ABSTRACT
Background: Utilization of teleneurology for MS care rapidly expanded during the COVID-19 pandemic to maintain healthcare access. Disparities in telehealth use have been described in other health conditions, but not in a MS population. Objectives/Aims: To evaluate longitudinal utilization of teleneurology across age, race, geographic factors, and insurance categories to identify potential disparities in utilization at a single academic MS center (Cleveland Clinic). Method(s): MS patients attending a specialty clinic in Cleveland, a medium-sized city, who completed >=2 visits at least 24 months apart from 1/2019 to 6/2021 were studied. Patients with fully inperson care were compared to patients with <50% or >50% teleneurology care. Categories of age, race, geographic factors, and insurance were compared using Kruskal-Wallis tests and pairwise Wilcoxon rank sum tests with Bonferroni correction for multiple comparisons. Result(s): 892 patients met the inclusion criteria and completed 3710 visits during the study timeframe: mean age 49.1+/-11.7 years, 73.7% female, 85.6% white, median disease duration 11.2 years [0.15;60.3], and relapsing-remitting 62.3%. 37% patients were fully in-person, 37.2% patients had <50% teleneurology care, and 25.8% patients had >50% teleneurology care. There were no significant differences for race (white, black, other), insurance type (Medicare, Medicaid, private, non/other), area deprivation index (ADI), and residence location (rural vs metropolitan) in the use of teleneurology. Use of teleneurology care varied based by age, with older patients utilizing more in-person care. In person care was 23.4% for ages 18-39, 38.5% for ages 40-60, and 47.8% for those greater than 60 (p<0.001). Patients residing in greater Cleveland had significantly more in-person care (55.3%) compared to residents residing in Ohio outside of the greater Cleveland area (34.7%) and outside of Ohio (10.1%) (p=0.031). Conclusion(s): There were no significant differences in teleneurology utilization across race, insurance, ADI or rural vs metropolitan residence, suggesting it is a broadly accessible tool to overcome disparities in access to MS care. Utilization of teleneurology care for older and local patients was lower, which may be due to decrease demand in these groups. Future studies should assess the optimal integration of teleneurology and in-person visits in MS management.
ABSTRACT
Introduction: The approval of ocrelizumab (OCR) for the treatment of primary progressive MS (PPMS) showed that the course of progressive MS (PMS) can be altered with effective treatment;however, direct evidence across the spectrum of PMS, including secondary progressive MS (SPMS), is still lacking. Objective(s): CONSONANCE (NCT03523858) is a single-arm, phase 3b, 4-year study designed to evaluate for the first time the effectiveness and safety of OCR in patients with SPMS or PPMS. Year 2 results are reported. Method(s): Patients with active or non-active PMS but showing disability progression in the past 2 years were enrolled. Primary outcomes are (1) proportion of patients with no evidence of progression (NEP) defined as no progression confirmed for >=24 weeks on Expanded Disability Status Scale (EDSS), no >=20% increase in timed 25-foot walk test (T25FWT), no >=20% increase in nine-hole peg test (9HPT) time, and no MS-related death or treatment discontinuation due to efficacy failure;(2) proportion of patients with no evidence of progression and no active disease (NEPAD) defined as NEP plus no protocol-defined relapse, no new/enlarging T2 lesions (N/E-T2, re-baselined at week 24), and no T1 gadolinium-enhanced lesions. Result(s): Patients (n=629;SPMS n=324, PPMS n=305) had mean (SD) age of 48.5 (9.2) years and 52.3% were female. At baseline (BL), median (IQR)/mean (SD) EDSS scores were 6.0 (4.5- 6.0)/5.3 (1.3) for patients with SPMS and 5.0 (4.0-6.0)/4.8 (1.3) for PPMS. Overall median times for 9HPT and T25FWT were 27.9 and 9.4 seconds, respectively. Over 2 years, 311/586 (53.1%) patients had NEP (SPMS 55.8%;PPMS 50.2%;progression was mostly driven by increases in T25FWT) and 283/588 (48.1%) had NEPAD (SPMS 49.5%;PPMS 46.7%;acute activity predominantly driven by N/E-T2 lesions). Overall EDSS remained stable from BL to year 2 (mean [SD] change of +0.07 (0.79) points). In patients with EDSS >=2.0 at BL (n=526), 24-week confirmed disability improvement in any of the components (EDSS, T25FWT, 9HPT) was observed in 29.8% of cases. Rates of serious AEs and serious infections were 7.6/100PY and 3.2/100PY, respectively. Eight deaths were reported (COVID=6, pulmonary embolism=1, non-small cell lung cancer=1). Conclusion(s): Over a 2-year period, treatment with OCR was associated with comparable rates of NEP and NEPAD in patients with SPMS and PPMS, and with functional improvement in about one-third of patients. Safety outcomes were consistent with known safety profile.
ABSTRACT
Background: Utilization of teleneurology rapidly expanded during the COVID-19 pandemic for multiple sclerosis (MS) care to maintain healthcare access. Feasibility and high patient satisfaction with virtual care has been studied, but there are no data regarding the impact of teleneurology on clinical outcomes. Objectives/Aims: To examine the impact of teleneurology care on MS outcomes at a single academic MS center (Cleveland Clinic). Methods: MS patients who completed ≥2 in-person visits 12 months apart (+/- 6 months) from 1/2019 to 12/2020 were studied. Patients with fully in-person care were compared to patients with a combination of teleneurology and in-person care during this timeframe. Multiple linear regression models were created to assess differences in clinical outcomes between groups, adjusting for age, sex, race, employment status, disease duration, education, MS course (relapsing remitting (RRMS), progressive), disability level measured by Patient Determined Disease Steps (PDDS), number of visits, and time from baseline. Significance was set at p<0.05. Results: For 2131 patients meeting the inclusion criteria: median time between the first and last in-person visits 366 days, mean age 49.5±12.6 years, 72.4% female, 81.4% white, 55.3% employed, disease duration 15.9±11.5, RRMS 58.5%, and 71.2% PDDS <=4, distance from center 65.3 [22.9, 409] ). 1905 (89.4%) had only in-person visits and 226 (10.6%) had both teleneurology and in-person visits. The teleneurology group had shorter disease duration (14.4±10.3 vs 16.1±11.6 years), higher disability score (32.3% vs 25.1% PDDS >4), greater interval between first and last visit (412 [367, 497] vs 363 [253, 424] days), lived closer to the center (34.8 [17.3, 83.0] vs 68.9 [23.3, 2081] miles), and higher total number of visits (4 [3, 4] vs 3 [2, 3] visits) (p<0.05 for all). The groups did not differ for age, sex, race, employment status, education, or MS course (p>0.05). Patients with teleneurology care had no significant difference in manual dexterity, processing speed, or walking speed compared to patients with only in-person care after adjustment for demographic and disease characteristics (p>0.05 for all). Conclusions: This study demonstrates that teleneurology care did not appear to have an effect on clinical outcomes in MS. These data support the continued use of teleneurology in MS care. Future studies are needed to elucidate the optimal combination of teleneurology and in-person visit types for MS patients.
ABSTRACT
Background: Data on the effects of multiple sclerosis (MS) disease modifying therapies (DMTs) on SARS-CoV-2 vaccine response are needed. Initial studies suggest CD20 cell depleting therapies and fingolimod attenuate IgG response to SARS-CoV-2 vaccination in MS patients (pts), consistent with previous studies of vaccine responses in pts treated with those DMTs. Methods: Participants with MS enrolled in the MS PATHS network in the US, Germany, and Spain were asked to provide blood serum samples up to 30 days pre-SARS-CoV-2 vaccination and 28-90 days post final vaccine dose. The goal is to obtain & ge;45 post-vaccination samples per approved DMT and among pts not currently treated with a DMT. Semi-quantitative measures of SARS-CoV-2 IgG response to spike protein (Siemens SARSCoV- 2 IgG assay) and nucleocapsid protein (Abbott SARS-CoV-2 IgG assay) will be used to distinguish humoral responses to vaccination vs prior infection. The impact of demographic factors, MS disease subtype and duration, disability level, DMT type, vaccine type, and time since last DMT dose, and vaccine dose on IgG response will be evaluated. Results: As of May 17, 2021, 379 unique pts provided a serum sample: CD20 DMTs (n=139), S1P DMTs (n=31), natalizumab (n=39), other DMTs (n=117), and no DMT (n=53);183 pts have a pre-vaccination sample awaiting a post-vaccination sample, 186 have only a post-vaccination sample, and 10 have both. Prevaccination samples were collected at a mean (SD) of 4.5 (7.5) days prior to the first vaccine dose, and post-vaccination samples were collected 46.6 (15.2) days after the last dose, 91.8% following an mRNA vaccine. Pt (n=379) characteristics were: age 50.3 (12.5) yrs, 67% female, disease duration 16.6 (9.6) yrs, 27.7% progressive MS, and Patient Determined Disease Steps 2.0 (2.3). Reactive IgG rates (IgG index & gt;1) from initial post-vaccination testing were CD20 DMTs 21/41 (51%), S1P DMTs 4/8 (50%), and 100% for all other groups, including natalizumab (n=9), fumarates (n=8), interferons (n=8), glatiramer acetate (n=8), teriflunomide (n=2), alemtuzumab (n=1) and no DMT (n=17). Conclusions: Preliminary results, based on a limited sample size, suggest CD20 and S1P DMTs may reduce IgG response to SARS-CoV-2 vaccination. Quantifying post-vaccination IgG response across DMTs is crucial to optimize MS management. Data from ongoing sample collection will be presented at the meeting.