Genentech, Inc.

Author Of 4 Presentations

Observational Studies Poster Presentation

P0856 - Collecting real world MRI in MS: preliminary results from FlywheelMS (ID 1226)

Speakers
Presentation Number
P0856
Presentation Topic
Observational Studies

Abstract

Background

Real-world evidence can be used to better characterize the course of multiple sclerosis (MS), care provision and outcomes in clinical practice. Magnetic resonance imaging (MRI) that occurs in the context of usual care is an important source of information that can inform clinical decision-making. Guidelines exist to enhance the clinical impact of routine MRI in MS, but it is unclear whether MRIs acquired as part of routine care in the United States adhere to these guidelines.

Objectives

To describe the clinical routine brain MRIs from patients with MS across different US imaging sites.

Methods

FlywheelMS is a novel patient-centered study that aims to extract and digitize health information not readily available in existing electronic health records of patients with MS. Up to 5,000 consenting adults with a confirmed MS diagnosis will be enrolled. Brain MRI data were retrieved, and summary statistics were computed to describe the sessions, imaging sites, scanner field strengths and slice thickness of T1-weighted and FLAIR (fluid-attenuated inversion recovery) images. Longitudinal acquisition consistency (i.e. MRIs acquired from the same center with the same scanner) was also assessed.

Results

Out of 2,389 patients enrolled, 1555 brain MRI data were retrieved from the first 492 patients (female, 81%; mean age at consent, 49±11 years). The mean number of MRI sessions per patient was 3.2±2.4, and data were captured between 1999 and 2018. Sessions were acquired at 598 different imaging sites, using mainly 1.5T scanners (61.3%), followed by 3T (32.7%) and lower field-strength magnets (3.4%; not available, 2.6%). The mean slice thickness of T1-weighted (3.1±1.7 mm) and FLAIR images (3.1±1.3 mm) was similar. Of the 352 patients (72%) that had more than one MRI session, 85 (24.1%) had consistent acquisition (i.e. same site/scanner), 153 (43.5%) had one site or scanner change, and 114 (32.4%) had more than one site and/or scanner change.

Conclusions

The novel, patient-centered approach of FlywheelMS can successfully extract imaging data from medical records of patients with MS across US imaging sites. These data will help us in describing the clinical routine MRI, determining the compliance to guidelines and understanding which measure (e.g. lesion volume and/or atrophy) could be potentially extracted from MRI data.

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Observational Studies Poster Presentation

P0875 - FlywheelMS: The prevalence of multiple sclerosis subtypes in digitized health records (ID 1882)

Speakers
Presentation Number
P0875
Presentation Topic
Observational Studies

Abstract

Background

Data generated from electronic health records (EHRs) offer insight into real-world care of people with multiple sclerosis (MS). Data extracted most readily from EHRs include templated or administrative health information (e.g., MS International Classification of Diseases codes). However, clinical data like disease subtype and characteristics are unlikely to be captured systematically. FlywheelMS is a novel patient-centered study with the aim of digitizing health records of patients with MS and extracting information not readily available in existing EHRs.

Objectives

To evaluate patient characteristics and the prevalence of MS subtypes (i.e., relapsing-remitting MS [RRMS], secondary progressive MS [SPMS], primary progressive MS [PPMS], progressive relapsing MS [PRMS]) in the FlywheelMS cohort and to compare them with existing real-world data sources.

Methods

Adults with MS are recruited across the US via advocacy groups, social media and healthcare professionals. Supervised machine learning with human curation is used to retrieve, digitize and abstract medical records, which are collected as far back as are available and prospectively up to 5 years after enrollment. The most recent non-negated MS subtype from neurology visit records was used as a proxy for the prevalent subtype. Summary statistics were calculated and compared with other MS cohorts.

Results

As of March 1, 2020, 2,389 patients with MS with 24,362 neurology visits across 3,093 neurologists have enrolled in FlywheelMS. Data on MS subtype were available for 973 patients (40.7%); this proportion will increase as abstractions continue. RRMS accounted for 78.9% of patients, followed by SPMS (12%), PPMS (7.3%) and PRMS (1.7%). These findings were comparable to the MSBase Registry (RRMS=76.9%, SPMS=13.0%, PPMS=8.0%, PRMS=2.2%; Kister et al., J Neurol Sci 2012) and NARCOMS Registry (RRMS=65.6%, SPMS=25.1%, PPMS=9.3%; Salter et al., Mult Scler 2018). Mean [SD] age at mention of MS subtype and percent female distribution were as follows: RRMS (46.4 [10.9] years, 80.4%), SPMS (56.4 [9.6] years, 81.2%), PPMS (53.9 [10.7] years, 62.0%), PRMS (mean 53.9 [5.5] years, 82.4%).

Conclusions

The prevalence of MS subtypes in the digitized health records of patients in FlywheelMS was comparable to other real-world data sources. Digitizing and machine-learning guided abstraction of patient healthcare records in MS yields important data about clinical features not readily available in other EHR data sets.

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Observational Studies Poster Presentation

P0897 - Persistence and adherence to ocrelizumab compared with other disease-modifying therapies for multiple sclerosis for up to 18 months in the US (ID 1222)

Speakers
Presentation Number
P0897
Presentation Topic
Observational Studies

Abstract

Background

Adherence to disease-modifying therapy (DMT) is critical for achieving therapeutic goals in multiple sclerosis (MS). Real-world evidence on persistence and adherence with ocrelizumab (OCR) is limited.

Objectives

This analysis aimed to examine the persistence and adherence to OCR compared with other MS DMTs.

Methods

This analysis was conducted in the PharMetrics Plus commercial claims database and included patients with MS who initiated a new DMT between April 2017 and September 2018. Patients were required to have health plan enrollment for ≥12 months before and after DMT initiation. Persistence and adherence were measured in patients with ≥12 months and ≥18 months of follow-up. Persistence was defined as no switch to other DMTs and no gap in supply of initiated DMT for ≥60 days. Adherence was assessed using the proportion of days covered (PDC), calculated as the total days of supply of DMT during the postinitiation period divided by either 365 days (12-month analysis) or 548 days (18-month analysis). Multivariable Poisson regression models were used to compare discontinuation of (nonpersistence) and nonadherence (PDC <0.80) with OCR vs oral, injectable, and other intravenous (IV) DMTs.

Results

A total of 4,587 (OCR, 1,319; injectable, 1,051; oral, 1,876; IV, 341) patients were included. At 12 months, patients initiating OCR had the highest mean PDC (93.4%) compared with other groups (injectable, 69%; oral, 74%; IV, 76%) and the highest proportion of patients persistent with therapy (92% vs 57%, 68% and 72%, respectively). Compared with OCR, adjusted relative risks of 12-month discontinuation (95% CI) were 5.5 (4.1–7.5), 3.8 (3.0–4.9) and 3.3 (2.3–4.6) in patients initiating injectable, oral and IV DMTs, respectively, and relative risks of nonadherence were 6.8 (5.0–9.3), 5.1 (3.9–6.6) and 4.9 (3.6–6.8), respectively. Among patients with 18 months of follow-up (n=2,319), 83% of OCR patients demonstrated persistence vs 45%, 59% and 60% of injectable, oral and IV patients, respectively. Trends in discontinuation and nonadherence for the DMT groups over 18 months were consistent with 12-month results in fully adjusted models.

Conclusions

Patients initiating ocrelizumab had superior persistence and adherence at both 12 and 18 months of follow-up compared with other groups of MS DMTs. Long-term persistence and adherence should be monitored as ocrelizumab experience accrues in a real-world setting.

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Patient-Reported Outcomes and Quality of Life Poster Presentation

P1023 - Early experience engaging patients in the use of a mobile application for tracking multiple sclerosis. (ID 1522)

Speakers
Presentation Number
P1023
Presentation Topic
Patient-Reported Outcomes and Quality of Life

Abstract

Background

When patients with multiple sclerosis (MS) are seen only 2-3 times per year, the in-clinic interview and patient recall are the main means of capturing between-visit information on MS disease status and treatment status. Recall error and limited clinical time can diminish the quality of these data. Mobile applications have the potential to fill in the gaps with structured, quality and timely information to inform the clinical encounter. Few mobile apps have shown wide adoption. It is unclear whether patients embrace these solutions and if they provide useful data to clinicians. This pilot test assessed the adoption and usability of an MS-focused mobile app called Floodlight Open (FLO).

Objectives

Our objective was to understand the barriers and facilitators to introducing patients to the app in clinical practice, use over time, and patient and clinicians’ experience.

Methods

We piloted FLO in three neurology practices. Enrollment relied on a clinician-mediated model in which a neurologist introduced an MS patient to a researcher, who enrolled them in the study and encouraged use for at least 30 days. We modified the enrollment process mid-way to demonstrate the assessments in the app. Usage data were complemented by patients and clinician interviews.

Results

Initially we recruited 50 patients, 46% of whom used the app. Female users were 78%. The average use was 30 days over the first 60 days from enrollment; 30% of patients contributed 30+ days of data. Patients over 35 years of age contributed the most and the 25-34 age group contributed the least data. After the protocol change, 46 patients were recruited, 48% of whom used the app. 86% of users were female. The average use was 31 days; 23% patients contributed 30+ days of data. Patients in the 45-64 age group were most likely to be persistent users and the 35-44 age group were the least persistent user. Qualitative results indicate that: 1) patient participation is strongly driven by willingness to help research, 2) patients perceive a trade-off between effort to use the app and its value in an encounter, 3) physician use of the data motivates patient app use, 4) reminders are important to ongoing use.

Conclusions

Physician’s endorsement is influential and helps initial uptake, as does a patient’s desire to participate in research. Routine use of data by physicians in the encounter is important to motivate patients to use a mobile app longer term and outside of a research context.

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