Contributions
Abstract: EP1510
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: The efficacy of Natalizumab (NTZ), Fingolimod (FTY), Dimethylfumarate (DMF), Teriflunomide (TERI) and Alemtuzumab (AZM) in the treatment of relapsing-remitting multiple sclerosis (MS) has been proven in randomized trials. However, such trials do not necessarily reflect real-life situations faced in everyday practice. The Austrian MS Treatment Registry (AMSTR), established in 2006 and extended in 2011, 2014 and 2015 to maintain quality control and comply with reimbursement regulations of the Austrian sick funds, allows to obtain such data, to assess indications, the clinical profiles of the treated populations and to monitor safety in a real life setting.
Methods: The baseline documentation within the AMSTR includes duration of disease, relapses within the last 12 months, EDSS, MRI activity and previous disease modifying therapies. Entry of follow up data (relapses, EDSS, adverse events) is required at 3 months intervals. In addition, changes in treatment are documented. The statistical values below indicate means (range), unless otherwise indicated.
Results: As of April 16th 2016, the registry comprised 1402 patients started with NTZ (70.8% female), 693 patients with FTY (68.7% female), 204 patients with DMF (68.6% female), 138 patients with TERI (60.1% female) and 12 patients with AZM (41.7% female). DMF and TERI are reimbursed only since August 2015 in Austria. Altogether 353 patients switched within the AMSTR, most from NTZ to FTY (n=284). At baseline, the mean age was 35.3 (14-67) years in the NTZ, 39.1 (16-72) years in the FTY, 37.4 (16-67) years in the DMF, 42.1 (18-71) years in the TERI and 32.9 (24-46) years in the AZM group, with disease durations of 7.6 (0-40), 9.1 (0-39), 6.9 (0-25), 8.2 (0-28) and 3.0 (0-12) years respectively. The relapse rate in the year before start of respective drugs was 2.2 with NTZ, 1.6 with FTY, 0.9 with DMF, 0.6 with TERI and 2.2 with AZM. For those treated for at least one year, the subsequent annualized relapse rates decreased to 0.20 (NTZ), 0.23 (FTY), 0.16 (DMF), 0.22 (TERI) and 0 (AZM).
Conclusion: The availability of an increasingly broad treatment armamentarium with its consequences for daily practice (e.g. monitoring long-term benefit/risk profiles of individual drugs but also of their sequential use) emphasizes the need and the crucial importance of this registry for improved real life management of MS patients in Austria.
Disclosure:
Dr. Guger received support and honoraria for research, consultation, lectures and education from Allmirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Sanofi Aventis, Roche and TEVA ratiopharm.
Dr. Enzinger has received funding for travel and speaker honoraria from Biogen, Bayer Schering Pharma, Merck Serono, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd./sanofi-aventis.
Dr. Leutmezer has received funding for travel and speaker honoraria from Biogen, Bayer Schering Pharma, Merck Serono, Novartis, Genzyme, Santhera and Teva Pharmaceutical Industries Ltd./sanofi-aventis.
Dr. Kraus received support for research, consultation, and education from Allmirall, Bayer, Biogen-Idec, Biotest, Genzyme, Medtronic, Merck-Serono, Novartis, Octapharma, Sanofi-Aventis, TEVA ratiopharm.
Thomas Berger has participated in meetings sponsored by and received honoraria from Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, ratiopharm, Roche, Sanofi Aventis and TEVA.
Abstract: EP1510
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: The efficacy of Natalizumab (NTZ), Fingolimod (FTY), Dimethylfumarate (DMF), Teriflunomide (TERI) and Alemtuzumab (AZM) in the treatment of relapsing-remitting multiple sclerosis (MS) has been proven in randomized trials. However, such trials do not necessarily reflect real-life situations faced in everyday practice. The Austrian MS Treatment Registry (AMSTR), established in 2006 and extended in 2011, 2014 and 2015 to maintain quality control and comply with reimbursement regulations of the Austrian sick funds, allows to obtain such data, to assess indications, the clinical profiles of the treated populations and to monitor safety in a real life setting.
Methods: The baseline documentation within the AMSTR includes duration of disease, relapses within the last 12 months, EDSS, MRI activity and previous disease modifying therapies. Entry of follow up data (relapses, EDSS, adverse events) is required at 3 months intervals. In addition, changes in treatment are documented. The statistical values below indicate means (range), unless otherwise indicated.
Results: As of April 16th 2016, the registry comprised 1402 patients started with NTZ (70.8% female), 693 patients with FTY (68.7% female), 204 patients with DMF (68.6% female), 138 patients with TERI (60.1% female) and 12 patients with AZM (41.7% female). DMF and TERI are reimbursed only since August 2015 in Austria. Altogether 353 patients switched within the AMSTR, most from NTZ to FTY (n=284). At baseline, the mean age was 35.3 (14-67) years in the NTZ, 39.1 (16-72) years in the FTY, 37.4 (16-67) years in the DMF, 42.1 (18-71) years in the TERI and 32.9 (24-46) years in the AZM group, with disease durations of 7.6 (0-40), 9.1 (0-39), 6.9 (0-25), 8.2 (0-28) and 3.0 (0-12) years respectively. The relapse rate in the year before start of respective drugs was 2.2 with NTZ, 1.6 with FTY, 0.9 with DMF, 0.6 with TERI and 2.2 with AZM. For those treated for at least one year, the subsequent annualized relapse rates decreased to 0.20 (NTZ), 0.23 (FTY), 0.16 (DMF), 0.22 (TERI) and 0 (AZM).
Conclusion: The availability of an increasingly broad treatment armamentarium with its consequences for daily practice (e.g. monitoring long-term benefit/risk profiles of individual drugs but also of their sequential use) emphasizes the need and the crucial importance of this registry for improved real life management of MS patients in Austria.
Disclosure:
Dr. Guger received support and honoraria for research, consultation, lectures and education from Allmirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, Sanofi Aventis, Roche and TEVA ratiopharm.
Dr. Enzinger has received funding for travel and speaker honoraria from Biogen, Bayer Schering Pharma, Merck Serono, Novartis, Genzyme and Teva Pharmaceutical Industries Ltd./sanofi-aventis.
Dr. Leutmezer has received funding for travel and speaker honoraria from Biogen, Bayer Schering Pharma, Merck Serono, Novartis, Genzyme, Santhera and Teva Pharmaceutical Industries Ltd./sanofi-aventis.
Dr. Kraus received support for research, consultation, and education from Allmirall, Bayer, Biogen-Idec, Biotest, Genzyme, Medtronic, Merck-Serono, Novartis, Octapharma, Sanofi-Aventis, TEVA ratiopharm.
Thomas Berger has participated in meetings sponsored by and received honoraria from Almirall, Bayer, Biogen, Genzyme, Merck, Novartis, Octapharma, ratiopharm, Roche, Sanofi Aventis and TEVA.