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Quality of Life in MG – Neurology Live

Posted: April 9, 2024 at 1:04 pm

This is a video synopsis/summary of a panel discussion involving James Howard, MD; Nicholas Silvestri, MD, FAAN; Tuan Vu, MD; Ali Habib, MD; and Beth Stein, MD.

The discussion delves into the administration of treatments for myasthenia gravis (MG), emphasizing its impact on patients' quality of life. Traditionally, Intravenous immunoglobulin (IVIG) has been the go-to therapy for disease exacerbations, but this paradigm is shifting with the emergence of newer therapies, each with its own unique administration methods.

The insidious progression of MG often sets a new normal for patients, leading them to attribute symptoms to aging rather than disease progression. Physicians must engage patients in conversations about the risks and benefits of trying new treatments, challenging the notion that certain limitations are solely due to age.

Moreover, as MG symptoms are brought under control, it's crucial not to attribute every symptom to the disease itself. Patients may have other comorbidities contributing to their symptoms, requiring a comprehensive approach to management.

The term "refractory" is controversial, with physicians acknowledging that almost every patient responds to some degree of treatment. However, there's a push to redefine success in MG management, aiming for optimal control with minimal side effects.

Physicians note varying experiences with treatment efficacy, influenced by factors like patient demographics and practice settings. With the goal of achieving no symptoms and minimal adverse events, the consensus is that a significant portion of patients can achieve better outcomes with current therapies. Practice settings may influence success rates, with university-based practices potentially encountering more complex cases.

Overall, the conversation highlights the need for a patient-centered approach to MG management, with an emphasis on individualized treatment plans and realistic expectations for outcomes.

Video synopsis is AI-generated and reviewed by NeurologyLive editorial staff.

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Quality of Life in MG - Neurology Live

Recommendation and review posted by G. Smith

This Week on NeurologyLive April 8, 2024 – Neurology Live

Posted: April 9, 2024 at 1:04 pm

Every week, the NeurologyLive staff prepares this preview of what to expect from our coverage. This week on NeurologyLive, there are a number of hot topics that we will be posting on the website. As always, our weekly coverage extends beyond just these topics, so make sure to check out the rest of the site!

Click through the slides below to see what you can expect from our team this week. Click any slide to check out the content.

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This Week on NeurologyLive April 8, 2024 - Neurology Live

Recommendation and review posted by G. Smith

Reevaluating Neuroprotective Multiple Sclerosis Trial Designs Using the Visual System: Shiv Saidha, MBBCh – Neurology Live

Posted: April 9, 2024 at 1:04 pm

WATCH TIME: 9 minutes

If you're going to use anything as an outcome, you also need to understand very well what the outcome is that you're using."

Registry to Evaluate Novantrone Effects in Worsening Multiple Sclerosis (RENEW) was a phase 4 study that assessed the long-term safety profile of mitoxantrone in patients with secondary progressive multiple sclerosis (SPMS), progressive relapsing multiple sclerosis (PRMS), and worsening relapsing-remitting multiple sclerosis (RRMS). In the study, investigators enrolled 509 patients who received at least one infusion of mitoxantrone, an antineoplastic medicine used to treat MS, prostate cancer, and acute nonlymphocytic leukemia. During the treatment period, patients received laboratory workups and cardiac monitoring every 3 months and then annually up to 5 years.

Overall, annual follow-up data were only available for 250 of the enrolled patients, and 172 (33.8%) completed the 5-year period. Safety cardiovascular end points included left ventricular ejection fraction (LVEF), symptoms of congestive heart failure (CHF), and cardiac-related serious adverse events. In total, 27 (5.3%) patients reported LVEF reduction under 50% during the treatment phase (n = 509) and 14 (5.6%) patients reported it in the annual follow-up phase (n = 250). In additional safety findings, 10 (2.0%) patients reported signs and symptoms of CHF (treatment phase, n = 6; annual follow-up phase, n = 4). These findings are consistent with the known safety profile of mitoxantrone, and provide additional long-term safety data of the treatment in patients with MS.

Shiv Saidha, MBBCh, professor of neurology at Johns Hopkins Medicine, talked about the visual system as a model for neuroprotective trials in MS in a session at the 2024 Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held February 29 to March 2, in West Palm Beach, Florida. Following the session, Saidha sat down with NeurologyLive to discuss the primary challenges of the RENEW clinical trial design as an example of using the visual system model. In addition, he talked about the use of fellow-eyes as surrogates affect outcome interpretation, as well as some of the advantages and disadvantages of acute optic neuritis versus non-optic neuritis models in neuroprotection studies.

Click here for more coverage of ACTRIMS 2024.

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Reevaluating Neuroprotective Multiple Sclerosis Trial Designs Using the Visual System: Shiv Saidha, MBBCh - Neurology Live

Recommendation and review posted by G. Smith

Insights for Future Adult BMD Clinical Trials: Detecting Disease Progression via Muscle MRI, Clinical, and PROs – Physician’s Weekly

Posted: April 9, 2024 at 1:04 pm

The following is a summary of Lessons for future clinical trials in adults with Becker muscular dystrophy: Disease progression detected by muscle magnetic resonance imaging, clinical and patient-reported outcome measures, published in the March 2024 issue of Neurology by Wel et al.

Researchers started a retrospective study to address the gap in outcome measure evaluation for adult Becker muscular dystrophy (BMD), a disease with variable progression.

They assessed muscle MRI, patient-reported outcomes (PROs), and various clinical measures (Motor Function Measurement (MFM), muscle strength, and timed-function tests) in 21 adults diagnosed with BMD at the beginning of the study and at 9 and 18 months into the follow-up period.

The results showed a significant increase in proton density fat fraction in 10 out of 17 thigh muscles after 9 months and in all thigh and lower leg muscles after 18 months. The 32-item MFM-32 scale showed a decrease of 1.3% (P=0.017), North Star Ambulatory Assessment decreased by 1.3 points (P=0.010), and the patient-reported activity limitations scale deteriorated by 0.3 logits (P=0.018) after 9 months. After 18 months, the 6-minute walk distance decreased by 28.7 meters (P=0.042), 10-meter walking test decreased by 0.1 meters per second (P=0.032), time to climb four stairs test decreased by 0.03 meters per second (P=0.028), and Biodex peak torque measurements of quadriceps decreased by 4.6 Nm (P=0.014) and hamstrings by 5.0 Nm (P=0.019). MFM-32 domain 1 had the highest sensitivity to change, with a standardized response mean of 1.15.

Investigators concluded that whole-thigh PDFF MRI was sensitive to BMD muscle fat changes and that MFM-32 was the most responsive clinical measure.

Source: onlinelibrary.wiley.com/doi/full/10.1111/ene.16282

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Insights for Future Adult BMD Clinical Trials: Detecting Disease Progression via Muscle MRI, Clinical, and PROs - Physician's Weekly

Recommendation and review posted by G. Smith

Amylyx Pulls ALS Drug AMX0035, Gene Therapy Shows Promise in Giant Axonal Neuropathy, Eisai Submits sBLA for … – Neurology Live

Posted: April 9, 2024 at 1:04 pm

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. Im Marco Meglio.

According to an announcement, Amylyx Pharmaceuticals will voluntarily discontinue AMX0035 (Relyvrio) and remove it from the market in the United States and Canada based onnegative topline datafrom its phase 3 PHOENIX trial (NCT05021536) that showed AMX0035 did not meet its primary end point of change in ALS Functional Rating Scale-Revised (ALSFRS-R).1,2AlthoughAMX0035will no longer be available for new patients with amyotrophic lateral sclerosis (ALS), those currently on therapy in the US and Canada who wish to stay on treatment and consult with their cliniciancan be transitioned to a free drug program. In PHOENIX, results showed no significant difference on ALSFRS-R between AMX0035-treated and placebo-treated patients over a 48-week treatment period (P = .667).

In a newly published first-in-human trial (NCT02362438), treatment with scAAV9/JeT-GAN, an investigational gene therapy administered directly into the spinal fluid, was well tolerated and showed signs of therapeutic benefit among children with giant axonal neuropathy (GAN). Published in theNew England Journal of Medicine,the investigators observed various rates of slowed motor function decline, with nearly half of the small cohort regaining sensory nerve response. scAAV9/JeT-GAN is a self-complementary adeno-associated viral (AAV) serotype 9 vector that carries a codon-optimized humanGANtransgene with expression controlled by the minimal synthetic recombinant JeT promoter consisting of 5 elements.

According to an announcement from Eisai and Biogen, the companies have officially submitted a supplemental biologics license application (sBLA) for a new monthly intravenous (IV) maintenance dosing for lecanemab-irmb (Leqembi), its FDA-approved therapy for early-stage Alzheimer disease (AD). Those whove already completed the biweekly IV initiation phase are now eligible to receive a monthly IV does that maintains effective drug concentration to sustain the clearance of highly toxic protofibrils. Lecanemab, a humanized immunoglobulin gamma 1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid-, was approved in July 2023 in 100 mg/mL injections for IV use. In the newly submitted sBLA, the companies included data from Study 201 (NCT01767311), a phase 2 trial, and its open-label extension (OLE), as well as the phase 3 Clarity AD trial (NCT03887455), the study that lecanemab was traditionally approved on, and its OLE.

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Amylyx Pulls ALS Drug AMX0035, Gene Therapy Shows Promise in Giant Axonal Neuropathy, Eisai Submits sBLA for ... - Neurology Live

Recommendation and review posted by G. Smith

Neurological Conditions Found To Be The Most Common Disease – Muscle & Fitness

Posted: April 9, 2024 at 1:04 pm

A report recently published in The Lancet, using vast data from 1990 to 2021, has found that heart disease is now trailing behind neurological conditions in terms of commonality, but it remains our biggest killer.

According to the statistical analysis more than 3.4 billion people, thats 43 percent of the global population, suffered with a neurological condition in 2021, a number far more than experts had previously feared. The study was overseen by researchers at the Institute of Health Metrics and Evaluation (IHME) in Seattle, Washington, and illustrates that nervous system disorders have overtaken heart disease as the number one cause of ill health. Neurological conditions (diseases of the central and peripheral nervous systems) such as strokes and dementia, in addition to migraines and other mental health diseases has now topped the list in terms of commonality.

Researchers looked at 37 different neurological conditions to determine just how they influenced illness, disabilities, and premature deaths in more than 204 territories across the world and found that an 18% decrease in life years had been experienced collectively due to those disorders. More than 11 million people had sadly died from neurological conditions in 2021 concluded the report.

While adjustments for the populations age and overall growth could refute the findings in terms of the decrease in terms of life years, stroke still comes out as the most serious neurological ailment. Other neurological conditions follow, such as encephalopathy (a type of brain damage) and Alzheimers disease. Nerve damage suffered as a result of diabetes is also significantly hampering the population.

One reason for neurological conditions overtaking heart disease in terms of prevalence can be attributed to a recent World Health Organisation classification edit, since the WHO has recently moved stroke into the neurological grouping. But, while weve established that stroke has emerged as the most serious cognitive ailment faced today, the biggest overall killer is still cardiovascular disease.

According to the IHME, heart disease accounted for 19.8 million worldwide deaths in 2022.It is no doubt sobering to read that both heart and cognitive diseases are still very much at war with the human race, but its somewhat its reassuring to know that exercise is one of the best methods we have for improving both mental and physical health. The ultimate reason to renew that gym membership!

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Neurological Conditions Found To Be The Most Common Disease - Muscle & Fitness

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