Contributions
Abstract: EP1638
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Teriflunomide, a once-daily, oral first-line disease modifying treatment (DMT), has demonstrate efficacy and safety in patients with relapsing-remitting multiple sclerosis (RRMS) through numerous clinical trials, but there is a shortage of data from real-world evidence.
Objective: To describe our experience with teriflunomide in clinical practice within the two years of follow up in terms of efficacy and safety.
Methods: Prospective, observational, noncontrolled study with 116 patients. We evaluated the clinical effectiveness (annualized relapse rate -ARR- and expanded disability status scale -EDSS-) and safety of teriflunomide in those patients who completed the two years of treament. Changes in MRI performed at year 1 after receiving teriflunomide was also evaluated. Patients with clinical activity and those who discontinued teriflunomide for any reason before completing one year of follow-up, or between the first and second year, were classified in the group of patients who completed one year and two years of follow-up, respectively.
Results: We analyzed 116 patients who switched to teriflunomide, due to adverse events (59.5%) or unefficacy (19%) to previous DMTs (86.7% injectable immunomodulators; 9.2% dimethyl fumarate; 4,1% natalizumab), or as first-line treatment (21.5%). Median age was 42 [range 21-65]. 71% women (64% < 45 years). Time of disease evolution: 46% < 4 years, 30% between 5-10 years, 24% >10 years. Mean baseline ARR vs mean ARR 1-year and 2-years: 0.49 vs 0.17 and 0.21 (ARR reduction: 65.4% and 57.2% respectively, p< 0.0001). Mean baseline EDSS vs mean EDSS 1-year and 2-years: 2.41 vs 2.16 and 2.36 respectively (p>0.05). Annual MRI showed 88% and 90% of patients without new lesions in T2 or gadolinium enhanced lesions, respectively. 98 patients completed 1-year follow-up, 75 2-years and 13 without clinical activity have not completed 2-years follow-up yet. 18 and 10 patients discontinued teriflunomide during the first year (9 ineffectiveness, 9 adverse events) and the second year (6 ineffectiveness, 4 adverse events) respectively. None of them discontinued due to hepatic disorders.
Conclusion: In our experience, teriflunomide shows a high effectiveness and a good safety profile in real-life settings in the short and medium term,which make it an outstanding therapeutic option not only for naïve and patients who switched because of lack of efficacy, but also for those who switched due to adverse effects with previous DMTs.
Disclosure: J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
The other authors disclose neither conflict of interest in the elaboration of this communication.
Authors have not received any funding for the elaboration of this study.
Abstract: EP1638
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Teriflunomide, a once-daily, oral first-line disease modifying treatment (DMT), has demonstrate efficacy and safety in patients with relapsing-remitting multiple sclerosis (RRMS) through numerous clinical trials, but there is a shortage of data from real-world evidence.
Objective: To describe our experience with teriflunomide in clinical practice within the two years of follow up in terms of efficacy and safety.
Methods: Prospective, observational, noncontrolled study with 116 patients. We evaluated the clinical effectiveness (annualized relapse rate -ARR- and expanded disability status scale -EDSS-) and safety of teriflunomide in those patients who completed the two years of treament. Changes in MRI performed at year 1 after receiving teriflunomide was also evaluated. Patients with clinical activity and those who discontinued teriflunomide for any reason before completing one year of follow-up, or between the first and second year, were classified in the group of patients who completed one year and two years of follow-up, respectively.
Results: We analyzed 116 patients who switched to teriflunomide, due to adverse events (59.5%) or unefficacy (19%) to previous DMTs (86.7% injectable immunomodulators; 9.2% dimethyl fumarate; 4,1% natalizumab), or as first-line treatment (21.5%). Median age was 42 [range 21-65]. 71% women (64% < 45 years). Time of disease evolution: 46% < 4 years, 30% between 5-10 years, 24% >10 years. Mean baseline ARR vs mean ARR 1-year and 2-years: 0.49 vs 0.17 and 0.21 (ARR reduction: 65.4% and 57.2% respectively, p< 0.0001). Mean baseline EDSS vs mean EDSS 1-year and 2-years: 2.41 vs 2.16 and 2.36 respectively (p>0.05). Annual MRI showed 88% and 90% of patients without new lesions in T2 or gadolinium enhanced lesions, respectively. 98 patients completed 1-year follow-up, 75 2-years and 13 without clinical activity have not completed 2-years follow-up yet. 18 and 10 patients discontinued teriflunomide during the first year (9 ineffectiveness, 9 adverse events) and the second year (6 ineffectiveness, 4 adverse events) respectively. None of them discontinued due to hepatic disorders.
Conclusion: In our experience, teriflunomide shows a high effectiveness and a good safety profile in real-life settings in the short and medium term,which make it an outstanding therapeutic option not only for naïve and patients who switched because of lack of efficacy, but also for those who switched due to adverse effects with previous DMTs.
Disclosure: J. Meca-Lallana has received consulting or speaking fees from Almirall, Biogen, Genzyme, Merck Serono, Novartis, Roche and Teva.
The other authors disclose neither conflict of interest in the elaboration of this communication.
Authors have not received any funding for the elaboration of this study.