Contributions
Abstract: P1187
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Subcutaneous peginterferon beta-1a (PegIFN) was approved for relapsing-remitting multiple sclerosis (RRMS) in Europe 2014. Real-world data to complement the pivotal ADVANCE study have not yet been presented. The Swedish “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 6)-cohort characterizes the real-world profile of PegIFN including efficacy, safety, tolerability and patient outcome parameters.
Objectives: Provide observational, longitudinal data for PegIFN and characterize real-world use to inform on clinical profile from Swedish nationwide post marketing surveillance study (IMSE 6).
Methods: 60 collaborating neurology clinics continuously recruited PegIFN patients and documented clinical and demographic data within this IMSE 6 cohort study from June 2015 to March 2017.
Results: 286 patients (80% female; 92% RRMS; mean age 42 years) were followed up to 21 months (mean 11 months) with 22% treatment naïve and 52% switched from other injectables. Mean duration from initial symptom(s) to treatment start was 116 months, and 65 months from MS diagnosis to start. In total, 108 patients discontinued for various reasons (54% adverse events, 24% lack of effect) and switched mainly to rituximab (42 patients). The discontinuation rate at 12 months was 40.1%. Relapses were reduced from 184 to 90/1000 patient years with 49% having no relapse and 4% having 1 relapse during treatment period (47% missing data). After 12 months, all clinical effectiveness measures (extended disability status scale (EDSS), multiple sclerosis severity scale (MSSS), multiple sclerosis impact scale (MSIS-29), European quality of life - 5-dimension test (EQ-5D), visual analogue score (VAS), and the mean symbol digit modalities test (SDMT)) remained stable. A total number of 4 adverse events (2 serious: 1 diarrhoea, 1 pyrexia) were reported to Swedish Medical Product Agency (MPA).
Conclusions: This real-world study presentation from IMSE 6 is consistent with PegIFN clinical trial data and also shows a positive efficacy and safety profile in long-term clinical use.
Disclosure: The IMSE 6 study has received unrestricted grants from Biogen.
Stina Kågström has nothing to disclose.
Åsa Leandersson has nothing to disclose.
Linda Forsberg 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: P1187
Type: Poster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Subcutaneous peginterferon beta-1a (PegIFN) was approved for relapsing-remitting multiple sclerosis (RRMS) in Europe 2014. Real-world data to complement the pivotal ADVANCE study have not yet been presented. The Swedish “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 6)-cohort characterizes the real-world profile of PegIFN including efficacy, safety, tolerability and patient outcome parameters.
Objectives: Provide observational, longitudinal data for PegIFN and characterize real-world use to inform on clinical profile from Swedish nationwide post marketing surveillance study (IMSE 6).
Methods: 60 collaborating neurology clinics continuously recruited PegIFN patients and documented clinical and demographic data within this IMSE 6 cohort study from June 2015 to March 2017.
Results: 286 patients (80% female; 92% RRMS; mean age 42 years) were followed up to 21 months (mean 11 months) with 22% treatment naïve and 52% switched from other injectables. Mean duration from initial symptom(s) to treatment start was 116 months, and 65 months from MS diagnosis to start. In total, 108 patients discontinued for various reasons (54% adverse events, 24% lack of effect) and switched mainly to rituximab (42 patients). The discontinuation rate at 12 months was 40.1%. Relapses were reduced from 184 to 90/1000 patient years with 49% having no relapse and 4% having 1 relapse during treatment period (47% missing data). After 12 months, all clinical effectiveness measures (extended disability status scale (EDSS), multiple sclerosis severity scale (MSSS), multiple sclerosis impact scale (MSIS-29), European quality of life - 5-dimension test (EQ-5D), visual analogue score (VAS), and the mean symbol digit modalities test (SDMT)) remained stable. A total number of 4 adverse events (2 serious: 1 diarrhoea, 1 pyrexia) were reported to Swedish Medical Product Agency (MPA).
Conclusions: This real-world study presentation from IMSE 6 is consistent with PegIFN clinical trial data and also shows a positive efficacy and safety profile in long-term clinical use.
Disclosure: The IMSE 6 study has received unrestricted grants from Biogen.
Stina Kågström has nothing to disclose.
Åsa Leandersson has nothing to disclose.
Linda Forsberg 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.