Dosing intervals up to 8 weeks 5 days did not diminish effectiveness of NTZ therapy. Further monitoring is ongoing to evaluate if the risk of PML is reduced in patients on EID.
The objective of this study was to describe SymptoMScreen, an in-house developed tool for rapid assessment of MS symptom severity in routine clinical practice, and to validate SymptoMScreen against Performance Scales (PS). MS patients typically experience symptoms in many neurologic domains. A tool that would enable MS patients to efficiently relay their symptom severity across multiple domains to the healthcare providers could lead to improved symptom management. We developed "SymptoMScreen," a battery of 7-point Likert scales for 12 distinct domains commonly affected by MS: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. We administered SymptoMScreen and PS scales to consecutive MS patients at a specialty MS Care Center. We assessed the criterion and construct validity of SymptoMScreen by calculating Spearmen rank correlations between the SymptoMScreen composite score and PS composite score, and between SymptoMScreen subscale and the respective PS subscale scores, where applicable. A total of 410 patients with MS (age 46.6 ± 12.9 years; 74% female; mean disease duration 12.2 ± 8.7 years) completed the SymptoMScreen and PSs during their clinic visit. Composite SymptoMScreen score correlated strongly with combined PS score (r = 0.88, p < 0.0001). SymptoMScreen sub scores correlated strongly with the criterion measures of the respective PS (r = 0.69-0.87, p < 0.0001). Test-retest reliability of SymptoMScreen and its subscales was excellent (r = 0.71-0.94, p < .0001). SymptoMScreen is a single-page battery of Likert scales that assesses symptom impact in 12 domains commonly affected in MS. It has excellent criterion and construct validity. SymptoMScreen is patient and clinician friendly, takes approximately one minute to complete, and can help better document, understand, and manage patients' symptoms in routine clinical practice. SymptoMScreen is freely available to clinicians and researchers.
Background:
Dimethyl fumarate (DMF) was approved by the US Food and Drug Administration (FDA) for treatment of relapsing–remitting multiple sclerosis (RRMS) based on two phase III randomized clinical trials (RCTs). There were not enough non-White patients enrolled in these RCTs to allow for subgroup analysis based on race. Efficacy and tolerability of DMF therapy across various racial groups is unknown.
Methods:
Retrospective chart review was performed on all patients with RRMS who were started on DMF in two tertiary multiple sclerosis (MS) clinics. Efficacy and tolerability of DMF was compared across three self-identified racial groups: White-American (WA), African-American (AA) and Hispanic-American (HA).
Results:
A total of 390 RRMS patients were included in the study: 261 (66.9%) WA, 69 (17.7%) AA and 52 (13.3%) HA. When comparing ‘pre-DMF’ (1 year) and ‘on DMF’ (mean follow up of 14 months) periods, statistically significant reduction in rates of annualized relapses (WA from 0.44 to 0.19, AA from 0.39 to 0.15, and HA from 0.39 to 0.14; no differences between groups), new T2 lesions (WA from 45% to 23%, AA from 39% to 23%, HA from 52% to 26%; no difference between groups), and Gd+ lesions (WA from 25% to 13%, AA from 24% to 7%, HA from 23% to 12%; no difference between groups) were seen. DMF was relatively well tolerated across all groups, with an overall discontinuation rate of 20% (no difference between the three groups).
Conclusion:
Efficacy of DMF in our clinic population did not differ across three major ethnic groups, WA, AA and HA, and was comparable with results observed in the pivotal studies. These ‘real-life’ data suggest that race is not a factor that needs to be taken into account when initiating DMF.
We explored the feasibility of a mindfulness plus sleep education intervention, SleepWell!, delivered via videoconference compared to onsite among adults with MS. A non-randomized wait-list control design was used. Participants wore actigraphy watches and kept sleep diaries for seven days pre- and post intervention. Questionnaires were completed pre-intervention, post-intervention, and three months post-intervention. One group was conducted onsite. Three groups participated via videoconference. Attrition among videoconference groups was 23% compared to 57% in the onsite group. Within group analysis showed moderate-to-large effect sizes on sleep efficiency (d=0.78) and total sleep time (d=0.54) in the videoconference groups. One-way repeated measures ANOVA post-hoc analysis suggested small-to-medium effect over three months on sleep quality (ηp2 =0.28), physical health quality of life (ηp2 =0.42), mental health quality of life (ηp2 =0.13), and mindfulness (ηp2 =0.29). Results indicate feasibility of providing our intervention via videoconferencing. Preliminary analysis suggests that SleepWell! improves sleep and mindfulness among adults with MS.
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