Adherence is a critical factor for optimal clinical outcomes in multiple sclerosis (MS) treatment. This study investigated the adherence and clinical outcomes of MS patients treated with subcutaneous ...(sc) interferon (IFN) (β)-1a, an established immunomodulatory treatment for relapsing MS. The benefits of a patient support programme (PSP) were also studied.
This phase-IV prospective, observational multicentre study enrolled patients with relapsing MS who were treated with sc IFN β-1a for 24 months was conducted at 53 centres across 17 countries. The primary endpoint was adherence to sc IFN β-1a treatment, as assessed using Morisky Green Levine Medication Adherence Scale (MGLS) scores at 24 months. The MGLS is a self-reported diagnostic tool to address medication non-adherence, with a score ranging from 0 to 4, with 0 representing high adherence, 1-2 representing medium adherence, and 3-4 representing low adherence. Other endpoints included time to study and treatment discontinuation over 24 months, the proportion of relapse-free patients, and Expanded Disability Status Scale (EDSS) progression (defined as ≥1.0 point increase sustained for 3 months) at 24 months. A subgroup analysis was performed for endpoints based on patients assigned to PSP (yes/no-PSP versus non-PSP subgroup).
Of the 577 patients enrolled, 408 had evaluable MGLS scores at 24 months. A total of 336 (58.2%; 95% confidence interval CI: 54.1-62.3%) patients reported high adherence, 57 (9.9%; 95% CIs: 7.6-12.7%) reported medium adherence, and 15 (2.6%; 95% CI: 1.5-4.3%) reported low adherence at 24 months. The PSP subgroup reported higher adherence (n = 206; 65.8%) than the non-PSP subgroup (n = 130; 56.5%). By 24 months, 52.2% of the patients were relapse-free and 17.2% patients experienced ≥1 relapse. Expanded Disability Status Scale progression was observed in 12.3% of patients. Over the 24-month period, 30.8% of the patients discontinued treatment, and the most common reasons for treatment discontinuation were adverse events (AEs, 10.4%), being lost to followup (7.1%), and a lack of efficacy (5.5%). Overall, 39.6% patients experienced ≥1 AE, which ranged from mild to moderate.
The study demonstrated high adherence to sc IFN β-1a treatment with an added benefit of PSP participation. More than half of the patients remained relapse-free over a 24-month period. No new safety concerns to sc IFN β-1a treatment were observed.
https://clinicaltrials.gov/study/NCT02921035, NCT02921035.
Background:
Time matters in multiple sclerosis (MS). Irreversible neural damage and cell loss occur from disease onset. The MS community has endorsed a management strategy of prompt diagnosis, timely ...intervention and regular proactive monitoring of treatment effectiveness and disease activity to improve outcomes in people with MS.
Objectives:
We sought to develop internationally applicable quality standards for timely, brain health–focused MS care.
Methods:
A panel of MS specialist neurologists participated in an iterative, online, modified Delphi process to define ‘core’, ‘achievable’ and ‘aspirational’ time frames reflecting minimum, good and high care standards, respectively. A multidisciplinary Reviewing Group (MS nurses, people with MS, allied healthcare professionals) provided insights ensuring recommendations reflected perspectives from multiple stakeholders.
Results:
Twenty-one MS neurologists from 19 countries reached consensus on most core (25/27), achievable (25/27) and aspirational (22/27) time frames at the end of five rounds. Agreed standards cover six aspects of the care pathway: symptom onset, referral and diagnosis, treatment decisions, lifestyle, disease monitoring and managing new symptoms.
Conclusion:
These quality standards for core, achievable and aspirational care provide MS teams with a three-level framework for service evaluation, benchmarking and improvement. They have the potential to produce a profound change in the care of people with MS.
Background:
As of September 2022, there was no globally recommended set of core data elements for use in multiple sclerosis (MS) healthcare and research. As a result, data harmonisation across ...observational data sources and scientific collaboration is limited.
Objectives:
To define and agree upon a core dataset for real-world data (RWD) in MS from observational registries and cohorts.
Methods:
A three-phase process approach was conducted combining a landscaping exercise with dedicated discussions within a global multi-stakeholder task force consisting of 20 experts in the field of MS and its RWD to define the Core Dataset.
Results:
A core dataset for MS consisting of 44 variables in eight categories was translated into a data dictionary that has been published and disseminated for emerging and existing registries and cohorts to use. Categories include variables on demographics and comorbidities (patient-specific data), disease history, disease status, relapses, magnetic resonance imaging (MRI) and treatment data (disease-specific data).
Conclusion:
The MS Data Alliance Core Dataset guides emerging registries in their dataset definitions and speeds up and supports harmonisation across registries and initiatives. The straight-forward, time-efficient process using a dedicated global multi-stakeholder task force has proven to be effective to define a concise core dataset.
It has been over a year since people with multiple sclerosis (pwMS) have been receiving vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With a negligible number of ...cases in which vaccination led to a relapse or new onset MS, experts around the world agree that the potential consequences of COVID-19 in pwMS by far outweigh the risks of vaccination. This article reviews the currently available types of anti-SARS-CoV-2 vaccines and the immune responses they elicit in pwMS treated with different DMTs. Findings to date highlight the importance of vaccine timing in relation to DMT dosing to maximize protection, and of encouraging pwMS to get booster doses when offered.
Changing the Landscape of Stroke in Egypt Aref, Hany; Zakaria, Magd; Shokri, Hossam ...
Cerebrovascular diseases extra,
12/2021, Volume:
11, Issue:
3
Journal Article
Peer reviewed
Open access
Egypt, a low-middle-income country, is the most populated nation in the Middle East with a high overall crude prevalence rate of stroke (963/100,000 inhabitants), accounting for 6.4% of all deaths. ...In this article, we discuss how, through a corrective plan, we could change the landscape of stroke services in Egypt, in a relatively short time, raising thrombolysis rate from <1% to 12.3%, with shortening of door-to-needle time. We could build a database that now exceeds 5,000 patients, our centers received international accreditation and several awards, and we developed tele-stroke service.
Background
Assessment of multiple sclerosis (MS) patients during the era of the coronavirus disease 2019 (COVID-19) pandemic was confronted with the overwhelmed healthcare facilities in Egypt and ...fear of the patients to get infected while attending the follow-up visits. This study aimed to assess the value of telephone-based assessments in the follow-up of MS patients. It includes one hundred and five patients who participated in the study and completed 3 telephone-based assessments which are the Hauser Ambulation index, Multiple Sclerosis Neuropsychology Questionnaire (MSNQ), and Symptoms of Multiple Sclerosis Scale (SMSS).
Results
The Hauser Ambulation index was significantly correlated with the latest Expanded Disability Status Scale (EDSS) score done within 1 month from the telephone call (
r
=0.738,
P
<0.001). The analysis of MSNQ scores showed that one-third of the study population had evidence of cognitive and/or neuropsychological impairment. Post hoc analysis regarding the cognitive and psychological impairment component of SMSS revealed that the patients who answered “Never” had significantly lower MSNQ scores compared to those who answered “Sometimes” (
P
=0.016), “Often” (
P
=0.022), and “Always” (
P
=0.001). The comparison of the EDSS scores of the patients regarding the sensory-motor impairment component of SMSS showed a non-significant difference.
Conclusion
The Hauser Ambulation index may be a reliable telephone-based tool for the assessment of physical disability. The MSNQ and the cognitive and psychological impairment component of SMSS can be used for the assessment of cognitive and psychological impairment among patients with MS.
The majority of disease-modifying drugs (DMDs) available for the management of active relapsing–remitting multiple sclerosis (RMS) depend on continuous drug intake for maintained efficacy, with ...escalation to a more active drug when an unacceptable level of disease activity returns. Among continuously applied regimens, interferons and glatiramer acetate act as immunomodulators, while dimethyl fumarate, fingolimod, ocrelizumab, natalizumab and teriflunomide are associated with continuous immunosuppression. By contrast, immune reconstitution therapy (IRT) provides efficacy that outlasts a short course of treatment. Autologous hemopoietic stem cell transplantation is perhaps the classic example of IRT, but this invasive and intensive therapy has challenging side-effects. A short treatment course of a pharmacologic agent hypothesized to act as an IRT, such as Cladribine Tablets 3.5 mg/kg or alemtuzumab, can provide long-term suppression of MS disease activity, without need for continuous treatment (the anti-CD20 mechanism of ocrelizumab has the potential to act as an IRT, but is administered continuously, at 6-monthly intervals). Cladribine Tablets 3.5 mg/kg shows some selectivity in targeting adaptive immunity with a lesser effect on innate immunity. The introduction of IRT-like disease-modifying drugs (DMDs) challenges the traditional maintenance/escalation mode of treatment and raises new questions about how disease activity is measured. In this review, we consider a modern classification of DMDs for MS and its implications for the care of patients in the IRT era.
Background
Many reports have emphasized that watershed infarcts are the consequence of hemodynamic compromise, but other reports have suggested that this is not always the case and have suggested ...that embolization plays a major role in the development of watershed infarcts
.
Impaired cerebral vasomotor reactivity has certain correlates in watershed hypoperfusion strokes.
Objectives
This study aimed to assess the role of vasomotor reactivity impairment in watershed infarcts by transcranial Doppler. It also recorded correlates associated with impaired vasomotor reactivity in such patients.
Methodology
Sixty patients with watershed infarction after more than 1 month from onset were studied and grouped into three groups (14 patients with mixed internal and external watershed, 28 patients with internal watershed and 18 patients with external watershed infarcts). Magnetic resonant imaging and angiography of brain, carotid duplex, and echocardiography were done. CO
2
reactivity to assess vasomotor reactivity was determined using Doppler
.
Results
Cerebral vasomotor reactivity was impaired significantly among the internal watershed group compared with the external watershed group (
P
value = 0.040). In external watershed infarcts, the anterior external watershed group showed significant impairment of vasomotor reactivity compared to posterior external watershed group (
P
value = 0.046). Impaired cerebral vasomotor reactivity was more evident in diabetic patients and not statistically related with other risk factors. It was also associated with middle cerebral artery stenosis.
Conclusion
The hemodynamic impairment is related to internal watershed more than external watershed infarcts, also it is more associated with anterior than posterior external watershed infarcts. Diabetes mellitus is the most correlated cerebrovascular risk factor associated with impaired vasomotor reactivity in such patients.
•This is the first Egyptian study showing MRI markers of disability in MS patients.•T1 hypointense, infratentorial and confluent lesions significantly correlated to disability.•The total number of T2 ...lesions was not a factor determining the EDSS score.•The duration of illness was the predictor of the presence of more than 10 T2 lesions.
The aim of this work was to identify the magnetic resonance imaging (MRI) markers of disability in Egyptian multiple sclerosis (MS) patients.
This retrospective observational study included 673 patients recruited from the registry of the MS unit at Ain Shams University hospitals. At the time when the MRI scans of the brain and spinal cord were done (with and without gadolinium enhancement), clinical disability was rated using the Expanded Disability Status Scale (EDSS) during the patient's first visit.
Females represented 72.5%, all types of MS were included, the mean age of onset was 26.1 ± 7.7(SD) years, mean duration of illness was 8.3 ± 5.5(SD) years. The mean EDSS of the patients was 3.5 ± 2.1. The study population was divided into three groups according to the EDSS score; mild from 0–3 (56.6%), moderate from 3.5–6 (34.9%) and severe more than 6 (8.5%). The number and types of MRI lesions (T2, T1 black holes, T1 contrast and confluent lesions) in the different anatomical locations (periventricular, juxtacortical, infratentorial and spinal) were correlated with the clinical and demographic data of the patients as well as with the EDSS score. The presence of confluent brain lesions (P ˂ 0.001), brain T1 hypointense lesions (P = 0.009), and infratentorial T2 lesions (from 1 to 3 lesions (P = 0.04), from 4 to 10 (P ˂ 0.001) and more than 10 (P ˂ 0.001)), were significantly correlated to high EDSS scores after linear regression analysis.
This is the first Egyptian study to show that infratentorial lesions, confluent brain lesions and T1 hypointense lesions are conventional MRI parameters that correlate with the degree of disability in Egyptian MS patients.
The burden of multiple sclerosis (MS) in women of childbearing potential is increasing, with peak incidence around the age of 30 years, increasing incidence and prevalence, and growing female : male ...ratio. Guidelines recommend early use of disease-modifying therapies (DMTs), which are contraindicated or recommended with considerable caution, during pregnancy/breastfeeding. Many physicians are reluctant to prescribe them for a woman who is/is planning to be pregnant. Interferons are not absolutely contraindicated during pregnancy, since interferon-β appears to lack serious adverse effects in pregnancy, despite a warning in its labelling concerning risk of spontaneous abortion. Glatiramer acetate, natalizumab, and alemtuzumab also may not induce adverse pregnancy outcomes, although natalizumab may induce haematologic abnormalities in newborns. An accelerated elimination procedure is needed for teriflunomide if pregnancy occurs on treatment or if pregnancy is planned. Current evidence supports the contraindication for fingolimod during pregnancy; data on other DMTs remains limited. Increased relapse rates following withdrawal of some DMTs in pregnancy are concerning and require further research. The postpartum period brings increased risk of disease reactivation that needs to be carefully addressed through effective communication between treating physicians and mothers intending to breastfeed. We address the potential for use of the first- and second-line DMTs in pregnancy and lactation.
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