Contributions
Abstract: P735
Type: Poster
Abstract Category: Therapy - disease modifying - 28 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). IMSE 1 includes patients starting NTZ treatment and data is collected from Neuroreg. Adverse events (AEs), JC-virus status (JCV) and clinical effectiveness measures are registered prospectively.
Results: 2968 patients (72% female; 90% RRMS) have been included in IMSE 1 from August 2006 until May 2017. Mean age at treatment start was 36 years. Mean treatment duration was 43.6 months. 1244 were currently treated with NTZ at cutoff date, 186 (15%) of which were JCV + with a mean JCV index at 1.09± 0.89. A total of 1907 patients (64%) discontinued NTZ treatment at some time point, where the main reason for discontinuation were anti-JCV antibodies (JCV+) (41%) and pregnancy/planning pregnancy (15%). 1264 (42.6%) patients starting NTZ were JCV+ and 760/1126 (68%) later discontinued their NZT treatment due to JCV+. In contrast, JCV negative (JCV-) patients mainly discontinued due to pregnancy/planning pregnancy (39.2%). The one and two-year drug survival rate was 88% and 68% for JCV+ and 91% and 83% for JCV-. The overall drug survival rate was 11% for JCV+ and 69% for JCV-. 95 Serious AEs had been reported to the Swedish MPA and included 8 cases (1 fatal) of progressive multifocal leukoencephalopathy (PML), reported between 2008 and 2012. A total of 15 patients have died during or within 6 months after NTZ discontinuation, as reported in Neuroreg. None were reported to be associated to NTZ.
In patients with continuous NTZ treatment for ≥5 years (n=728), long lasting stabilization of disease activity was observed.
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 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: P735
Type: Poster
Abstract Category: Therapy - disease modifying - 28 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). IMSE 1 includes patients starting NTZ treatment and data is collected from Neuroreg. Adverse events (AEs), JC-virus status (JCV) and clinical effectiveness measures are registered prospectively.
Results: 2968 patients (72% female; 90% RRMS) have been included in IMSE 1 from August 2006 until May 2017. Mean age at treatment start was 36 years. Mean treatment duration was 43.6 months. 1244 were currently treated with NTZ at cutoff date, 186 (15%) of which were JCV + with a mean JCV index at 1.09± 0.89. A total of 1907 patients (64%) discontinued NTZ treatment at some time point, where the main reason for discontinuation were anti-JCV antibodies (JCV+) (41%) and pregnancy/planning pregnancy (15%). 1264 (42.6%) patients starting NTZ were JCV+ and 760/1126 (68%) later discontinued their NZT treatment due to JCV+. In contrast, JCV negative (JCV-) patients mainly discontinued due to pregnancy/planning pregnancy (39.2%). The one and two-year drug survival rate was 88% and 68% for JCV+ and 91% and 83% for JCV-. The overall drug survival rate was 11% for JCV+ and 69% for JCV-. 95 Serious AEs had been reported to the Swedish MPA and included 8 cases (1 fatal) of progressive multifocal leukoencephalopathy (PML), reported between 2008 and 2012. A total of 15 patients have died during or within 6 months after NTZ discontinuation, as reported in Neuroreg. None were reported to be associated to NTZ.
In patients with continuous NTZ treatment for ≥5 years (n=728), long lasting stabilization of disease activity was observed.
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 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.