Background

The 2019 coronavirus (COVID19) is a novel infectious entity that has incited a global pandemic. Most infected patients experience mild to moderate upper respiratory symptoms but up to 20% have severe pulmonary and multisystem organ involvement. Few studies have assessed the risk for severe COVID19 infection among persons with multiple sclerosis (MS) or other neuroimmunological disorders, many of whom are treated with disease-modifying therapy (DMT).

Objectives

To describe the baseline clinico-sociodemographic characteristics and recent COVID19 epidemiology of patients managed at our center.

Methods

The electronic medical record was queried for patients evaluated at our center with at least two clinical visits within the past 2 years from censure date 1 March 2020. Variables of interest were collected from 1 March to 31 July 2020, and descriptive statistics were obtained.

Results

717 patients were included in the study, comprising 90.7% MS, 5.6% neuromyelitis optica spectrum disorder (NMOSD), 2.0% autoimmune encephalitis (AE), and 1.7% other neuroinflammatory. Median age was 43 (range 14-80), and 69.5% were women. The most commonly reported race and ethnic identities were 14.8% Black, 50.9% Caucasian, and 16.2% Hispanic. The most frequent DMT regimens were anti-CD20 therapy (38.5% ocrelizumab [OCV], 19.8% rituximab [RTX]), dimethyl fumarate (9.8%), and no DMT (8.9%). We found a 9.9% (n=71) report rate of symptoms suspicious for COVID19 of whom 37% (n=26) had confirmatory viral PCR testing. Two subgroups were compared: COVID19 asymptomatic (n=79) and COVID19 symptomatic PCR confirmed. PCR confirmed cases had statistically significant higher rates of Black race (26.9%, p=0.000), Hispanic ethnicity (26.9%, p=0.042), and multiple medical co-morbidities (42%, p=0.002). Most COVID19 symptomatic patients were managed at home (86%). Serious COVID19 infection necessitating hospitalization occurred rarely in patients treated on glatiramer acetate (1), natalizumab (1), OCV (3), or RTX (5). Of those hospitalized (n=10), 4 were admitted to ICU and 5 died (3 MS, 1 NMOSD, 1 AE).

Conclusions

Among a diverse population of patients with neuroimmunological disorders on various DMT regimens residing in one of the epicenters of the COVID19 pandemic, our retrospective observational study found lower rates of hospitalization and mortality compared to the general population of New York City. Significantly higher rates of Black and Hispanic patients tested positive for COVID19 compared to a subgroup who denied symptoms.

Background

The arrival of the Covid-19 pandemic in the United States brought a heightened level of anxiety to the general population. Individuals with chronic diseases such as multiple sclerosis (MS) were expected to be particularly affected. To address mental health needs safely and immediately, we conducted a trial of a group-based telehealth treatment of professional online support groups to reduce anxiety in persons with MS, the SUNLIGHT study.

Objectives

To determine feasibility and initial efficacy of a pilot trial of online structured, moderated professional support groups to reduce anxiety in persons with MS during the US outbreak of Covid-19. Trial was registered at clinicaltrials.gov (NCT04379661).

Methods

All procedures were conducted remotely. Thirty-two patients with MS were recruited in March-April 2020 at an MS Center in New York City. Consent was obtained via eConsent. 21 received active treatment: 1 hour/week online structured group therapy; 11 served as an inactive control group (i.e., treatment as usual, TAU). Baseline measures were collected from all participants: anxiety (Stait-Trait Anxiety Inventory, primary efficacy outcome), stress (Perceived Stress Scale), distress (Impact of Event Scale), mood (Patient Health Questionnaire), loneliness (UCLA Loneliness Scale), self-efficacy (General Self-Efficacy Scale), quality of life (Functional Assessment of Multiple Sclerosis).

Results

Sample was diverse: 83% female; 23.3% Hispanic / Latino, 10% Black, 3.3% Asian; age range: 24-72 years; disease duration: .25 -38 years. 30% Major Depressive Disorder, 30% anxiety disorder. At baseline, 36.6% had an anxiety attack within past 4 weeks.

Feasibility: Completion and adherence for treatment group were high; 80.9% completed the intervention; average adherence was 75%.

Efficacy results: Anxiety decreased in the treatment group after 12-weeks (STAI mean change = -2.7 points; p=.09).

Qualitative results: 100% responded YES to 'did you find the SUNLIGHT study to be worth your time,' and 'would you recommend SUNLIGHT study to a friend with MS;' 95% responded YES to 'if it were possible to continue your participation in the SUNLIGHT study, would you choose to do so;' 53% responded YES to 'do you think participation in the SUNLIGHT study contributed to a decrease in any of your MS symptoms?'

Conclusions

Telehealth provides an acceptable, accessible, safe vehicle for delivering mental health treatment to chronic disease populations during Covid-19. High adherence and completion, and initial evidence showing reduced anxiety bolster professional support groups as a promising treatment option for individuals with MS. Low cost, high return solutions such as online support groups should be further explored in future large-scale trials. Rigorous clinical trail evidence is needed to elevate the priority given to telehealth behavioral treatments.

Background

We have limited understanding of the risks and impact of COVID-19 in neuroinflammatory diseases (NID) of the central nervous system, particularly among patients receiving disease modifying therapies (DMTs).

Objectives

To report initial results of a planned multi-center year-long prospective study examining the risk and impact of COVID-19 among persons with NID.

Methods

In April 2020, we deployed online questionnaires to individuals in their home environment to assess the prevalence and potential risk factors of COVID-19 symptoms in persons with and without NID.

Results

Our cohort included 1,115 participants (630 NID, 98% MS; 485 reference) as of April 30, 2020. 202 (18%) participants, residing in areas with high COVID-19 case prevalence, met the April 2020 CDC symptom criteria for suspected COVID-19, but only 4% of all participants received testing given testing shortages. Among all participants, those with suspected COVID-19 were younger, more racially diverse, and reported more depression and liver disease. Persons with NID had the same rate of suspected COVID-19 as the reference group. Early changes in disease management included telemedicine visits in 21% and treatment changes in 9% of persons with NID. After adjusting for potential confounders, increasing neurological disability was associated with a greater likelihood of suspected COVID-19 (OR_adj=1.45, 1.17-1.84).

Conclusions

Our study of real-time, patient-reported experience during the COVID-19 pandemic complements physician-reported MS case registries that capture an excess of severe cases. Overall, persons with NID seem to have a risk of suspected COVID-19 similar to the reference population.

Background

We are social animals who naturally seek the companionship of others as an essential part of our physical and psychological well-being. Patients with multiple sclerosis (MS) who are dealing with a chronic and often debilitating disease are at higher risk for social isolation, which may be particularly detrimental to their health.

Objectives

We investigated associations of social support with mental health, cognition, and motor functioning in cross-sectional data from two independent cohorts of patients with MS. We further explored sex differences in these relationships, based on a bioevolutionary theoretical justification.

Methods

Social support was assessed in 185 recently diagnosed patients (RADIEMS cohort), and in an independent validation sample (MEM CONNECT cohort, n = 62). Patients also completed a comprehensive neurobehavioral evaluation including measures of mental health, fatigue, quality of life, cognition and motor function. Correlations tested links between social support and these variables, along with potential gender differences.

Results

In both samples, higher social support was associated with better mental health, quality of life, subjective cognitive function, and less fatigue. In the RADIEMS cohort, correlations showed positive associations between social support and motor functions. The most robust relationships were observed for gross motor functions (gait, grip strength), especially in women.

Conclusions

These findings highlight associations of social support to overall psychological health and motor functioning in persons with MS, underlining the potential opportunity of evaluating and promoting social engagement as a novel treatment strategy.

Background

A more severe disease course has been reported in African-American (AA) in comparison with Caucasian (CA) MS patients. Sociodemographic differences and limited access to treatment have been often used to explain the different disability profile in the two groups. To date, an objective assessment of disability in AA and potential differences with CA patients is still lacking.

Objectives

Here, we characterized sociodemographic, motor and neuropsychological features of AA and CA patients with multiple sclerosis.

Methods

Fifty-seven AA patients (43F, mean age 37.84 ± 10.54 yrs, mean disease duration 5.64 ± 5.74 yrs, median EDSS 2, EDSS range 0-6.5), 37 AA healthy controls (HC) (25F, mean age 35.97 ± 12.44 yrs), 50 CA patients (36F, mean age 39.02 ± 10.83 yrs, mean disease duration 5.90 ± 5.94 yrs, median EDSS 1.5, EDSS range 0-6) and 28 CA HC (17F, mean age 35.57 ± 11.77 yrs) were prospectively enrolled. In all subjects, an extensive neuropsychological and sensory-motor evaluation was performed. The sensory-motor evaluation included 9-hole peg test (9-HPT), grooved pegboard test (GPT), finger tapping test (FTT), 25-foot walk test (25-FWT), 2-minutes walk test (2-MWT), evaluation of segmental strength, grip strength, vibration sensitivity (VS) and standing balance (theta score from NIH toolbox). The neuropsychological evaluation included Symbol Digit Modalities Test (SDMT), California Verbal Learning Test-II (CVLT), Brief Visuospatial Memory Test–Revised (BVMT), Stroop Color and Word Test (SCVT), Controlled Oral Word Association Test (COWAT) and a multitasking attention-memory test (MAMT). Each patient’s group was compared with a race-matched HC group via ANCOVA analysis, accounting for age, gender, years of education and socioeconomic status expressed as yearly income (9 categories with 1 = less than $5,000 and 9 = $100,000+). In the comparison of cognitive performance, years of education, premorbid intelligence estimated with the Wechsler Test of Adult Reading (WTAR) and depressive symptoms evaluated via Beck Inventory were also included as covariates of no interest.

Results

AA and CA patients did not differ in age, gender, disease duration, while they did differ in total years of education (p<0.001) and yearly income (p=0.001). When compared to their matched HC group, AA and CA patients showed similar deficits in information processing speed, ambulation, manual dexterity, sensitivity and balance (p ranging from 0.029 to <0.001). While CA showed an additional impairment of verbal memory (p=0.009), AA patients showed additional involvement of verbal fluency (p=0.005), multitasking capability (p=0.024), motor speed and coordination (p=0.048) and grip strenght (p=0.041).

Conclusions

Even when accounting for sociodemographic features, AA patients show more severe and widespread disability than CA patients with MS.

Background

Background Exercise holds many benefits for persons with multiple sclerosis (MS), yet many MS patients are heat sensitive and therefore avoid exercise due to overheating and exhaustion that result. The exercise literature in MS to date is likely subject to bias by predominant representation of patients who are not heat sensitive and may not be a representative sample. Finding ways to facilitate comfortable engagement in exercise for persons with MS is a key priority. Our pilot trial of aspirin as a cooling pretreatment for exercise in MS showed favorable results: after aspirin, participants who experience overheating during exercise were able to exercise longer and the amount of body temperature increase they experienced was reduced by 56%.

Objectives

Objective Conduct a large-scale double-blind randomized controlled trial of aspirin (acetylsalicylic acid, ASA) pretreatment as a convenient and inexpensive method to prevent overheating and improve exercise performance in persons with MS, compared to placebo and acetaminophen.

Methods

Methods Participants are seen for three separate sessions (separated by at least one week) for a laboratory maximal exercise test. At each session, body temperature is measured tympanically before oral administration of a standard adult dose (650 mg) of aspirin, acetaminophen (APAP), or placebo. Participants then perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (TTE, i.e., time spent cycling to peak exertion) and (b) body temperature change. Secondary outcomes include patient reported outcomes including pain, fatigue, and mood. Cross-over analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.

Results

Results Enrollment in the ASPIRE trial was begun in February 2019. Adherence and acceptability of the treatment are high. To date, 35 participants have been enrolled; of these, 16 have completed all 3 study visits. There have been 6 drop-outs and 7 non-serious adverse events. Heterogeneity of sample is notable, with 26% men, 9% Black, 6% Hispanic/Latinx. Study data will not be unblinded until completion of all participants (target N=60).

Conclusions

Conclusions Exercise is highly beneficial for persons with MS, but only if they do it. Positive findings from this trial would yield an effective, inexpensive, readily available, unobtrusive treatment to allow many more persons with MS access to the benefits of exercise via a cooling mechanism. Thus far, enrollment and adherence in the ASPIRE trial, as well as diversity of our sample suggest good acceptibiliity of aspirin as a treatment, and favorable generalizability of trial results.

Background

Seminal trials evaluating ocrelizumab in multiple sclerosis (MS) have primarily shown benefit in patients with younger age, lower baseline EDSS, shorter disease duration, and evidence of higher inflammatory disease activity. The risk/benefit profile in patients who do not fit this description, accounting for a significant proportion of patients with progressive MS on this therapy, is unknown.

Objectives

To describe our experience with older primary progressive MS (PPMS) and secondary progressive MS (SPMS) patients on ocrelizumab.

Methods

The Genentech My Patient Solutions^® online database was queried for patients at our center at least 55 years old at the time of ocrelizumab enrollment. Patients with PPMS or SPMS were entered into a database for retrospective chart review. Descriptive statistics were performed.

Results

A total of 56 patients with progressive forms of MS (33% PPMS, 66% SPMS) ages 55 years and older (median 64, range 56-77) at the time of ocrelizumab initiation were identified. At baseline, 46% of patients had more than three documented comorbidities, median EDSS was 6.0 (range 2 - 7.5) and disease duration was 17.7 years. 87% of patients had exposure to at least one prior DMT (most commonly rituximab n=27; glatiramer acetate n=18; interferon beta-1a n=17). At two years, 44% of patients with a baseline EDSS < 5.5 had >1-point increase (n=4, delta-EDSS 1.5) and 39% with a baseline EDSS >5.5 had >0.5-point increase (n=11; delta-EDSS 0.5) confirmed on sequential visits >12 weeks apart. EDSS remained stable in 57% (n=21) and improved in 3.0% (n=1). T25FW increased by >20% in 21% of patients (n=8; delta-T25FW 33%); though data was limited by ambulatory status and variable testing. Subjectively, 46% of patients reported feeling worse, 17% stable, 13% equivocal, and 5% improved at two years. Infections were reported in 27% (n=15) of patients, 2 of which were severe. No neoplasms were diagnosed during treatment. 13 patients discontinued therapy due to progression of disease (n=4), infection (n=4), clinical trial enrollment (n=2), hypogammaglobulinemia (n=1), infusion-related reaction (n=1), and poor venous access (n=1).

Conclusions

In this small, retrospective study of older progressive patients on ocrelizumab, 40% (n=15) had clinically meaningful disability progression at two years. This is a higher rate than reported in younger, less disabled patients with PPMS in clinical trials. More research is still needed to clarify the risk/benefit profile in this understudied MS subpopulation with a high rate of comorbidities and unique disease trajectory contributing to functional decline.