Contributions
Abstract: P687
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod was approved for use within Scotland in April 2013 for highly active relapsing remitting multiple sclerosis (RRMS). The occurrence and impact of reduced neutrophil counts in patients treated with fingolimod is not clearly defined in the real world setting. Reduced neutrophil counts are stated to be an uncommon effect of fingolimod in the UK Summary of Product Characteristics (UK-SPC), and chronic dosing is thought to lead to a decrease of approximately 20% from baseline.
Objectives: To investigate the frequency of reduced neutrophil counts in RRMS patients treated with fingolimod in GMSC and determine the incidence in patients who experienced infection.
Methods: A retrospective review of electronic medical records and blood results was undertaken in all fingolimod patients within GMSC (n=93), 76 had neutrophil counts available for analysis. Patients were identified using prescription records. Each patient"s blood results were split into 3 categories for analysis: first level taken after commencing fingolimod, lowest, and most recent.
Results: Mean (95% CI) fingolimod treatment duration was 407 days (353-459). First bloods were measured on average 38 days (32-45) after commencing fingolimod. At this point, a fall in neutrophil count was observed in 74% of patients with a mean reduction of 1.26 x10^9/l (0.99-1.52), or 31% from mean baseline pre-fingolimod levels. Lowest neutrophil counts were observed after 162 days (123-201) of fingolimod treatment with a mean reduction of 36% from baseline (1.46 x10^9/l (1.19-1.73)). Most recent neutrophil counts were measured after 342 days (292-392) on treatment, and 68% of patients had reduced neutrophil counts at this time-point, with a mean reduction of 32% from baseline (1.29 x10^9/l (1.02-1.56)). All post-treatment mean neutrophil counts showed a statistically significant reduction from the baseline mean.
In patients who had suffered infection during fingolimod therapy (n=21), 19 had neutrophil counts available for analysis. Of those, 74% had a reduced first neutrophil count and 68% had a reduced most recent count, exactly mirroring the frequency of reduced neutrophil counts in the whole cohort.
Conclusion: Reduced neutrophil counts occur in the majority of patients treated with fingolimod. The reduction is of a greater magnitude (31-36%) than that stated in the UK-SPC, happens soon after initiation, and is maintained. It was not more common in patients who experienced infection in our cohort.
Disclosure:
Kieran Fitzpatrick: Nothing to disclose
James Overell: Nothing to disclose
Lesley Murray: Nothing to disclose
Abstract: P687
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Fingolimod was approved for use within Scotland in April 2013 for highly active relapsing remitting multiple sclerosis (RRMS). The occurrence and impact of reduced neutrophil counts in patients treated with fingolimod is not clearly defined in the real world setting. Reduced neutrophil counts are stated to be an uncommon effect of fingolimod in the UK Summary of Product Characteristics (UK-SPC), and chronic dosing is thought to lead to a decrease of approximately 20% from baseline.
Objectives: To investigate the frequency of reduced neutrophil counts in RRMS patients treated with fingolimod in GMSC and determine the incidence in patients who experienced infection.
Methods: A retrospective review of electronic medical records and blood results was undertaken in all fingolimod patients within GMSC (n=93), 76 had neutrophil counts available for analysis. Patients were identified using prescription records. Each patient"s blood results were split into 3 categories for analysis: first level taken after commencing fingolimod, lowest, and most recent.
Results: Mean (95% CI) fingolimod treatment duration was 407 days (353-459). First bloods were measured on average 38 days (32-45) after commencing fingolimod. At this point, a fall in neutrophil count was observed in 74% of patients with a mean reduction of 1.26 x10^9/l (0.99-1.52), or 31% from mean baseline pre-fingolimod levels. Lowest neutrophil counts were observed after 162 days (123-201) of fingolimod treatment with a mean reduction of 36% from baseline (1.46 x10^9/l (1.19-1.73)). Most recent neutrophil counts were measured after 342 days (292-392) on treatment, and 68% of patients had reduced neutrophil counts at this time-point, with a mean reduction of 32% from baseline (1.29 x10^9/l (1.02-1.56)). All post-treatment mean neutrophil counts showed a statistically significant reduction from the baseline mean.
In patients who had suffered infection during fingolimod therapy (n=21), 19 had neutrophil counts available for analysis. Of those, 74% had a reduced first neutrophil count and 68% had a reduced most recent count, exactly mirroring the frequency of reduced neutrophil counts in the whole cohort.
Conclusion: Reduced neutrophil counts occur in the majority of patients treated with fingolimod. The reduction is of a greater magnitude (31-36%) than that stated in the UK-SPC, happens soon after initiation, and is maintained. It was not more common in patients who experienced infection in our cohort.
Disclosure:
Kieran Fitzpatrick: Nothing to disclose
James Overell: Nothing to disclose
Lesley Murray: Nothing to disclose