Contributions
Abstract: P748
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod (FGL) is an oral disease modulatory drug for patients with relapsing-remitting multiple sclerosis (RRMS).
Objective: To follow up the effectiveness and long-term safety of FGL in a real-world setting.
Methods: Swedish MS patients are registered into the nationwide web-based Swedish neuro registry (neuroreg). Before FGL initiation patients are asked to participate in the “Immunomodulation and Multiple Sclerosis Epidemiology” study (IMSE 2). Adverse events (AEs) and clinical measures; extended disability status scale (EDSS), multiple sclerosis severity scale (MSSS), symbol digit modalities test (SDMT), multiple sclerosis impact scale (MSIS-29), European quality of life - 5 dimension test (EQ-5D), are obtained from neuroreg. The Wilcoxon signed-rank test was used to assess changes in effectiveness.
Results: From September 2011 until April 2017, 1564 patients (68% female; 92% RRMS) were included in IMSE 2. Mean age at treatment start was 38.8 years and mean treatment duration was 28.8 months. 702 patients discontinued FGL at some point after initiation, mainly due to lack of effect (43%) and AEs (34%). 129 AEs were reported to the Swedish Medical Products Agency, 50 events were classified as serious and the most common organ class involved were cardiac disorders (22%) and infections and infestations (16%). Two deaths were registered in the IMSE 2 study, none were reported to be related to FGL. 899 patients were currently treated with FGL at cut-off date and 1159 patients had been treated for at least 12 months. In patients treated at least 36 months (n=563, 64% female), mean age at treatment start was 39.6 years and mean treatment duration was 50.5 months. Most patients switched treatment from interferon or glatimer acetat treatment (43%) or natalizumab treatment (27%) to FGL and mean number of drugs used before FGL was 2.4. The most common drug used after FGL discontinuation was rituximab. In patients with data available at both baseline and 36 months significant improvements were seen for MSSS (3.2±2.4 - 2.6±2.2, n=157), MSIS-29 Psychological (27.4±23.4 - 22.7±21.9, n=224), SDMT (53.8±14.4 - 57.0±14.4, n=228) and VAS (69.6±20.7 - 73.5±19.0, n=192). Conclusions: FGL is a generally well-tolerated drug that reduces the clinical activity in MS patients. Neuroreg provides to function well as a drug surveillance platform, enabling monitoring of long-term effectiveness and AEs.
Disclosure: The IMSE 2 study has received unrestricted grants from Novartis.
Åsa Leandersson has nothing to disclose.
Stina Kågström has nothing to disclose.
Linda Forsberg has nothing to disclose.
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: P748
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Fingolimod (FGL) is an oral disease modulatory drug for patients with relapsing-remitting multiple sclerosis (RRMS).
Objective: To follow up the effectiveness and long-term safety of FGL in a real-world setting.
Methods: Swedish MS patients are registered into the nationwide web-based Swedish neuro registry (neuroreg). Before FGL initiation patients are asked to participate in the “Immunomodulation and Multiple Sclerosis Epidemiology” study (IMSE 2). Adverse events (AEs) and clinical measures; extended disability status scale (EDSS), multiple sclerosis severity scale (MSSS), symbol digit modalities test (SDMT), multiple sclerosis impact scale (MSIS-29), European quality of life - 5 dimension test (EQ-5D), are obtained from neuroreg. The Wilcoxon signed-rank test was used to assess changes in effectiveness.
Results: From September 2011 until April 2017, 1564 patients (68% female; 92% RRMS) were included in IMSE 2. Mean age at treatment start was 38.8 years and mean treatment duration was 28.8 months. 702 patients discontinued FGL at some point after initiation, mainly due to lack of effect (43%) and AEs (34%). 129 AEs were reported to the Swedish Medical Products Agency, 50 events were classified as serious and the most common organ class involved were cardiac disorders (22%) and infections and infestations (16%). Two deaths were registered in the IMSE 2 study, none were reported to be related to FGL. 899 patients were currently treated with FGL at cut-off date and 1159 patients had been treated for at least 12 months. In patients treated at least 36 months (n=563, 64% female), mean age at treatment start was 39.6 years and mean treatment duration was 50.5 months. Most patients switched treatment from interferon or glatimer acetat treatment (43%) or natalizumab treatment (27%) to FGL and mean number of drugs used before FGL was 2.4. The most common drug used after FGL discontinuation was rituximab. In patients with data available at both baseline and 36 months significant improvements were seen for MSSS (3.2±2.4 - 2.6±2.2, n=157), MSIS-29 Psychological (27.4±23.4 - 22.7±21.9, n=224), SDMT (53.8±14.4 - 57.0±14.4, n=228) and VAS (69.6±20.7 - 73.5±19.0, n=192). Conclusions: FGL is a generally well-tolerated drug that reduces the clinical activity in MS patients. Neuroreg provides to function well as a drug surveillance platform, enabling monitoring of long-term effectiveness and AEs.
Disclosure: The IMSE 2 study has received unrestricted grants from Novartis.
Åsa Leandersson has nothing to disclose.
Stina Kågström has nothing to disclose.
Linda Forsberg has nothing to disclose.
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.