Contributions
Abstract: EP1682
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Dimethyl fumarate (DMF) is an oral therapy for relapsing-remitting multiple sclerosis (RRMS), the efficacy of which has been shown in phase II and III studies. However; post-marketing surveillance is important to determine the long-term safety and effectiveness in a real-world setting. DMF has therefore been included into the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology” (IMSE).
Objectives: To follow-up the long-term safety and effectiveness of DMF in a real-world setting.
Methods: MS patients in Sweden are registered into the nationwide web-based Swedish Neuro registry (Neuroreg). The IMSE study includes descriptive data of adverse events (AEs), extended disability status scale (EDSS), MS severity scale (MSSS), symbol digit modalities test (SDMT), MS impact scale (MSIS-29), European quality five dimensions (EQ-5D) and Visual Analog scale (VAS) obtained from Neuroreg. Blood samples are collected at baseline and after 12 and 24 months of treatment. Drug survival was measured using the Kaplan-Meier curve and effectiveness measures were assessed using the Wilcoxon Signed Rank Test.
Results: 1820 DMF-treated patients have been included in the IMSE 5 study between March 25th, 2014 and April 30th, 2017 most of which have switched from interferons or glatiramer acetate (44%), 23% of the patients were treatment naïve (11% missing data on prior treatment). 91% of the patients have RRMS (4% missing data on MS phenotype). The mean treatment duration is 18.0 ± 11.1 months, the mean age at treatment start is 40.8 ± 11.0 years and 73% are female.
The one year drug survival was 74% and discontinuation was significantly more common among female than male patients (p< 0.05).
In patients treated with DMF continuously for ≥24 months (n=669), significant improvements in mean values at 24 months of treatment compared to mean baseline values have been noted for MSSS by 24% (2.6 ± 2.4 to 2.1 ± 2.2, n=120); SDMT by 2% (52.0 ± 10.8 to 53.0 ± 11.4, n=242); and MSIS-29 Psychological subscale by 15% (27.9 ± 23.0 to 24.3 ± 21.1, n=240). EDSS, MSIS-29 Physical subscale, EQ-5D and VAS did not improve significantly.
Conclusions: Neuroreg proves to function well as a post-marketing drug surveillance platform, providing data regarding drug effectiveness and AEs. DMF is generally well tolerated; however a longer follow-up period is needed to assess the real-world effectiveness and safety of DMF.
Disclosure: The IMSE 5 study has received unrestricted grants from Biogen.
Linda Forsberg has nothing to disclose.
Stina Kågström has nothing to disclose.
Åsa Leandersson has nothing to disclose.
Anders Berglund is employed at Biogen, Sweden
Jan Hillert has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering.His MS research is funded by the Swedish Research Council and the Swedish Brain foundation.
Petra Nilsson has received travel support from Bayer Schering Pharma, Merck Serono, Biogen and Sanofi Genzyme, honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme, advisory boards for Novartis and Roche, lectures for Biogen and has received unrestricted grants from Biogen.
Charlotte Dahle has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Anders Svenningsson has nothing to disclose.
Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Novartis, Teva and Sanofi Genzyme; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Sanofi Genzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
Anne-Marie Landtblom has received honoraria from Merck Serono, Teva, Biogen Sanofi Genzyme.
Joachim Burman has received travel support and/or lecture honoraria from Almirall, Biogen, Sanofi Genzyme, Hospira and Merck Serono; has received unconditional research grants from Biogen and Merck Serono.
Fredrik Walentin has received research grants from Biogen and Merck Serono.
Claes Martin has received honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme.
Fredrik Piehl has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merck Serono, Novartis, Sanofi Genzyme and Teva, which have been exclusively used for the support of research activities.
Tomas Olsson has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Abstract: EP1682
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Dimethyl fumarate (DMF) is an oral therapy for relapsing-remitting multiple sclerosis (RRMS), the efficacy of which has been shown in phase II and III studies. However; post-marketing surveillance is important to determine the long-term safety and effectiveness in a real-world setting. DMF has therefore been included into the Swedish post-market surveillance study “Immunomodulation and Multiple Sclerosis Epidemiology” (IMSE).
Objectives: To follow-up the long-term safety and effectiveness of DMF in a real-world setting.
Methods: MS patients in Sweden are registered into the nationwide web-based Swedish Neuro registry (Neuroreg). The IMSE study includes descriptive data of adverse events (AEs), extended disability status scale (EDSS), MS severity scale (MSSS), symbol digit modalities test (SDMT), MS impact scale (MSIS-29), European quality five dimensions (EQ-5D) and Visual Analog scale (VAS) obtained from Neuroreg. Blood samples are collected at baseline and after 12 and 24 months of treatment. Drug survival was measured using the Kaplan-Meier curve and effectiveness measures were assessed using the Wilcoxon Signed Rank Test.
Results: 1820 DMF-treated patients have been included in the IMSE 5 study between March 25th, 2014 and April 30th, 2017 most of which have switched from interferons or glatiramer acetate (44%), 23% of the patients were treatment naïve (11% missing data on prior treatment). 91% of the patients have RRMS (4% missing data on MS phenotype). The mean treatment duration is 18.0 ± 11.1 months, the mean age at treatment start is 40.8 ± 11.0 years and 73% are female.
The one year drug survival was 74% and discontinuation was significantly more common among female than male patients (p< 0.05).
In patients treated with DMF continuously for ≥24 months (n=669), significant improvements in mean values at 24 months of treatment compared to mean baseline values have been noted for MSSS by 24% (2.6 ± 2.4 to 2.1 ± 2.2, n=120); SDMT by 2% (52.0 ± 10.8 to 53.0 ± 11.4, n=242); and MSIS-29 Psychological subscale by 15% (27.9 ± 23.0 to 24.3 ± 21.1, n=240). EDSS, MSIS-29 Physical subscale, EQ-5D and VAS did not improve significantly.
Conclusions: Neuroreg proves to function well as a post-marketing drug surveillance platform, providing data regarding drug effectiveness and AEs. DMF is generally well tolerated; however a longer follow-up period is needed to assess the real-world effectiveness and safety of DMF.
Disclosure: The IMSE 5 study has received unrestricted grants from Biogen.
Linda Forsberg has nothing to disclose.
Stina Kågström has nothing to disclose.
Åsa Leandersson has nothing to disclose.
Anders Berglund is employed at Biogen, Sweden
Jan Hillert has received honoraria for serving on advisory boards for Biogen, Sanofi-Genzyme and Novartis and speaker's fees from Biogen, Novartis, Merck-Serono, Bayer-Schering, Teva and Sanofi-Genzyme. He has served as P.I. for projects, or received unrestricted research support from, BiogenIdec, Merck-Serono, TEVA, Sanofi-Genzyme and Bayer-Schering.His MS research is funded by the Swedish Research Council and the Swedish Brain foundation.
Petra Nilsson has received travel support from Bayer Schering Pharma, Merck Serono, Biogen and Sanofi Genzyme, honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme, advisory boards for Novartis and Roche, lectures for Biogen and has received unrestricted grants from Biogen.
Charlotte Dahle has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Anders Svenningsson has nothing to disclose.
Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Novartis, Teva and Sanofi Genzyme; has served on scientific advisory boards for Almirall, Teva, Biogen, Novartis and Sanofi Genzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
Anne-Marie Landtblom has received honoraria from Merck Serono, Teva, Biogen Sanofi Genzyme.
Joachim Burman has received travel support and/or lecture honoraria from Almirall, Biogen, Sanofi Genzyme, Hospira and Merck Serono; has received unconditional research grants from Biogen and Merck Serono.
Fredrik Walentin has received research grants from Biogen and Merck Serono.
Claes Martin has received honoraria for lectures and advisory boards from Merck Serono and Sanofi Genzyme.
Fredrik Piehl has received unrestricted academic research grants from Biogen, Genzyme and Novartis, and travel support and/or compensation for lectures and/or participation in advisory boards from Biogen, Merck Serono, Novartis, Sanofi Genzyme and Teva, which have been exclusively used for the support of research activities.
Tomas Olsson has received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.