Performance Improvement Strategies in Multiple Sclerosis. Community of Practice Audioconference. Recorded March 27, 2012

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1 Performance Improvement Strategies in Multiple Sclerosis Community of Practice Audioconference Recorded March 27, 2012 Audioconference Faculty: Douglas R. Jeffery, MD, PhD Director, Multiple Sclerosis Center Advance Neurology at Cornerstone Healthcare Advance, NC

2 MODERATOR: Welcome to the Multiple Sclerosis Community of Practice audioconference with faculty expert, Dr. Douglas Jeffery. I m Olivia, your moderator for today s discussion. This audioconference is being recorded; however, resale of the content is prohibited. During today s call, you will have an opportunity to discuss strategies for overcoming barriers in multiple sclerosis (MS) management. We will review recent developments and new insights that can help improve care and outcomes for patients with MS. You are invited to join the conversation with questions or comments during this live discussion for immediate faculty feedback. This activity has been developed as part of the complimentary PI CME initiative, Performance Improvement Strategies in Multiple Sclerosis, for which Dr. Jeffery has served as faculty chair. Additional details about this initiative will be discussed during today s audioconference. I am pleased to now introduce Dr. Jeffery. Dr. Jeffery is director of the Multiple Sclerosis Center at Advance Neurology at Cornerstone Health Care in Advance, North Carolina. Dr. Jeffery? DOUGLAS JEFFERY, MD: Thank you very much. Good morning and welcome to this community of practice audioconference for MS. The goal of this is to bring together clinicians who are interested in the care of patients with MS and to define current challenges and advances in the care of these patients. I ll start with some brief opening remarks, and then open it up to questions. These audioconferences are one part of our performance improvement, or PI program, and I d like to acknowledge my colleagues who have helped develop this PI program, Dr. Patricia Coyle and Dr. Mark Friedman. For those of you who may not be familiar with PI programs, this is an AMA-approved CME format in which clinicians work on improving individual performance by assessing their own practice through retrospective chart reviews, developing and implementing a plan for improvement in their own practice, and then assessing their performance. There is an increasing understanding that improving care will require clinicians to measure and monitor indicators of quality, with the goal of identifying areas where current practice falls below established standards and more opportunities for improvement are present. Performance improvement CME is one method to do this. There are 3 phases to the PI process, and 5 CME credits are available for completing each step, with an additional 5 credits available to clinicians who complete the entire activity, for a total of 20 credits. In this MS PI program, you have to complete 5 chart reviews in the pre and post period. You can see how your practice compares to those of your peers and optimal goals for performance. A CME-certified resource is also available to help you with ideas for improving your 1

3 practice if you feel it is needed after seeing your summarized chart reviews. The American Board of Psychiatry and Neurology has reviewed this PI program and accepted it as meeting the maintenance of certification requirements for the performance and practice program. So this program can help you also complete your MOC requirements. Now that we ve briefly discussed the framework of the PI CME, I d like to take a few minutes to highlight some of the key challenges in managing MS as well as some of the preliminary data we ve seen in this PI program. Although significant advances in the recognition and management of MS have provided us with more understanding of the disease and more therapeutic options, this has also increased the complexity of optimizing treatment for the individual patient. This PI program focuses on three general areas of care in patients with MS, namely initiating and monitoring disease-modifying therapies (DMTs), education and communication with patients, and assessment and management of MS-related symptoms. Let s start with DMTs. That s an area in which there are many complicated decisions. There s general consensus that DMTs are useful in relapsing forms of MS to reduce the frequency and severity of relapses and reduce disease activity, resulting in improved quality of life. The early recognition and treatment of MS can reduce the risk and severity of relapse and prevent disability accumulation. Current data suggest that early therapeutic intervention in clinically isolated syndrome (CIS) is critical because of the early and ongoing CNS damage and the high probability of progression to definite MS. However, factors entering into a decision to initiate treatment are complex, there are potential adverse events, and patient adherence has to be taken into account, and then monitored. As I said before, the improved understanding of MS and the availability of more complex treatment options has improved our ability to manage the condition, but has also increased the complexity of management. There is no longer a clear distinction between first- and second-line therapies; there is more of a movement toward individualization of patient treatment. Therapy selection often depends on the potential adverse event profile and the route of administration, and how this will affect patient characteristics and comorbidities. The interferon beta agents and glatiramer acetate have long been considered firstline agents, and nataluzimab may also be a first-line agent in some patients, especially now that we can test for JC virus antibodies. Although the approval of the first oral agent, fingolimod, is great news in that we finally have an alternative to the currently available injectable agents, it actually makes treatment decisions a little more complex in nature, as we try to determine how this and other future oral agents could fit into therapy, how their side-effect profiles will differ, and, more importantly, how their toxicity profiles will differ from 2

4 currently available injectable agents. This treatment paradigm will continue to shift, as there are a number of investigational agents that are currently being developed for MS that may soon be available on the market. As I m sure you re aware, MS is a highly variable and individual disease, and it s difficult to anticipate the response to therapy that an individual patient will have. Therefore, monitoring disease activity and assessing treatment response are important components in identifying patients who are having a suboptimal response to therapy. There is no universally accepted or validated definition of what constitutes suboptimal response. Therefore, it is often difficult to determine when a change in therapy is needed and what the best course of management is in these patients. As a part of our PI program, we developed some resources that discuss the factors to consider when determining whether a change in treatment may be necessary. This includes the number and severity of relapses, the level of disability progression, and the changes that are present in MRI. We would recommend reading through those materials, but again, it often comes down to assessing the individual patient and focusing on to their risk of progression. So what are we seeing in this PI program? The program launched at the very end of 2011, and, to date, about 70 clinicians have started the program and submitted their baseline charts for 225 patients. We re seeing great performance in clinicians considering the use of DMT in eligible patients, providing verbal education regarding treatment expectations and adverse events, and appropriate monitoring of adverse effects. One potential area for improvement is in monitoring patients for disease progression and treatment response. Nearly 50% of patients haven t had cognitive function assessed; MRI wasn t done in about 30% of patients; and disability progression wasn t monitored in about 20% of patients. Although 82 of the 225 patients had shown at least 1 sign of suboptimal response to treatment, changes in therapy were not initiated in more than one-third of these patients. Although it s difficult to tell from the results whether the decision to change therapy may have been appropriate, it does suggest that there may be some room for improvement in monitoring patients and identifying suboptimal treatment response and when treatment changes are indicated. So let s switch gears for a minute and talk about the assessment and management of symptomatic complications related to MS. Symptomatic issues such as fatigue, cognitive dysfunction, depression, bladder dysfunction, and gait dysfunction are quite common in MS and occur in all phases of the disease. These symptoms may be disproportionately severe in comparison with physical disability and may really impair patients quality of life. Patients may not always raise symptomatic issues themselves for a variety of 3

5 reasons, and an active approach to assessing patients for MS symptoms, as well as effective symptomatic treatment, is an essential component of managing MS. We re finding that this is the area of the PI program that people report the largest need for improvement. In the baseline data collected to date, 62% of clinicians report that they don t have a standard method for assessing symptomatic issues. Despite this, it appears that most clinicians are routinely assessing patient for the majority of major symptomatic complaints. One area of improvement identified is sexual dysfunction: 53% of patients have not been assessed for this symptom. This result is probably not surprising, as this may be something that patients have difficulty bringing up themselves. A systematic method for assessing the common complications in MS could help identify patients with these concerns. Checklists and flow sheets may help with remembering to ask patients about the myriad of possible symptoms and doing so in an efficient manner. Once a symptom has been identified, it s important to try to determine the cause and recommend treatment strategies, either pharmacologic or nonpharmacologic. The PI program resources include tables that summarize the various symptoms and treatment strategies, as well as an example checklist. In conclusion, I ve really just touched on a few of the many challenges in managing MS, the expanding understanding of the disease, and the hope that additional treatment options will become available in the near future. The development of new agents may help with some of our management challenges, but MS will remain a complex disease. I would now like to open it up to comments and questions about the challenges you face in MS care and strategies for improving management of these patients. We ll begin with one or two of the questions we received in advance by , but feel free to let the operator know if you have a question you would like to address. DR. JEFFERY: The first question is: how important is physical therapy in MS care? That really depends on the extent of disability. For patients who have very mild disability, physical therapy is not really important, but a daily exercise program is incredibly important. A daily exercise program has been shown to reduce depression and help with fatigue, and it s also very important for general health and well-being. In patients with very low disability, physical therapy itself may not be very important, but, again, that exercise program is extremely important. As disability increases, physical therapy becomes increasingly important. In my more disabled patients, or patients with ambulatory limitations, I think physical therapy is very important. DR. JEFFERY: And then the next question is: is osteoporosis still an issue with current MS treatments, especially with female patients? If so, what, if anything, can be done to limit the potential for pathologic fractures? 4

6 Osteoporosis is a very important issue, and there are studies showing that even patients with early MS may have decreased bone density. Surprisingly, one of the most important factors in determining bone density is actually not the number of courses of steroids that somebody has had, but weight-bearing status. The more patients bear weight, the better their bone density. This is extremely important. It also goes back to that need for the exercise program to help preserve bone density. As far as I m aware, current MS treatments don t have much of an effect on bone density. There may be some papers in the literature that examines interferon or glatiramer acetate and their effects on bone density, but I m not aware of any. It s been my general impression that the interferon and glatiramer acetate don t affect bone density; the most important factor affecting bone density is probably weight-bearing status. That being said, what should we do to try to prevent osteoporosis? Of course, exercise. But also I think we need to work with our internist colleagues and make sure that patients are having their bone density measured and receiving appropriate prophylaxis or treatment when warranted. I think this is an area that is very important. There s also vitamin D supplementation, nutritional factors, and making sure their calcium intake is adequate. There are a whole lot of factors that sort of interact there. DR. JEFFERY: Next question is: what investigational agents will be on the market soon, and how do you think they will affect practice? I get asked that question frequently. The next medications that are going to be on the market will include, very likely, teriflunomide and BG-12. Both of these are probably going to have a major affect on the market. BG-12 looks to be an effective oral agent. One of the issues with BG-12, however, is going to be tolerability. When patients first start this medication, they can get a lot of flushing, itching, pruritus, and nausea and some GI side effects. So we ll very likely be using a dose escalation if this drug gets approved. The efficacy looks good; it s decreasing T2 lesions by about 71% to 74% in various studies, so it looks to be as effective as what we have now; perhaps not more effective, but it will be a welcome addition to our armamentarium. Teriflunomide also should become available. It decreased relapse rates by about 30% in the phase 3 trial; it was much more effective on MRI. This drug is one that can be used as a monotherapy, and combination-therapy trials are currently ongoing. So teriflunomide may have use in combination if it is approved by the FDA when those studies are available. So these are two potential additions to the therapeutic armamentarium that could provide additional options. 5

7 MODERATOR: Doctor, we do have a live question at this time coming from New Haven, Connecticut. Please go ahead. PARTICIPANT: Thank you very much. I wanted to ask you a question about a specific patient who has had difficulty with her right-lower limb and had seen orthopaedists for about 3 years, but they couldn t identify the problem. She finally saw a physical therapist, who realized that the reflexes were actually enhanced, and appropriate lesions were subsequently identified, both in the brain and at the cervical cord. The problem with her diagnosis is that she carries a hepatitis C diagnosis as well. When I was in residency, I remember having conversations about overlap with rheumatologic conditions, vasculitis induced by viruses. How much of that should I be worried about when I m treating this patient? Can I expose her to steroids? What should I do? I m in a quandary. DR. JEFFERY: You can expose her to steroids. The important consideration here is that hepatitis C can be associated with acute myelitis. I ve seen patients who have a very severe acute myelitis, and it s associated with cryoglobulinemia. In the absence of cryoglobulinemia, I m not sure they re likely to have a myelitis. If the lesions are more typical MS-appearing lesions oval, perpendicular to the ventricle, just classic MS lesions then I d say that s very unlikely to be due to hepatitis. The patient probably has MS and also happens to have hepatitis C. Obviously, she should be treated for the hepatitis C. Interferon is effective for the treatment of hepatitis C, and there are also other adjunctive therapies. She should clearly be treated for both MS and hepatitis C if we think she has both. The only pitfall that you want to watch out for is that hepatitis C with cryoglobulinemia can mimic MS, so you want to make sure that s not in the picture. If that were in the picture, then she would be treated with steroids and plasma exchange. DR. JEFFERY: Okay. The next question is: which treatment do you usually initiate if interferon beta fails? Well, this is a great question. There s some data that if the patient is on a low-dose interferon, you can move to a high-dose interferon, and you ll likely get some control of disease activity. Now, let s say you re on a high-dose interferon and the patient has had relapses or new lesions. For every new lesion on the MRI scan, there is a 10-fold greater likelihood that the patient will have disability progression within a 2- to-3-year follow-up period. So these new lesions are very important. It s very clear, anecdotally, that some patients who don t respond well to interferon go on glatiramer acetate and respond beautifully. So if you have fairly mild breakthrough, that would be a perfectly reasonable option to consider. If you have really severe breakthrough, where you ve got a really bad relapse or multiple new lesions, then switching back and forth between glatiramer acetate and interferon is probably not your most effective strategy. At that point you want to think about a rescue therapy like natalizumab (Tysabri). 6

8 DR. JEFFERY: Next question: Is there any treatment for people with advanced MS who, for example, have quadriplegia, dysphagia, dysarthria, optic neuritis, or cognitive decline, that will improve function? The answer to that is, unfortunately, no. I don t think we have anything that will help improve function in patients with very advanced MS, and that s something that we would really like. That s going to be the next challenge in drug development looking for drugs that are truly neuroprotective and neurorestorative. DR. JEFFERY: The next question is: if a patient has had MS for 33 years and is on treatment and has had no new lesions in the past 7 years, but now has an MRI with 2 new black holes, is the condition of the patient worse or in a flare? If this patient has 2 new black holes, they are going to be associated with bright lesions on a T2 or flare-weighted MRI scan. So basically, this is a patient who has been stable for a long time, hasn t had any attacks, but is worsening by MRI criteria. This patient really requires a reassessment. We generally think that the longer patients have MS, the more likely the disease is to calm down and the inflammation is to burn out. There is a general tendency for that to occur, but there are plenty of patients who, after many years of disease, still have active and inflammatory disease activity. For example, I have a 78-year-old patient who we thought didn t have any further inflammatory disease activity, and for whom I stopped therapy. Lo and behold, she had a relapse, and I had to put her on steroids and put her back on therapy. So while it s true as a general tendency, it s not true in every case, and there were studies done many years ago showing that patients who died with advanced MS still had active inflammatory lesions at the time of autopsy. So sometimes it burns out, but a lot of the time it doesn t. So it sounds like this patient still has active inflammatory disease and still needs to be on treatment. DR. JEFFERY: Next question: are there any updates on disease biomarkers such as IL-6, nitric oxide, osteopontin, etc.? There s a lot of research going on with biomarkers, but, unfortunately, it s a really tall order to find a biomarker that accurately reflects inflammatory disease activity, and that s something that we don t yet have. So while there is still lots of research being conducted, we don t have any biomarker that s ready for prime-time clinical use. MODERATOR: We have an additional question at this time, coming from Hattiesburg, Pennsylvania. Please go ahead with your question. PARTICIPANT: What is your experience with dalfampridine (Ampyra) and gait problems in patients with MS? 7

9 DR. JEFFERY: Dalfampridine (Ampyra) is a wonderful medication. The literature suggests that it seems to work in about 35% of the patients. In clinical practice, that s exactly what you find. You can never tell who it s going to work for. In the studies, they looked for any demographic or clinical characteristics that would predict who might respond, and they were unable to find anything. It s the same in clinical practice. I never know who it s going to work in. So when I have a patient with ambulatory difficulty, I will usually try the medication. Just like the clinical trials, it works in about one-third of patients, and when it works, it works great. When it doesn t work, it doesn t work at all. When it works, you ll find people who have a really robust response to it. For example, I had one patient who could take a few steps with a walker, but she was using a motorized scooter most of the time. We tried her on dalfampridine and she was up on her walker all the time and she was able to get around much better. She was the last person I would have thought it would have worked for, but it worked great. MODERATOR: Thank you. Dr. Jeffery, I will turn the conference back to you at this time. DR. JEFFERY: Okay. The next question is: why is lifestyle modification, such as plantbased diet, exercise, sunlight exposure, vitamin D and omega-3 supplementation, and meditation and stress, not receiving more funding for research? There is evidence that MS patients can improve their quality of life and function after making these changes. Yes, there is evidence that these modifications can work; this does receive some funding, but I think the majority of the funding in basic science really goes to laboratory research, looking at what factors prevent regrowth of myelin in the nervous system and what drives the biologic process. So I agree with you, I think these things are really important, and there is a lot of research going on. There s always a competition for research dollars, and research dollars are getting harder and harder to find, so it s really a difficult thing. I think the funding authorities would like to fund everything, but they can t, and they re very limited in what they can fund, so they have to select the things that they think are going to bring about the highest yield. I m not sure a plant-based diet is so important, as I don t think there s ever been a study that shows that diet affects MS one way or the other, but other lifestyle modifications, such as exercise, vitamin D, and stress relief, are all things that are being actively looked at. DR. JEFFERY: Next question: is there anything that can be done to improve symptomatic fatigue in MS patients? That s a great question, and it s something we address every day. The first thing I tell patients to do is to start a daily exercise program it is the single-most effective treatment for MS fatigue. 8

10 Beyond that, you want to examine sleep hygiene and make sure that they are sleeping at night, that they re not taking naps during the day so that they re up half the night, and that they don t have sleep apnea all those things that neurologists normally do. When we have fatigue that is absolutely due to MS and the patient s sleep habits are okay and the patient is exercising regularly, there are medications we use to treat fatigue. There s amantadine, which is an old medication; you can dose it once or 3 times daily. You want to dose in the morning, at noon, and then around 2:00pm; it works a little bit, but not very well. There were two medications that we used for a long time: modafinil (Provigil) and armodafinil (Nuvigil). They worked pretty well, but they re not FDA approved for MS, and are rarely used now because they are very expensive. These agents cost about $17 a pill, or about $3,000 a month. As a result, the insurance companies just completely refuse to pay for them, and I agree with their decision. Those drugs are priced ridiculously, so I stopped using them altogether. For severe MS fatigue that hasn t responded to exercise, I will usually use methylphenidate (Ritalin); it is a controlled substance, but it works fairly effectively. You advise the patient not to take it every day; if they take it every day, it tends to become less effective. And you basically tell them to have at least 2 days a week when they don t take it. It s also inexpensive, so it s affordable for the patient if they don t have insurance, and it s affordable for the insurance company. Some people use the combination of dextroamphetamine and amphetamine (Adderall), but I don t typically use this because I don t think it s a very safe drug. The abuse potential is very high. DR. JEFFERY: Next question is: do you ever start therapy with an oral agent? Absolutely. The FDA approved fingolimod (Gilenya) as a first-line oral agent for the treatment of MS, and I use it as such. There s no reason to not use it; it works fine. DR. JEFFERY: Next question, and then I think we ll probably wind up pretty soon: are there any promising new clinical trials or therapies on the horizon? Clinical trials are always interesting. There are a lot of interesting clinical trials that are currently ongoing or in development, and I think the ones we re most interested in are the ones for secondary-progressive MS and primary-progressive MS because we re still looking for effective therapies for those disease states. MODERATOR: Dr. Jeffery, that will be our final question for today. Thank you. This concludes today s MS Community of Practice audioconference, which has been sponsored by Med-IQ and supported by an educational grant from Teva Neuroscience. This activity is part of the complimentary PI CME series, Performance Improvement Strategies in Multiple Sclerosis. Now in its second year, this series has been approved by the American Board of Psychiatry and Neurology as a performance-in-practice and CME program, which are part of the overall ABPN maintenance of certification program. To learn more about this complimentary CME 9

11 series, or to start participating today, please visit Thank you for your time and commitment to improving MS patient care. 10

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