Contributions
Abstract: P609
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: Natalizumab (NTZ) was approved in 2006 for treatment of active relapsing-remitting MS (RRMS). Because of progressive multifocal leukoencephalopathy (PML) during NTZ treatment, a global risk management plan was introduced. Increased risk of PML is found in patients with previous immunosuppressive therapy, NTZ treatment >24 months and in patients with high titre JC virus (JCV) serology.
Aim: To investigate influence of the national PML risk management of NTZ for treatment of RRMS in Sweden.
Methods: Swedish MS registry data was retrospectively collected on NTZ treatment, other disease modifying treatments, and JCV serology from 2006 to March 2018. The risk management plan included JCV serology and index (introduced in late 2011). The data from Sweden was compared to the global number of PML cases diagnosed during NTZ treatment reported by Biogen.
Results: Since the introduction of NTZ 763 cases have been diagnosed with PML globally (March 2018). Eight of these PML cases have been diagnosed in Sweden between June 2008 and December 2012. Mean NTZ treatment duration at the time of PML diagnosis was 36 months (range 17-50 months) in Sweden compared with 50 months (range 8-144 months) globally. In February 2018, the incidence of PML in Sweden and globally was 0.7 and 4.2 per 1000 patient years, respectively. The number and proportion of RRMS treated patients in Sweden with an ongoing NTZ treatment increased from 113 (4%) in 2006 to 1139 (23%) in 2011. Although the number of NTZ treated patients was similar thereafter (n=1116, year 2018), the proportion of JCV + NTZ treated patients decreased to 13%. The main reasons for NTZ discontinuation were JCV+ (41%) and pregnancy/planning pregnancy (15%). Patients who discontinued NTZ treatment mainly switched to rituximab (33%) and fingolimod (19%). In 2011, available JCV serology showed that 55% were JCV+ and the corresponding value in 2018 was 13%. However, of the JCV+ patients 34% had an index >0.9, i.e. approximately 4.5% had increased PML risk according to JCV index, and 66% of these had been treated >24 months, indicating that the number of patients at risk was < 3%.
Conclusion: Since 2012, no new PML cases have been diagnosed during NTZ treatment in Sweden. This is probably due to improved nation-wide PML risk management. The proportion of JCV+ has been markedly reduced and second-line treatment alternatives to NTZ have been used more frequently. Similar development has not been seen globally.
Disclosure: This study has received unrestricted grants from Biogen.
Stina Kågström has nothing to disclose.
Anna Fält has nothing to disclose.
Anders Berglund is employed at Biogen, Sweden and holds stocks in Biogen.
Ali Manouchehrinia has received speaker honoraria from Biogen.
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, Novartis, Merck, Roche and Sanofi Genzyme.
Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Merck, Novartis, Teva and Sanofi Genzyme; has served on scientific advisory boards for Almirall, Teva, Biogen, Merck, Novartis and Sanofi Genzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.
Abstract: P609
Type: Poster Sessions
Abstract Category: Therapy - Risk management for disease modifying treatments
Background: Natalizumab (NTZ) was approved in 2006 for treatment of active relapsing-remitting MS (RRMS). Because of progressive multifocal leukoencephalopathy (PML) during NTZ treatment, a global risk management plan was introduced. Increased risk of PML is found in patients with previous immunosuppressive therapy, NTZ treatment >24 months and in patients with high titre JC virus (JCV) serology.
Aim: To investigate influence of the national PML risk management of NTZ for treatment of RRMS in Sweden.
Methods: Swedish MS registry data was retrospectively collected on NTZ treatment, other disease modifying treatments, and JCV serology from 2006 to March 2018. The risk management plan included JCV serology and index (introduced in late 2011). The data from Sweden was compared to the global number of PML cases diagnosed during NTZ treatment reported by Biogen.
Results: Since the introduction of NTZ 763 cases have been diagnosed with PML globally (March 2018). Eight of these PML cases have been diagnosed in Sweden between June 2008 and December 2012. Mean NTZ treatment duration at the time of PML diagnosis was 36 months (range 17-50 months) in Sweden compared with 50 months (range 8-144 months) globally. In February 2018, the incidence of PML in Sweden and globally was 0.7 and 4.2 per 1000 patient years, respectively. The number and proportion of RRMS treated patients in Sweden with an ongoing NTZ treatment increased from 113 (4%) in 2006 to 1139 (23%) in 2011. Although the number of NTZ treated patients was similar thereafter (n=1116, year 2018), the proportion of JCV + NTZ treated patients decreased to 13%. The main reasons for NTZ discontinuation were JCV+ (41%) and pregnancy/planning pregnancy (15%). Patients who discontinued NTZ treatment mainly switched to rituximab (33%) and fingolimod (19%). In 2011, available JCV serology showed that 55% were JCV+ and the corresponding value in 2018 was 13%. However, of the JCV+ patients 34% had an index >0.9, i.e. approximately 4.5% had increased PML risk according to JCV index, and 66% of these had been treated >24 months, indicating that the number of patients at risk was < 3%.
Conclusion: Since 2012, no new PML cases have been diagnosed during NTZ treatment in Sweden. This is probably due to improved nation-wide PML risk management. The proportion of JCV+ has been markedly reduced and second-line treatment alternatives to NTZ have been used more frequently. Similar development has not been seen globally.
Disclosure: This study has received unrestricted grants from Biogen.
Stina Kågström has nothing to disclose.
Anna Fält has nothing to disclose.
Anders Berglund is employed at Biogen, Sweden and holds stocks in Biogen.
Ali Manouchehrinia has received speaker honoraria from Biogen.
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, Novartis, Merck, Roche and Sanofi Genzyme.
Jan Lycke has received travel support and/or lecture honoraria from Bayer Schering Pharma, Biogen, Merck, Novartis, Teva and Sanofi Genzyme; has served on scientific advisory boards for Almirall, Teva, Biogen, Merck, Novartis and Sanofi Genzyme; serves on the editorial board of the Acta Neurologica Scandinavica; has received unconditional research grants from Biogen, Novartis and Teva.