Contributions
Abstract: P969
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Many relapsing remitting Multiple Sclerosis (MS) patients experience end of dose interval (EDI) symptoms by the end of each monthly administration cycle. This is hard to explain based on the mechanism of action and pharmacokinetics of natalizumab. Although less recognized, natalizumab may affect the peripheral immune system by influencing serum cytokine levels. Variability in serum cytokine kinetics during natalizumab treatment may explain EDI symptoms in some patients.
Objective: To evaluate short-term effects of natalizumab on fatigue, cognition and mood parameters in patients with or without EDI symptoms and its potential correlation with serum cytokine levels.
Methods: A prospective study including 42 relapsing remitting MS patients receiving monthly intravenous natalizumab treatment was conducted. Participants were evaluated before natalizumab administration (day 0) and 7 days afterwards (day 7). At both time points blood samples were taken and fatigue, mood and cognition were evaluated using the fatigue severity scale (FSS), visual analogue scale for fatigue (VAS-F), the inventory of depressive symptomatology (IDS-SR) and the symbol digit modality test (SDMT). On day 7 an additional questionnaire on recurrence of symptoms at the end of natalizumab administration interval was filled out. Patients were then divided in two subgroups based on the occurrence of EDI symptoms (EDI group and non-EDI group). Key variables of interest were compared at both time points for both subgroups.
Results: Twenty-five patients reported EDI symptoms (59.5%). On day 0 there were no significant differences in fatigue, mood and cognition between both subgroups. Although fatigue was the most reported EDI symptom (80% of EDI-patients) FSS and VAS-F scores did not significantly change from day 0 to 7. IDS-SR and SDMT significantly ameliorated in both EDI and non-EDI patients from day 0 to 7. Comparative analysis of score changes between EDI and non-EDI patients was non-significant.
Conclusion: Natalizumab administration significantly improved mood and cognition parameters in both EDI and non-EDI subgroups at day 7 after administration. Objective arguments for fatigue amelioration could not be found. Results of cytokine analysis will be presented at the ECTRIMS meeting.
Disclosure: This study was sponsored by Biogen as an investigator-initiated trial.
Dekeyser Cathérine: nothing to disclose
De Pue Annelien: has received travel compensation from Biogen
Sieben Anne: nothing to disclose
Algoed Luc: has received travel compensation from Biogen
Vanhijfte Liesbeth: nothing to disclose
Gerlo Sarah: nothing to disclose
Laureys Guy: has received travel compensations, consultancy, speakers and advisory board fees from Biogen.
Abstract: P969
Type: Poster Sessions
Abstract Category: Therapy - Others
Background: Many relapsing remitting Multiple Sclerosis (MS) patients experience end of dose interval (EDI) symptoms by the end of each monthly administration cycle. This is hard to explain based on the mechanism of action and pharmacokinetics of natalizumab. Although less recognized, natalizumab may affect the peripheral immune system by influencing serum cytokine levels. Variability in serum cytokine kinetics during natalizumab treatment may explain EDI symptoms in some patients.
Objective: To evaluate short-term effects of natalizumab on fatigue, cognition and mood parameters in patients with or without EDI symptoms and its potential correlation with serum cytokine levels.
Methods: A prospective study including 42 relapsing remitting MS patients receiving monthly intravenous natalizumab treatment was conducted. Participants were evaluated before natalizumab administration (day 0) and 7 days afterwards (day 7). At both time points blood samples were taken and fatigue, mood and cognition were evaluated using the fatigue severity scale (FSS), visual analogue scale for fatigue (VAS-F), the inventory of depressive symptomatology (IDS-SR) and the symbol digit modality test (SDMT). On day 7 an additional questionnaire on recurrence of symptoms at the end of natalizumab administration interval was filled out. Patients were then divided in two subgroups based on the occurrence of EDI symptoms (EDI group and non-EDI group). Key variables of interest were compared at both time points for both subgroups.
Results: Twenty-five patients reported EDI symptoms (59.5%). On day 0 there were no significant differences in fatigue, mood and cognition between both subgroups. Although fatigue was the most reported EDI symptom (80% of EDI-patients) FSS and VAS-F scores did not significantly change from day 0 to 7. IDS-SR and SDMT significantly ameliorated in both EDI and non-EDI patients from day 0 to 7. Comparative analysis of score changes between EDI and non-EDI patients was non-significant.
Conclusion: Natalizumab administration significantly improved mood and cognition parameters in both EDI and non-EDI subgroups at day 7 after administration. Objective arguments for fatigue amelioration could not be found. Results of cytokine analysis will be presented at the ECTRIMS meeting.
Disclosure: This study was sponsored by Biogen as an investigator-initiated trial.
Dekeyser Cathérine: nothing to disclose
De Pue Annelien: has received travel compensation from Biogen
Sieben Anne: nothing to disclose
Algoed Luc: has received travel compensation from Biogen
Vanhijfte Liesbeth: nothing to disclose
Gerlo Sarah: nothing to disclose
Laureys Guy: has received travel compensations, consultancy, speakers and advisory board fees from Biogen.