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Thursday, October 21, 2021

Learning about Myasthenia Gravis (gMG)

 Normally, a part of the immune system (called complement) is activated to help fight bacteria and other threats.


In people with anti-AChR Ab+ gMG, complement stays activated even when it shouldn’t be and starts to damage the place where your nerves and muscles meet (the neuromuscular junction). This is why your muscles can’t always contract when they should.

CLICK HERE to read more 

What is Lupus?


Lupus is a chronic (long-term) disease that can cause inflammation and pain in any part of your body. It’s an autoimmune disease, which means that your immune system — the body system that usually fights infections — attacks healthy tissue instead.

Connecting patients, caregivers, and doctors in the gMG community


Ask questions and gather information about generalized myasthenia gravis (gMG) at a free webinar or in-person event. These events are open to patients and their caregivers in the United States.

To Learn More, click:  https://alexiongmgevents.com/


Eculizumab Shows Better Prolonging of Time to NMOSD Relapse Than Other Treatments

 October 17, 2021  - 

An indirect comparison study evaluated relative treatment effects of eculizumab (Soliris; Alexion), inebilizumab (Uplizna; Horizon), and satralizumab (Enspryng; Genentech), the 3 FDA-approved options for NMOSD.

figure image

Sean Pittock, MD

Using a Bayesian network meta-analysis (NMA), findings showed that treatment with eculizumab (Soliris; Alexion) monotherapy and combination of eculizumab and immunosuppressant (IST) has greater success in prolonging time-to-first relapse in patients with aquaporin-4 immunoglobulin G-positive (AQP4-IgG+) neuromyelitis optica spectrum disorder (NMOSD) compared with other FDA-approved treatments.1

Senior author Sean J. Pittock, MD, director, Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, presented these data at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 13-15. Pittock and colleagues extracted data from randomized controlled trials that reported the relative treatment effects of these therapies. Additionally, the analysis sorted subpopulations based on 3 treatment networks: monotherapy, combination therapy, and mixed mono-combination therapy.

A regression model comprised of a contrast-based normal likelihood for the log HR and the corresponding standard error of each trial in the network was used to calculate time-to-first relapse. Time-to-first relapse was the only outcome measure reported across the RCTs.

At the conclusion of the analysis, time-to-first relapse was 90% less likely for patients on eculizumab monotherapy than for those on satralizumab (Enspryng; Genentech) monotherapy (HR, 0.10 [95% credible interval (Crl), 0.01-0.65]). Furthermore, these patients were also 89% less likely to experience a first relapse compared to patients on inebiluzumab (Uplizna; Horizon) monotherapy (HR, 0.11 [95% Crl, 0.02-0.68]). A combination approach using eculizumab and IST was also found to be associated with a 76% less likelihood to experience a first relapse compared to satralizumab with IST (HR, 0.24 [95% Crl, 0.06-0.98]).

The discovery of AQP4 led to the breakthrough of the first treatments for NMOSD in 2019 with eculizumab. Following that, the FDA then greenlit inebilizumab in June 2020 and satralizumab in August 2020. Corticosteroids and immunomodulatory or ISTs have also shown benefit within this patient population. Pittock has had first-hand experience with understanding the clinical pipeline of the disease, serving as an investigator for multiple trials such as PREVENT (NCT01892345) of eculizumab and N-MOmentum (NCT02200770) of inebilizumab.

Most recently, he and his colleagues published post-hoc findings from PREVENT and its open-label extension (NCT02003144), which highlighted eculizumab’s safe and effective profile as a long-term, monotherapy option. Findings showed the treatment provided relapse protection seen previously in clinical trials and helped patients avoid the use of off-label IST.2

In September 2021, Pittock sat down with NeurologyLiveto discuss the state of the disease space, noting that, "Now that we have 3 drugs, there are issues that are related to those specific drugs, one being cost. These are very costly medications. Though they may be available to patients in the US covered by insurance, there are many patients around the world who don’t have access or potentially won’t have access to these medications."




Wednesday, October 20, 2021

Unraveling the substrates of cognitive impairment in multiple sclerosis: A multiparametric structural and functional magnetic resonance imaging study

 Lorenzo Conti 1Paolo Preziosa 1 2Alessandro Meani 1Elisabetta Pagani 1Paola Valsasina 1Olga Marchesi 1Carmen Vizzino 1Maria A Rocca 1 2 3Massimo Filippi 1 2 3 4 5

  • PMID: 34255918
  • DOI: 10.1111/ene.15023
  • PubMed
  • Abstract

    Background: Cognitive impairment frequently affects multiple sclerosis (MS) patients. However, its neuroanatomical correlates still need to be fully explored. We investigated the contribution of structural and functional magnetic resonance imaging (MRI) abnormalities in explaining cognitive impairment in MS.

    Methods: Brain dual-echo, diffusion tensor, 3D T1-weighted and resting-state (RS) MRI sequences were acquired from 276 MS patients and 102 healthy controls. Using random forest analysis, the contribution of regional white matter (WM) lesions, WM fractional anisotropy (FA) abnormalities, gray matter (GM) atrophy and RS functional connectivity (FC) alterations to cognitive impairment in MS patients was investigated.

    Results: Eighty-four MS patients (30.4%) were cognitively impaired. The best MRI predictors of cognitive impairment (relative importance [%]) (out-of-bag area under the curve [AUC] = 0.795) were (a) WM lesions in the right superior longitudinal fasciculus (100%), left anterior thalamic radiation (93.4%), left posterior corona radiata (78.5%), left medial lemniscus (74.2%), left inferior longitudinal fasciculus (70.4%), left optic radiation (68.7%), right middle cerebellar peduncle (60.6%) and right optic radiation (53.5%); (b) decreased FA in the splenium of the corpus callosum (64.3%), left optic radiation (61.0%), body of the corpus callosum (51.9%) and fornix (50.9%); and (c) atrophy of the left precuneus (91.4%), right cerebellum crus I (84.4%), right caudate nucleus (78.6%), left thalamus (76.2%) and left supplementary motor area (59.8%). The relevance of these MRI measures in explaining cognitive impairment was confirmed in a cross-validation analysis (AUC =0.765).

    Conclusion: Structural damage in strategic WM and GM regions explains cognitive impairment in MS patients more than RS FC abnormalities.

    Keywords: MRI; cognitive impairment; gray matter atrophy; multiple sclerosis; resting state functional connectivity.

    Tuesday, October 19, 2021

    Evaluate the efficacy and safety of alemtuzumab in CARE-MS II patients over 10 years

    Knowing what MS can do to people and seeing these results who wouldn’t want to be treated with, or at least offered the option of being treated with, alemtuzumab or another IRT when they are diagnosed? 

    Giovannoni et al. Early treatment with alemtuzumab maintains its efficacy on clinical and MRI disease activity outcomes, including slowing of brain volume loss, over 10 years in RRMS patients: CARE-MS II follow-up (TOPAZ Study). ECTRIMS 2021, P722.

    Introduction: In CARE-MS II (NCT00548405), alemtuzumab (12 mg/day; baseline: 5 days; 12 months later: 3 days) significantly improved clinical/MRI outcomes versus SC IFNB-1a over 2 years (y) in RRMS patients with inadequate response to prior therapy and further minimised disease in a 4-y extension study (NCT00930553). Further follow-up was available in an additional 5-y extension, TOPAZ (NCT02255656).

    Aims: Evaluate the efficacy and safety of alemtuzumab in CARE-MS II patients over 10 y.

    Methods: At investigator discretion, patients in TOPAZ can receive additional alemtuzumab as needed for disease activity (≥12 months apart) or other disease-modifying therapy (DMT) at any time.

    Results: Proportions of patients remaining on study after 10 y were 62% (271/435) among those treated initially with alemtuzumab in the core study and 73% (107/146) among those treated with SC IFNB-1a for 2 y before switching to alemtuzumab in the extensions. In the extension studies, 39% of the alemtuzumab group did not receive further treatment (alemtuzumab or other DMT). Among the alemtuzumab group over the combined core and extension studies, 71% of patients had stable/improved EDSS scores, the mean change in EDSS score was +0.34, 58% of patients were free of 6-month confirmed disability worsening, and 49% achieved 6-month confirmed disability improvement. In Y10, the annualised relapse rate was 0.11, 71% of patients were free of MRI disease activity, 92% were free of new gadolinium-enhancing lesions, and 72% were free of new/enlarging T2 hyperintense lesions. The median annual brain volume loss was ≤0.19% each year over Y3–10. Alemtuzumab had a consistent safety profile over 10 y, with the incidence of overall adverse events (AEs) and infections declining through Y10. Cumulative incidence of thyroid AEs was 44% and immune thrombocytopaenia was 4%. Efficacy and safety in SC IFNB-1a–treated patients from the core study who switched to alemtuzumab in the extension were consistent with those treated with alemtuzumab in both the core and extension.

    Conclusions: Early treatment efficacy with alemtuzumab on clinical, MRI lesion, and brain volume outcomes was maintained over 10 y in CARE-MS II patients, with 62% remaining on study and 39% receiving no additional courses or other DMTs through Y10. Safety remained consistent and manageable over 10 y, with declining AE incidences over time, including a consistent reduction in autoimmune AE occurrence after Y3.


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    Study Explores Link Between MS and Bowel Dysfunction


    • The authors of a recent study reviewed the Neurogenic Bowel Dysfunction scores of 1,100 participants across nine multiple sclerosis (MS) centers in Italy.
    • Researchers found a “relatively high prevalence” of moderate to severe bowel dysfunction among the study participants.
    • Researchers recommend health care providers proactively screen people with MS for symptoms of neurogenic bowel dysfunction.

    Results from a new multicenter study may be helpful in quantifying just how prevalent bowel issues are in people with multiple sclerosis. A report published on Aug. 4 in the Journal of Neurology focused on whether bowel symptoms were common in people with MS, and whether any demographic variables were linked to symptom severity. The multicenter study, which included people with MS who were 18 years of age or older, was conducted in Italy.

    The authors analyzed responses from 1,100 people with MS over the course of one month at nine MS centers in Italy. They used the 10-question Neurogenic Bowel Dysfunction (NBD) score, which asked participants to evaluate their NBD symptoms, including those related to both incontinence and constipation.

    The researchers found that 14 percent of participants had moderate to severe bowel dysfunction. Bowel dysfunction was more likely among people with more severe levels of disability, progressive phenotypes, older age, and longer disease duration. The study authors said the severity of participants’ bowel dysfunction was predicted by such factors as bladder symptoms, difficulty walking, and female sex.

    The authors noted that the rate of bowel dysfunction in participants was lower in this study as compared to other studies. However, the researchers added that this current analysis was performed on people who were classified as having a relatively low level of disability.

    The study authors suggested that health care providers should proactively screen people with MS for symptoms of NBD so these symptoms can be addressed before they reach moderate to severe levels of bowel dysfunction.

    Continue reading






    Majority of People With MS Report Communication Changes


    • A new study investigates the impact of communication changes in the lives of people with multiple sclerosis (MS).
    • The majority of study participants with MS indicated they have experienced issues with language and verbal communication since being diagnosed with the condition.
    • The study’s authors call for more awareness about the option of speech-language pathology services for those with MS.

    Living with multiple sclerosis can lead to a wide variety of symptoms. Among those that could impact quality of life are communication issues, according to a new study.

    A team of scientists from Australia’s University of Sydney reviewed online questionnaires from 260 people with MS to evaluate whether they experienced any changes that affected their ability to communicate. The study authors found that the majority of participants — 75.8 percent — said they had experienced communication changes, such as:

    • Language changes
    • Cognitive shifts
    • Speech changes (known as dysarthria)
    • Voice issues
    • Fluency changes

    Stress, heat, and fatigue were among the factors that influenced communication changes, the study participants reported. Although the majority of study participants did indicate that they were affected by communication problems, just 11.2 percent had accessed services provided by speech-language pathologists, the researchers said.

    Communication issues can have an impact far beyond simply being another MS symptom. In daily life, problems with communicating were found to affect participants’ interpersonal relationships, psychological well-being, career pathways, workforce identity, and social lives.

    The study authors concluded that the health care community should work harder to raise awareness of how speech-language pathology services can help those with MS manage changes in communication. Helping people with MS navigate these issues when they arise could reduce the impact of communication changes on other areas of life.

    Continue reading

    Friday, October 8, 2021

    Migraine significantly worsens sleep quality, architecture

     September 28, 2021

    Individuals with migraine had much poorer subjective sleep quality and altered sleep architecture vs. healthy individuals, according to results of a meta-analysis published in Neurology.

    “Despite its association, there remains a paucity of research into sleep in migraine, and there is no consensus on whether patients exhibit objective changes in sleep architecture,” Emily Charlotte Stanyer, MPsych, of the Wolfson Centre for Age-Related Diseases at King’s College London’s Institute of Psychiatry, Psychology & Neuroscience in the U.K., and colleagues wrote. “This is partly due to the small sample sizes of polysomnographic (PSG) studies which measure sleep.

    “The current meta-analysis aims to overcome this by aggregating data from multiple studies investigating differences in subjective sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) and objective sleep architecture measured using PSG between patients with migraine and healthy controls,” they added.

    The investigators sought to assess whether differences existed in subjective sleep quality measured via the PSQI and objective sleep architecture measured via polysomnography for adult and pediatric patients and healthy controls. They systematically searched five databases for case-controlled studies that measured polysomnography and/or PSQI among patients with migraine, excluding participants who were pregnant or who had other headache disorders. They entered effect sizes into a random effects model meta-analysis. They included 21 studies measuring PSQI and Migraine Disability Assessment Test scores among adults, as well as six studies and five studies measuring polysomnography among adults and children, respectively.

    Results showed an overall mean study quality score of 5/9. The researchers observed no moderating effect of this score on any of the results, nor did they report any risk for publication bias. Adults with migraine had higher PSQI scores compared with health controls, with a larger effect among those with chronic vs. episodic condition. In polysomnographic studies, adults and children with migraine vs. controls had a lower percentage of rapid eye movement sleep. Pediatric patients vs. controls had less total sleep time, more wake and shorter sleep onset latency.


    1 Year of Ocrevus Not Linked to Higher Risk of Brain Infection PML

     By Steve Bryson PhD on Oct 07, 2021

    One year of Ocrevus (ocrelizumab) treatment does not increase the risk for a rare brain infection — called progressive multifocal leukoencephalopathy (PML) — in people with multiple sclerosis (MS), a study suggests.

    The study, “Risk Assessment of Progressive Multifocal Leukoencephalopathy in Multiple Sclerosis Patients during 1 Year of Ocrelizumab Treatment,” was published in the journal Viruses.

    MS therapies are designed to suppress the immune system and limit the inflammatory damage to the myelin sheath that surrounds nerve fibers, an underlying cause of MS.

    PML is a rare and potentially fatal brain infection caused by the common John Cunningham (JC) virus. It has been associated with the extended use of Tysabri (natalizumab), an MS therapy that suppresses the immune response in the brain by limiting the access of immune cells.

    Ocrevus is a different MS therapy that also suppresses the immune system, but works by depleting antibody-producing B-cells. Although a few cases of PML have been reported in patients treated with Ocrevus, most had been prescribed other immune-suppressing MS therapies. As such, the risk of PML in those treated with Ocrevus remains unclear.

    To investigate further, scientists based at the Sapienza University of Rome, in Italy, collected blood and urine samples from 42 relapsing-remitting MS patients (24 females and 18 males) before Ocrevus treatment (baseline) and at various timepoints over one year of treatment to assess PML risk.

    The study included 19 patients who had not been treated with any MS therapy (treatment-naive), four who had previously received Tysabri, and 19 who had switched from other MS treatments, such as Gilenya (fingolimod), Aubagio (teriflunomide), and Tecfidera (dimethyl fumarate).

    Before Ocrevus initiation, JC viral DNA was detected in urine samples from 34 (81%) patients, but was absent from all blood samples. Viral DNA was found in all patients who received previous MS treatments and in 11 out of the 19 who were treatment-naive. The results were the same after six months of treatment.