Multiple Sclerosis Webinar: Ocrelizumab Q&A with Dr. Tim Vollmer

[Music] get ready yeah hello everyone I'm Tim Bulmer medical director Rahman MSN and co-director of the Rocky Mountain MS clinic at the University of Colorado Hospital we are putting on this webinar on Oakland map which has a brand name Volk Rivas basically to help anybody who's thinking about this drug by answering questions as best we can and also helping to us to support your physicians in terms of being able to help you move forward if you would like to try this medication I don't get to move on I just have trouble moving the slides give me a second here so have you those okay so these are this slide is very important for you to understand in that it's important for you to know what financial relationships speakers like me might have particularly the company that's manufacturing the drug that I'm going to be talking about as you can see I have consulted with a large number of companies and we have quite a few grants that includes Genentech and Roche which are the companies that are involved with Oakley besouro CLA's mint so if you have any questions about that please let me know so just get started here I wanted to review a little bit with you what be lymphocytes are or also called b-cells these are part of the immune system that work with respiration system to help you respond to infections cancer and other issues they're made in the bone marrow which is you can see here that come from a stem cell I turn it into preview cells those cells move to your lymph nodes and spleen and there they become activated and educated in terms of what kind of a protein target they're respond responding to as these cells proliferate in the lymph node and spleen they then enter the blood and circulate to the brain and some of those cells are full of promoting inflammation in multiple sclerosis so they cross the blood-brain barrier they then activate a whole cascade of events that leads to the inflammation that causes the demyelination and damages the brain the Okaloosa map as well as for tuckson map are multiple antibodies that specifically target a protein it's only expressed on these cells and it starts from the previous cell up to the memory diesel and that protein is called cd20 it's not expressed than anything else in the body which makes these drugs very selective in a way they work it turns out why this is important in ms is that you have a list node at the base of the skull called a deep cervical lymph node that's connected to your brain and spinal fluid drains into it on a regular basis current data suggests it's in that lymph node that B cells that can cause MS are generated and they move from that lymph node back into the blood and again cross the blood-brain barrier where they make where they cause an MS plaque and damage to the brain and what's happening with Oakland is map and rituximab is they're catching it in an intravascular phase where it's moving into the bloodstream and kills the cells there so they're not able to circulate to the brain and cross the blood-brain barrier and cause problems and that has turned out to be a very key issue for multiple sclerosis and it's identified these B cells as being the primary driver of the inflammation that characterizes multiple sclerosis so the studies the phase three trials that led to the approval of Oklahoma were called the upper one and opportu studies these were in relapsing remitting and secondary progressive MS these are large studies they involved over 1,600 patients 800 patients on Oh Cletus map and around 1800 807 Riva which is an interferon therapy so to briefly review these studies these studies actually we're identify designed to be identical and they were very similar in all characteristics this is listing the baseline characteristics of the patients and the reason that we list that is just to make sure there's no imbalances in the population that we're studying - that would confound the results as you can see here there are no significant differences the groups are very well matched this is the primary outcome of the study this is looking at the number of relapses that are occurring per patient over the two years of the study in both studies are listed here independently but they have exactly the same results so here is the Reeb it patients again their interferon that's injected three times a week and they're compared against focus is an ad that is injected once every six months in which you can see here that compared to the Reeb if the Oakland is now decreasing relapse by another almost 50% and it made the actual number of relapses per patient down to 0.15 relapses per patient per year which is quite low it's about 65 percent lower than what the natural history is and that occurred in both studies this is looking at its secondary outcome in other words the study wasn't dependent upon this in order to succeed it was depend on the relapse rates but this is looking at progression of disability so the definition here for confirmed disability progression is that patients have a worsening on a scale called the EDS s that lasts for three months in this first case and six months in the second case this data is combined from the two studies this is a standard definition for disability progression used in essentially all AMS clinical trials and what you can see here is that the blue line here is the Oakland is map on both sides and the purplish line is the rebid patients and basically the treatment of localism AB decreased the risk of having a progression of a disability by around 60% forty to sixty percent and so that's a good strong finding not something we see with all the therapies but is similar to two sabri and possibly some Golmud or jelenia in terms of benefit so that's a very important outcome they also looked at new MRI lesions occurring in patients on either Rivas or the Ovilus map and they're looking at six months one year and then two years and it's comparing the two studies which again have essentially identical results and basically what we see that compared to the reboot of patients in the first six months there was over a 90% reduction in new lesion formation and in at one year it was close to a hundred percent and it held out to a weak ninety-six it turned out that in a study the new lesions that did form which were relatively few occurred mostly in the first three months of treatment that indicates that the treatment takes about three months to really have full effect and that's something to keep in mind if you decide to go on this therapy you need to give at least three months four to stabilize things so this level reduction has not been seen with any prior study of any other ms agent this is looking at brain volume change the reason that this is important for us is that brain volume change in other words how fast the brain is shrinking which occurs in all of us but it's faster in MS patients determines long-term disability so the rate of the brain shrinking is a very powerful predictor of the disability some might have five ten fifteen years down the road the difference here may not look that large but it is statistically significant and the trend is for the Oakley's lab patients to begin flattening out here and the realist patients will continue to go downward we're doing more Studies on that now but it may be that it takes two to three years maybe longer for the rate of brain volume loss to normalize and be equal to patients who don't have MS and we have some preliminary data with two sabri and with jelenia that that does occur the next table over here are the graph is looking at a definition of disease activity and that's called no evidence of digit activity and we're looking at the percent of patients that no relapses no new MRI lesions and no progression of disability over the two years of the study and what you can see is that in the interim group only about 30% of patients we sat definition and in the demamp group it was close to 48% close to 50% this is a an increasingly important outcome that we use in the treatment of MS to determine whether a therapy's working adequately we really want in this day and age to use a therapy that really prevents patients from having any further disease activity that would allow them to reach this deaf definition of needle no evidence of disease activity we're actually interested in even having a better outcome which we call Neeta plus that means patients have no evidence of disease activity plus they're getting better and that is possible with the more modern therapies including two Sabra jelenia and Oklahoma in this particular table is looking at the results in the primary progressive study which is called the oratorio study the primary outcome here was looking at the percent of patients that would have progression of their disability lasting for three months and what you can see here is a decrease in the patient opal is now is twenty four percent compared to the patients on rebid whether that will continue to separate we don't know but that is statistically significant and it's the first phase three trial in primary progressive MS to actually have a positive result as a consequence the FDA has approved Oakland map for essentially all forms of MS clinic isolate syndrome with apps from emitting ms secondary progressive MS and primary progressive MS so this is the first drug to be approved for all forms of MS and it's a very important advancement force this is looking at side effects and we're looking at in fusion reactions here so the most common side effect of Okaloosa map is on the first infusion in particularly patients developing an itchy rash sometimes a red rash scratching their throat tightness in the throat swelling of the tongue or lips and these are allergic type reactions that occur when the drug is given sometimes through the drug it also may be due to the number of B cells that are dying in that short period of time they also release inflammatory molecules and my causes so this first table is looking at the patients that are on Reba interferon beta and they also received infusions once every six months and even though the intrusion was just saline didn't have any drug in it about seven percent of patients reported some time in a huge reaction the first one and about two three percent thereafter with the Okaloosa map it's closer to twenty eight percent of patients reported an acute reaction with the first cycle and in one case one out of the six out of the eight hundred patients here had a more severe reaction and needed to be admitted to the hospital overnight for observation they did fine after that but that can occur although it's rare the other classifications here are mild moderate and severe mild means that we don't need to provide any other medications such as benadryl or steroids the moderate and the spirit-being they required more medications we gave them more steroids and another dose benadryl to control the symptoms and that's the normal case so if you start on Oakland AB or rituximab you should expect on the first cycle to have some infusion reaction most the time they're mild don't require an additional treatment but sometimes they do require more of the benadryl and more the steroids the frequency of in fusion reactions drop off rather dramatically after the first confusion in this study patients were receiving a half dose otherwise I mean 300 milligram and then we're given that dose twice two weeks apart and so this is the first dose of three hundred milligrams this is the second dose of three and milligrams you can see the pregnancy of imputing reactions are much less this infusion out here was the first six hundred milligram infusion they got so after the first two injections there's the dose that 600 milligrams given once every six months and the infeed reactions were down about fourteen fifteen percent and they continued to drop off after that again the vast majority were mild a few required a little bit more benadryl so this is a typical response and most of our patients are touching that where we have the most experience are not having a fusion reactions after the first one and in fact we the option of not using the pre medications of the steroid and the benadryl if they wish another way to look at side effects of the drugs is to look at those that meet the definition of serious adverse events this is defined by the government and it's been in place since 1970s and it means that the drug either caused the hospitalization of a patient or prolonged hospitalization of patient was life-threatening for the associate with cancer or its associated with birth defects so it's a very specific definition what you can see here if you look at the overall numbers of serious adverse events they were a bit higher in the interferon beta group the readeth group than they were in Oakland that certainly no trend in the opposite that was true for infections there was sight more infections with the rebus and there were with the Oakland is Matt and this is indicating that the Blues map is really not suppressing the immune system significantly for most functions nervous system disorders could be irritability depression anxiety and again there was basically the same tune to drugs and then this last one first primarily to infusion reaction are not an acute reaction side effect and again they were either the same or slightly less noted as a map so the importance behind this is that over this map even those appears to be more effective than the other medications does not appear to be a more risky drug in fact compared to Alan to some abdic lism AB might as an shown on stem cell transplant it's remarkably less toxic it has a much lower risk of any serious adverse event and it's comparable to Fabry in patients that are negative for the JC virus but probably better than what we see with jelenia and tecfidera so this is a comparison of some of the other drugs to the slide from of mine and it's looking from the published reports of the phase three trial of the impact of the treatment on sustained disability progression that that we talked about earlier and also the effect on brain atrophy and then I'm using my own classification in terms of the risk of a serious adverse event or a serious health problem from the drugs and again this is my classification so you can see in terms of the medications we have that the reduction in sustained disability progression for vertex mentalism at which are very similar drugs is between about 21% for the primary progressive patients and 40% vs. Reba for the relapsing remitting in those patients this is quite similar to what the sabri does on Tues map also called LEM Trotta it appears to be a little bit less effective in this category similar to jelenia this is tecfidera and this is the albedo and this is interferons and Copaxone numbers down here the problem with these numbers is that the studies were designed differently and it's hard to compare these drugs directly but you can see a trend that some of the more modern drugs appear to have a bigger effect on this particular aspect and that's been confirmed and another number of open label studies that have been done at various clinics around the world the techno brain atrophy as I said before is a very important issue for us because that's the strongest predictor of disability you see the interferons have very little to no effect on this and albedo and Copaxone andlet opa have a modest effect and then the newer drugs have increasing effects as you go up from out to the map to to sovery to rituximab and opal is map so touch me we have a very loose data here but we have more than a ton on ilysm so these numbers may be the same they may be different it's hard to tell because they're different studies but during the same ballpark and this is only at 2 years we have some summary data suggesting that the effect is even better if you look at year three and four well we're here I'm rating the drugs based on the chance for having a serious health problem from the drug we all know the Copaxone is quite a safe drug going to use a gold standard compare safety interferons have a bit of higher safety profile with some hepatitis occurring some skin necrosis occurring and the tolerability in terms of the flu-like symptoms is a little bit worse and that's true for all the interferons the tariff luna my main issue here is that there is a slight rise in infections and there's some hair loss that occurs with it and it can cause hepatitis so again it would be similar to the interferons the tecfidera is similar it has some gastrointestinal side effects and may cause some other systemic column's jelenia is the problem with it is that it has impacts on the heart lungs and on the retina of the eye so it takes more monitoring but in carefully selected patients that can be is just as safely as these drugs down here but you have to not put patients have diabetes or hypertension or cardiovascular disease on Gillette in order to minimize the risks to Zermatt or limb Trotta is a fairly risky drug in terms that about 40% of patients will develop another autoimmune disease such as thyroid problems but also some more serious ones related to blood clotting problems and things like that this also rise in infection and appear to be arising cancers to sovery is rated as a for the patient has the JC virus and I would not recommend personally to salary to be using but it was positives with JC virus but if they're negative for the JC virus this is a remarkably benign drug in very large studies from the touch program looking at several thousands of patients they do not appear to have any particular safety issues different than a non ms population of the same distribution that is true for tucks a map and it's also true for Oakland M so the safety profile does not necessarily correlate with the effectiveness of the drug so this is the last slide this is just telling you what we do at the Rocklin MS Center all the neurologist here practice basically the same they're the same criteria for selecting patients for different drugs in the same goal and basically if somebody is positive to the JC antibody then to Sabri would be at the very bottom because of the risk with it but the taxman toklas math are the first choice if we get them approved Jelani and tecfidera would be the second choice if we can't get the first two drugs approved or there's a safety issue with the patient such as having hepatitis B or C and then the tariff Linum ID and albedo would be a two or three at best and we rarely used Lim trot around to Zermatt because of the long term problems with autoimmune disease and infections and then the Copaxone and the interference are Tier four so they would be close to our last choice and that's only because their level of effectiveness of preventing disability progression and relapses is only about 30 percent whereas opens matters in the 80% range and we believe we're tuckson have a similar to that over here is the classification that we use for patients that are jc- and sorry we didn't change if sovery is actually in the tier 1 so we would use duck map Oakland or - sorry for patients that they're jc- and then the second line would be the Jelani and tecfidera and the third line would be the Ave GLM trata and the fourth Klieman Kopacz interferons so that was just a brief overview like now we would like to focus on questions and they can type the questions in so there's a box on your screen if you have a question just type it in there and my colleagues here will help me get those and we'll try to answer as many as we can we have gotten some already and so I'm just going to move through them there are several questions about what to expect if you go on a quiz and have in terms of changes in symptoms and disability and basically if you have lapsed remitting disease or clinic lactated syndrome or even just an abnormal MRI that led to a diagnosis of MS in those patients they begin to notice in year two that they feel more stable and have fewer symptoms by year end of year two most patients feel that they've had substantial improvement or much more stable and that continues to improve in our experience up to four to five years which is about as long as we follow large numbers of patients so with absolutely mitting or patient with relapses tend to improve very significantly we've had patients go from using a cane to being able to walk independently long distances and take up hiking again for progressive patients is a little bit different they definitely begin to stabilize particularly after year two so you're three and four most patients will come back and say they feel like that I'm not changing very much changing a little bit but we believe that's mostly due to the effect of aging on the brain so all of us have our brains begin to shrink around age 35 just part of being alive and with MS the problem there is is that patients with progressive forms of disease have used up the reserve capacity or the ability of the brain to compensate for this normal aging process and for injury prematurely as a result that uncovers the effect of aging on disability progression but the district aggression is much less in the treated patients after year two than it is in the untreated patients another question is about PML so rituximab has been used in over four million people and there has been have been a few cases of PML in that situation but that was in the setting with people who are getting steroids and chemo therapies at the same time any of you assume the risk of sudra tuckson that was less than one in 30,000 there are not any PML cases attributed to rituximab in ms nor are there any female cases in any indication pro kleh demap it's not that they may not ultimately occur but their risk appears to be very low so i said the risk with protect amount was less than one in 30,000 with two sorry it's one in 180 after three years of treatment which is a very high risk so at this point we do not think PML will be a major issue for this drug and probably be less of an issue than it is for two sabri jelenia and tecfidera okay there's a question on cancer and this is a very important issue so there's been a review of vertex map which is very summer toklas map again which has over 4 million people exposed and in that review there was no evidence increased risk of cancer in that 4 million population-based over based against patients who do not have MS and we're not treated with that drug however in the phase 3 trials with Oakland ISM ad there was an imbalance in the number of cancers that occurred in the Oakland map group versus the interferon group so the inferior group had two cancers in both skin cancers and in the Oakland is map group there was one melanoma skin cancer one basal cell carcinoma and then also is a case of renal cell carcinoma but there were up to six cases of breast cancer if you combine the primary progressive study with throughout some minging studies and there were no breast cancer cases in the interferon group now the issue with that is that when you do clinical trials and you look at rare events it's not uncommon for them to be different in the two groups and yet not be related to the therapy so that may need explanation is just a random event that just is confusing issue but on the other hand it's enough that we have to think about this and as a result will be ongoing safety monitoring to continue among to the risk of having cancer if you're on local ISM a versus on the other medications right now the number of breast cancers that occur in the open is macGruber fairly similar a little bit higher or not much of what we would expect in just a natural population being followed to the same length of time so this is an issue it's a rare event basically we would recommend that if women go on this drug they should definitely follow up their physicians for the normal screening evaluations are done for breast cancer that most people most want to undergo the in terms of the other cancers we do not think that they're related to the drug at all those are relatively low rates and similar to what we've seen a non MS population there's a quest series of questions on costs so we do expect most insurance companies including Medicare and Medicaid to cover the cost however insurances differ in terms of what your co-pays or your out-of-pocket expense it can range from zero to as much as 20% and in some patients have a amount of money I have to spend on health and health before they're actually covered by their insurance so those dishes can count issues a bit but opal is now is actually priced lower than the other drugs with the exception of late' OPA that's the only drug that's about 15 dollars cheaper a year so the average wholesale price for Oakland is nav is $65,000 for the other drugs at 70 to 80 thousand dollars so it's not more expensive all the companies that have drug this area tend to have out-of-pocket expense reduction programs for patient assistance programs that they help sponsor that's also going to be true for Oakland map the Roche and Genentech are have developed a patient Assistance Program it's very similar to what we see with other medications their goal is to try to decrease the cost for patients in general to about $5 for the drug and $5 for the infusion at each infusion which means about $20 a year it should be the cost to most patients however I do not know about Medicare and Medicaid they have different rules and it's illegal for the company is to use a patient systems programs if you have that kind of insurance however with rituximab Moeller patient and medicaid have that covered fully don't have any out-of-pocket expenses and our patients with Medicare that you for Chuck's map if they have a supplemental insurance also seem not to have much at any out-of-pocket expenses so it'll vary from person to person is something you really need to discuss with your physician in their office team and there is a company representative that can help with this as well but in general I think this will be certainly no more expensive don't we see with the other medications and then there are a number of questions about comparing this drug to to sabri so to sabri is a highly effective therapy we've had out since 2006 as I mentioned before from a safety profile standpoint the only real problem we have it to Sabri is the risk of PML caused by the JC virus and that risk is very high as you carry viruses commute as high as one in 80 and on average is one chance in less than to hundreds of developing that disease which is a very serious disease however patients that are jc- and are monitored every six months for that virus we've not had any cases of PML anybody's had more than two blood tests done for the JC virus and so careful monitoring for that particular issue can make to sabri a very safe therapy in terms of efficacy we believe that to Fabray and Okaloosa have more toxin that were all pretty similar to each other so even though the clinical trial data is slightly different they were done in different decades with different groups of patients with different clinicians so I think they're within range of each other and certain our experience with - sorry which we have very extensive experience with suggests that most patients do extremely well on it and over time also are improving so patients are chasing negative - sabri which is given IV once a month is certainly a reasonable alternative and is quite comparable to Auckland map in efficacy and safety the major difference is just that the infusions with the focus isn't a vertex member once every six months and with Sabra it's once a month in patients who are on to Sabri yet they're doing well and they're negative for the JC virus we would suggest to either stay on the drug or Swiss chocolate is going to have in that sort of a personal decision based on the number of infusions and the out-of-pocket expenses and that's up to patients who will come about both drugs and explain it and let them make a decision which one they would like to try so many of our patients decide to stay on - Sabri some just decide to switch to Oakland there's a quick question on if patients are wanting to switch over this map and they have unopened bottles of jelenia can they return the jelenia are you cleaning with it and the answer is no it's actually illegal to give prescription drugs to anybody else besides the prescribed patient and the pharmacies and the company can't take back the drug once it's shipped out so unfortunately that's an expensive drug is probably together you should probably discard it when there's the community programs to deal with prescription petitions there's a question about the NBC news coverage that suggested that patients go from walk not walking - walking we do see that in patients have relapsed from bidding disease but to be honest with you it's a very rare event in patients that have progressive forms of disease as a secondary or primary what we do see improvement particularly in fatigue cognition depression in patients who have progressive disease are on these types of medications so there are benefits there may be possible in the future to use an additional therapy to add on to Oklahoma and to Sabra to focus mainly on repair and there's drugs such as biotin which is a B vitamin alpha lipoic acid which is over-the-counter medication that's used to synthesize myelin and then there's other drugs statins the Quinta mode Co betas all my Kaunas all that have some suggestion they may also be to help be able to help so I think the future of clinical trials in progressive MS in particular will be add-on studies adding one of these therapies that might induce repair in the nervous system onto something like poke ELISA memory types of men okay so I would ask to compare the tissue side effects and risks between these drugs and as I've already discussed the in the appropriately selected patient to sabri in opal is map appear to be as safe as Copaxone in general and certainly comparable to interferons as we saw in the Opera studies it was actually superior to interference in terms of side effects with jelenia and tecfidera they definitely have more side effects in fact our experiences at patient exid are about a third will discontinue the medication because of tolerability issues or ms disease activity issues within two years and about 25% will do that with selenium in our experience with rituximab if we don't include lack of insurance then the rate is about 10% so I would say these drugs are more tolerable to patients they can have fewer side effects and as I said that the doses we use with them we really don't see a rise in infections in general except for maybe a four percent increase in normal viral colds and influenza but no bacterial infections no fungal infections yeah we have a few questions about the transition from one treatment to another mom specifically with Jian jelenia which construct generally about maybe washout periods for different drugs and what the sort of the onboarding process would be for for sure this is a very important question the reason is is that when patients go off to sabri or jelenia they can have a burst of ms disease activity starting about three months after last dose of we believe the true rebound in ms is not just return to normal activity but actually an overshoot and that ms activity leads to additional symptoms and increased disability so in looking at the potential risk of having two drugs that affect the immune system on at the same time versus the risk of having a rebound effect we have carefully studied and documented that we can start rituximab within a month of the last dose of two sovereign which prevents the rebound effect completely so far we're going to see any relapses most patients and or MRI digty and it does not lead to an increased risk of infections or the problem so we don't see any safety issues in our practice with starting the Oakland zoom AB within a month of the last dose of two sovery and I would say the same is true for jelenia we've moved hundreds of patients from these drugs to Chuck's mavin will do so localism m so I would just recommend doing it sooner and preferably before four weeks that's the last dose of any of the medications in the case of chilling in tecfidera we have patients just stopped the drug the day before they went to over this map with no problem either so you don't have to wait for weeks but I wouldn't go longer than four weeks for the interferons and Copaxone there's no washout period you can start focusing them at any time if you compress questions about the infusion process could you just describe what the infusion process looks like maybe compared to some other could treatment reduces so there's a alum to zoom a bore limb trata is a third line drug in other words the FDA suggests that and not be used until patients that failed other drugs and particularly what we call the second-generation first-line drugs such as vocalism apt esophageal any and tepidarium so I'm not going to really discuss that one has a different inclusion rate but in terms of comparing this to Sabra which is the other key intrusion that we use the solver is given monthly it takes between one hour and three hours to get the infusion done depending on the impedance Center and where the patients have any fusion reactions with Oakland ISM app there are two ways to start that medication the way they did in the studies were to split the dose the six or milligram dose into two 300 milligram doses and give them individually two weeks apart however they have done studies giving patients a single 600 milligrams fusion and a single thousand milligram infusion so there's slightly more in fusion reactions if you go larger doses but it's actually quite small it's maybe 5% or so so whether to have the split dose or not with the Oakland map is again something you discuss with your physician position depending on cost issues and challenges of having two infusions or two weeks apartment in terms of how long the infusion is it's designed to be after the first one which is about 2 to 3 hours to be done in one hour of localism at so there's about 30 minutes of times to get the pre medications to work so we do give steroids and benadryl to patients prior to in queues Madoka's min and we wait 30 minutes and then we start to Oakland have infusion and try to complete it in about an hour after the person fusion and then the patient will be observed for another hour that's optional and it's something I would do for the first two infusions definitely but they may not be necessary after that but that's a judgment issue with you and your physician so the infusions are shorter than the are localism app similar to what they are to Sabri except there once six months rather than monthly a couple of follow-up questions to the infusions the lose might have to be infused at a hospital or can they go to any infusion center we believe you should be able to go to any infusion center there's no special requirements by the FDA for infusing okla SMAP essentially all infusing centers are comfortable with rituximab which is basically the same drug so there may be a little delay in in terms of each infusion center reviewing the drug and getting familiar with it but you should be able to find and choose centers close to you or less expensive than other ones and that should be fine and what type of monitoring with where the patient expected between interviews for from the standpoint of safety monitoring we monitor your blood counts and general chemistry panels once every six months we also look at your B cell counts to make sure you're being fully depleted by the drug once every six months we screen for hepatitis and tuberculosis prior to starting the drug we might repeat that at year two although I'm not sure that's useful but if you're initially negative ten people didn't stay negative but right now that's the major issue that we only do that once every two years outside of that there's not much else the tradition our habit is to get a baseline MRI after patients been on drug for at least three months and then to do a one-year follow-up and if there's no difference between them then decrease the frequency of MRIs to when every two years or less in fact in my practice I don't we do the MRIs on these drugs because they memorize don't change so I reserved the MRIs for there's new symptoms where we can use and then to make sure we're not seeing a true relapse one last question on infusions it's a clarify infusion like they're shorter or lose men is that right yes but they don't need to be the infusion times are based on the experience in cancer new to arthritis and lupus and they those patients receiving up to 2,000 milligrams every six months and we're only using 500 milligrams and we're not using with any steroids or chemotherapy so we are working with the infusion center here I think we're down to less than two hours and out for rituximab and I think we use exactly the same as Oakland is Nev is with orbit loserman being cheaper than Tysabri do you think the insurance companies will begin to force patients to move to Oakland either if they're stable on tests I agree I don't think they will do that with the sovery I think they may begin to look at the interferons of which there are four and the Copaxone the topo medications because those drugs are associated with higher health-related cost there's more hospital visits and more relapses more MRIs used for them so they may begin to look at that first generation of first-line drugs the older ones and maybe in those patients to move on to one of these more effective therapies so we have one question about dueling with Tysabri during the last few days before another types every infusion this person notices feel too sluggish since the upper bluesman intrusions are spaced out even further what would you expect people to need to prepare for as the animal politics infusion yeah we hear this commonly with patients booked on to Sabri and rituximab and I expect to hear the same thing with Elizabeth there's a small percent I would say it's probably 10% or less that do feel that the effect of these infusion begins to wear off prior to the next infusion and the timing is variable from person to person so I don't understand the basis for that you know based on what we understand from excellence of action I'm not quite sure why patients would have that pattern but they do and they report it well through regularly so with the Oval is map we do not find that the patient's report this is more of a problem than it was with the sovereigns about the thing it's usually in the week or they get their infusions that they feel things aren't quite as good as they are right after the infusions are the last few questions I think indicate how excited you were about this folks want to know when will Grievous be available for infusion at uch and being that it's just approved is there an estimate of when it will be available to patients well actually there are patients in the country have already already received a openness map Oh Cletus and so it's a matter of each Hospital has what we call a pharmacy and Technology Committee I think is called anyways I will be presenting to that committee for the University of hospital next week on the 18th to explain some why we want this drug on the formulary so we can use it I expect it to be approved the following week the major delay is probably going to be insurance companies because they also have to prove and decide how they're going to manage the drug and for United Healthcare I understand they already have made that decision and it should be approval right away I don't know whether require patients have failed other therapies for MS before using this or not we won't know that until we begin to submit those prescriptions for Blue Cross Blue Shield anthem the other ones is harder to tell companies are obviously working with all the insurance companies so I helped them move through this as all companies do but sometimes they can take up to six months before they finally write a policy and decide whether to approve this without having appeals or not so I expect all will approve it and based on the farm quick anomic sigh expect them to make it a Tier one drug in MS and possibly preferred drug for many of the insurers I thought we were finishing up but we did have a few more questions come in from first G do we need to take a few days off for fatigue or other symptoms after the infusion of groups there are a few patients that do feel more fatigued for a few days afterwards it could be because at an infusion reaction which might cause that it could be just because of the stress of going to the infusion center and sitting through the infusions however the number of patients I hear saying that is quite small and it is probably in the 5% range or left and the presented patients have had that problem that was significant to them has dropped off for the last few years with four types of map I expect it to be the same with Oakland is map but if you're sensitive to medication changes or infusions particularly progressive patients yes you may experience that that fatigue and so on the first dose I would suggest planning for the possibilities you may not be able to do your normal activities or go to work after that that effect falls off rather dramatically alright what I think is our last question how long is over lose my been on the market we know that it's just a couple of weeks now has the drug or something closely related to the drug been around for longer yes so we've been working with on okhla cement for more than ten years we started with the phase 1 studies did the stage 2 and the phase 3 trials and we've been working with company like we do all the companies that generate in this medications the drug is extremely similar to rituximab so rituximab is an older molecule that was approved in 1996 issues for lupus from - arthritis lymphoma we've been using an MS for more than ten years and the reason it was not approved by the FDA is that the company realized they were going to lose their patent protection on rituximab before they could get to market with MS so they generated a new molecule called plasma which is more humanized but otherwise very similar and that they developed and now have FDA approval it's been out for a couple of weeks there the main argument for using Okaloosa mAb I think are - one is that the manufacturers believe that the risk of developing antibodies that would neutralize the drug is lower we don't really see much of a problem with rituximab in that situation so it may be a little bit low if I don't think as a dramatic effect but that's the main marketing advantage I think the second marketing advantage is that we have more studies in Oklahoma more patients treated longer follow-up there's only one study that's randomized with rituximab and that was the Hermes trial than ten years ago so Oakland is I would say it has more data and we have better data to extrapolate from and then the final issue is out-of-pocket expenses because we touch the map is a off-label use is illegal for drug companies to have patient assistance program that might promote the drug they can't promote drugs that they don't have approval from the FDA for fact they people can go to jail for that so Oakland I was approved and they do have a patient Assistance Program and because it's approved it should have a more predictable coverage by the insurance in the a debauch expenses should also be more predictable over time but as we've talked to Matt we may get it approve the first time then not get it approved a second time get it covered the first time and then they don't cover the interest doesn't cover the next time it's more unpredictable so I think having a drug approved has a patient Assistance Programs also an important variable all right now I think most of the people online here are our patients here at the Rocky Mountain SNR but we do have a few that are not could you give a patient a little bit of advice on how to get their local hospital for infusion center or even there the neurologists that they see up to speed on secretest and what they need to do to get that processing well understand where the hospitals as I said I it's mainly just getting the hospital pharmacy committee to approve the drug to put on their formulary however the drug can be ordered through a specialty pharmacy mail-order and sent directly to the infusion center you go to so if you go to infusion centers not in a hospital when it's pre standing the community that you may not have to worry about having that authorization through the hospital system in terms of physicians I think the the issue here is that the data is relatively new so if they haven't been involved with this class of agents in the past that they have used for tuks mAb and what's involved in the Oakland up studies I think there's going to be some more hesitancy to use it because in the Moot arthritis and lupus literature and the cancer literature there are very significant side effects including major infections that can occur because we're using the drug as a solo therapy and we're using much lower dose it's a very different drug and also understand the maximization where we really don't see suppression the immune system as a significant problem with this drug is important so if they are familiar with rituximab I think we'll be perfectly happy with opal is Amman if they haven't yet started either one of them you may take them a little while to go through the various education programs that we all go through and go to the international meetings and get all the data they need to be able to make an informed decision so we're happy at the record MSN or talk with any of the physicians if they want some advice about how we manage things in and what laboratory tests we do for safety monitoring they can give me a call or send me an email and we'll be happy to send them our protocol and discuss any aspect of the therapy with them probably looks pretty close to the end of our question and it is very close to the end of our time today thank you dr. Palmer for joining us and thanks everyone who listened online just a quick reminder we will be posting this webinar on our YouTube channel later we will get an email out to everybody including in our EMS news newsletter with links back to today's presentation little bits like that also be double the size and similar to the slides oh yeah if we can make that happen we can get this live available row so if you want to look back at the data slides they'll be available as well just to refresh your memory and I'd like to thank all of you for participating and if there's other ways we can help please let us know question

Channel: TheMSCenter

Views: 22,631

Rating: 4.9234447 out of 5

Keywords: MS, webinar, multiple sclerosis, Rocky Mountain MS Center

Id: J4prsO-FDzs

Length: 49min 12sec (2952 seconds)

Published: Tue Apr 11 2017