Contributions
Abstract: EP1653
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod (FTY) is a well-known and effective Sphingosine-1-phosphatase receptor immunomodulator to treat patients with Multiple Sclerosis (MS). Hispanic MS patients comprise less than 3% of the patient population in major clinical trials. Therefore, clinical data regarding treatment efficacy in controlling disease burden via MRI parameters is vastly limited.
Aim: FTY efficacy in Hispanic MS patients by MRI outcomes on T1 gadolonium enhancing lesions (GAD+), new/enlarging T2 lesions (T2), T1 hypointense lesions (T1BH).
Methods: Single-center, open label, non-comparative, 2-year observational longitudinal follow-up study from 2012-2014. All patients were diagnosed by the 2010 McDonald Criteria and treated by a MS specialized neurologist at the largest nationally accredited MS center in Puerto Rico (PR). All patients had pre and post treatment imaging at a designated center with 1.5T MR and interpreted by a Neuroradiologist trained in MS imaging protocol. Patients were imaged at 1 year intervals. IRB approval and informed consent was obtained.
Results: 150 patients were enrolled and 81.5% (119) patients completed the 2 year trial. Females represent 78.1%(114) of original patient population. Mean age of diagnosis was 40.8 ±10.9 and mean duration of disease (years) 6.6 ± 6.0. 13%(19) of the patient population was treatment naive. 2.6%(4) of patient population were lost to follow up and 18.4%(27) discontinued treatment. Reasons for discontinuation include 11.1%(3) experienced adverse events (AE), 2 macular edema and 1 arrhythmia, and 25.9%(7) were non-responders. At baseline, 22%(31) of patients had GAD+ lesions. At 1 year and
2 years, 8.6%(9) and 5.2%(4) of patients had T1GAD+ lesions, respectively. This means at year 1 and year 2 there was a 91.3% and 94.5% reduction in T1GAD+ lesions. At baseline, 24.5%(34) had T2 lesions. At 1 year and 2 years, 78.9%(82) and 77.9%(60) of patients showed a reduction of T2lesions. At baseline, 44.6%(62) of patients had T1BH. Of the T1BH negative patients, at 1 and 2 year follow up, 3%(3) and 0% (0) developed T1BH lesions, respectively.
Conclusion: FTY showed a great response in MRI outcomes in PR Hispanic population. Specifically, in patients with active disease. The authors recommend the inclusion of Hispanic population in future clinical trials.
Disclosure: Angel Chinea: consultant and speaker for Novartis, BIOGEN, TEVA, SANOFI, ACCORDA.
The remaining authors have no other disclosure.
Abstract: EP1653
Type: ePoster
Abstract Category: Therapy - disease modifying - 26 Immunomodulation/Immunosuppression
Background: Fingolimod (FTY) is a well-known and effective Sphingosine-1-phosphatase receptor immunomodulator to treat patients with Multiple Sclerosis (MS). Hispanic MS patients comprise less than 3% of the patient population in major clinical trials. Therefore, clinical data regarding treatment efficacy in controlling disease burden via MRI parameters is vastly limited.
Aim: FTY efficacy in Hispanic MS patients by MRI outcomes on T1 gadolonium enhancing lesions (GAD+), new/enlarging T2 lesions (T2), T1 hypointense lesions (T1BH).
Methods: Single-center, open label, non-comparative, 2-year observational longitudinal follow-up study from 2012-2014. All patients were diagnosed by the 2010 McDonald Criteria and treated by a MS specialized neurologist at the largest nationally accredited MS center in Puerto Rico (PR). All patients had pre and post treatment imaging at a designated center with 1.5T MR and interpreted by a Neuroradiologist trained in MS imaging protocol. Patients were imaged at 1 year intervals. IRB approval and informed consent was obtained.
Results: 150 patients were enrolled and 81.5% (119) patients completed the 2 year trial. Females represent 78.1%(114) of original patient population. Mean age of diagnosis was 40.8 ±10.9 and mean duration of disease (years) 6.6 ± 6.0. 13%(19) of the patient population was treatment naive. 2.6%(4) of patient population were lost to follow up and 18.4%(27) discontinued treatment. Reasons for discontinuation include 11.1%(3) experienced adverse events (AE), 2 macular edema and 1 arrhythmia, and 25.9%(7) were non-responders. At baseline, 22%(31) of patients had GAD+ lesions. At 1 year and
2 years, 8.6%(9) and 5.2%(4) of patients had T1GAD+ lesions, respectively. This means at year 1 and year 2 there was a 91.3% and 94.5% reduction in T1GAD+ lesions. At baseline, 24.5%(34) had T2 lesions. At 1 year and 2 years, 78.9%(82) and 77.9%(60) of patients showed a reduction of T2lesions. At baseline, 44.6%(62) of patients had T1BH. Of the T1BH negative patients, at 1 and 2 year follow up, 3%(3) and 0% (0) developed T1BH lesions, respectively.
Conclusion: FTY showed a great response in MRI outcomes in PR Hispanic population. Specifically, in patients with active disease. The authors recommend the inclusion of Hispanic population in future clinical trials.
Disclosure: Angel Chinea: consultant and speaker for Novartis, BIOGEN, TEVA, SANOFI, ACCORDA.
The remaining authors have no other disclosure.