Contributions
Abstract: EP1766
Type: ePoster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Quantitative magnetic resonance imaging (QMRI) is not used routinely in multiple sclerosis (MS) clinical practice, but is regularly used in clinical trials and by some imaging research groups. 'No evidence of disease activity' (NEDA) status is a recent concept that has been examined in few real-world MS cohorts.
Objectives:
(i) To compare lesion activity and whole brain volume change data obtained by radiologist MRI review with data provided by formal QMRI analysis, performed locally and using MSmetrix;
(ii) To determine whether QMRI analysis data influences NEDA3 and NEDA4 status in this MS cohort.
Methods: Clinical brain MRIs (3D T1 and 2D/3D FLAIR sequences) were acquired at baseline and follow-up (≥12 months) from 150 MS patients: 50 each from three centres located in Buffalo (USA), Prague (Czech Republic) and Sydney (Australia). MRIs were reviewed by expert neuroradiologists; QMRI analyses were performed both locally and centrally (MSmetrix). Clinical parameters, including relapses and Expanded Disability Status Scale (EDSS) scores, were recorded at both time points. Patients were classified as NEDA3 +/- NEDA4 based on clinical activity/progression criteria combined with MRI activity +/- progression criteria. MRI progression was defined as >0.4% (annualised) whole brain volume loss.
Results: 150 MS patients (77.3% female; 98.0% Relapsing-remitting MS), mean age 38.8(10.2) years, mean disease duration 9.0(7.3) years and median baseline EDSS 2.0 (range 0-7.0), were evaluated. Based on clinical criteria alone, 65.3% of the cohort were NEDA. With the addition of MRI data from radiologist review, 46.3% were NEDA3 and 45.6% NEDA4. Using local and MSmetrix QMRI data, NEDA3/NEDA4 rates fell to 44.9%/23.8% and 38.8%/19.7%, respectively. Comparison of local and MSmetrix QMRI data revealed discrepancies in the presence of MRI lesion activity and progression in 26.5% and 24.5%, respectively.
Conclusions: Incorporating QMRI lesion data had only a modest impact on NEDA3 status in this cohort, which was greater for MSmetrix. Thus QMRI only provides minor additional benefit in NEDA3 assessment over experienced neuroradiologists. However, volumetric QMRI data significantly influenced NEDA4 status, regardless of whether local or MSmetrix QMRI data was used. QMRI is critical for accurate NEDA4 assessment, as relevant brain atrophy rates are not detectable by experienced neuroradiologists.
Disclosure:
Heidi N Beadnall has received compensation for education travel, speaker honoraria and consultant fees from Biogen, Novartis, Merck and Sanofi-Genzyme.
Thibo Billiet is an employee of IcoMetrix.
Dana Horakova has received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Bayer, Roche, Sanofi Genzyme and Teva, as well as support for research activities from Biogen Idec.
Deepa P Ramasamy has nothing to disclose.
Linda Ly is an employee of Sydney Neuroimaging Analysis Centre.
Annemie Ribbens is an employee of IcoMetrix.
Michael G Dwyer has received consultant fees from Claret Medical and EMD Serono and research grant support from Novartis.
Tomas Uher has received financial support for conference travel and honoraria from Biogen Idec, Novartis, Genzyme, Roche and Merck Serono, as well as support for research activities from Biogen Idec.
Niels Bergsland has nothing to disclose.
Eva Havrdova has received speaker honoraria and consultant fees from Biogen Idec, Merck Serono, Novartis, Genzyme and Teva, as well as support for research activities from Biogen Idec and Merck Serono.
Chenyu Wang is an employee of Sydney Neuroimaging Analysis Centre.
Ellen Carl has nothing to disclose.
Wim van Hecke is an employee of IcoMetrix.
Manuela Vaneckova was supported by Czech Ministry of Health, grant RVO-VFN 64165. She has received compensation for speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono and Teva, as well as support for research activities from Biogen Idec.
Robert Zivadinov has received personal compensation from EMD Serono, Genzyme-Sanofi, Novartis, Claret-Medical, Celgene for speaking and consultant fees. He has received financial support for research activities from Claret Medical, Genzyme-Sanofi, QuintilesIMS Health, Intekrin-Coherus, Novartis and Intekrin-Coherus.
Michael H Barnett has received institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).
Abstract: EP1766
Type: ePoster
Abstract Category: Therapy - disease modifying - 30 Tools for detecting therapeutic response
Background: Quantitative magnetic resonance imaging (QMRI) is not used routinely in multiple sclerosis (MS) clinical practice, but is regularly used in clinical trials and by some imaging research groups. 'No evidence of disease activity' (NEDA) status is a recent concept that has been examined in few real-world MS cohorts.
Objectives:
(i) To compare lesion activity and whole brain volume change data obtained by radiologist MRI review with data provided by formal QMRI analysis, performed locally and using MSmetrix;
(ii) To determine whether QMRI analysis data influences NEDA3 and NEDA4 status in this MS cohort.
Methods: Clinical brain MRIs (3D T1 and 2D/3D FLAIR sequences) were acquired at baseline and follow-up (≥12 months) from 150 MS patients: 50 each from three centres located in Buffalo (USA), Prague (Czech Republic) and Sydney (Australia). MRIs were reviewed by expert neuroradiologists; QMRI analyses were performed both locally and centrally (MSmetrix). Clinical parameters, including relapses and Expanded Disability Status Scale (EDSS) scores, were recorded at both time points. Patients were classified as NEDA3 +/- NEDA4 based on clinical activity/progression criteria combined with MRI activity +/- progression criteria. MRI progression was defined as >0.4% (annualised) whole brain volume loss.
Results: 150 MS patients (77.3% female; 98.0% Relapsing-remitting MS), mean age 38.8(10.2) years, mean disease duration 9.0(7.3) years and median baseline EDSS 2.0 (range 0-7.0), were evaluated. Based on clinical criteria alone, 65.3% of the cohort were NEDA. With the addition of MRI data from radiologist review, 46.3% were NEDA3 and 45.6% NEDA4. Using local and MSmetrix QMRI data, NEDA3/NEDA4 rates fell to 44.9%/23.8% and 38.8%/19.7%, respectively. Comparison of local and MSmetrix QMRI data revealed discrepancies in the presence of MRI lesion activity and progression in 26.5% and 24.5%, respectively.
Conclusions: Incorporating QMRI lesion data had only a modest impact on NEDA3 status in this cohort, which was greater for MSmetrix. Thus QMRI only provides minor additional benefit in NEDA3 assessment over experienced neuroradiologists. However, volumetric QMRI data significantly influenced NEDA4 status, regardless of whether local or MSmetrix QMRI data was used. QMRI is critical for accurate NEDA4 assessment, as relevant brain atrophy rates are not detectable by experienced neuroradiologists.
Disclosure:
Heidi N Beadnall has received compensation for education travel, speaker honoraria and consultant fees from Biogen, Novartis, Merck and Sanofi-Genzyme.
Thibo Billiet is an employee of IcoMetrix.
Dana Horakova has received compensation for travel, speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck, Bayer, Roche, Sanofi Genzyme and Teva, as well as support for research activities from Biogen Idec.
Deepa P Ramasamy has nothing to disclose.
Linda Ly is an employee of Sydney Neuroimaging Analysis Centre.
Annemie Ribbens is an employee of IcoMetrix.
Michael G Dwyer has received consultant fees from Claret Medical and EMD Serono and research grant support from Novartis.
Tomas Uher has received financial support for conference travel and honoraria from Biogen Idec, Novartis, Genzyme, Roche and Merck Serono, as well as support for research activities from Biogen Idec.
Niels Bergsland has nothing to disclose.
Eva Havrdova has received speaker honoraria and consultant fees from Biogen Idec, Merck Serono, Novartis, Genzyme and Teva, as well as support for research activities from Biogen Idec and Merck Serono.
Chenyu Wang is an employee of Sydney Neuroimaging Analysis Centre.
Ellen Carl has nothing to disclose.
Wim van Hecke is an employee of IcoMetrix.
Manuela Vaneckova was supported by Czech Ministry of Health, grant RVO-VFN 64165. She has received compensation for speaker honoraria and consultant fees from Biogen Idec, Novartis, Merck Serono and Teva, as well as support for research activities from Biogen Idec.
Robert Zivadinov has received personal compensation from EMD Serono, Genzyme-Sanofi, Novartis, Claret-Medical, Celgene for speaking and consultant fees. He has received financial support for research activities from Claret Medical, Genzyme-Sanofi, QuintilesIMS Health, Intekrin-Coherus, Novartis and Intekrin-Coherus.
Michael H Barnett has received institutional support for research, speaking and/or participation in advisory boards (Biogen, Novartis, and Sanofi Genzyme); research consultant (Medical Safety Systems).