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Group Medical Director, Neuroscience, U.S. Medical Affairs, Genentech
Over the past decade I’ve worked in clinical development to advance new medicines to treat multiple sclerosis (MS). My job has been to design clinical trials and monitor the data they generate to determine a potential medicine’s safety and efficacy. One question we aim to answer is whether the new medicine is more effective than what’s already available. Answering this question of efficacy requires tools for measuring and comparing both the state and progression of the disease.
Measuring the impact of MS isn’t as simple as unspooling a tape measure – we’re limited both by what a patient can report and what a neurologist can assess. The biology of MS is not fully understood, symptoms of MS vary from person to person, and the biological markers of MS don’t always correlate with a patient’s clinical signs and symptoms. MS usually appears early in life and it is a chronic, lifelong disease, where symptoms typically evolve over time. Furthermore, there are different subtypes of MS.
Most people living with MS have the relapsing form, in which new symptoms abruptly appear or old symptoms worsen for a limited period of time and are followed by either full or partial recovery, in episodes known as relapses or MS attacks. Others have progressive MS, in which the disease steadily worsens over time. Thus, demonstrating the efficacy of treatments for MS is complicated and the science around this continuously evolves.
In designing a therapeutic clinical trial, patients are randomly assigned into two or more treatment groups, those receiving the new medicine and those receiving an existing treatment or placebo (also known as the control group). Then we identify patient outcomes that are important in that disease and use them to define the trial’s endpoints, which are quantified outcome measures used to formally compare results between the two groups. We assess all of the patients over time, record their outcomes during the trial, and compare the two groups at the end of the trial using the pre-defined endpoints.
At present, neurologists use three major types of outcome measures to assess the state of one’s MS disease: frequency of relapses; physical disability status; and biological markers, including brain scans using MRI. In MS clinical trials, these same types of outcomes are used to define the specific endpoints to be statistically analyzed.
Relapses are meaningful as they reflect how individuals experience fluctuations in symptoms that are central to relapsing MS. In many clinical trials, the relapse frequency, measured by the Annualized Relapse Rate, is a primary endpoint. For progressive MS, where relapses don’t occur frequently, other endpoints are used.
Physical disability is an important measure to track because MS is a chronic condition where a person’s functional disability worsens over time. A neurologist’s physical examination is still the gold standard for its measurement. That examination is a remarkable process and reflects the foundation of what a neurologist does. We use our eyes, ears and hands to assess a patient’s problems with cognition, vision, strength, coordination, sensation, walking and agility. In order to compare one patient to another (or one patient to himself or herself over time), we’ve developed ways to rate the individual symptom assessments numerically and then combine them into a single score. The most widely used neurologic exam in MS is called the Expanded Disability Status Scale (or EDSS), which is often used as an endpoint in clinical trials. The goal is to find medicines that stabilize or potentially even improve disability scores.
In the early 1980s, a new assessment tool became available – MRI brain scans. For the first time, we could actually see lesions or damaged areas in the brain, and we could count new lesions by comparing MRI scans over time. When drug approval agencies evaluate new medicines, however, they prefer to rely on clinical outcomes that more closely reflect the patient’s symptomology – relapses and disability scores. Nonetheless, MRI is a valuable secondary tool in both clinical trials and in individual patient care. MRI can highlight the presence of MS disease activity in the brain, whether or not this activity directly results in physical, cognitive or visual symptoms a person may experience.
There’s no single measure that captures the entire MS experience. As more becomes known about the biology of disease and treatment, the field develops newer ways to integrate relapse records, disability scores and biological markers. One example of progress in MS outcomes measurement is NEDA, an acronym for No Evidence of Disease Activity. If, over a certain period, a patient experiences no relapses, if his or her disability score remains stable and if no new or enlarged brain lesions appear in MRI scans, then that patient can be classified as having achieved NEDA. It provides a simple “yes/no” endpoint for a clinical trial, investigating whether a new medicine increases the percentage of patients with NEDA compared to an existing medicine. Emerging combination endpoints that give us a fuller, more comprehensive picture of the disease in clinical trials may find their way into clinical practice to help doctors make treatment decisions.
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Right now we need help alerting our members of
congress about the Patient Protection and Affordable Care Act and how it
affects those of us with M.S. This bill protects people living with MS
and other pre-existing conditions, as well as removing lifetime and yearly
insurance caps for those hit by sudden and expensive health costs.
One of the protections contained in the legislation is that it bans charging
women higher health premiums then men. It also protects all Americans by
limiting out of pocket expenses. Please contact your members of congress
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Observational study finds almost half of patients progression-free at 5 years
by Kate Kneisel
Contributing Writer, MedPage Today
FEBRUARY 21, 2017
Autologous hematopoietic stem cell transplantation (AHSCT) was associated with long-term attenuation of disability progression in almost half of patients with aggressive, treatment-refractory multiple sclerosis (MS), researchers found. The long-term observational study of 281 patients with predominantly progressive forms of MS found that 46% of the 239 evaluable patients were free from progression and overall survival was 93% at 5 years, Paolo Muraro, MD, of Imperial College London in England, and colleagues reported online in JAMA Neurology.
The profile of a patient who may benefit from AHSCT for treatment of aggressive MS includes being younger in age, with relapsing forms of MS, a low number of prior immunotherapies, and low or moderate but not severe level of established neurological disability, Muraro told MedPage Today.
"The study results suggest a long-term treatment effect of AHSCT and strengthen the case [presented in a 2012 position paper] for randomized controlled trials of AHSCT against standard care," he added.
Patients in the multicenter study were followed for up to 16 years (mean 6.6 years). Three-quarters of patients had progressive forms of MS, mostly secondary progressive MS (66.2%). Transplant occurred a median of 81 months after MS diagnosis; 61% of patients had received at least 2 MS treatments before transplant. Median EDSS score was 6.5.
I’ve written many articles and blog posts about the benefits of exercise for multiple sclerosis (MS), but it occurred to me recently that I don’t actually practice what I preach! I talk the talk but always find excuses not to walk the walk (or stagger the stagger in my case).
I worry about exercise making fatigue worse and being unable to meet all my daily commitments like work and taking care of my children. I also worry about how much I can physically do due to my disabilities.
How can I join an exercise class, for example, when I can’t walk well or stand for long periods? How can I go swimming when heat intolerance makes getting dressed again impossible?
I needed to find something I could do at home on my own terms and at my own pace, so I started to make enquiries about private Pilates lessons.
I’d been talking to a friend with MS a few months ago who’d done a six-week course of Pilates and the results were amazing. She’d managed to get rid of her walking stick as her strength and balance had improved so much. I figured I might be able to improve and either get rid of one of my sticks or at least improve my confidence with two.
METHODS: All patients underwent 2 single treatment sessions: physical therapy and robotic-assisted gait training. Both before and after the treatment sessions, the self-report Mood Survey Scale was used to assess the effects of the treatment on distinct affective states. The subscales of the Mood Survey Scale were tested for pre-post changes and differences in effects between treatments, using non-parametric tests.
RESULTS: Fourteen participants completed the study. Patients showed a significant increase in activation (r = 0.55), elation (r = 0.79), and calmness (r = 0.72), and a significant decrease in anger (r = 0.64) after robotic-assisted gait training compared with physical therapy.
CONCLUSION: Affective responses might be positively influenced by robotic-assisted gait training, which may help to overcome motivational problems during the rehabilitation process in neurological patients.
Click here to receive MS news via e-mail Vitamin D - Wonder Pill or Overkill? Can one vitamin build stronger bones, help you lose weight, and protect against diabetes, depression, and more? Hopes are high. Get the facts. Wouldn’t it be great if one vitamin could build stronger bones and protect against diabetes, multiple sclerosis, cancer, heart disease, and depression? Or even help you lose weight? Researchers have high hopes for vitamin D -- which comes from our skin's reaction to sunlight, a few foods, and supplements. Learn the facts in the slides ahead … and see who's at risk for a "D" deficiency. Vitamin D is critical for strong bones, from infancy into old age. It helps the body absorb calcium from food. In older adults, a daily dose of "D" and calcium helps to prevent fractures and brittle bones. Children need "D” to build strong bones and prevent rickets, a cause of bowed legs, knock knees, and weak bones. Adding the vitamin to milk in the 1930s helped to nearly eliminate rickets. Read more (click the arrows on page that opens, to advance the slides)
EMD Serono has recently published Phase 3 clinical data showing that Cladribine tablets reduced the annualized rate of brain volume loss (BVL, brain atrophy) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS).
CLARITY was a randomized, double-blind, three-arm, placebo-controlled, multi-center Phase 3 clinical trial (NCT00213135) that evaluated the safety and efficacy of oral Cladribine in 1,326 RRMS patients. The primary endpoint was the assessment of the annualized rate of relapse (ARR) at 96 weeks, and key secondary endpoints included the number of relapse-free patients and the sustained progression of disability.
Click here to receive MS news via e-mail “Brain fog” isn’t a medical condition. It’s a term used for certain symptoms that can affect your ability to think. You may feel confused or disorganized or find it hard to focus or put your thoughts into words
Many women find it’s harder to remember things during pregnancy. Carrying a baby can change your body in lots of ways, and chemicals released to protect and nourish your baby may bring on memory problems.
This disease affects your central nervous system and can change the way your brain “talks” to the rest of your body. About half the people who have MS have issues with memory, attention, planning, or language. Learning and memory exercises can help, and a therapist can give you new ways to handle the tasks you have trouble with.
Some kinds of drugs -- over-the-counter and prescribed -- can cause brain fog. If you take medicine and notice that your thinking isn’t as clear as it should be or you suddenly can’t remember things, call your doctor. Be sure to let him know all the medications you take.