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Thread: Highlights of MS studies at annual AAN meeting

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    Default Highlights of MS studies at annual AAN meeting

    Maybe some of us will be cheered to know how diligently researchers are working towards finding some answers about MS. The MS Association has published a summary of highlights of presentations at the AAN conference. Excerpts:

    Highlights from the American Academy of Neurology's Annual Meeting


    The American Academy of Neurology’s (AAN’s) 66th Annual Meeting took place in Philadelphia, Pennsylvania April 26th-May 3rd. The AAN is an association of more than 27,000 neurologists and neuroscience professionals dedicated to advancing the care of individuals with neurologic disease. Every year, these professionals gather to hear the latest findings in research and treatments for neurological conditions, including multiple sclerosis (MS). To follow are some important highlights.

    Please note that at the time of this writing, 10 drugs were approved by the United States Food and Drug Administration (FDA) for the long-term treatment of MS. Known as disease-modifying therapies (DMTs), nearly all of these drugs continue to show long-term safety and significant effectiveness in reducing MS-disease activity. In addition to these 10 DMTs, several other experimental treatments are making their way through the approval process.

    FDA-Approved Medications for MS

    Results of a prospective evaluation of the use of theAvonex Pen autoinjector to self-administer Avonex® (interferon beta-1a) intramuscularly were reported. Users’ self-reports demonstrated that fear of injection decreased from 17.5 percent to only 2.4 percent at month 12 and the proportion of those requiring assistance for injections decreased from 10 percent to 5.2 percent.

    Betaseron® (interferon beta-1a) was the first drug approved by the FDA for the long-term treatment of MS. In the BENEFIT trial, individuals with clinically isolated syndrome (CIS) who were randomized to receive early treatment with Betaseron did not advance to clinically definite MS (CDMS) as quickly as those who began treatment at a later time. Study participants who began Betaseron early also experienced lower relapse rates than those who were treated at a later time. Patient-reported outcomes on Quality of Life (QoL) remained high for both groups of treated patients.

    ...

    The majority of people with relapsing forms of MS using the Rebismart autoinjector to self-administer Rebif® (interferon beta-1a) rated the convenience of the device positively. In a separate study, researchers conducted a post-hoc analysis of the PRISMS study, looking at the data to determine the relapse rates of patients on Rebif versus placebo over the course of one year. The study concluded that treatment with Rebif “was associated with rapid onset of action over zero to three months despite titration” (titration refers to starting at a lower dose and increasing to a full dose over time). Treated patients improved to a rate of 39-percent fewer relapses over the first year compared to placebo.

    Two of the most important factors contributing to a good outcome in Tysabri® (natalizumab)-treated individuals diagnosed with progressive multifocal leukoencephalopathy (PML-a rare but severe complication of treatment) are early diagnosis and treatment. A case was reported of a patient who was successfully treated after being diagnosed with PML following six years of treatment with Tysabri. In this specific instance, the patient went to the hospital following a disturbance in his gait. After PML was diagnosed, he underwent the prescribed therapy to remove Tysabri from his system (through plasma exchange). According to the study, “The patient was clinically stable during the entire period and the initial gait disturbance diminished after a few weeks.”

    Only 9.1 percent of individuals treated with Tysabri who had an EDSS score of ≥2 had progressed to an EDSS score of ≥4, six years later. Additionally, in the AFFIRM study, Tysabri was shown to increase the probability of confirmed improvement in walking speed (CIWS). A post-hoc analysis found that patients with a confirmed improvement in walking speed had better self-reported physical functioning.

    The rate of serious infections or of opportunistic infections in patients treated with Aubagio® (teriflunomide) for up to 12 years did not differ from those treated with placebo. ...

    Another study looked at two Phase III trials of Aubagio, the TEMSO and TOWER studies, to evaluate the drug’s effect on clinical MS-disease activity in 2,251 study participants. A post-hoc analysis of these studies was performed to determine the proportion of patients who remained free of clinical MS-disease activity while taking Aubagio. The study concluded that this approved disease-modifying therapy reduces the risk of clinical disease activity with consistent effectiveness across a wide range of patients with relapsing forms of MS.

    ...

    Researchers also looked at the effects of Gilenya on reducing the amount of brain-volume loss in individuals with MS who were treated with Gilenya in Phase III and extension trials. The study concluded that the annualized percentage of brain-volume change (PBVC) for all patients individually showed a consistently low rate of brain atrophy versus placebo in the Phase III trials (FREEDOMS and FREEDOMS II) as well as versus Avonex in the one-year extension study (TRANSFORMS). According to the authors, this supports previous observations from individual studies.

    About half of individuals (most with relapsing-remitting MS [RRMS]) taking Tecfidera™ (dimethyl fumarate) reported experiencing gastrointestinal symptoms and about half reported flushing. These rates were similar to those found in prior clinical trials. Sixteen percent discontinued treatment due to these side-effects, a rate that was slightly higher than found in previous studies. Efforts to reduce these symptoms are ongoing.

    The use of Tecfidera is frequently associated with gastrointestinal (GI) symptoms, including abdominal discomfort, diarrhea, nausea, and vomiting. Within a group of four individuals who took the oral asthma medication montelukast, 10 mg once daily (while continuing treatment with Tecfidera), GI symptoms decreased within 72 hours and the improvement persisted for 30 days. Symptom severity, as measured by the Gastrointestinal Symptom Rating Scale (GSRS), decreased by 81 percent.

    A four-year follow-up was conducted to determine the integrated clinical efficacy results of three studies using Tecfidera in treating RRMS. The studies included the Phase III DEFINE and CONFIRM studies, as well as the five-year ENDORSE extension study. Results of this analysis show that both low relapse rates and low disability progression continued during the four-year follow-up. These are in addition to the neuroradiologic efficacy (as found through MRI scans) and an acceptable safety profile.

    MS Treatments under Review by the FDA

    Efficacy was better in individuals receiving Plegridy™ (PEGylated interferon beta-1a) every two weeks than those receiving it every four weeks in the second year of ADVANCE, a Phase II study of 1,512 people with RRMS. The safety profile was consistent with both year one of ADVANCE and with other beta interferons.

    Versus placebo, both dose frequencies of Plegridy (once every two weeks and once every four weeks) significantly reduced the risk of 12-week confirmed disability progression by 38 percent with both dosages, and significantly reduced the annualized relapse rate by 36 percent and 28 percent, respectively. Given the lower risk of disability at year one, the authors of the study suggest that Plegridy may improve recovery following relapses.

    Four-year follow-up data from the ongoing CARE-MS extension study found that in years zero to four, 35 percent of individuals receivingLemtrada® (alemtuzumab, formerly Campath) experienced a thyroid adverse event, a well-known risk of treatment with the drug. None of these events resulted in discontinuation of treatment with Lemtrada, and most of the thyroid-related adverse events were treated with conventional treatment. The incidence of events peaked at month 36 and decreased thereafter. Ongoing patient education and quarterly laboratory monitoring allow for timely detection and treatment.

    Three-year follow-up data from the CARE-MS II extension study demonstrated that Lemtrada has a durable treatment effect. Eighty percent of individuals with RRMS who received two yearly courses of the drug in the CARE-MS II trial did not receive a third course of treatment. Seventy percent of EDSS scores were stable or improved at year three, compared to the baseline measurement upon entry into the trial.

    Impairments in visual function can impact disability in individuals diagnosed with RRMS. In the CARE-MS II study, individuals taking Lemtrada had improved visual outcomes as compared to those taking Rebif.

    Studies in Progressive MS

    In a randomized trial of 20 adults with chronic-progressive MS, both arm use and neuroplasticity (the brain's capacity to change and adapt) improved using a therapy called constraint-induced movement therapy (CI). This therapy forces the use of the affected arm by restraining the unaffected arm in a sling. These results suggest that CI therapy may counteract the progressive loss of function as well as central nervous system (CNS) degeneration in progressive MS.

    Pixantrone (PIX) is under investigation as an alternative for the effective but cardio-toxic drug Novantrone® (mitoxantrone or MIX) in the treatment of aggressive RRMS or secondary-progressive MS (SPMS). In a Phase I/II study of 18 patients with aggressive disease, pixantrone was as effective as Novantrone with less cardiotoxicity. According to the study abstract, pixantrone is structurally similar to Novantrone and both drugs have similar immunosuppressive properties in animal studies. However, the authors state that pixantrone is less toxic to the heart.

    In a Phase II double–blind, placebo-controlled study of 20 people with SPMS, SR-CRH-01was well tolerated and resulted in significant improvements in several secondary endpoints. These endpoints included the MS Functional Composite (MSFC), the Timed 25-Foot Walk, and the mean 9-Hole Peg Test (9-HPT). SR-CRH-01 is a stabilized, neuropeptide, also known as Aimspro®. Larger, longer-term studies are warranted given these promising results.

    The ALLEGRO and BRAVO trials studied the effects ofLaquinimod on individuals with RRMS. Pooled data from these trials were examined to determine the effect of Laquinimod confirmed disability progression (CDP) in several subgroups, including a group with the least favorable MSFC scores. The results were encouraging and suggest that Laquinimod may benefit people with progressive types of MS. Laquinimod is an experimental oral medication that works as an immunomodulator.

    A retrospective evaluation of clinical outcomes of individuals with SPMS demonstrated that 48 percent stabilized and 36 percent significantly improved following treatment withRituxan® (rituximab). No significant adverse events were reported. While Rituxan is not likely to continue in development for the treatment of MS, these data support continued development of the next-generation anti-CD20 monoclonal antibodies.

    Other Experimental Treatments for MS

    Vitamin D

    A total of 158 people with MS (most with RRMS) were treated with either 1 mcg ofAlfacalcidol (a Vitamin D analog) once daily for six months, or with a placebo. Patients in the Alfacalcidol-treated group had a reduced number of relapses compared to the placebo group. They also experienced a significant improvement in fatigue, based on the Fatigue Improvement Scale (FIS), compared to the placebo group. Quality of Life scales were positively affected as well. No serious adverse events occurred in either arm of the study.

    Stem Cell Transplant

    The safety and feasibility of autologous (from the patient) mesenchymal stem cell transplant is being studied in STREAMS, a Phase II trial of individuals with highly active MS. No adverse events have been seen in the five patients who have been infused to date (a total of 15 patients will be recruited). Preliminary results support the safety and feasibility of mesenchymal stem cell transplant in this population. No data are available to indicate whether their MS was affected.

    Ofatumumab

    Results from MIRROR, a 12-week Phase II study, comparing several doses of Ofatumumab (also known as Arzerra®) in RRMS were reported. Significant reductions in new gadolinium-enhancing lesions were seen in all treatment groups compared to placebo. Five serious adverse events were reported, all in the highest dose treatment group. No cases of PML were observed. Ofatumumab (also known as Arzerra®) is an anti-CD20 monoclonal antibody given via IV.

    Anti-LINGO-1

    The design of SYNERGY, a Phase II trial studying the safety and efficacy of the anti-LINGO-1 monoclonal antibody BIIB033, was presented. A total of 396 subjects with active RRMS or SPMS will be randomized to intravenous (IV) infusions of this experimental medication or placebo. All subjects will also receive once-weekly injections of Avonex. Results are expected to aid in the decisions on further development of this drug for CNS neuroprotection or repair. Anti-LINGO-1 is an agent under investigation for its potential remyelinative properties, after animal studies showed that it blocks this protein responsible for stopping the growth of myelin.

    Daclizumab HYP

    Results of the SELECT and SELECT Extension studies indicate that treatment with Daclizumab HYP (High Yield Process) may result in a reduction in the rate of brain atrophy in MS patients, suggesting the drug may have a long-term neuroprotective effect. Daclizumab (also known as Zenapax®) is a genetically engineered monoclonal antibody that is administered via IV and is being studied in individuals with RRMS and SPMS.

    Siponomid (BAF312) is an oral drug that is in the same class of drugs as Gilenya. Safety and efficacy results from the BOLD extension study in individuals with RRMS demonstrated sustained efficacy. These findings were consistent with the core BOLD study. No new safety concerns were identified.

    Pregnancy while Taking a DMT

    Despite a requirement for reliable contraception, 83 pregnancies were reported in women who were either (A) taking Aubagio during clinical trials, or (B) partners of men taking Aubagio during clinical trials. Upon learning of pregnancy, women were instructed to discontinue Aubagio and undergo a procedure that results in rapid elimination of the drug. Pregnancy outcomes were consistent with those in the non-MS population. No structural or functional problems have been reported in any of the infants exposed to Aubagio in the context of these clinical trials.

    Women with RRMS planning to become pregnant are advised to discontinue treatment with Tysabri before conception. However, it is known that there is a high risk of severe relapse following discontinuation of Tysabri and that these relapses frequently require high-dose steroid treatment to manage. Results of a prospective controlled study of 97 women with RRMS who did not discontinue treatment during their pregnancy were reported. When compared to both healthy and disease-matched control groups, the rates of major malformation, low birth weight, and premature birth did not differ significantly. It will be important to weigh the risks and benefits of continuation of treatment with Tysabri against the risks and benefits of high-dose steroid treatment during pregnancy.

    Only 16 percent of women with MS who responded to a reproductive-events questionnaire said the reason they did not want to become pregnant was because of their concerns about raising a child as a parent with MS. Other reasons recorded: 30 percent did not want children; 24 percent were unsuccessful in trying to become pregnant; 18 percent did not have a spouse; 5 percent were considering pregnancy; and 3 percent had adopted.

    A retrospective analysis of population-based databases in British Columbia found no evidence that infants born to fathers who were exposed to Betaseron or Copaxone around the time of conception were associated with altered birth weight or gestational age. An Italian study found that infants of fathers with MS taking one of these same DMTs (Betaseron or Copaxone) around the time of conception had similar outcomes to infants of fathers with MS who did not take these drugs (ever or around the time of conception). No differences were observed in: birth weight or length; the frequency of pre-term delivery; or the incidence of spontaneous abortion. No pregnancy or delivery complications, or infant malformations, were reported following exposure to these drugs.

    Cognition

    A study of 48 people with RRMS found that MS relapses did not cause a significant decline in tests measuring cognitive functions.

    Treatment with Tysabri has been shown to be superior to placebo in preserving cognitive function during the first two years of therapy. An interim analysis of data from an observational study of 63 patients treated with Tysabri continuously for more than two years suggests that treatment can preserve and possibly improve cognitive function beyond two years of continuous therapy.


    Examples of Other Interesting Studies


    ...
    In an observational study of 681 people diagnosed with MS, smoking cessation was found to significantly reduce the risk of progression (either to EDSS of 6 or to SPMS).

    In a group of 70 people with RRMS, individuals with high-sodium intake were 3.4 times more likely to develop a new lesion and had an average of eight more T2 lesions on MRI than those with low- or moderate-sodium intake. People with medium- or high-sodium intakes had a 2.75 to 3.95-fold greater chance of experiencing a worsening of their disease than those with low-sodium intake. The findings were replicated in a separate study of 52 people with MS.

    Previous studies have estimated the prevalence rate of taste dysfunction to be 1 percent in MS. This study of 73 people with MS and matched controls found that almost 22 percent of people with MS exhibited taste dysfunction. All types of taste were affected, including sweet, sour, bitter, and salty.
    The whole article can (I hope) be seen here: http://mymsaa.org/news-msaa/1123-aan-highlights-2014
    Last edited by agate; 06-06-2014 at 07:56 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Hopefully, these research efforts will be of benefit to patients who are fortunate enough to be diagnosed early in the disease process. The only research which might benefit any of us who have managed to live long enough and have fought hard enough to get an accurate diagnosis will be stem cell research and the efforts to find something to help restore the myelin which has been destroyed by the illusive cause of MS.

    However.... the insurance companies will probably refuse to pay out 100,000 plus dollars to cover the treatments for the hundreds of thousands of MS patients who are now considered progressive. So let's applaud all the BigPharma researchers as they continue to help the stock market continue making profits for the investors!

    I will buy more lottery tickets in the future as winning the lottery is the only hope I would have for any treatment if one becomes available.

    Blessings,
    Gabriella
    Progressive/Relapsing MS, Myasthenia Gravis, Spinal Stenosis, Degenerative Disc Disease, Diabetes, Hypertension, Hashimoto's Thyroiditis
    Advocate for ADA, Artist's Community for Change, ADAPT, Universal Living in Place, HopeKeepers, Complementary and Alternative Medicine

    "Life is mostly froth and bubble, two things stand like stone. Kindness in another's trouble, Courage in your own"........Adam Lindsay Gordon

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    Distinguished Community Member agate's Avatar
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    A couple of the studies mentioned in that MSAA article are dealing with progressive forms of MS.

    Also, there were over 600 MS-related presentations at that one AAN conference, and that's just one conference of several that are held each year. There are also ACTRIMS, ECTRIMS and others.

    Maybe most of the studies are just helping the drug companies along and supporting some researchers, but sooner or later something useful just might come of it.

    There are studies being done that aren't funded by drug companies. If you look at the funding sources, you'll find many that are sponsored by the NIH, the Sylvia Lawry Center, the MS Society, and other nonprofit organizations that are not associated with the pharmaceutical companies and are trying to stay objective.
    Last edited by agate; 06-06-2014 at 08:53 PM.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    It takes so many years to finish all the clinical trials that are ongoing now that we probably will not be around for the results. I saw the two studies mentioned.... one of which was the SYNERGY study in phase II on Pixantrone which helps with remylination and is less cardiotoxic than Novantrone but only 18 patients were involved....not really enough for a viable result.... and if you have any heart issues you still can't take it.

    The New York Times had an article June 4th which reported some interesting news. Independent researchers have developed a testing method which can identify bacteria in a person's DNA which is the cause of a patients illness. This has never been done before. A young man with swelling in his brain, who was dying, has recovered from his illness after the bacteria was identified and properly treated with the correct antibiotics. Here's the website.....

    www.nytimes.com
    Search for the article "In a First, Test of DNA Finds Root of Illness." dated June 4, 2014

    Finding the cause of MS and treating it..... IS something to get excited about! Hoping bacteria will be found to be the cause and we can all be cured!

    Blessings,
    Gabriella
    Last edited by Gabriella7; 06-07-2014 at 07:32 PM.
    Progressive/Relapsing MS, Myasthenia Gravis, Spinal Stenosis, Degenerative Disc Disease, Diabetes, Hypertension, Hashimoto's Thyroiditis
    Advocate for ADA, Artist's Community for Change, ADAPT, Universal Living in Place, HopeKeepers, Complementary and Alternative Medicine

    "Life is mostly froth and bubble, two things stand like stone. Kindness in another's trouble, Courage in your own"........Adam Lindsay Gordon

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    Thanks for the info on the AAN conference, Agate. Let's hope something promising comes of one of the studies. It's still concerning to me the seriousness of side effects, but I'm glad that pixantrone seems less cardiotoxic...that's a step in the right direction and at least they are attempting to lessen the risks of taking these drugs. People say we're brave to live with MS, but it takes bravery to undergo some of these treatments, they are not for the faint of heart, that's for sure. Figuratively AND literally.

    Thanks for keeping the Board up-to-date on what's going on in efforts to "fix us".

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    Distinguished Community Member agate's Avatar
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    Quote Originally Posted by dumblonde View Post
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    Thanks for the info on the AAN conference, Agate. Let's hope something promising comes of one of the studies. It's still concerning to me the seriousness of side effects, but I'm glad that pixantrone seems less cardiotoxic...that's a step in the right direction and at least they are attempting to lessen the risks of taking these drugs. People say we're brave to live with MS, but it takes bravery to undergo some of these treatments, they are not for the faint of heart, that's for sure. Figuratively AND literally.

    Thanks for keeping the Board up-to-date on what's going on in efforts to "fix us".
    How nice to hear from you, DB!

    This just proves what I've been trying to say to those who get discouraged about this board because it's not the lively way it was--there are people checking in here and reading all the time, people who've been part of this board since its pioneering days.

    How has life been treating you?
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Quote Originally Posted by agate View Post
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    How has life been treating you?
    Yes, I have wonderful memories of the early days here. So much learning and fun. I am so glad to see so many familiar names here and a lot of humour being shared...we need all the laughs we can get! I see no one's humour has dried up over time...it remains vibrant and infectious here.

    I'm doing relatively well, thanks. It's all relative, of course, though, isn't it? I'm over 24 years since diagnosis and almost 30 since my first symptom. That seems crazy to me. Time really does fly, doesn't it? The time of my life that I didn't have MS is becoming increasingly small in the realm of my life and increasingly distant. And yet I still remember way back at diagnosis when my neurologist reassured me that a cure would be available "within the next five years. Try to remain as stress-free as possible until that happens", he said oh so many years ago now. How many people today are still being told that, I wonder? I would have had an awful lot of years of "reclining" if I had followed his advice and put my life on hold until that magical cure came around. I guess I'd say I'm doing better than I probably thought I'd be doing at this age way back when I was diagnosed, but worse than I'd really like to be if I had my druthers.

    As an aside, I wonder if the drug companies are going to be looking at the clinical trial data on all of our meds now that there is irrefutable research that shows that men and women react very differently to the same dose of meds. I wonder, if they separated the men and the women in the studies, if the efficacy would be different, or perhaps dosages would change for us? Certainly, I hope moving forward that they split men and women... these meds are potent, and we really need to know if there is a gender difference in effects. The study on ambien's dosing and different effects on men and women is quite alarming.

    And how you doing?
    Last edited by dumblonde; 06-11-2014 at 05:14 PM. Reason: I was missing a crucial comma. lol

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    Distinguished Community Member agate's Avatar
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    Quote Originally Posted by dumblonde View Post
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    ...The time of my life that I didn't have MS is becoming increasingly small in the realm of my life and increasingly distant.
    Interesting point. If you have MS you'll reach a point where you've lived more years with it than without it, and those years without it will probably be in your most distant past. So, in a way, having MS becomes your "normal."

    I agree that drugs as powerful as the ones for MS should be prescribed with more attention to individual differences, and in fact I think they're working toward a more "personalized" treatment regimen. The MS drugs might be prescribed in dosages related to weight and height and maybe with different dosages for men and women as well.

    Nice to know you've been trying to stay stress-free. Hard to do for most. Some of the stress people with MS have to put up with is astonishing.

    I've been very lucky. The MS is worsening but it's been very very slow.

    You had one optimistic neurologist. The one who diagnosed me said, "Learn to live with it. I've never known a case of MS to get better." I think it's called the "diagnose and adios" approach.
    MS diagnosed 1980. Avonex 2002-2005. Copaxone 6/07 - 5/10.
    Member of this MS board since 2001.

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    Quote Originally Posted by agate View Post
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    Interesting point. If you have MS you'll reach a point where you've lived more years with it than without it, and those years without it will probably be in your most distant past. So, in a way, having MS becomes your "normal."
    No, I reached that point of living more than half my life with MS a long, long time ago, I was young at diagnosis. I'm not sure if I'll ever consider living with MS to be a state of "normalcy" though since it (at least mine) varies and changes so much. My health status is not stable and my symptoms fluctuate too much to make a definitive adjustment and move forward..."how" I'm doing changes daily. It could certainly be worse though and I look at the glass as being half full.

    Glad to hear you're in the slow MS lane. If you have to live with it, that's the road you want to be on.

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