One-On-One With the Experts: Frequently Asked Questions in MS

Transcription

1 One-On-One With the Experts: Frequently Asked Questions in MS From April 2013 to March 2014, Med-IQ sponsored personalized teleconferences for nurse practitioners, physician assistants, and nurses who treat patients with multiple sclerosis (MS) in the CME-certified series, One-On-One With the Experts: Individualized Interventions to Overcome Practical Challenges in MS. In these teleconferences, participants were able to speak one on one with a nationally recognized MS expert. The following experts participated in these conversations: Kathleen Costello, MS, ANP-BC, MSCN Associate Vice President, Clinical Care Advocacy, Services and Research Department National Multiple Sclerosis Society New York, NY Adjunct Assistant Professor Department of Neurology Johns Hopkins Medicine Baltimore, MD Brant J. Oliver, PhD, NP, MSN, MPH, MSCN Assistant Professor MGH Institute of Health Professions Boston, MA Nurse Practitioner in Neurology and Psychiatry Multiple Sclerosis Specialty Care Program Concord Neurology Associates Concord Hospital Concord, NH Jennifer M. Smrtka, MSN, ANP-C, MSCN Certified Adult Nurse Practitioner Multiple Sclerosis Specialist South Florida Neurology Associates Boca Raton, FL These experts discussed topics such as comparing the safety and efficacy of available diseasemodifying therapies (DMTs) for the treatment of MS, identifying appropriate patient candidates for DMT, designing effective, individualized treatment strategies, and incorporating evidence-based methods for monitoring disease activity, including recognizing suboptimal response to DMT. In this brief publication, we present select real-world questions and frontline perspectives gained from the CME teleconference series. These frontline perspectives represent some of the most pressing questions asked by teleconference participants. Expert commentary offered by our faculty in 1

2 response to these challenging clinical issues serve as illustrations of real-world application of recent advances in the treatment of MS. Call Participant: For first-line therapy, do you prefer injectable or oral agents? Faculty Expert: Just today I started two people on injectable therapies one was an interferon and one was glatiramer. If I have a patient who has newly diagnosed disease, who is early on in the disease process, and who may be concerned about safety, then I choose an injectable. If they have difficulties depending on what the difficulties are I ll switch them. I think the injectable therapies are safe so they are my choice if someone hasn t been on them. They are a viable option because they are effective and have long-term safety data. They ve been in the market for a long time, so we know they re not going to harm anybody. In fact, the two people who started injectable therapy today did not want to take the risk of trying a new drug. They preferred to receive something that had been around for a while. If patients have concerns about safety but are averse to injections, I would consider an oral agent with the best possible safety profile. Call Participant: What can primary care physicians (PCPs) do to monitor or evaluate response to DMTs or assess for acute illness? What could I do to help neurologists do their job? Faculty Expert: Thank you for that question. I think very often when people have symptoms that might be considered an MS relapse, they can often be provoked by infection, for instance upper respiratory, bladder, or urinary tract infections. So we may often send people to their PCP to get evaluated for infection rather than assume that they re having a suboptimal response or a relapse. I think it s important to look at the whole situation. Infections are usually not good for people with MS because they can provoke worsening symptoms that might just be temporary. I think that monitoring for medication-related side effects, like skin or gastrointestinal side effects, is also important. The new medication dimethyl fumarate can cause nausea, bloating, diarrhea, flushing, and other symptoms. Many of our drugs can elevate liver function values or cause lymphopenia. Some can interfere with heart rate. Often I try to partner with my colleagues in primary care so that they are obtaining the lab work it s often easier for patients to get their labs done with their PCP and then we can discuss those results. I think ongoing monitoring for side effects and risks and maybe assessing for any infection would be ideal. When we have smokers, we really try our best just like you do to get them to quit or reduce smoking over time because smoking leads to more progressive MS. Also, some studies show that smoking can increase the likelihood of new lesions on MRI. It really becomes an additional reason why someone should quit, aside from all of the other ill effects on the lungs and the cardiovascular system. Call Participant: In my 9 years of practice, I ve had only two acute cases of undiagnosed MS. I believe the one young lady had a CT for migraines, and it showed some lesions. The more interesting case was a Hispanic gentleman who was uninsured and actually had optic neuritis and an acute vision change. Sometimes I have people come in for acute vision changes. That s something that always comes into play as far as a differential diagnosis. How often do you see that? Faculty Expert: That s a great question. I just saw a young girl who was 24 years old with optic neuritis. The statistics show that about one-quarter of the people who will ultimately have MS start their disease process with optic neuritis. I think that s huge. It can occur in isolation and not indicate MS, but very, very often optic neuritis with an MRI that has more than two lesions on it indicates a very, very high risk of developing MS. People often describe that they feel like they have a screen 2

3 over their vision or are looking through water, or if they were wearing contact lenses it would feel like their lens was smudged. They often have pain when they move their eyeball, and they have a pupillary defect where they have a dilation-to-light response or a slowed light response in the affected eye. Sometimes the pupil is a little bit larger. When those symptoms occur in an otherwise healthy young person, it s probably optic neuritis. That would certainly be a great time to refer to ophthalmology, but if you could also at that point get an MRI of the brain, it would be perfectly legitimate and appropriate. Because people who are diagnosed earlier and started on treatment (and stay on treatment) earlier have better outcomes, it is critical to diagnose MS and start treatment as soon as possible. Call Participant: I'm not clear on when to change medications. That s a gray area for me. Could you explain when it would be appropriate? Faculty Expert: Sure. Let me give you some examples that might help. I have a patient who is 28 years old. I started her a year ago on glatiramer acetate. She s taking it regularly. She's not had any clinical symptoms. She's functioning in all of her activities of daily living. She works full time as a high school English teacher, and she's feeling well. She has good energy and good cognitive function. Her mood isn t affected. She can do all of her normal activities without limitations. Say we obtain an MRI and it shows that she has one new periventricular lesion that's small and non-enhancing, which is evidence of disease activity. Do I change her therapy? Remember, she has no symptoms whatsoever. No worsening, no cognitive changes. Everything is perfectly fine, except she has one new lesion. The answer is no, I wouldn t change DMTs here. I look at that situation as evidence for me to be more vigilant, meaning I'm not going to wait a year to do another MRI. I'm going to do an MRI in 6 months. If she develops clinical symptoms between now and that 6-month visit, I'm going to go ahead and switch her because then we will have MRI evidence and clinical evidence. That's enough for me. If I reimage her in 6 months and we have no new activity and still no symptoms, I'd say push on, stay on the therapy. We can be tempted to change more quickly just because we can, especially when there are more options available. In this case, that is not necessary. Now, we have somebody else who's in the same situation. He s asymptomatic, but you do the MRI and it shows 5 new enhancing lesions, one of which is in the cerebellum. Now what? This patient has been on glatiramer for a year, swears that he s been regular with it, and has no new symptoms but 5 enhancing lesions, one in the cerebellum. Do you change DMTs for that person? Yes, of course that would be enough evidence, even if they weren t enhancing. In fact, to me, that would be evidence that this patient is lucky. He s lucky he doesn t have symptoms. Next example, what about the same person, but we'll give him a different therapy. He is on fingolimod. His white blood cell count is decent. He s had no new MRI activity that you can see, but he s had three exacerbations that have objective evidence. Say he s had double vision, weakness, and banding, but there's nothing new on his MRI. Would you keep him on the fingolimod? No, it would be time to change. It would be odd that he wouldn t have any MRI changes. But, it's happened. Depending on the slices and the positioning, maybe something was missed. What about a patient who is on interferon beta-1a subcutaneous, taking it regularly, no new lesions, no exacerbations. She used to be able to walk a block, but now she can walk only about 10 steps before her legs start to get stiff, weak, and tired and she has to kind of drag them along. I would certainly consider changing DMTs here, particularly because of the impact on her activities of daily living, although this is my personal opinion I don't think that you'd find evidence to say that you have to do that. But, as I said before, in my mind and in many of the providers' minds, time is brain. Once it's gone, it's gone, and the function is lost. So even though these drugs are really not indicated for progressive MS, they have a variable effect on progression, on that Expanded Disability Status Scale (EDSS) score, so I think that it would be 3

4 worthwhile trying a new therapy in someone who is worsening. Why not? We have 10 therapies, for heaven's sake. Why not give them the opportunity for trying something different? The question, then, may often be which one? Which one do you use? If they're on glatiramer acetate, do you have to change them to an interferon? Or, can you move on? Honestly, other than insurance, which can dictate what we do, I think we should go with the drug that we think has the efficacy for this individual, that we think they can be adherent to, and that has an acceptable safetyto-efficacy ratio. For instance, if they're on glatiramer and they had a heck of a time with shots, I would probably not use an interferon if I could avoid it. I'd use an oral therapy. Or, if they have uncontrollable depression, I'd probably not go with an interferon because that, we know, can worsen depression. Some people might argue that point, but I think overall that's a risk. If they had cardiac issues, maybe an arrhythmia, we're not going to use fingolimod. Or say 10 years ago they had breast cancer and were given chemotherapy. You'd better be sure that they're John Cunningham (JC) virus antibody negative if you're going to consider natalizumab because the previous chemotherapy would put them at a huge risk of progressive multifocal leukoencephalopathy (PML). Call Participant: Some patients want an oral drug. How do you decide which one of the orals to use? Faculty Expert: If they have known contraindications, I would avoid whichever one seems to be contraindicated. For instance, I had a patient who had irritable bowel and was just terribly sensitive to medications from a gastrointestinal standpoint. No cardiac issues. She was young and otherwise healthy, so in this case, I may lean toward fingolimod just to avoid the gastrointestinal symptoms associated with dimethyl fumarate because, sometimes, they can be pretty bad. I try to go over the risks. If we're going to try an oral, I lay out the risks and the benefits of the therapies. Then, I help the patient understand what that means, so that they can also be part of an informed choice. They may say, Listen, I don t like all those risks of fingolimod. They make me uncomfortable. I'll take my chances with the gastrointestinal symptoms. Or, the reverse might be true. Honestly, I don t think any drug is a wrong decision other than the contraindications that I mentioned. Because all of these treatments have different risk and efficacy profiles, it is a very preference-sensitive decision, and it depends a lot on the risk tolerance and efficacy needs and expectations of the patient. Insurance coverage is a consideration, too. I know that some companies will cover fingolimod, but they don t want to cover dimethyl fumarate, or they will if I jump through a zillion hoops first. But, all other things being equal, I might choose the ones that are covered just because it's going to be simpler moving forward for the patient. I tend to practice similarly to the rest of the folks here in my center and I guess, over time, we developed a comfort level with dimethyl fumarate and fingolimod in terms of the oral therapies. But you could go someplace else and see that someone uses teriflunomide. I have a colleague in Canada who has been part of the research on teriflunomide, and she says that people do fabulously on it. As I'm sure you have experienced, you develop comfort levels with certain things because you achieve familiarity you understand the response, the side effects, and the management. It makes it easier and, in my mind, safer when I have patients on something I know well. I think really the message is that if someone is not responding to or not tolerating a drug, switch them. Consider the contraindications, and exclude drugs that are clearly not a good choice due to cardiac, gastrointestinal, or other issues. Then, go over the risks with the patient and mutually decide on one that seems like a good choice in terms of adherence and obviously one that the insurance covers. 4

5 Call Participant: Could you give me an example of how it could be easy to miss a pseudo relapse versus a relapse? Faculty Expert: Of course. Let's take the case of a patient who is reporting new-onset right lower extremity motor symptoms maybe weakness or increased spasticity. He calls and says it's been going on for 3 days straight. It would seem that this patient has a new presenting symptom and has presented acutely, and it's been around for more than 24 hours. It is highly likely that it could be an MS relapse. On further investigation, though, it turns out that the symptoms aren't consistently present. They come and go, and it becomes apparent that they're happening because the patient is exercising for long periods of time without taking breaks. The leg flares up and gets weaker when the temperature increases, and then when he cools off, the symptom goes away. But he's been doing this repeatedly over the course of 3 days. Sometimes if the triage process isn't specific in getting at that relapse criteria, it can seem like a relapse, but in reality this patient is having repeated pseudo attacks. Obtaining a better history and, when in doubt, getting a clinical evaluation are essential here. Sometimes in rural populations, patients can't come to the MS center. Sometimes the PCP has to do the exam, which is fine if they have some experience doing it and will talk with you about the results afterwards. The other thing, which I'm sure you're well aware of already, is infection. You know, urinary tract infection is the number one trigger on the list. Other triggers that I also see a lot include elevated chronic stress, sleep problems and disorders, recent upper respiratory infection, and uncontrolled major depression. All of those have been correlated with an increased risk of relapse. It s also important to mention that identifying a relapse early can make a big difference; steroid treatment is optimally effective within 14 days of onset of the relapse event, although it can certainly be used after that time. This activity is supported by educational grants from Novartis Pharmaceuticals Corporation and Teva Pharmaceuticals Med-IQ. All rights reserved. 5