Author Of 2 Presentations
P0577 - Feasibility of thalamic atrophy measurement in clinical routine using artificial intelligence: Results from multi-center study in RRMS patients (ID 1058)
Abstract
Background
The thalamus is a key gray matter structure, and a sensitive marker of neurodegeneration in multiple sclerosis (MS). Previous reports have indicated that thalamic volumetry on clinical-quality T2-FLAIR images alone is fast and reliable, using artificial intelligence (AI).
Objectives
To investigate the feasibility of thalamic atrophy measurement using AI in patients with MS, in a large multi-center, clinical routine study.
Methods
DeepGRAI (Deep Gray Rating via Artificial Intelligence) is a multi-center (31 USA sites), longitudinal, observational, real-word, registry study that will enroll 1,000 relapsing-remitting MS patients. Brain MRI exams previously acquired at baseline and at follow-up on 1.5T or 3T scanners with no prior standardization are used, in order to resemble real-world situation. Thalamic volume measurement is performed at baseline and follow-up on T2-FLAIR by DeepGRAI tool and on 3D T1-weighted image (WI) and 2D T1-WI by using FIRST software.
Results
In this pre-planned interim analysis, 515 RRMS patients were followed for an average of 2.7 years. There were 487 (94.6%) T2-FLAIR, 342 (66.4%) 2D T1-WI and 176 (34.2%) 3D T1-WI longitudinal pair of MRI exams available for analyses. Estimation of thalamic volume by DeepGRAI on T2-FLAIR correlated significantly with FIRST on 3D-T1-WI (r=0.733 and r=0.816, p<0.001) and with FIRST on 2D-T1-WI (r=0.555 and r=0.704, p<0.001) at baseline and at follow-up. The correlation between thalamic volume estimated by FIRST on 3D T1-WI and 2D T1-WI was r=0.642 and r=0.679, p<0.001, respectively. The thalamic volume % change over the follow-up was similar between DeepGRAI (-0.75) and 3D T1-WI (-0.82), but somewhat higher for 2D T1-WI (-0.92). Similar relationship was found between the Expanded Disability Status Scale (EDSS) and thalamic volume by DeepGRAI on T2-FLAIR and by FIRST on 3D T1-WI at baseline (r=-0.214, p=0.01 and r=-0.287, p=0.001) and at follow-up (r=-0.298, p=0.001 and r=-0.291, p=0.001).
Conclusions
DeepGRAI provides feasible thalamic volume measurement on multi-center clinical-quality T2-FLAIR images. The relationship between thalamic atrophy and physical disability is similar using DeepGRAI T2-FLAIR and standard high-resolution research approaches. This indicates potential for real-world thalamic volume monitoring, as well as quantification on legacy datasets without research-quality MRI.
P0895 - Outcomes from a prospective observational registry of repository corticotropin injection for the treatment of multiple sclerosis relapse (ID 414)
Abstract
Background
Effective treatment of relapse is critical for minimizing disability in patients with multiple sclerosis (MS). Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is approved by the US Food and Drug Administration for treatment of MS exacerbations.
Objectives
This multicenter, prospective, observational, registry study aimed to characterize treatment patterns, recovery, and safety outcomes from patients receiving RCI for acute MS relapse.
Methods
Subjects were recruited before initiation of RCI for an MS exacerbation. Clinician assessments included the Expanded Disability Status Scale (EDSS), Functional System Score (FSS), and Clinical Global Impression of Improvement scale (CGI-I). Patient-reported outcome questionnaires included the MS Impact Scale (MSIS-29v1), Work Productivity and Activity Impairment: MS (WPAI:MS), and Health Resource Utilization (HRU). Safety was assessed by adverse events (AEs).
Results
In all, 125 subjects received ≥1 dose of RCI. Mean scores significantly decreased from baseline to month 6 for the EDSS (–0.45, n=56) and total (sum of all subsystem domain scores) FSS (–1.55; n=56) (p<0.0001 for both) with RCI treatment. The CGI-I also indicated statistically significant improvement at 6 months (p<0.0001). Mean MSIS-29v1 physical subscale scores decreased from baseline to month 2 (–7.99, p=0.0002, n=69, primary endpoint) and month 6 (–9.64, p<0.0001, n=48). For the WPAI:MS, mean changes from baseline to month 6 were statistically significant for percent work time missed due to MS (–27.75, p=0.0255, n=17) and percent activity impairment due to MS (–11.52, p=0.0003, n=46). Regarding HRU measures, the mean number of MS-related emergency department visits, hospitalizations, numbers of days in the hospital, and outpatient visits (other than healthcare professional visits at home) decreased from baseline at month 6. Thirty-five subjects (28.0%) reported 83 AEs, the most common being MS relapse, urinary tract infection (UTI), nasopharyngitis, and peripheral edema. Eleven subjects (8.8%) reported 16 serious AEs, the most common being MS relapse, UTI, and asthenia.
Conclusions
Clinically meaningful improvements on the EDSS, CGI-I, and MSIS-29v1 physical subscale, along with statistically significant improvements in additional clinician- and patient-reported outcomes and the low incidence of serious AEs, support the efficacy and safety of RCI for the treatment of MS relapse.
Presenter Of 1 Presentation
P0895 - Outcomes from a prospective observational registry of repository corticotropin injection for the treatment of multiple sclerosis relapse (ID 414)
Abstract
Background
Effective treatment of relapse is critical for minimizing disability in patients with multiple sclerosis (MS). Repository corticotropin injection (RCI, Mallinckrodt Pharmaceuticals) is approved by the US Food and Drug Administration for treatment of MS exacerbations.
Objectives
This multicenter, prospective, observational, registry study aimed to characterize treatment patterns, recovery, and safety outcomes from patients receiving RCI for acute MS relapse.
Methods
Subjects were recruited before initiation of RCI for an MS exacerbation. Clinician assessments included the Expanded Disability Status Scale (EDSS), Functional System Score (FSS), and Clinical Global Impression of Improvement scale (CGI-I). Patient-reported outcome questionnaires included the MS Impact Scale (MSIS-29v1), Work Productivity and Activity Impairment: MS (WPAI:MS), and Health Resource Utilization (HRU). Safety was assessed by adverse events (AEs).
Results
In all, 125 subjects received ≥1 dose of RCI. Mean scores significantly decreased from baseline to month 6 for the EDSS (–0.45, n=56) and total (sum of all subsystem domain scores) FSS (–1.55; n=56) (p<0.0001 for both) with RCI treatment. The CGI-I also indicated statistically significant improvement at 6 months (p<0.0001). Mean MSIS-29v1 physical subscale scores decreased from baseline to month 2 (–7.99, p=0.0002, n=69, primary endpoint) and month 6 (–9.64, p<0.0001, n=48). For the WPAI:MS, mean changes from baseline to month 6 were statistically significant for percent work time missed due to MS (–27.75, p=0.0255, n=17) and percent activity impairment due to MS (–11.52, p=0.0003, n=46). Regarding HRU measures, the mean number of MS-related emergency department visits, hospitalizations, numbers of days in the hospital, and outpatient visits (other than healthcare professional visits at home) decreased from baseline at month 6. Thirty-five subjects (28.0%) reported 83 AEs, the most common being MS relapse, urinary tract infection (UTI), nasopharyngitis, and peripheral edema. Eleven subjects (8.8%) reported 16 serious AEs, the most common being MS relapse, UTI, and asthenia.
Conclusions
Clinically meaningful improvements on the EDSS, CGI-I, and MSIS-29v1 physical subscale, along with statistically significant improvements in additional clinician- and patient-reported outcomes and the low incidence of serious AEs, support the efficacy and safety of RCI for the treatment of MS relapse.