Burning Debate @ ECTRIMS 15 Sep 2016
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This document discusses including people in wheelchairs in progressive multiple sclerosis (MS) trials. It presents perspectives from pathology studies showing extensive axonal loss associated with disease duration in progressive MS. Pharmacology evidence suggests some drugs may slow progression in progressive MS. Peer research and patients themselves also support inclusion in trials. The conclusion is that from an academic perspective considering these factors, people in wheelchairs should be able to participate in progressive MS trials to advance knowledge.
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While wheelchair-bound people with multiple sclerosis (MS) have historically been excluded from progressive MS drug trials, there are good reasons to continue this practice for pivotal phase III trials. Their more severe disability, comorbidities, and deconditioning could compromise results and risk trial failure. However, they should be included in natural history, symptom management, and rehabilitation studies when appropriate. Any approved treatments must also be made available to them if they still have central nervous system function that could potentially be lost.
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This document discusses the importance of hand function in assessing treatment outcomes for multiple sclerosis (MS). It notes that current clinical trials and regulatory outcomes primarily focus on mobility scales that are dominated by lower limb function, excluding people who use wheelchairs. It argues that assessing hand function could have led to different outcomes in past trials and enabled treatments years ago. The document advocates increasing awareness of hand function for people with MS, neurologists, and regulators. It promotes developing new patient-reported outcome measures that better capture elements of hand function that are important to people living with MS.
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While wheelchair-bound people with multiple sclerosis (MS) have historically been excluded from progressive MS drug trials, there are good reasons to continue this practice for pivotal phase III trials. Their more severe disability, comorbidities, and deconditioning could compromise results and risk trial failure. However, they should be included in natural history, symptom management, and rehabilitation studies when appropriate. Any approved treatments must also be made available to them if they still have central nervous system function that could potentially be lost.
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Finally, it summarizes evidence that immunotherapies can benefit those with progressive MS, including data from clinical trials showing patients with primary progressive MS experienced improved outcomes on fingolimod.
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Finally, it summarizes evidence that immunotherapies can benefit those with progressive MS, including data from clinical trials showing patients with primary progressive MS experienced improved outcomes on fingolimod.
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Jc eurotherm3235 ppt
This randomized controlled trial compared outcomes for patients with traumatic brain injury (TBI) and intracranial hypertension who received therapeutic hypothermia (32-35°C) plus standard care versus standard care alone. The trial was stopped early due to higher mortality in the hypothermia group. At 6 months, functional outcomes as measured by the GOSE were worse in the hypothermia group. While hypothermia successfully controlled intracranial pressure, it did not result in improved outcomes compared to standard care alone and was associated with higher mortality.
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#13. Breastfeeding Versus Bottlefeeding
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Safety and Efficacy of Autologous Intra-articular Platelet.pdf
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Study of current pattern of Cervical Spondylotic Myelopathy and to evaluate t...
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Perosnalized
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Brain Health: The Importance of Recognizing Cognitive Impairment: An IAGG Con...
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This research was presented by Dr. Emil Lou as part of the Special Interest Subgroup V presentation entitled “Tunneling Nanotubes, Cytonemes, and More: Highways for Cell-to-Cell Communication from Development to Disease,” Saturday, December 6, 2014, at the 2014 ASCB/IFCB Annual Meeting in Philadelphia, Pennsylvania.
The session was nicely summarized in a write-up by the team at Journal of Cell Biology:
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More from Klaus Schmierer
Berlin_KS_final.pdf
My presentation delivered at the MS Symposium of the Jewish Hospital Berlin (https://www.juedisches-krankenhaus.de/home.html) held on 29 Nar 2023 at the Centrum Judaicum, Oranienburger Strasse, Berlin
BartsMS info_safety_consent_pack_July 2018
Information, consent sheet, safety checklist, and Litak summary of medical product characteristics concerning the use of cladribine in people with multiple sclerosis, who are not eligible for disease modifying treatment under the commissioning policies of NHS England.
Disclaimer of liability:
The material and information contained in this document is for general information purposes only. You should not rely upon the material or information on the website as a basis for making any medical, legal or any other decisions. Whilst we endeavour to keep the information up to date and correct, neither the author Klaus Schmierer, his primary employer Queen Mary University of London, or Barts Health NHS Trust, make any representations or warranties of any kind, express or implied about the completeness, accuracy, reliability, suitability or availability with respect to the information contained in this document for any purpose. Any reliance you place on such material is therefore strictly at your own risk.
Klaus Schmierer, Queen Mary University of London, and Barts Health NHS Trust will not be liable for any false, inaccurate, inappropriate or incomplete information presented in this document.
Although every effort is made to keep this document up and running smoothly, due to the nature of the Internet and the technology involved, Klaus Schmierer, Queen Mary University of London, or Barts Health NHS Trust take no responsibility for, and will not be liable for the website being temporarily unavailable due to technical issues (or otherwise) beyond its control or for any loss or damage suffered as a result of the use of or access to, or inability to use or access this website whatsoever.
To the extent not prohibited by law, in no circumstances shall Klaus Schmierer, Queen Mary University of London, or Barts Health NHS Trust be liable to you or any other third parties for any loss or damage (including, without limitation, damage for loss of health, business or loss of profits) arising directly or indirectly from your use of or inability to use, this document or any of the material contained in it.
Chariot ms 4_ms-society_feb2018_4_slsh
The #ChariotMS project aims to test whether the drug cladribine can slow or stop deterioration of upper limb function in people with advanced multiple sclerosis. The study will enroll 180 participants across the UK who have disability levels between EDSS 6.5-8.5. Participants will be randomly assigned to receive either cladribine or a placebo over two treatment cycles 12 months apart. The primary outcome will be changes in upper limb function as measured by the 9-hole-peg test over two years. If successful, the study would provide evidence for regulatory approval and adoption of cladribine as the first approved disease-modifying treatment for people with advanced MS.
Reactivation rebound 26_jan2018_ks
This document discusses rebound/reactivation in multiple sclerosis patients switching between disease-modifying therapies. It defines rebound as evidently higher disease activity after starting a new drug. Principal causes include cells driving disease gaining access to their targets when previously suppressed. Drugs particularly associated with rebound are natalizumab and fingolimod upon withdrawal. The document recommends patients be aware of rebound risk and not stop therapies abruptly. Transitioning to dimethyl fumarate or immune reconstitution therapies can help avoid reactivation by not leaving cells unchecked.
Neuropathological correlates imperial_college_4_sl_sh_2feb2018
This document summarizes research on correlating MRI findings with neuropathological features in multiple sclerosis (MS). Key points include:
- MRI techniques like MTR can detect myelin and axonal loss validated by histology. Non-lesional white matter shows more extensive pathology than just lesions.
- Cortical grey matter also shows demyelination, neuronal loss, and atrophy correlated with disability.
- Spinal cord pathology including diffuse axonal loss and myelin damage contributes to disability, not just atrophy.
- Validating MRI with post-mortem tissue is important for diagnosis, predicting disease progression, and understanding substrates of disability in MS.
Sirt oslo 1_feb2018
1. Klaus Schmierer presents disclosures related to research funding and speaking engagements from various pharmaceutical companies involved in multiple sclerosis treatment.
2. He discusses two important lessons about MS treatment - that the disease is progressive from the start, and patients have a better chance of avoiding disability if treated early.
3. Selective immune reconstitution therapy (SIRT) and treatments like alemtuzumab and cladribine that deplete memory B cells have been shown to be highly effective at controlling disease activity, with alemtuzumab demonstrating similar efficacy to cladribine but with different adverse effect profiles.
Dl excemed neuro_2017_baveno_ks_final_version
Presentation delivered on 30 Nov 2017 at the 25th European Charcot Foundation meeting in Baveno. Emphasis on risk in disease modifying treatment.
ABN on NICE IPG venoplasty
Response (Nov 2011) by the Neuroinflammation & Multiple Sclerosis Subcommittee of the Association of British Neurologists to NICE Interventional Procedures Programmes (IPG) 420, and reply by NICE (Mar 2012).
BartsMS Information_Pack_Cladribine
1) Cladribine is an immunosuppressant drug that has been used to treat multiple sclerosis (MS) for many years and has been shown to be effective in reducing relapses and disease progression in clinical trials.
2) It works by suppressing lymphocytes, a type of white blood cell that is involved in MS, which lowers immune system activity that may be damaging in MS.
3) Cladribine is administered through subcutaneous injections over two 5-day treatment courses, one year apart, with monitoring of lymphocyte levels throughout treatment and follow-up.
Never stop k_sv1.4
1. Brain atrophy occurs across all stages of multiple sclerosis (MS), with around 40% of cortical neurons being lost over a lifetime without intervention. Early treatment with disease-modifying therapies (DMT) can help reduce disability and protect brain health.
2. Both inflammatory lesions and neurodegeneration are associated with disability progression in MS. Gadolinium-enhancing lesions are not fully indicative of disease phenotypes and inflammation may be present even without new lesions.
3. DMT have been shown to reduce disability accrual even at advanced stages of MS. While early treatment is important, evidence suggests that people with progressive forms may also benefit. Interventions should focus on outcomes beyond just lesion activity.
Time matters-brochure-digital
This document provides information about an event called "Time Matters in MS" that will address how early intervention and regular monitoring of disease activity offers the best outcome for people with multiple sclerosis. The event will include roundtable discussions on preserving brain health in MS and taking a comprehensive economic approach to evaluating treatment cost-effectiveness. It will take place in Lisbon, Portugal on World MS Day 2017 and feature several expert speakers in the field of MS research and treatment.
Letter to investigators involved in the Arpeggio study of Laquinimod in peopl...
The Data Monitoring Committee for the ARPEGGIO study reviewed cardiovascular events in ARPEGGIO and the CONCERTO study of the multiple sclerosis drug laquinimod. They found an imbalance of myocardial ischemic events in the higher 1.2mg dose of laquinimod in CONCERTO and recommended stopping all doses of laquinimod above 0.6mg. They also recommended re-consenting all patients in MS trials on laquinimod to inform them of cardiovascular concerns with higher doses. As a result, patients receiving the 1.5mg dose of laquinimod in ARPEGGIO will be contacted to stop study medication and attend an unscheduled visit.
Opera top line_results_30_jun2015
Two Phase III clinical trials found that the investigational drug ocrelizumab significantly reduced relapses and disability progression in people with relapsing multiple sclerosis compared to interferon beta-1a. Ocrelizumab also significantly reduced lesions in the brain. The safety profile was similar between the two drugs. Based on these results, Roche plans to submit the data to regulatory authorities in early 2016 for review. A Phase III study of ocrelizumab in primary progressive multiple sclerosis is ongoing.
EMA Guideline investigation medicinal products for Multiple Sclerosis Mar 2015
EMA Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis
BartsMS Clinical Guidance Tecfidera
This document provides guidelines for managing lymphopaenia in multiple sclerosis patients treated with dimethyl fumarate (DMF, Tecfidera). It summarizes clinical trial data showing DMF can decrease lymphocyte counts by about 30% on average. It recommends monitoring complete blood counts regularly for patients on DMF and considering discontinuing treatment if lymphocyte counts persistently fall below 0.8 x 109/L or reach below 0.5 x 109/L. This is due to one reported case of progressive multifocal leukoencephalopathy (PML) in a DMF-treated patient with long-term lymphopaenia below 0.5 x 109/L. The guidelines establish a
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Neuropathological correlates imperial_college_4_sl_sh_2feb2018
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Letter to investigators involved in the Arpeggio study of Laquinimod in peopl...
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EMA Guideline investigation medicinal products for Multiple Sclerosis Mar 2015
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Physiology of Special Chemical Sensation of Taste
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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Burning Debate @ ECTRIMS 15 Sep 2016
- 1. People in wheelchairs should be included in progressive MS trials YES, London, 15 Sep 2016 Klaus Schmierer, MB BS PhD FRCP Reader in Clinical Neurology & Consultant Neurologist
- 2. Disclosures PI of trials sponsored by Novartis, Roche, Teva, Medday. Involved in trials sponsored by Biogen, Genzyme, BIAL, Cytokinetics, Canbex. Speaking honoraria from, and/or served in an advisory role for, Biogen, Merck, Merck Inc., Novartis, Roche, Teva Supported for attendance of meetings by Genzyme and Novartis. Research grant support from Novartis, Biogen, National MS Society (US), MS Society of Great Britain & Northern Ireland, Royal College of Radiologists, and Barts Charity.
- 3. Motion: People in wheelchairs should be included in progressive MS trials - All people in wheelchairs, irrespective of the cause of their disability? - What is a progressive MS trial - a trial that leads to progress in knowledge creation? - What about the word should? Does that not rather sound like must be included?
- 4. People with progressive MS, who are wheelchair users due to their MS, should (be able to) participate in trials. The real motion
- 5. - Pathology - Pharmacology - Peers - Patients Perspectives on the motion
- 6. P 1 Perspectives on the motion
- 7. Tallantyre, et al. Brain 2009;132;1190-99. | DD 27 years de Luca, et al. Brain 2004;127:1009-18. | DD 17 years Ganter, et al. Neuropathol Appl Neurobiol 1999;25:459-67. | DD 14 years Petrova, et al. under revision MS pathology - 60% Axonal loss is associated with disease duration N= 18 cords N= 396 tissue blocks DD= 29 ± 11 years
- 8. www.ms-res.org MS pathology Length dependency versus neuroanatomy 55% of cortico- spinal tract axons terminate at the cervical level.
- 9. P 2 Perspectives on the motion
- 11. N= 73 pwPPMS
- 14. P 3 Perspectives on the motion
- 15. Current trials in progressive MS Ontaneda, et al. Lancet Neurol 2015
- 16. P 4 Perspectives on the motion
- 22. Conclusion From an academic perspective and based on the evidence from: - Pathology - Pharmacology - Peers - Patients The motion must be carried that…
- 23. People in wheelchairs should be included in progressive MS trials ! YES,
- 24. In Professor Coyle’s own words… https://www.youtube.com/watch?v=uy6EXPhfg-8 “Scientifically I should take them off treatment”
- 25. https://www.youtube.com/watch?v=uy6EXPhfg-8 “But can I say they don’t benefit from treatment? I can’t, and so I keep them on it” In Professor Coyle’s own words…