Contributions
Abstract: EP1512
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Brain MRI assessments in real world practice are often not linked with the supporting clinical data, limiting the depth of observational research. This is the first real word multicenter study linking quantitative MRI and clinical outcomes among relapsing remitting multiple sclerosis patients (RRMS).
Objective: To build a longitudinal cohort of RRMS patients to assess the impact of fingolimod on quantitative brain MRI measures and disease progression.
Design and methods: This is an ongoing, multicenter, retrospective, longitudinal chart review of RRMS patients. Clinical and brain MRI data are being collected from 600 patients over 48 months across 30-35 MS centers in the US. Key eligibility criteria include aged 18-65 years at initiation of fingolimod (index date (ID)), fingolimod treatment for at least 28 days and availability of retrospective brain MRI scans during index (6 months before to 1 month after ID) and post index periods (9-24 months after ID). Scans need to be performed on a 1.5 or 3T scanner and have a 2D or 3D FLAIR sequence or 2D/3D T1-weighted image. Patients with prior use of natalizumab are excluded. Clinical data collected include demographics, relapses, prescriptions, symptoms and disability progression. Scans are assessed centrally by an experienced imaging expert for slice thickness, excessive patient motion, image contrast and overall scan quality. Brain volume outcomes such as whole brain volume, lateral ventricle volume, T2- and T1- lesion volumes, and new/enlarging T2 and gadolinium-enhancing lesions are being analyzed using SIENA, VIENA and NeuroSTREAM methodology.
Results: Here we present interim study feasibility results on the first 252 patients. Median age was 44 years and 81% female. All patients had the two required scans and 34% patients also had a pre-index scan (9-24 months before ID). While all but one scan had FLAIR, 40% also had 3D T1 sequence in the pre-index period, increasing to 50% in the post-index period. Use of 2D T1 sequence decreased over time from 85% in the pre-index period to 65% in the post-index period. About 95% of the scans with FLAIR and 2D T1 were considered acceptable or good quality compared to 99-100% with 3D T1.
Conclusions: Initial readout of the study provides strong support for feasibility of the approach. Recruitment is on target and scans are generally of acceptable or good quality. The study also highlighted growth in the use of 3T scanners and 3D-T1 sequences in real world settings.
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: EP1512
Type: ePoster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Brain MRI assessments in real world practice are often not linked with the supporting clinical data, limiting the depth of observational research. This is the first real word multicenter study linking quantitative MRI and clinical outcomes among relapsing remitting multiple sclerosis patients (RRMS).
Objective: To build a longitudinal cohort of RRMS patients to assess the impact of fingolimod on quantitative brain MRI measures and disease progression.
Design and methods: This is an ongoing, multicenter, retrospective, longitudinal chart review of RRMS patients. Clinical and brain MRI data are being collected from 600 patients over 48 months across 30-35 MS centers in the US. Key eligibility criteria include aged 18-65 years at initiation of fingolimod (index date (ID)), fingolimod treatment for at least 28 days and availability of retrospective brain MRI scans during index (6 months before to 1 month after ID) and post index periods (9-24 months after ID). Scans need to be performed on a 1.5 or 3T scanner and have a 2D or 3D FLAIR sequence or 2D/3D T1-weighted image. Patients with prior use of natalizumab are excluded. Clinical data collected include demographics, relapses, prescriptions, symptoms and disability progression. Scans are assessed centrally by an experienced imaging expert for slice thickness, excessive patient motion, image contrast and overall scan quality. Brain volume outcomes such as whole brain volume, lateral ventricle volume, T2- and T1- lesion volumes, and new/enlarging T2 and gadolinium-enhancing lesions are being analyzed using SIENA, VIENA and NeuroSTREAM methodology.
Results: Here we present interim study feasibility results on the first 252 patients. Median age was 44 years and 81% female. All patients had the two required scans and 34% patients also had a pre-index scan (9-24 months before ID). While all but one scan had FLAIR, 40% also had 3D T1 sequence in the pre-index period, increasing to 50% in the post-index period. Use of 2D T1 sequence decreased over time from 85% in the pre-index period to 65% in the post-index period. About 95% of the scans with FLAIR and 2D T1 were considered acceptable or good quality compared to 99-100% with 3D T1.
Conclusions: Initial readout of the study provides strong support for feasibility of the approach. Recruitment is on target and scans are generally of acceptable or good quality. The study also highlighted growth in the use of 3T scanners and 3D-T1 sequences in real world settings.
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.