Welcome to the Virtual MS Center!
Ask any question you want about Multiple Sclerosis and one of our experts will answer it as soon as possible.
Question:
Is the rate of PML in patients after 2 years (1/100) of Tysabri when it’s administered at the 4 week interval dose or at the extended 6 week dose? I found charts of this but wasn’t sure of the interval being accounted for. Thanks again for your help and time, the content on this site had been very helpful for me and I’m sure others as well. Answer: The risk of PML after 2 years of treatment with Tysabri, when it is administered using the standard dosing regimen (300 mg iv every 4 weeks), is approximately 1 in 100 (1%) for people with a JCV index > 1.5 and no prior history of immunosuppression and approximately 1 in 100 (1%) for people with ANY positive JCV Index and a prior history of immunosuppression. Revere P (Rip) Kinkel, MD Professor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego
0 Comments
Question:
Can I take the morning-after pill while I'm on Tecfidera? Answer: There are no drug interactions between Plan-B and Tecfidera A. Scott Nielsen, MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
I’ve been stable on Copaxone since my diagnosis about 5 years ago, my latest MRI a few weeks ago showed 2 new lesions. I then changed doctors after finding a practice that seems to treat the whole person and not just the condition, and as this has ramped up my anxiety it seems to be more of the type of care I need. This new doctor is a big believer in Tysabri extended interval dosing and seems to have much success with it (several hundred patients, majority 8+years, many with high JCV titers) and feels this would be the beet route, with Vumerity as a second option but not nearly as favored. Since my diagnosis, from what I’ve read online in my panic-googling moments, Tysabri has always felt like the scariest option and when he named it my heart sank. Due to Covid vaccine concerns, he doesn’t suggest now is the time for Ocrevus or Kesimpta, which is what I was leaning towards. I am JCV+ with a titer of 2.8 (when tested 4 years ago) and I’m terrified of PML. The new Dr, and again my panic-googling, show that the EID of Tysabri significantly reduces the risk, and the doctor said they would do bloodwork and MRIs every 3 months along with me reporting any issues as soon as I notice them. Does this then keep me in a safe place for moving forward with Tysabri or should I require more monitoring, or a different med altogether. So many have a PML risk. It seems to be a very effective med to help freeze any progression and maintain my quality of life. The studies I’ve read all seem to show greater increase risk if staying on the med for more than 2 years, and it seems to me it’s difficult to safely switch to another effective DMT after this one without triggering progression. I just don’t know how to know what’s best to make these decisions, any insight is greatly appreciated! Answer: So much information can be overwhelming to anyone, so let's take apart your question and answer it logically.
Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
Does Kesimpta give you hair loss? Answer: We have not observed any hair loss with Kemsimpta. Some people report mild transient hair thinning with Ocrevus but this is because it is co-administered with steroids to prevent infusion reactions. Steroids are well known to cause hair thinning Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question: Which drug is better, Ocrevus or Kesimpta? I don't know which one to choose... Answer: Ocrelizumab (Brand name Ocrevus) and Ofatumumab (Brand name Kemsimpta) are the two currently approved anti-CD20 monoclonal antibodies for the treatment of multiple sclerosis. Both treatments are FDA approved for relapsing forms of multiple sclerosis. They are both humanized monoclonal antibodies (IgG1 subtype) that bind to a protein called CD20- a marker for all B cells beginning at the pre-B cell stage - and destroy these cells. Once destroyed these cells are gradually replenished over time by stem cells in the bone marrow. The extent and duration of B cell depletion depends on the method of administration, the dose administered, the interval between administered doses and several host factors (e.g. age, weight, prior immunosuppression). Both drugs are highly effective in relapsing forms of MS; although it is difficult to directly compare efficacy or safety without head-to-head clinical trials the reductions in annualized relapse rates, sustained disability progression and MRI measures of disease activity were similar for both drugs compared to the comparator drugs for each study, Rebif for the Ocrevus phase III clinical trials and Aubagio for the Kemsimpta Phase III clinical trials. So how do you decide between these different treatments? I've attached a table summarizing the pros and cons of each treatment, at least relative to the other treatment. To understand this table it is important to first understand several important concepts
You can open the file below to see the pros and cons of each drug. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego ![]()
Here is My Question:
Can you have gastric sleeve surgery if you have multiple sclerosis Answer: Gastric sleeve surgery is not contraindicated in MS. A. Scott Nielsen MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
Is ‘stable’ a good MRI result 18 months post-aletizumab? Is it the same as NEDA? Answer: We prefer explicit descriptions in our MRI reports. Words like "large", "numerous", or "small" are vague and of no meaning. "Stable" on the other hand means there are no changes, for better or worse, compared to a prior study. "Stable" would be equivalent to 'No Evidence of Disease Activity' (NEDA3), if there are no new or enlarging T2 hyperintensities and no enhancing lesions. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
I have RRMS according to my prior MS specialist but new doctor things it’s possibly PPMS. I’ve been on Ocrevus for about 2 years. He said that according to research and conferences that they are recommending that Ocrevus patients be switched to Zeposia due to new evidence that say Ocrevus may increase severity and frequency of COVID-19. Have you heard anything about this advice or recommendations? Answer: I’d suggest another opinion before deciding to transition therapies (especially if you’ve been stable on Ocrevus). At this time, there simply isn't compelling data to firmly conclude a b-cell biological is riskier than a S1P receptor modulator in context of covid infection. Moreover, distinguishing relapsing MS from Primary Progressive MS is not typically a difficult one to make so it seems odd to me that the possibility was communicated to you. Of those two therapies, Ocrevus was approved for PPMS. Another consideration is covid vaccines. It is reasonable to assume that both therapies can limit your response to a covid vaccine, but becoming vaccinated after enough time has elapsed from a b-cell biological treatment is possible since delaying infusion to receive a vaccine is not fraught with concerns about rebound disease activity which is not the case with S1P modulators. I’d request another opinion by a fellowship trained neuro-immunologist who can consider your entire history and response to treatment before making the switch. A. Scott Nielsen MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
I have SPMS and my condition is declining rapidly even though I am on Ocrevus. I have seen recommendations for long-term pulse therapy to treat SPMS (stand-alone or as adjunct to DMT) that call for 3 to 5 days of IV steroids anywhere from 3 to 6 times per year. Specifically, the National Clinical Advisory Board to the NMSS suggested every 3 to 4 months in a 2008 report and the Cleveland Clinic currently suggests every 8 weeks. Do you recommend long-term pulse therapy for treatment of SPMS, and if so, how often would you recommend? I would like to do everything possible to arrest my decline. Thank you. Answer: Many years ago, Donald Goodkin and I did a study at the Cleveland clinic using bimonthly (every 8 weeks) intravenous methylprednisolone pulses (also called high dose steroid pulses; uses 500 to 1000 mg IV x 3 days) to treat patients with what was then called relapsing progressive MS, but is now called secondary progressive MS. The treatment group did experience a slower rate of progression over 2 years, but the treatment never caught on in the MS community for two main reasons; first, steroids even when given as infrequent high dose pulses can be difficult for some people to tolerate and many physicians were unwilling to use this treatment based on their prior negative experience with the use of regular daily doses of steroids to treat MS ; second, the treatment effect from our study was modest. Many people now feel that combining pulse high dose steroid treatment with other disease modifying therapies could provide more meaningful benefits than using pulse bimonthly steroids alone. While combination treatments have been studied and found useful in relapsing remitting MS, this has not yet been done with secondary progressive MS. We currently have several patients doing well on combined treatment with Ocrelizumab and every 2-to-3-month pulses of high dose steroids but we really have too little data to support generally recommending this treatment strategy. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
My question is about Ocrevus and the timing of a COVID vaccine. A few days ago MedPage Today wrote: "Patients taking ofatumumab (Kesimpta), alemtuzumab (Lemtrada), cladribine (Mavenclad), ocrelizumab (Ocrevus), or rituximab (Rituxan) may need to coordinate vaccination timing with the timing of their DMT dose." I've read similar elsewhere, with guidance from neurologists recommending taking the vaccine at least six weeks before or after an Ocrevus infusion. What is your advice? Answer: The appropriate timing of viral vaccination, specifically vaccination against COVID19, is a subject of significant concern to specialists treating people with immune subset depleting therapies, including the disease modifying therapies listed in your question. Immune depleting therapies are given infrequently because it takes many months or years for the immune cells to be replenished by bone marrow derived stem cells. The time course of individual immune cell subset repletion varies with different treatments and how they are administered: dose, frequency and route of administration can affect the repletion timecourse. Anti-CD20 monoclonal antibody treatments (e.g., Rituximab, Ocrelizumab and ofatumumab) are a case in point. These treatments specifically target and destroy B cells expressing the CD20 'target' on their cell surface. This includes both naive B Cells and memory B cells. As these names imply naive B cells are important for learning about new viral infections and are required to mount strong antibody responses to viral vaccination. Memory B cells are created by exposure to vaccinations or native viruses; these cells allow you to respond quickly to eliminate a virus and other pathogens before they make you sick. Memory B cells, however, are a two-edged sword; they are also involved in autoimmunity, and their depletion by these therapies may be the main beneficial mechanism of action in diseases like Multiple Sclerosis or Neuromyelitis Optica. Naive B cells will return much earlier than memory cells and we can take advantage of this differential repopulation of B cell subsets in our vaccination protocols by vaccinating people after naive B cells return but before they are repopulated with memory B cells that can trigger autoimmunity. How do you know the sweet spot for vaccination after receiving B cell depleting therapies? One way is to measure B cells subsets after treatment with simple blood tests. For instance, after treatment with Rituximab and Ocrelizumab, naive B cells often start to return within 6 months, but memory B cells can take more than 12 months to start to return. If your doctor is unable to measure B cell subsets, he or she can simply measure total CD19+ B cells every 3 months after a treatment. Initially, there will be no CD19+ B cells detected at all but once the lab begins to see CD19 + B cells in your blood sample, the cells will only be naive B cells. In practice it is almost impossible to time your treatments precisely for vaccination. You should take comfort in several facts about the immune system response to viruses before this worries you too much. First, cytotoxic CD8+ T cells, which are not even targeted by anti-CD20 monoclonal antibodies, are created by vaccination and are the main line of defense, along with cells of the innate immune system, against respiratory virus like COVID19. In fact, it is the impaired innate immune response in the elderly that is partly responsible for the severity of COVID19 infections in older people. Second, we know that people receiving anti-CD20 therapies can mount antibody responses to vaccines; although these antibody responses tend to be muted, they are often strong enough to be protective. You should also take comfort in the fact that retreatment with immune depleting therapies can often be delayed for long intervals without your MS getting worse. It is a little trickier to delay these treatments with other conditions like Neuromyelitis Optica but some delay is still possible. So at present we are delaying anti-CD20 therapies whenever possible to allow for COVID19 vaccination during a period of naive B cell repletion. If this is not possible, we are not recommending any significant delay in vaccination (no more than 8-12 weeks) but do recognize that people vaccinated after an anti-CD20 therapy will likely require booster vaccines in the future. Please remember that regardless of your vaccination status, your main line of defense against COVID19 is wearing a mask and staying away from people who may be infected, especially in enclosed spaces like homes or restaurants, for more than a few minutes. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
Do you have any experience with plasma exchange (plasmapheresis) for progressive MS, and if so, do you believe that it can be helpful for some patients (even if it is difficult to predict which ones)? To be clear, I am NOT asking about using plasma exchange for an acute relapse. I have secondary progressive MS, have tried all of the latest and greatest DMTs (currently on Ocrevus), and my mobility continues to decline at an increasing rate. Thank you. Answer: PLEX isn't accepted as a disease modifying strategy for relapsing or progressive forms of MS. You are correct that is can be beneficial for those with a steroid-refractory relapse. More to your point, there is very little published data on use of PLEX in progressive forms of MS; however, those that are published suggest that if PLEX is helpful, it seems to skew towards younger patients with less MS disease duration. This isn't altogether surprising since approximately 30% of PPMS patients show signs of subclinical inflammatory disease activity (ie, new lesions showing up on a brain MRI). In fact, these patients seem to be the ones that benefit from immunotherapy (such as ocrevus, rituximab, siponimod, etc). Those without signs of inflammation tend not to show a response. Also, it is important to remember that there appears to be an independent neuro-degenerative ("progressive") phase of MS. In other words, the progressive phase in many respects appears to be independent of inflammation. So, even on a proven therapy such as Ocrevus, the data do not show a cessation of progression, but rather, a slowing of the rate of progression. At present, Ocrevus is likely a good option to maximize immunotherapy to benefit progressive MS (assuming you are still in the inflammatory phase as well), but given PLEX in addition does run the risk of removing the Ocrevus (monoclonal antibody) from your circulation and rendering it relatively ineffective. A. Scott Nielsen MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
Kesimpta is offering for the first time the possibility not to travel to an infusion centre twice a year in order to get a B-cell therapy (Ocrevus). Self administration at home sounds like more "freedom“. However - What about traveling under Kesimpta? As far as I know, it must continously be cooled. When traveling intercontinentally this can be difficult to achieve depending on the destination. Are there any guidelines or ideas how to manage this? Would it be a solution to take an additional "shot“ just before leaving for a three weeks trip? Or would it be safe to delay the next injection till returned home? Answer: According to the data provided in the package insert, Kesimpta does need to be continuously cooled at a stable refrigeration temperature (2ºC to 8ºC (36ºF to 46ºF)) until the time of use. It would be possible to maintain this in certain types of travel but not others as you mention. The best way to navigate travel and the injection schedule will be determined on an individual basis. Some predictions can be made based on how the drug works in the body and how long those effects last. Kesimpta binds to the CD20 cell surface antigen on certain B cells and destroys these cells. We are able to measure the depletion of these B cells using blood tests. The clinical trials for Kesimpta measured B cells to determine the optimal dosing for their product. Early dose finding trials showed a significant effect of treatment (on MRIs) even when dosed every 12 weeks (doses ranged from 3mg to 60mg). They also found that when people stopped treatment, the median time to B cell repletion was 40 weeks. This suggests that people can go at least 12 weeks between injections without a return of MRI disease activity. Assuming that a person has been on the treatment for 12 weeks (the point at which over 99% of patients in clinical trials had B cells below the lower limits of normal) then it would be safe to assume that the majority of people would be okay delaying their dose until they return home. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
I need advice. I have a unusual story, Six years ago I had unusual episode. Numbness, tremor, mostly on right side. It all resolved in a month. For the next five years I had stiffness in legs. My right leg would be weak if I walked too much. My rightt arm would be weak if I reached high for something. I saw doctors over the years and had MRIs that were all normal. Last Christmas my arms felt like 50lb weights were on them and I couldn’t use them as much. I keep having episodes like this but my MRIs are always normal. I've been tested for lupus, B12, ALS...I've had every test you can think of. I am 52 years old, can I have PPMS? This mimics MS I have so many same symptoms plus I feel like I have had flares. Where do I go from here I am getting worse and scared to have another episode. In November I was on a rowing machine working on my arm strength to get it back and a treadmill. I can’t even lift my arms well or lift my ankle up . Please help me I need help! Answer: It is very difficult to establish a diagnosis based on the history of symptoms you provide. I can tell you that it is rare for MRI scans to remain normal for over 6.5 years in people with MS of any type. There are many causes of waxing and waning weakness and fatigue including disorders of the muscle, neuromuscular junction, and peripheral nerves. I would begin by getting a second or third neurological evaluation, perhaps at an academic neurology clinic. Good luck Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Is it OK to get my Ocrevus infusion now and then get the COVID vaccine when it becomes available?1/6/2021 Here is My Question:
My neurologist is suggesting I get the Ocrevus infusion now and then get the Covid vaccine when it becomes available. I am 73 years old and have PPMS.; What do you think? Answer: Opinions on this matter differ, primarily because of the lack of information. Let's break down the information we know so that you can make an informed decision.
Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego How can I help my fiancee with the insomnia, depression and memory loss she is experiencing?1/6/2021 Here is My Question:
My fiancee has RRMS. She is currently experiencing chronic insomnia, depression and memory loss. I love her and I am doing my best to be patient and supportive. The mood swings are constant and I need help because it is seriously affecting our relationship. I am seeking advice and assistance. Thank you in advance. Answer: The symptoms of depression, insomnia and forgetfulness are very common in people with Multiple sclerosis (MS), even during early stages when individuals are not showing many visible manifestations of the disease. The symptoms are often interrelated and primarily a result of underlying depression or anxiety disorder. Depression itself is often considered a primary symptom of MS by many MS specialists. These symptoms affect both those afflicted by the disease and those close to them, as you've aptly described in your message. Both of you would benefit from further education and couples counseling to support your efforts to effectively manage these symptoms. Your fiancé needs to address these symptoms with her MS specialist, and seek an evaluation by a psychologist or psychiatrist knowledgeable about the psychiatric manifestations of MS. Good luck and try to be patient. Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
I am currently taking Gilenya. I've been on it since before it got approved. I was in a clinical trial. I'm facing hip replacement surgery in the next couple of months. I'm getting mixed information about the necessity to stop Gilenya a month before the surgery. I don't want to stop it as I don't want the risk of the relapse. What is the latest recommendation? This question was posed see you in May of 2017 and I want to know if there's any new or different information and/or recommendation. Answer: I can think of no reasons to discontinue Gilenya before or after a hip replacement. Stopping Gilenya a month prior to surgery would require you to undergo another first dose observation period when you restart it post operatively and would put you at risk for a rebound relapse. There is a black box warning in the package insert about stopping Gilenya without an alternative treatment to prevent rebound relapses. You've been on Gilenya for over a decade without complications. It makes no medical sense to stop it except for the day of surgery when you are NPO. Gilenya will not affect healing or your ability to form clots. There is no evidence it increases the risk of post-operative infections. Hope this information helps Revere P (Rip) Kinkel, MDProfessor of Clinical Neurosciences Director of the Multiple Sclerosis Program Clinical Neurosciences Director University of California San Diego Here is My Question:
Thank you for the opportunity; I do not currently have a primary care physician. At a very young age (3-4 I believe) I contracted a very serious case of meningitis. I know that I was close to death and had to be taken from Nor Cal to Anaheim. Without a background in medicine Google is a troubling source for self diagnosis. I do have a BA in Journalism and am at least able to filter BS. In short, my symptoms of left hemisphere weakening, numbness, spasticity, gait, etc sure sound like MS is slowly setting in over the past 8 years or so. I know my fever was extremely high when I was young. In short, am I likely correct (I know you can’t do much more than say ‘see a damn doctor already man!’ that the damage to demyelination from my 30 year old illness is a contributing factor to this motor control deterioration? I’ve tried yoga, Thai chi, etc abs still jog daily....Yet engaging/firing the correct muscles to support athletic and daily movement has become near impossible. It was therapeutic just to share that; so thanks. I have no health insurance and I hear constantly about early diagnosis abs therapy. I don’t want charity and I understand the pharmaceutical world more than most. Is there anything I can do (nutrition, supplements, style of exercise) to help slow my symptoms (assuming it is MS). Thank you! Ryan in Portland Answer: You’re right, Dr. Google isn’t an adequate substitute for the actual specialist. The assumption of MS is a big one and I remain unconvinced based on symptoms with a history of meningitis presented. However, I’ll play ball and simply say that in the case of confirmed MS—and in addition to a disease modifying therapy, a healthy/well-balanced diet, exercise, and potentially supplementing with vitamin D3 5,000 IU daily, may be helpful. Patients with MS are not exempt from other health issues that come with age. High blood pressure, diabetes, cholesterol problems, etc can also injure the nervous system and increase the rate of disability. Ultimately, however, a proper evaluation with an MS specialist is in order. Please be kind in response to this post. My knowledge and command of the English language is likely not up to par with a journalist. A. Scott Nielsen MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
What diet will help those with MS who are unable to take the medication? Answer: There have been many proposed MS diets over the years and many claim anecdotal evidence as proof of efficacy. The fact is that there is no high level scientific evidence for these diets. Many have been packaged as “anti-inflammatory” diets which is a testable hypothesis for a well designed clinical trial. It remains a challenge to carry out such a study because people, by nature, cheat on their diets (which make it difficult to confirm actual benefit). You can certainly trial a diet yourself and gauge your response. Of course, it would be best to review the selected diet with your PCP to ensure no contraindications to the diet based on your other health factors. It remains advisable to follow recommendations for a general well-balanced diet. Food choice affects other areas of health that MS patients are not excluded from. For instance, high salt, carbohydrate, fatty, etc diets can accelerate cardiovascular disease that can also injure the nervous system. As far as the inability to take an MS therapy, I have to question that statement. There are so many available (and different) MS therapies that it would be hard to believe that ALL are contraindicated in one person. Even if there was a religious or other exception of conscious to a specific type of therapy, there remains a variety of medication class/type/mechanism to find a suitable therapy for everyone who would otherwise qualify for a disease modifying therapy. Use of one of these therapies is better than nothing for MS patients who remain in the inflammatory phase of their MS. A. Scott Nielsen MD MMSc Neurologist and MS Specialist at Kaiser Permanente Here is My Question:
In your opinion-is it safe to take the Pfizer covid vaccine if I've had transverse myelitis? Answer: This is a great question. Having a history of transverse myelitis is not a contraindication for getting the vaccine. You should discuss this with your neurologist first as there may be factors in your medical history that may affect this decision. But in general, I would say that most neurologists recommend patients who have had transverse myelitis get the vaccine. Benjamin Osborne, MD Director, Neuromyelitis Optica (NMO), Neuro-Ophthalmology Clinics and MS/Neuro-immunology Fellowship Director Associate Director of the NIH/Georgetown Neurology Residency Program Medstar Georgetown University Hospital |
PLEASE NOTE: This information/opinions on this site should be used as an information source only. This information does not create any patient-HCP relationship, and should not be used as a substitute for professional diagnosis and treatment. Please consult your health care provider before making any healthcare decisions or for guidance about a specific medical condition.
Archives
February 2021
Categories
All
|