Contributions
Abstract: P695
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing-remitting multiple sclerosis (RRMS). Post-marketing surveillance is important for determination of long-term safety and effectiveness in a real-world setting. To this end the “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 1) was initiated upon NTZ launch in Sweden (Aug 2006).
Objective: To follow-up the long-term safety and effectiveness of NTZ in a real-world setting.
Methods: In Sweden MS patients are registered in the nationwide Swedish Neuroregistry (Neuroreg). Adverse events (AEs), Extended Disability Status Scale (EDSS), MS Severity Scale (MSSS), Symbol Digit Modalities Test (SDMT), MS Impact Scale (MSIS-29) and JC-virus status (JCV) are registered. IMSE 1 includes patients starting NTZ treatment and data is collected from Neuroreg. The Wilcoxon Signed-Rank Test was used to assess changes in effectiveness.
Results: 2822 patients (72% female; 89% RRMS) have been included in IMSE 1 from August 2006 until April 2016. Mean age at treatment start was 36 years. Mean treatment duration was 39 months. 1313/2822 were currently treated with NTZ at cut-off.
1667 patients (59%) discontinued NTZ treatment at some time point. Main discontinuation reasons were; anti-JCV antibodies (JCV+) (41%) and pregnancy/planning pregnancy (15%).
Serious AEs reported to the Swedish MPA were rare (84 events, 3.0%) but included 8 cases (1 fatal) of progressive multifocal leukoencephalopathy (PML), reported between 2008 and the latest case in 2012. 20% of patients with current NTZ treatment were JCV+, compared to 58% when testing started. 587/846 patients were JCV- at baseline, 109 later converted to JCV+.
15 patients died during or within 6 months after NTZ discontinuation in Neuroreg. None were reported to be associated to NTZ.
In patients with continuous NTZ treatment for ≥5 years (n=592), long lasting stabilization of disease activity was observed. The 5 year follow-up showed significant retained improvements in all effectiveness measures: EDSS -15% (n=291), MSSS -40% (n=281), MSIS-29 physical/psychological -26%/-28% (n=289), SDMT +27% (n=366).
Conclusions: Neuroreg functions well as a post-marketing drug surveillance platform, providing long-term data on drug effects and AEs. NTZ is generally well tolerated with sustained effectiveness. The introduction of JCV testing has led to fewer treated JCV+ patients, which likely explains a reduced incidence of PML.
Disclosure: The IMSE 1 Study have 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: P695
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Natalizumab (NTZ) is a highly effective disease modulatory treatment for relapsing-remitting multiple sclerosis (RRMS). Post-marketing surveillance is important for determination of long-term safety and effectiveness in a real-world setting. To this end the “Immunomodulation and Multiple Sclerosis Epidemiology Study” (IMSE 1) was initiated upon NTZ launch in Sweden (Aug 2006).
Objective: To follow-up the long-term safety and effectiveness of NTZ in a real-world setting.
Methods: In Sweden MS patients are registered in the nationwide Swedish Neuroregistry (Neuroreg). Adverse events (AEs), Extended Disability Status Scale (EDSS), MS Severity Scale (MSSS), Symbol Digit Modalities Test (SDMT), MS Impact Scale (MSIS-29) and JC-virus status (JCV) are registered. IMSE 1 includes patients starting NTZ treatment and data is collected from Neuroreg. The Wilcoxon Signed-Rank Test was used to assess changes in effectiveness.
Results: 2822 patients (72% female; 89% RRMS) have been included in IMSE 1 from August 2006 until April 2016. Mean age at treatment start was 36 years. Mean treatment duration was 39 months. 1313/2822 were currently treated with NTZ at cut-off.
1667 patients (59%) discontinued NTZ treatment at some time point. Main discontinuation reasons were; anti-JCV antibodies (JCV+) (41%) and pregnancy/planning pregnancy (15%).
Serious AEs reported to the Swedish MPA were rare (84 events, 3.0%) but included 8 cases (1 fatal) of progressive multifocal leukoencephalopathy (PML), reported between 2008 and the latest case in 2012. 20% of patients with current NTZ treatment were JCV+, compared to 58% when testing started. 587/846 patients were JCV- at baseline, 109 later converted to JCV+.
15 patients died during or within 6 months after NTZ discontinuation in Neuroreg. None were reported to be associated to NTZ.
In patients with continuous NTZ treatment for ≥5 years (n=592), long lasting stabilization of disease activity was observed. The 5 year follow-up showed significant retained improvements in all effectiveness measures: EDSS -15% (n=291), MSSS -40% (n=281), MSIS-29 physical/psychological -26%/-28% (n=289), SDMT +27% (n=366).
Conclusions: Neuroreg functions well as a post-marketing drug surveillance platform, providing long-term data on drug effects and AEs. NTZ is generally well tolerated with sustained effectiveness. The introduction of JCV testing has led to fewer treated JCV+ patients, which likely explains a reduced incidence of PML.
Disclosure: The IMSE 1 Study have 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.