immune therapy and 24.8% (280/1128) were treatment-naïve. Prior therapy was discontinued due to adverse reactions in 59.0% (500/848) of patients and for lack of efficacy in 24.2% (205/848). Mean [SD] number of MS relapses over the 24 months of teriflunomide treatment was 0.4 [0.7] compared with 0.9 [1.1] in the 24 months before starting teriflunomide (P≤0.001). The fatigue severity scale score decreased by -0.2 [1.7] points from baseline to 24 months (P=0.06). Treatment Satisfaction Questionnaire for Medication-9 scores for effectiveness, convenience and global satisfaction increased significantly (reflecting improved satisfaction) during treatment with teriflunomide (mean [SD] change from baseline to 24 months: 7.6 [27.9], 14.0 [25.9], and 12.8 [26.7] points, respectively; all P≤0.001 vs baseline). Mean Expanded Disability Status Scale (EDSS) score was stable over 24 months (baseline, 2.3; 24 months, 2.4). Teriflunomide was generally well tolerated. A total of 408/1139 patients in the safety analysis set experienced an adverse event (AE) (35.8%), most commonly diarrhoea (4.8%), MS relapse (4.2%) and hair thinning (3.3%). The rate of serious AEs was 13.0%.
Conclusions: Teriflunomide demonstrated sustained effectiveness over 24 months in a diverse population of RRMS patients in the real-world setting, of which a quarter had discontinued prior therapy due to a lack of efficacy. The benefit-risk ratio of teriflunomide was favourable and consistent with that in clinical trials.
Disclosure: TR: Received personal compensation from Abbvie, Bayer, Biogen, Genzyme, Merck, Novartis, Pfizer, Roche, Sanofi, and Teva. UE: Employee of Sanofi. JK: Employee of Sanofi. AC: Received research support and personal compensation from Bayer, Biogen, Sanofi, Genzyme, Merck, Novartis, Roche, Teva, and UCB. Study supported by Sanofi.