Contributions
Abstract: EP1345
Type: ePoster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: Novel disease-modifying therapies (DMTs) for multiple sclerosis (MS) have greatly improved treatment of the disease. However, real world data on long-term safety, tolerability, and comparative effectiveness, are still scarce. COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis, EudraCT 2016-003587-39) is a Swedish, nationwide, long-term, prospective cohort study, including all patients with relapsing-remitting MS (RRMS), starting a first DMT or switching DMT for the first time, between 1st Jan 2011 and 30th June 2018, at any of Sweden´s University Clinics. This corresponds to approximately 50% of the nationwide, eligible population. The primary objective of this study is to compare rituximab (RTX) with other MS-approved DMTs, regarding long-term safety and comparative effectiveness.
Methods: Current patients fulfilling the inclusion criteria were identified through the nationwide Swedish MS registry (SMSreg). For these patients, already registered data in the SMSreg, regarding disease history, disease status, treatments, relapses, and imaging, were validated by medical-chart review. These initial patients, together with future patients also fulfilling the inclusion criteria, are followed with annual, structured follow-up visits, for a minimum of three years after enrolment.
Results: A total of 3626 patients fulfilling inclusion criteria were identified through the SMSreg and included in the medical-chart review. Primary analyses of baseline characteristics for these patients suggest that geographic location (centre) is the main factor driving channelling to either RTX or another DMT. However, patients starting RTX at inclusion were in general a few years older (median 38 vs 35 years [p< 0.001]), had had the disease a few months longer (median 17 vs 13 months [p=0.023]), and had a slightly higher EDSS at the start of therapy (median 2 vs. 1.5 [p=0.001]), compared to all other therapies. Prospective follow-up began in June 2017.
Conclusions: Primary analysis suggest that the main driver for treatment choice is geographic location, rather than patient characteristics. However, some differences in characteristics were still observed and will have to be taken into consideration in future observational comparisons between RTX and other DMTs.
Disclosure:
The Combat-MS study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (MS-1511-33196).
PA, TF, AS, MG: Nothing to disclose.
JL 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.
PN 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.
JB 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.
JS has received research support from Synapsys.
KF has received an unrestricted academic research grant from Biogen and compensation for lectures from Biogen and Novartis, which have been exclusively used to support research activities.
ALG receives funding from NIH, National MS Society and PCORI. She was the site PI for 2 industry-sponsored phase 3 MS RCTs (Biogen-Idec, Roche).
MV has received unrestricted research grants from Novartis and lecture honoraria from Genzyme and for advisory boards from Roche and Novartis.
FP has received unrestricted academic research grants from Biogen, Novartis, and Genzyme.
Abstract: EP1345
Type: ePoster
Abstract Category: Clinical aspects of MS - 5 Epidemiology
Background: Novel disease-modifying therapies (DMTs) for multiple sclerosis (MS) have greatly improved treatment of the disease. However, real world data on long-term safety, tolerability, and comparative effectiveness, are still scarce. COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis, EudraCT 2016-003587-39) is a Swedish, nationwide, long-term, prospective cohort study, including all patients with relapsing-remitting MS (RRMS), starting a first DMT or switching DMT for the first time, between 1st Jan 2011 and 30th June 2018, at any of Sweden´s University Clinics. This corresponds to approximately 50% of the nationwide, eligible population. The primary objective of this study is to compare rituximab (RTX) with other MS-approved DMTs, regarding long-term safety and comparative effectiveness.
Methods: Current patients fulfilling the inclusion criteria were identified through the nationwide Swedish MS registry (SMSreg). For these patients, already registered data in the SMSreg, regarding disease history, disease status, treatments, relapses, and imaging, were validated by medical-chart review. These initial patients, together with future patients also fulfilling the inclusion criteria, are followed with annual, structured follow-up visits, for a minimum of three years after enrolment.
Results: A total of 3626 patients fulfilling inclusion criteria were identified through the SMSreg and included in the medical-chart review. Primary analyses of baseline characteristics for these patients suggest that geographic location (centre) is the main factor driving channelling to either RTX or another DMT. However, patients starting RTX at inclusion were in general a few years older (median 38 vs 35 years [p< 0.001]), had had the disease a few months longer (median 17 vs 13 months [p=0.023]), and had a slightly higher EDSS at the start of therapy (median 2 vs. 1.5 [p=0.001]), compared to all other therapies. Prospective follow-up began in June 2017.
Conclusions: Primary analysis suggest that the main driver for treatment choice is geographic location, rather than patient characteristics. However, some differences in characteristics were still observed and will have to be taken into consideration in future observational comparisons between RTX and other DMTs.
Disclosure:
The Combat-MS study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (MS-1511-33196).
PA, TF, AS, MG: Nothing to disclose.
JL 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.
PN 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.
JB 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.
JS has received research support from Synapsys.
KF has received an unrestricted academic research grant from Biogen and compensation for lectures from Biogen and Novartis, which have been exclusively used to support research activities.
ALG receives funding from NIH, National MS Society and PCORI. She was the site PI for 2 industry-sponsored phase 3 MS RCTs (Biogen-Idec, Roche).
MV has received unrestricted research grants from Novartis and lecture honoraria from Genzyme and for advisory boards from Roche and Novartis.
FP has received unrestricted academic research grants from Biogen, Novartis, and Genzyme.