Contributions
Abstract: P697
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Dimethyl fumarate (DMF) is a novel 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 MS registry (SMSreg). 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 SMSreg. Blood samples are collected at baseline and after 12 months of treatment. Drug survival was measured using the Kaplan-Meier curve and effectiveness measures were assessed using the Wilcoxon Signed Rank Test.
Results: 1,565 DMF-treated patients have been included in the IMSE 5 study between March 25th, 2014 and March 31th, 2016 most of which have switched from interferons or glatiramer acetate (47%), 21% of the patients were treatment naïve (10% missing data on prior treatment). 89% of the patients have RRMS (6% missing data on MS phenotype). The mean treatment duration is 11.0±6.6 months, the mean age at treatment start is 41.0±11.0 years and 74% are female.
The one year drug survival was 76% and discontinuation was significantly more common among female than male patients (p< 0.05). 355 patients terminated their treatment at some point. The most common reason for discontinuation was AEs (58%) and lack of effect (27%).
In patients treated with DMF continuously for ≥12 months (n=549), significant improvements in mean values at 12 months of treatment compared to mean baseline values have been noted for EDSS scores by 8%; MSSS by 16%; SDMT by 1%; MSIS-29 Psychological by 15% EQ-5D by 6%, and VAS by 3%.
Conclusions: SMSreg 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.
Susanne Johansson and Linda Forsberg: Nothing to disclose.
Jan Hillert, Fredrik Piehl, Charlotte Dahle and Tomas Olsson have received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Claes Martin has received honoraria for lectures and advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
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.
Anders Svenningsson has served on advisory board for Sanofi Genzyme and has received travel funding from Biogen, Novartis and Baxter Medical.
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.
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.
Anne-Marie Landtblom has received honoraria from Merck Serono, Teva, Biogen Sanofi Genzyme.
Fredrik Walentin has received research grants from Biogen and Merck Serono.
Abstract: P697
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Dimethyl fumarate (DMF) is a novel 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 MS registry (SMSreg). 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 SMSreg. Blood samples are collected at baseline and after 12 months of treatment. Drug survival was measured using the Kaplan-Meier curve and effectiveness measures were assessed using the Wilcoxon Signed Rank Test.
Results: 1,565 DMF-treated patients have been included in the IMSE 5 study between March 25th, 2014 and March 31th, 2016 most of which have switched from interferons or glatiramer acetate (47%), 21% of the patients were treatment naïve (10% missing data on prior treatment). 89% of the patients have RRMS (6% missing data on MS phenotype). The mean treatment duration is 11.0±6.6 months, the mean age at treatment start is 41.0±11.0 years and 74% are female.
The one year drug survival was 76% and discontinuation was significantly more common among female than male patients (p< 0.05). 355 patients terminated their treatment at some point. The most common reason for discontinuation was AEs (58%) and lack of effect (27%).
In patients treated with DMF continuously for ≥12 months (n=549), significant improvements in mean values at 12 months of treatment compared to mean baseline values have been noted for EDSS scores by 8%; MSSS by 16%; SDMT by 1%; MSIS-29 Psychological by 15% EQ-5D by 6%, and VAS by 3%.
Conclusions: SMSreg 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.
Susanne Johansson and Linda Forsberg: Nothing to disclose.
Jan Hillert, Fredrik Piehl, Charlotte Dahle and Tomas Olsson have received unrestricted research grants or honoraria for lectures or advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
Claes Martin has received honoraria for lectures and advisory boards from Biogen, Novartis, Merck Serono, Teva and Sanofi Genzyme.
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.
Anders Svenningsson has served on advisory board for Sanofi Genzyme and has received travel funding from Biogen, Novartis and Baxter Medical.
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.
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.
Anne-Marie Landtblom has received honoraria from Merck Serono, Teva, Biogen Sanofi Genzyme.
Fredrik Walentin has received research grants from Biogen and Merck Serono.