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Friday, June 7, 2013

Medical breakthrough for multiple sclerosis

Medical breakthrough for multiple sclerosis sufferers



NewBrain_640

In a breakthrough discovery, researchers have discovered a treatment capable of reducing the debilitating autoimmune response that occurs in people suffering from multiple sclerosis (MS).

When patients are diagnosed with multiple sclerosis, their bodies begin to attack the protein myelin, which insulates the body’s spinal cord, brain and optic nerves. As a result, MS patients experience symptoms such as numbness in their limbs, paralysis and sometimes blindness.

However, during a phase one clinical trial of a new treatment for MS patients, researchers were able to curtail the body’s attacks on myelin by 50 to 75 percent, while sustaining the functionality of the rest of the immune system.

Current treatments for MS seek to lessen the body’s autoimmune response to myelin, but this often results in decreased effectiveness of the entire immune system.

“Most therapies for autoimmune diseases employ approaches broadly called immunosuppressors – they knock down immune response without specificity,” study co-author Stephen Miller, professor of microbiology-immunology at Northwestern University Feinberg School of Medicine, told FoxNews.com. 

“People can become highly susceptible to everyday infections and develop higher rates of cancer.”

Miller and his colleagues sought a more targeted ‘tolerance’ treatment that would leave the greater immune system intact while knocking out only the autoimmune response to myelin.

“In MS, the idea is to target autoreactive T-cells directed against myelin…which would (reduce) disease progression, but wouldn’t make patient susceptible to higher rates of infection,” Miller said.

In a study published in the journal Science Translational Medicine, a small group of MS patients were treated intravenously with an infusion of their own white blood cells, which had been engineered to carry billions of myelin antigens. Researchers hoped the cells would teach the body to stop attacking myelin.

Miller and his team needed to determine if the treatment, which was based on 30 years of previous research, could be safely applied in humans – and they were pleased to discover it could be.

“It was safe to infuse as many as 3 billion autologous cells that we collected and manipulated back into the same patient and didn’t trigger exacerbations,” Miller said. “Most patients didn’t show any increased signs of disease during the six-month follow up.”

Furthermore, the treatment did not seem to impede the larger immune system. Researchers tested this by analyzing whether or not each patient continued to retain their immunity to tetanus, for which all of the patients had previously been vaccinated.

“Among four patients receiving the highest doses (of autologous cells),  immune response to myelin antigens had diminished or gone away - but tetanus had not gone away,” Miller said.

This indicated that the immune system’s ability to fight other diseases after the procedure remained intact.

Though researchers caution that the study was too small to draw any significant conclusions, they are optimistic about the outcomes of larger studies and the ability of this treatment to help halt the progress of MS – particularly among recently-diagnosed patients.

“The idea is that if we’re able to intervene early enough in disease process, we can stop the autoimmune destruction and (the patient) will have little or no clinical deficit as result of earlier attacks before being diagnosed,” Miller said.

Researchers hope to receive funding to begin a phase two trial soon.

Source: FOX NEWS



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Thursday, June 6, 2013

Tysabri Screening Test May Be Unreliable

By John Gever, Deputy Managing Editor, MedPage Today
Published: June 05, 2013
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

About one-third of multiple sclerosis patients testing negative for antibodies against the JC virus -- suggesting that natalizumab (Tysabri) would be relatively safe -- were found to have active viremia, researchers said.
The report, published in the June 6 issue of the New England Journal of Medicine, raises the specter that patients with negative JC serology results could be given natalizumab when they may actually be at high risk for progressive multifocal leukoencephalopathy (PML), an often fatal type of brain inflammation.
PML is caused by JC virus becoming active in the brain. Natalizumab appears to contribute to reactivation of latent JC virus infections. MS patients with such infections face a PML risk while on natalizumab ranging from about 0.01% to 0.1% depending on the presence of other risk factors
Eugene O. Major, PhD, of the National Institute of Neurological Disorders and Stroke in Bethesda, Md., and colleagues reported having tested blood samples from 49 patients for anti-JC virus antibodies and for JC virus DNA.
In 26 of the patients, the samples were obtained immediately before starting on natalizumab. Samples from the other 23 were obtained after at least 2 years of periodic natalizumab infusions.
Ten patients in the first group were found to have JC viral DNA in their blood, with four lacking a positive result in anti-JC virus antibody testing. (Seronegativity was defined as antibody titers of less than 2,560 units.)
In the group of 23 patients tested after 2 years of natalizumab treatment, seven were found to be viremic and two were seronegative, the researchers reported.
Overall, they indicated, six of 17 patients (35%) showing JC viremia were seronegative with the antibody test.

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Study Hints of Rituximab MS Benefit

By John Gever, Deputy Managing Editor, MedPage Today
Published: June 03, 2013
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner


Most patients receiving off-label rituximab (Rituxan) for secondary progressive multiple sclerosis either improved or showed little further progression, according to results from a small retrospective study.
Among 25 patients with secondary progressive MS treated with rituximab, nine showed decreases in disability and 12 appeared to stabilize after receiving at least three cycles of rituximab given every 6 months, said Christopher Perrone, a fourth-year medical student at the University of Massachusetts Medical School in Worcester, Mass.
Compared with patients' previous rates of disability progression before starting rituximab, as measured with the Expanded Disability Status Scale (EDSS), further progression appeared to slow markedly while on the drug, Perrone said at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
By the third cycle of rituximab treatment, mean EDSS scores were almost exactly equal to the mean 1 year before starting treatment.
Rituximab is an anti-CD20 monoclonal antibody drug approved for certain hematologic malignancies and for rheumatoid arthritis. It is sometimes used off-label in MS, but its effectiveness and optimal role have never been firmly established.
Perrone told MedPage Today that some patients with secondary progressive MS have been receiving the drug at his institution when they have exhausted other options. He noted that mitoxantrone is FDA-approved for secondary progressive MS but, like other immunosuppressant drugs used in the disorder, it is relatively toxic.
For the current study, he and colleagues at UMass examined records of 30 patients who had received rituximab after failing conventional MS drugs including interferon-beta and glatiramer acetate (Copaxone) as well other therapies such as methotrexate, cyclophosphamide, mycophenolate mofetil, and corticosteroids. Such agents are treatments of last resort in many other autoimmune diseases.
Some patients considered for the study had received natalizumab, but they did not meet all the study's inclusion criteria and were therefore left out, Perrone said.
Patients in the cohort had shown significant declines in functional ability during the 2 years prior to starting rituximab, gaining about 0.5 EDSS points per year (increased EDSS scores reflect growing disability).
But after the first cycle of rituximab -- 1-g intravenous infusions 2 weeks apart -- the mean increase in EDSS over the following 6 months was less that 0.1 point. Mean progression after the second cycles was 0.05 points, Perrone reported.
By the time of the third cycle, analysis of each patient's pretreatment rate of disability progression suggested that the cohort's mean EDSS score would have reached about 6.2. Instead, it was about 5.6.
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Wednesday, June 5, 2013

Multiple Sclerosis Breakthrough Resets Patients' Immune Systems

Written by  | Published on June 5, 2013

A phase 1 trial of a new treatment to reset the immune systems of multiple sclerosis patients shows the therapy is safe and highly effective.

German researchers today unveiled the results of a study on a new procedure that safely resets a multiple sclerosis (MS) patient's immune system. It can reduce the body's attacks on the protective myelin sheath that insulates nerve cells in the brain.
For this small Phase 1 trial, which was a collaboration between Northwestern University’s Feinberg School of Medicine, University Hospital Zurich in Switzerland, and University Medical Center Hamburg-Eppendorf in Germany, ten patients were selected. Eight patients with relapsing-remitting MS (RRMS) and two with secondary progressive MS (SPMS) were enrolled initially, but one RRMS patient withdrew before the procedure.
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CCSVI: Controversy and Reality

Consortium of Multiple Sclerosis Centers Annual Meeting 2013

Faculty:  Alex Rae-Grant, MD

Reported by:  Cherie C. Binns RN BS MSCN

This is the second in a series of articles reporting on educational sessions I attended at the Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in Orlando Florida between May 29 and June 1, 2013.  This presentation was part of a larger discussion on “Complementary and Alternative Medicine: Controversial and Unconventional Therapies”.

Dr. Rae-Grant began by giving dictionary definitions of “controversy” and “reality” then went on to explain that CCSVI (Central Cerebrospinal Vascular Insufficiency) as described by Dr. Zamboni from Italy in 2009 swept the MS Community off its feet with the claim that 100% of all MS was caused by this condition and was treatable (curable) by a simple vascular surgery labeled “Liberation Therapy”.  Zamboni was a vascular surgeon whose wife had Multiple Sclerosis.   Dr. Rae-Grant explained, “If you are a carpenter, your tools are hammer and nails.  If you are a neurologist, your tools are neurological exam and MRI.   If you are a vascular surgeon, your tools are Doppler and scalpel”.  By saying this, he told us that we each work with the knowledge and tools we are most skilled in working with and most knowledgeable about.   This is exactly what Zamboni did when identifying and treating CCSVI.

Dr. Rae-Grant went on to give a history of vascular theories for Multiple Sclerosis (MS) dating back to the mid-1800s and coming up through the end of the 20th Century.   Most of these theories came about from examination of tissue on the autopsy table or under a microscope following brain or spinal cord biopsies.  None of these theories, until Zamboni’s was presented in 2009, brought with it any hope of treatment or cure of MS.  With Zamboni’s publication of his theory and subsequent Liberation Therapy, MS patients around the world began to demand that their physicians test them for this condition and treat accordingly.   “For a  while”, said Rae-Grant, “Drs were doing Liberation Therapies right and left because it was a relatively safe, simple and low cost procedure and there was big money potential in it as well as the probability of curing a large segment of the MS population and reducing health care cost across the board!”   Soon, however, they began to see that patients who initially saw improvement were losing that gain within days to weeks and the procedure needed to be repeated…often 3-4 times. 

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Medical Marajuana: Consortium of Multiple Sclerosis Centers

Faculty: Allen Bowling, MD PhD and Mark A. Ware MD
Reported by Cherie C. Binns RN BS MSCN

This is the first in a series of articles on topics covered in classes I attended at the annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in Orlando, Florida between May 29 and June 1, 2013.  In a symposium entitled “Complementary and Alternative Medicine:  Controversial and Unconventional Therapies”, Drs Bowling and Wade discussed the history and use of Medical Marijuana and canniboid derivatives currently approved by the FDA.

In his introduction, Dr. Bowling told us that the use of Medical Marijuana is now legal in 19 States, the District of Columbia and Canada.  Its legality has also been legislated for any adult wishing to use it for other reasons in the States of Colorado and Washington.  HOWEVER, it is still illegal to cross State lines or International borders in possession of prescription Marijuana in any amount and is subject to high fines and even imprisonment if caught.  This is true even if crossing from one legal domain into another.   Therefore, he asks patients using this product to let him know prior to travel and he will see to it that they have a prescription for a legal canniboid derivative such as Marinol®.

For centuries and in countries around the globe, Humans have identified the medicinal benefits of pain relief, sleep enhancement, relief of spasticity , relief of nausea and a number of other properties of smoking or eating portions of the marijuana plant.  It was freely used in the United States until the 1930s when a National Law was enacted vetoing its use.  

Many people continued to use the Plant in medicinal ways until the 1960s when it gained favor in higher doses with greater frequency as a recreational drug.  The struggle between users of this drug and Federal and State Governments continues as States are, one by one, approving the use of it in certain populations for specific purposes.

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Transplant Promising as MS Therapy

By John Gever, Deputy Managing Editor, MedPage Today
Published: June 03, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

ORLANDO -- High-dose immunosuppressant therapy and autologous hematopoietic stem cell transplant (HSCT) induced durable freedom from relapses and MRI lesions in patients with multiple sclerosis, researchers reported here.
At evaluations performed 1 and 2 years after the procedure, patients showed no gadolinium-enhancing lesions on MRI scans, and only six of the 24 patients receiving the transplants experienced relapses, reported Richard A. Nash, MD, of Colorado Blood Cancer Institute in Denver, and colleagues.
In a poster presented at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis, the investigators indicated that overall functional ability and quality of life were improved as well with the transplant procedure.
Immunosuppressant therapy with drugs and dosages high enough to be severely myelosuppressive, followed by HSCT, had been tested previously in patients with advanced, progressive MS, for which there is currently no broadly effective treatment. The results were disappointing, Nash and colleagues indicated, as "many patients continued to lose neurological function."
But it was unclear whether the lack of effect was because the treatment failed to suppress MS autoimmune activity or because the process of neurodegeneration had become independent of autoimmune mechanisms.
Since the latter seemed like the more likely explanation, Nash and colleagues tested a similar regimen in patients with relapsing-remitting MS, in which autoimmunity is widely believed to be the chief pathological process.
The 25 patients enrolled in the study had a median age of 38 and median duration of disease of 6.4 years. Median score on the Expanded Disability Status Scale (EDSS) was 4.5, indicating moderate disability. About 40% had gadolinium-enhancing lesions at baseline, including five patients with two or more each.
Participants first underwent stem cell mobilization with granulocyte colony-stimulating factor (along with cyclophosphamide in one patient who did not mobilize enough cells with G-GSF alone), with CD34 stem cells then collected.
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Novartis Says Gilenya Improves All 4 Key Measures Of Multiple Sclerosis

6/5/2013 1:32 AM ET

Swiss drug maker Novartis AG announced that the new data would be presented at the 23rd meeting of the European Neurological Society or ENS that show how Novartis' Gilenya, the first once-daily oral therapy approved to treat people with relapsing multiple sclerosis, positively impacted the key measures for multiple sclerosis or MS - relapse rates, brain volume loss, lesions as well as disability progression. The improvement of these key measures resulted in favorable clinical outcomes.

The new findings from the TRANSFORMS study demonstrated that a greater proportion of patients were disease free after one year on Gilenya treatment compared to interferon. For patients on interferon in the first year, the proportion who were disease free during the second year grew after they were switched from interferon to Gilenya treatment. The above findings suggest that switching from interferon to Gilenya is beneficial for patients with RMS to achieve and maintain long-term disease-free status.

Gilenya, which is licensed from Mitsubishi Tanabe Pharma Corp., is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor modulators. To date, nearly 63,000 patients have been treated with Gilenya showing a positive benefit-risk profile in clinical study and real-world settings.

Source: RTT News

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Multiple Sclerosis: Autoimmune or Neurodegenerative?

ORLANDO, Florida — Despite all the evidence to the contrary — and maybe even common sense — there's some indication that multiple sclerosis (MS) is not primarily an autoimmune disease but instead is due to a neurodegenerative process that sparks an inflammatory response.
That point was argued by Peter Stys, MD, professor, neurology, University of Calgary, Alberta, Canada, during a debate here at the 5th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research In Multiple Sclerosis (ACTRIMS).
"MS is an autoimmune disease, but the question is, is MS primarily an autoimmune disease?" said Dr. Stys.
He squared off with Richard Ransohoff, MD, director, Neuroinflammation Research Center, Cleveland, Ohio, who argued the more "orthodox" view of MS.
Little Evidence
While he conceded there is "overwhelming evidence" that MS is an immunologic disorder, Dr. Stys pointed out several factors that raise doubts that the condition is primarily autoimmune. For one thing, in the earliest lesions, where there is profound myelination, there’s little evidence of any inflammatory response.
Dr. Stys pointed out that anti-inflammatory treatments don't have much effect on the progressive phase of the disease and that some nonautoimmune diseases share pathologic and immunologic characteristics with MS.
The argument that because some patients with MS benefit from bone marrow transplants, MS must be an autoimmune disease doesn't hold up, said Dr. Stys. He noted some "clearly genetically mediated neurometabolic disorders" that are "absolutely not primarily autoimmune" disorders are also helped by bone marrow transplants.
One example he used was adrenoleukodystrophy (ALD), a genetically inherited disorder in which patients lack a protein necessary to sustain myelin.
Dr. Stys believes that MS has 2 key contributing factors: dysimmunity and an underlying cytodegeneration. "In my mind, the underlying degeneration may well be primary," he said.
He pointed out that the overwhelming majority of patients in MS studies have relapsing-remitting MS (RRMS). This research, he said, has taught scientists little about the progressive phase of the disease.
"Despite common sense, despite what’s obvious, maybe the real MS is primary progressive disease, and relapsing-remitting MS, which curiously represents the vast majority of our patients, is actually a reaction, a distraction if you will, to the primary root cause," said Dr. Stys. "I don’t know the reason for that reaction, but I suspect it has to do with myelin being so antigenic."
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Monday, June 3, 2013

Promoting Remyelination in Multiple Sclerosis

By  

The Mayo Clinic and Acorda recently enrolled the first patient in their phase 1 clinical trial of a remyelinating antibody that may potentially reverse the damage caused by multiple sclerosis. I recently interviewed Anthony O. Caggiano, MD, PhD, Vice President of Research & Development at Acorda since February 2009. Since joining Acorda in 2001, he has served in various roles in preclinical science and research and development, directing basic research and product development efforts, coordinating external research programs with academic and commercial partners, and collaborating in business development activities
.Neuron black
SL: What is the current state of knowledge on the pathogenesis of multiple sclerosis?
AC: In multiple sclerosis (MS), a person’s own immune system destroys myelin, a substance that insulates nerves and facilitates conduction of nerve impulses that control neurological function such as movement and vision. Without myelin, the neurons in the brain, spinal cord or central nervous system communicate less effectively.
Progressive damage to myelin causes functional impairment in people with MS. Currently there are no approved therapies that stimulate the repair or regrowth of myelin once it has been damaged. Acorda is now studying an antibody called rHIgM22 which has been shown to potentially stimulate remyelination and improve the function of neurons.
SL: How do our current lines of treatment for MS affect the disease course?
AC: There are two main categories of MS treatments. The first involves the use of disease-modifying agents (interferon beta-1a, interferon beta-1b, glatiramer acetate, natalizumab and fingolimod), which have been found to help with relapse management, decrease MRI activity and potentially delay disability. The second category is treatments that target specific symptoms of MS, such as AMPYRA (dalfampridine), which is indicated to improve walking in people with MS.
Disease-modifying agents are an important part of managing MS, and evidence suggests that they can be combined with other treatments to target different aspects of immune response or therapeutic targets such as inflammation or neuroprotection.
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What is the Difference between Primary Progressive and Secondary Progressive MS?

You all asked brilliant questions and we got them answered by Prof Alan Thompson, so here is our 7th edition of the People’s Hot Topic.
We are releasing each question day by day on Facebook and Twitter – but you can watch the full set (21 Questions!) below.  (( 21 Short Videos shown below))
If any of the answers spark more questions for you please do ask them below in the comments and we will get them answered by Prof T.

It’s been great hearing from people in the last few weeks who wanted to see the video – sorry for the delay. As you can see we have been working on a new format that we hope will lead to a more valuable long-term archive.  We also hope that the next PHT will be done with the researcher answering questions direct as they come in… should be exciting.
Please do let us know your thoughts and again, if any of these video answers spark new questions for you then please do ask more questions below in the comments and we will do our best to get them answered in a new video.
Source: http://shift.ms/2013/05/from-relapsing-remitting-ms-to-secondary-progressive-ms/
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RESEARCH UPDATE: Genzyme's Alemtuzumab shows being effective in patients with highly active multiple sclerosis (MS)

By John Gever, Deputy Managing Editor, MedPage Today
Published: June 01, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

ORLANDO -- The investigational drug alemtuzumab was effective in patients with highly active multiple sclerosis (MS), to the point that disease activity vanished in one-quarter, a researcher said here.
A subgroup analysis of data from the pivotal CARE-MS II trial, involving patients with multiple recent relapses and MRI-detected gadolinium-enhancing lesions at study entry, found an annualized relapse rate of 0.33 during the first 2 years of alemtuzumab (Lemtrada) treatment, compared with 0.65 for patients receiving interferon-beta-1a (Rebif), said Stephen Krieger, MD, of Mount Sinai School of Medicine in New York City.
The 51% reduction in relapse rate (P<0.0001) was virtually identical to the 49% decrease seen in the full CARE-MS II datareported last year, Krieger told attendees at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
The most stringent criteria for response -- no relapses, no sustained accumulation of disability, and no new gadolinium-enhancing lesions or new or enlarging T2 lesions -- were met by 24.2% of patients receiving alemtuzumab, compared with none of the interferon-beta control group, Krieger said.
Alemtuzumab is an anti-CD52 monoclonal antibody formerly sold as a cancer drug under the name Campath. In MS, it is believed to induce a shift in immune responsiveness to downregulate the T cell-mediated attack on myelin in the nervous system.
In the MS clinical trials, alemtuzumab was administered by infusion in an initial 5-day course, followed by a second 3-day course a year later. Two phase III trials testing alemtuzumab against interferon-beta-1a have been conducted: CARE-MS I in treatment-naive patients, and CARE-MS II in patients showing continued disease activity while on an approved disease-modifying MS drug.
Of the 667 patients in the latter study, 145 had what the investigators called highly active disease at enrollment -- at least two relapses in the previous year plus at least one gadolinium-enhancing lesion. Presumably, these would represent a more treatment-resistant group of patients.
The subgroup analysis generally supported that view. Response rates to both drugs were lower in the high-activity cohort than in the overall CARE-MS II data, in which the annualized relapse rates after 2 years were 0.26 and 0.52 for alemtuzumab and interferon, respectively.
Alemtuzumab consistently outperformed interferon in every other outcome measures Krieger reported for the highly active subgroup during the 2-year study (all P<0.001):
  • Proportion with relapse: 36% alemtuzumab, 65% interferon
  • Proportion with sustained reduction in disability: 31% alemtuzumab, 16% interferon
  • Proportion without either relapse or sustained accumulation of disability: 61% alemtuzumab, 33% interferon
  • Proportion MRI free of disease activity: 40% alemtuzumab, 8% interferon
Safety findings were similar in the subgroup to what had been seen in other patients, Krieger said. Serious infections were somewhat more common with alemtuzumab (seen in 3.9% of patients, compared with 2.4% of the interferon control group). Serious infusion reactions were common, an effect not seen with interferon, which is given by subcutaneous injection.
No cases of autoimmune thrombocytopenia were seen in the analysis, Krieger said. Overall, he said, adverse effects with alemtuzumab were not "unexpectedly disproportionate" in the highly active subgroup.
There was one death in the subgroup -- a patient in the alemtuzumab arm who died in a traffic accident.
Alemtuzumab's developer, the Genzyme unit of Sanofi, has applied for U.S. marketing approval. A decision is expected this fall.
The study was funded by Genzyme/Sanofi and Bayer HealthCare.
Krieger reported relationships with both of those companies and also Acorda, Biogen Idec, EMD Serono, Novartis, Questcor, and Teva.
Primary source: CMSC-ACTRIMS Joint Meeting
Source reference:
Krieger S, et al. "Alemtuzumab is efficacious in highly-active RRMS patients in CARE-MS II" CMSC-ACTRIMS 2013; Abstract DX01.

Source: MedPageToday

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Sunday, June 2, 2013

Drug Relieves MS Constipation -- at a Price

By John Gever, Deputy Managing Editor, MedPage Today
Published: June 02, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

ORLANDO -- Treatment of constipation in multiple sclerosis (MS) patients with lubiprostone increased spontaneous bowel movements but also appeared to induce diarrhea, according to a small trial reported here.
In a 21-patient randomized, double-blind, placebo-controlled study lasting 3 weeks, the rate of spontaneous bowel movements more than tripled in the 11 assigned to lubiprostone (P=0.04), but only when initial effects in three patients who discontinued early were assumed to have continued had they stayed in the trial, reported Cynthia Irish, RN, and colleagues at the University of Rochester in N.Y.
In analyses that handled the dropouts differently -- such as excluding them altogether or assuming that they had no spontaneous bowel movements after leaving the study -- lubiprostone showed only a weak advantage over placebo, according to the researchers' report at the joint meeting of the Consortium of Multiple Sclerosis Centers and the Americas Committee for Treatment and Research in Multiple Sclerosis.
The adverse events driving the three patients from the trial appeared to be diarrhea, suggesting that lubiprostone may have been too effective in these individuals.
Results from the analyses "would lead one to believe that lubiprostone was effective in increasing the number of spontaneous bowel movements at the price of an increase in diarrheic events," Irish and colleagues concluded.
Constipation is one of the many less-publicized effects of MS, affecting more than 40% of patients in one study. Whether conventional treatments for the condition are effective in MS patients remains unclear.
Lubiprostone (Amitiza) is FDA-approved for relieving chronic idiopathic constipation and opioid-induced constipation in adults as well as constipation-predominant irritable bowel syndrome (IBS) in women. The American College of Gastroenterology has recommended the drug for constipation associated with IBS.
However, as Irish and colleagues pointed out, the drug has not been evaluated for constipation arising from neurological disorders.
In their study, they recruited a total of 40 MS patients reporting chronic constipation. Of these, 19 were excluded, most because they had more than four spontaneous bowel movements during a 2-week washout period, when patients' previous constipation medications were stopped. Patients then received either placebo or 24 mcg of lubiprostone twice daily for 3 weeks.
Patients included in the trial represented a mix of MS types, including both relapsing and progressive forms. Their mean age was 45 and the mean duration of their MS was 14.5 years. The mean expanded disability status scale (EDSS) score was 5.2.
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