Contributions
Abstract: EP1693
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Natalizumab (NAT) prevents the transmigration of immune cells across the blood-brain barrier thus inhibiting CNS inflammation.
Objectives: In this study we present real world laboratory data of 123 NAT treated patients up to 72 months follow up.
Methods: 123 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) and highly active disease course were included. Monitoring of distinct lymphocyte subtypes and standardized lab testing were realized before and every third infusion in 72 months' follow-up. Generalized linear mixed models were used to assess the significance of the results.
Results: At every evaluation the lymphocyte count during NAT therapy was significantly higher compared to baseline for all patients (on average 1,8-fold, p< 0,001). Although 31% of patients presented lymphocyte count lower than normal limit at treatment initiation, lymphocytes count increased higher than the reference range in 14 % of the patients 6 months after start of NAT. B cells, T cells and NK cells increased significantly (2.6-, 1.6- and 2.0-fold, each p< 0,01) after three months and remained stable up to 72 months follow up. Within CD3+ T cells the increase upper normal limit was primarily evoked by CD8+ T cells (increase about 1.8 fold, p< 0.01) whereas CD4+ T cells varied in normal range (increase about 1,5- fold, p< 0,01). No significant changes were detectable in CD4+/CD8+ ratio, neutrophils or in routine complete blood count. No changes were detectable in serological parameters including creatinine, CRP or liver enzymes.
Conclusions: In order to improve decision-making and thus to optimize treatment management long-term monitoring of real world data is notably important. In our present report we observed no relevant immunological effects accompanied with the changes in peripheral immune cell subtypes or standard lab testing of NAT treatment in a 72 months' long-term follow-up.
Disclosure:
K. Thomas received personal compensation for from Novartis, Biogen Idec and Roche for consulting service. Ziemssen received personal compensation from Biogen Idec, Bayer, Novartis, Sanofi, Teva, and Synthon for consulting services. Ziemssen received additional financial support for research activities from Bayer, Biogen Idec, Novartis, Teva, and Sanofi Aventis.
M. Kaufmann und R. Haas have nothing to disclose.
Abstract: EP1693
Type: ePoster
Abstract Category: Therapy - disease modifying - 28 Long-term treatment monitoring
Background: Natalizumab (NAT) prevents the transmigration of immune cells across the blood-brain barrier thus inhibiting CNS inflammation.
Objectives: In this study we present real world laboratory data of 123 NAT treated patients up to 72 months follow up.
Methods: 123 patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) and highly active disease course were included. Monitoring of distinct lymphocyte subtypes and standardized lab testing were realized before and every third infusion in 72 months' follow-up. Generalized linear mixed models were used to assess the significance of the results.
Results: At every evaluation the lymphocyte count during NAT therapy was significantly higher compared to baseline for all patients (on average 1,8-fold, p< 0,001). Although 31% of patients presented lymphocyte count lower than normal limit at treatment initiation, lymphocytes count increased higher than the reference range in 14 % of the patients 6 months after start of NAT. B cells, T cells and NK cells increased significantly (2.6-, 1.6- and 2.0-fold, each p< 0,01) after three months and remained stable up to 72 months follow up. Within CD3+ T cells the increase upper normal limit was primarily evoked by CD8+ T cells (increase about 1.8 fold, p< 0.01) whereas CD4+ T cells varied in normal range (increase about 1,5- fold, p< 0,01). No significant changes were detectable in CD4+/CD8+ ratio, neutrophils or in routine complete blood count. No changes were detectable in serological parameters including creatinine, CRP or liver enzymes.
Conclusions: In order to improve decision-making and thus to optimize treatment management long-term monitoring of real world data is notably important. In our present report we observed no relevant immunological effects accompanied with the changes in peripheral immune cell subtypes or standard lab testing of NAT treatment in a 72 months' long-term follow-up.
Disclosure:
K. Thomas received personal compensation for from Novartis, Biogen Idec and Roche for consulting service. Ziemssen received personal compensation from Biogen Idec, Bayer, Novartis, Sanofi, Teva, and Synthon for consulting services. Ziemssen received additional financial support for research activities from Bayer, Biogen Idec, Novartis, Teva, and Sanofi Aventis.
M. Kaufmann und R. Haas have nothing to disclose.