Contributions
Abstract: P521
Type: Poster
Abstract Category: Pathology and pathogenesis of MS - Imaging
Background: While there is an increasing need to monitor the effect of disease-modifying treatment on individual patient level in real time, the assessment of brain atrophy is not part of standard clinical evaluation.
Objective: The objective of this analysis was to evaluate brain volume changes and presence of new/enlarging T2, T1 and gadolinium positive brain lesions on MRI performed in routine clinical practice among patients with relapsing remitting multiple sclerosis (RRMS) initiating fingolimod treatment.
Design and methods: This is an ongoing, multicenter, retrospective, chart review of RRMS patients. Clinical and brain MRI data are being collected from 600 patients over 48 months.
Patients aged 18-65 who initiated fingolimod (index) and received at least 28 days of treatment are included. Patients had data collected at index (6 months prior to 1 month after index) and post-index (9-24 months after index); all patients included had MRI available at both times. Patients with prior use of natalizumab are excluded. Detailed methodology is being presented in a separate abstract.
Global MRI atrophy measures include annualized percent change in whole brain (WB) volume assessed by the SIENA method on 2D-T1 and 3D-T1 scanners, and percent change in lateral ventricular volume (LVV) assessed by VIENA on 2D-T1 and 3d-T1 scanners and NeuroSTREAM on FLAIR. Lesion measures include T2- and T1- lesion volumes (LV), new/enlarging T2 and gadolinium-enhancing (Gd+) T1 lesions.
Results: Here we present results from interim analysis (N=252). New/enlarging T2 lesions were absent in 76% of patients and Gd+ lesions were absent in 96% of patients. There was slight increase in T2- and T1-LV (1.74% and 5.08%, respectively). The annualized WB volume loss was 0.20%, 0.34%, and 0.29%, as measured on 2D-T1, 3D-T1 sequences, or combined (3D-T1 used, 2D-T1 if missing); annualized LVV increased by 1.26% and 0.55%, as measured on 2D-T1 and 3D-T1 sequences, by 0.85% on FLAIR sequence, and by 0.91% overall (FLAIR used, 3D-T1 and 2D-T1 if missing).
Conclusions: These interim results show that routine scans can be used for MRI assessment. Fingolimod treatment effect on MRI lesion and brain volume measures is comparable to that obtained in pivotal clinical trials, and results are consistent across scan types. Results from full analysis of 600 patients will be presented to confirm these preliminary findings.
Disclosure:
Study Supported by: Novartis Pharmaceuticals AG
Robert Zivadinov received personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Genzyme-Sanofi, Claret Medical, IMS Health and Novartis for speaking and consultant fees. He received financial support for research activities from Teva Pharmaceuticals, Genzyme-Sanofi, Novartis, Claret Medical, Intekrin and IMS Health.
Nasreen Khan is an employee of IMS Health, Switzerland
Jennie Medin is an employee of Novartis Pharmaceuticals AG, Switzerland
Jon Korn is an employee of IMS Health, United States
Niels Bergsland has nothing to disclose.
Pia Christoffersen is an employee of IMS Health, Switzerland
Ellen Carl have nothing to disclose.
Michael G. Dwyer has received consultant fees from Claret Medical and EMD Serono. and research grant support from Novartis.
Jennifer Price is an employee of IMS Health, Switzerland
Ian Bonzani is an employee of IMS Health, United Kingdom
Diego Silva is an employee of Novartis Pharmaceuticals AG, Switzerland
Bianca Weinstock- Guttman received honoraria as a speaker and as a consultant for Biogen Idec, Teva Pharmaceuticals, EMD Serono, Genzyme&Sanofi, Novartis and Acorda. Dr Weinstock-Guttman received research funds from Biogen Idec, Teva Pharmaceuticals,, EMD Serono, Genzyme&Sanofi, Novartis, Acorda.
Abstract: P521
Type: Poster
Abstract Category: Pathology and pathogenesis of MS - Imaging
Background: While there is an increasing need to monitor the effect of disease-modifying treatment on individual patient level in real time, the assessment of brain atrophy is not part of standard clinical evaluation.
Objective: The objective of this analysis was to evaluate brain volume changes and presence of new/enlarging T2, T1 and gadolinium positive brain lesions on MRI performed in routine clinical practice among patients with relapsing remitting multiple sclerosis (RRMS) initiating fingolimod treatment.
Design and methods: This is an ongoing, multicenter, retrospective, chart review of RRMS patients. Clinical and brain MRI data are being collected from 600 patients over 48 months.
Patients aged 18-65 who initiated fingolimod (index) and received at least 28 days of treatment are included. Patients had data collected at index (6 months prior to 1 month after index) and post-index (9-24 months after index); all patients included had MRI available at both times. Patients with prior use of natalizumab are excluded. Detailed methodology is being presented in a separate abstract.
Global MRI atrophy measures include annualized percent change in whole brain (WB) volume assessed by the SIENA method on 2D-T1 and 3D-T1 scanners, and percent change in lateral ventricular volume (LVV) assessed by VIENA on 2D-T1 and 3d-T1 scanners and NeuroSTREAM on FLAIR. Lesion measures include T2- and T1- lesion volumes (LV), new/enlarging T2 and gadolinium-enhancing (Gd+) T1 lesions.
Results: Here we present results from interim analysis (N=252). New/enlarging T2 lesions were absent in 76% of patients and Gd+ lesions were absent in 96% of patients. There was slight increase in T2- and T1-LV (1.74% and 5.08%, respectively). The annualized WB volume loss was 0.20%, 0.34%, and 0.29%, as measured on 2D-T1, 3D-T1 sequences, or combined (3D-T1 used, 2D-T1 if missing); annualized LVV increased by 1.26% and 0.55%, as measured on 2D-T1 and 3D-T1 sequences, by 0.85% on FLAIR sequence, and by 0.91% overall (FLAIR used, 3D-T1 and 2D-T1 if missing).
Conclusions: These interim results show that routine scans can be used for MRI assessment. Fingolimod treatment effect on MRI lesion and brain volume measures is comparable to that obtained in pivotal clinical trials, and results are consistent across scan types. Results from full analysis of 600 patients will be presented to confirm these preliminary findings.
Disclosure:
Study Supported by: Novartis Pharmaceuticals AG
Robert Zivadinov received personal compensation from Teva Pharmaceuticals, Biogen Idec, EMD Serono, Genzyme-Sanofi, Claret Medical, IMS Health and Novartis for speaking and consultant fees. He received financial support for research activities from Teva Pharmaceuticals, Genzyme-Sanofi, Novartis, Claret Medical, Intekrin and IMS Health.
Nasreen Khan is an employee of IMS Health, Switzerland
Jennie Medin is an employee of Novartis Pharmaceuticals AG, Switzerland
Jon Korn is an employee of IMS Health, United States
Niels Bergsland has nothing to disclose.
Pia Christoffersen is an employee of IMS Health, Switzerland
Ellen Carl have nothing to disclose.
Michael G. Dwyer has received consultant fees from Claret Medical and EMD Serono. and research grant support from Novartis.
Jennifer Price is an employee of IMS Health, Switzerland
Ian Bonzani is an employee of IMS Health, United Kingdom
Diego Silva is an employee of Novartis Pharmaceuticals AG, Switzerland
Bianca Weinstock- Guttman received honoraria as a speaker and as a consultant for Biogen Idec, Teva Pharmaceuticals, EMD Serono, Genzyme&Sanofi, Novartis and Acorda. Dr Weinstock-Guttman received research funds from Biogen Idec, Teva Pharmaceuticals,, EMD Serono, Genzyme&Sanofi, Novartis, Acorda.