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    Ofatumumab

    My husband was diagnosed with RRMS about 2 months ago. His neurologist suggested Ocrevus as his first treatment choice since he has risk factors which predict a poor prognosis—older age of onset (43), being male, and having many (20) lesions including 2 in his cervical spine. Unfortunately our insurance co. has rejected this medication twice so the next option is Tysabri but that brain infection possibility terrifies me. He has an opportunity to enter a phase 3 clinical trial of a drug that works similar to Ocrevus called Ofatumumab. The fact that it’s not yet FDA approved for MS and that there are no long term results available gives me pause. Has anyone heard of this drug? Any thoughts, opinions? We are at a stage of major confusion and would greatly appreciate any insight. Thanks!

    #2
    Originally posted by Christina419 View Post
    My husband was diagnosed with RRMS about 2 months ago. His neurologist suggested Ocrevus as his first treatment choice since he has risk factors which predict a poor prognosis—older age of onset (43), being male, and having many (20) lesions including 2 in his cervical spine. Unfortunately our insurance co. has rejected this medication twice so the next option is Tysabri but that brain infection possibility terrifies me. He has an opportunity to enter a phase 3 clinical trial of a drug that works similar to Ocrevus called Ofatumumab. The fact that it’s not yet FDA approved for MS and that there are no long term results available gives me pause. Has anyone heard of this drug? Any thoughts, opinions? We are at a stage of major confusion and would greatly appreciate any insight. Thanks!

    Rituximab, the precursor to ocrelizumab, is FDA approved and essentially works the same way. It is not FDA approved for MS, but many insurance companies will cover it off-label. If approved, rituximab might be the drug you are more comfortable with.

    I wish you well...

    Comment


      #3
      Thanks a lot Marco! He has a doctor’s appt. tomorrow and we will be sure to ask about the rituximab. That sounds like a good option. I hope our insurance will cover that one.

      Comment


        #4
        Hello, Since Ocrevus is a good deal less expensive that Tysabri you may want to speak with insurance on that basis. I suspect the only problem is that Ocrevus is so new they are lagging. In any case, I hope this info will be helpful...

        https://mymsaa.org/publications/msre...17/ofatumumab/

        Ofatumumab (also known as Arzerra®)

        Experimental Medications: Monoclonal Antibody Medications

        Company: Novartis

        Given via IV infusion and also studied via subcutaneous injection
        Like Rituxan and Ocrevus, ofatumumab is an anti-CD20 monoclonal antibody. It has the potential advantage of being a human monoclonal antibody (versus antibodies from non-human species that have been modified).

        Ofatumumab has a unique target on the CD20 molecule and is approved for certain forms of leukemia. Genmab, the pharmaceutical company developing this medication prior to Novartis, announced positive interim results for a Phase II safety and pharmacokinetics (how the body processes the drug) study of ofatumumab in 2010.

        This study had 38 people with RRMS who were randomized to ofatumumab or placebo in a cross-over design. Statistically, the number of gadolinium-enhancing lesions and new or enlarging T2 lesions was significantly less in patients treated with ofatumumab compared to placebo in this 48-week study.

        Results from MIRROR, a 12-week Phase II study comparing several doses of ofatumumab in RRMS, were reported in 2014.15 In the MIRROR study, 231 people with RRMS were assigned to one of four doses of ofatumumab or placebo.

        This “dose-ranging study” included doses of 3 mg every 12 weeks, 30 mg every 12 weeks, 60 mg every 12 weeks, and 60 mg every four weeks. After 12 weeks, the placebo group received 3 mg of ofatumumab. The study treatments were given for 24 weeks. The primary endpoint was suppression of MRI-lesion activity during the first 12 weeks. Results suggested a 90-percent or greater reduction in the active, enhancing lesions for all cumulative doses of ofatumumab 30 mg or greater.

        Five serious adverse events were reported, all in the highest-dose treatment group. This study design allows for an “optimal dose” to be utilized in future studies of ofatumumab. The aim is to achieve suppression of MS-disease activity without completely eliminating B cells, with the intent of minimizing adverse events.

        The MIRROR trial extension data presented in fall 2015 demonstrated continued suppression of new MRI lesions at week 48 and a dose-responsive effect on B cells. The success of these early trials prompted a Phase III study program with two trials in 2016.

        The trials, ASCLEPIOS I and II, are slated to enroll 900 patients each to study the effect of ofatumumab versus the FDA-approved oral medication, Aubagio® (teriflunomide). The trial time is 24 weeks plus an extension.

        Ofatumumab is intriguing – not only because it is a unique but similar drug to Rituxan and Ocrevus – but because it has an easier route of administration, as it is dosed subcutaneously every four weeks rather than via IV infusion.

        https://mymsaa.org/publications/msre...17/ofatumumab/

        Comment


          #5
          This information was extremely helpful Myoak. At least now I know that if he can’t get on Ocrevus, this medication is an acceptable, well-studied alternative. One issue is that the clinical trial he can get into is in Colorado and we live in Ohio so flying there every 2 weeks for 12 weeks is quite inconvenient...but at least we have a last resort option.

          It is shocking to me that an insurance company would deny someone the medication their doctor prescribes! I hear of horror stories about insurance cos. but this is the first time I have had to deal with it directly and it is adding so much stress to an already extremely stressful situation. I feel like we are losing time dealing with bureaucracy when I know how important it is to start treatment as soon as possible to optimize outcome.

          Thanks again for the extremely useful information. I can now have a much more educated discussion with his doctor about it today.

          Comment


            #6
            I hope everything goes well for your husband!

            I'm glad the information was helpful.

            May I share a few thoughts? I am going to be very frank.

            First, it appears there will be some people will be getting placebo in ASCLEPIOS I and II trials and the placebo appears to be Aubagio (teriflunomide) which has small chance of controlling MS.

            If your husband's MS is aggressive, perhaps, his MS treatment should reflect that.

            In my unqualified, layman opinion I believe the treatment with the highest probability for effectively treating MS is HSCT. If HSCT is not an option, and for most it isn't (personally I would be very reluctant to undergo HSCT outside the US!!!). Tysabri would be next on the list.

            I realize PML risk scares you. But aggressive MS can be pretty scary, too.

            The JC virus causes PML. If your husband is JCV- he cannot get PML unless he converts to positive and a host of other things occur, also. My wife was on Tysabri and was JCV positive with a high titer for many, many years so just because you are JCV+ does not mean you will get PML.

            There is plenty of good information on this site about PML risk and Tysabri (natalizumab).

            I can tell you that PML risk is greatly reduced in those who are JCV by going 6 weeks between doses rather than the standard 4 weeks.

            However, even in those who are JCV+, getting PML during the first 2 years on Tysabri is extremely rare.

            The plain truth is that there is nothing as effective as Tysabri outside HSCT. Yes, that is only an opinion but it is based on literally decades of study and experience as an extremely interested person. I could write page after page supporting that opinion. I am traveling at the moment and cannot but I did want to take time at this critical moment in your husband's life and make this expression to you.

            Please don't fear Tysabri more than you fear MS.

            Sometimes, I wonder if difficulty is not one way God has of directing our course of action. In other words, if things didn't go to hell on one course would we ever choose another? Why would we change direction if the way we are going is easy?

            But when I encounter huge problems on one path I understand there may be good reasons for those difficulties and I look for new and different openings. Difficulty is what gets me looking and considering a new direction, not ease. And, if things fall into place regarding a new direction and peace settles in my heart about it... well, for me, that is guidance leading me in that new direction, the one right for me.

            We are not all the same! Each of us may interpret data in an individual and personal way. That is fine and is to be expected.

            In my opinion, the best chance your husband has for the most normal life possible is Tysabri because it is demonstrably the most effective in real world experience. Be sure your husband is well informed, I trust you will.

            Best wishes for your highest success!

            Comment


              #7
              I wish I had joined this board sooner. I am so impressed with the extensive knowledge and compassion I am finding here. I have been researching this disease and its various treatment options tirelessly since my husband’s shockingly unexpected diagnosis at the end of July. It has been a scary and tumultuous time. He is actually taking it much better than I am and I try hard to hide my feelings of fear from him so as not to dampen his optimistic attitude. He has always been the strong unflappable one and now suddenly after 16 years of marriage I find myself in this very unfamiliar position of trying to show a brave and confident front when inside I feel nothing but helplessness and uncertainty in trying to navigate these uncharted waters.

              Myoak, I appreciate your frankness and your wise words. Even though my husband’s MRI looked bad, he actually has no symptoms right now. He is very fit and now follows a strict diet. His only symptom was on and off numbness in his one foot which is why he had the MRI leading to the diagnosis, but that has since gone away.

              It turns out he is highly JCV+ so although I know the PML risk is extremely low, I just know that with my hypervigilant personality, I would be a nervous wreck every time he so much as got a headache. I believe that it is the most effective drug and his doctor confirmed that, but also said Ocrevus and Ofatumumab were proving to be just as effective without the PML risk. The good news is that the Ofatumumab study is a new one that is testing the mode of delivery (auto inject vs syringe) and everyone in the study receives the actual drug. If for whatever reason he doesn’t qualify, his doctor recommended Gilenya and said “it’s as if Ocrevus, Tysabri, and Ofatumumab are Ferraris and Gilenya is a Lexus—it’s still a good reliable car.” I was not at all convinced by that comparison. Why the hell would I want a Lexus if I could have a Ferrari?!?

              This difficult and convoluted path is certainly forcing us to do some serious contemplation to figure out the best way forward. I have faith God will help steer us in the right direction and all will work out as it should. Thank you for taking the time to write such an informative and thoughtful message. It’s reassuring to know that during the darkest of times, there are such kind and generous people out there willing to give support and guidance 🌺

              Comment


                #8
                Thank you for your kind expressions. You are so welcome for whatever assistance may be helping at this time.

                So, a couple additional thoughts...

                Don't give up on Ocrevus with your insurance if that is what fits best at this time. And, I agree, it is likely the best option in a situation of having a high JCV titer and PML apprehension. You rightfully want the most effective med possible and Ocrevus is a very good one.

                I think you have leverage with your insurance because Ocrevus costs less than Tysabri. Ocrevus costs around $34,000 every six months (that is the cost on the invoice have I from 2 weeks ago.) We were paying $5700 per infusion of Tysabri (drug cost only, not infusion cost, I am strictly comparing drug cost here) 2 years ago. They increase prices every year, at least they have, so Tysabri per infusion has to be around $6,000 making it cost $78,000 per year because it is infused every 4 weeks or 13 infusions per year. It is not infused monthly... there are 13 infusions per year, not 12.

                The frequency of Tysabri infusions are every 4 weeks or 13 times a year the first two years or unless or until dose is extended. I tell you this so you can articulate to your insurance that they are not doing their fiduciary obligation by forcing a more expensive medicine on your husband. I would be willing to bet if you raise enough hell they will grant you approval for Ocrevus if they were willing to pay for Tysabri. Contact everyone you can... the president of the insurance company, for one. Tell him/her that you want a lesser expensive medicine that would save the company money. Work that angle every chance you get. The squeaky wheel gets the grease. Squeak a lot.

                Next, I would try for Ofatumumab trial. You live in Ohio. There are great MS clinics at Cleveland, Columbus, and not too far from NW Ohio in Farmington Hills MI. It is hard for me to believe none of those centers would not be participating in the trial you seek. Call and ask, if you wish. If you happen to choose the Michigan site schedule only with Dr. Martin Belkin and you will be very happy you did, IMO.

                Work the insurance like heck and I bet they will give in, IF YOU PERSIST!

                Next, try to find a clinic close to you for the trial you seek. And yes, IMO, that trial, if you are certain of getting the drug is much preferable to Gilenya.

                Good Luck! Hang in there and get what you want!

                Comment


                  #9
                  Myoak, we have started looking into clinical trials closer to us and there do seem to be a couple that look promising but I’m not sure of eligibility requirements or recruiting status. I will call on Monday to get more information.

                  As far as the insurance, his doctor recommended Tysabri but because of high JC numbers did not submit it to the insurance co. They likely would have rejected that too. It sounded like the options were down to the clinical trial or Gilenya. My fear in all of this is that we are losing time in getting started on any treatment and I know that can be detrimental. His first MRI showing the demyelination was at the end of June so it’s already been 2 1/2 months and who knows how long he had the lesions before that.

                  The trial we found that is close by starts at the end of October so that’s another month lost. His doctor didn’t seem too concerned but I keep thinking that there may be preventable damage being done and that possibility worries me. I guess we have no choice but to wait and hope this trial works out. Thanks for the very useful advice and encouragement!

                  Comment


                    #10
                    Originally posted by Christina419 View Post
                    Myoak, we have started looking into clinical trials closer to us and there do seem to be a couple that look promising but I’m not sure of eligibility requirements or recruiting status. I will call on Monday to get more information.

                    As far as the insurance, his doctor recommended Tysabri but because of high JC numbers did not submit it to the insurance co. They likely would have rejected that too. It sounded like the options were down to the clinical trial or Gilenya. My fear in all of this is that we are losing time in getting started on any treatment and I know that can be detrimental. His first MRI showing the demyelination was at the end of June so it’s already been 2 1/2 months and who knows how long he had the lesions before that.

                    The trial we found that is close by starts at the end of October so that’s another month lost. His doctor didn’t seem too concerned but I keep thinking that there may be preventable damage being done and that possibility worries me. I guess we have no choice but to wait and hope this trial works out. Thanks for the very useful advice and encouragement!
                    Hello Christina,

                    It may be prudent for you to call your insurance to make certain what MS drugs are covered. It might also be a time to mention Ocrevus is priced under several of the other meds... and even though I haven't researched it, I would bet Ocrevus costs less per year than Gilenya. You should be able to look it up. You know the cost of Ocrevus, $68,000. I think you should question your insurance about their policy... something along the lines of... why does insurance want to pay more for a less effective MS med?... especially since a less effective MS med inherently implies more cost to insurance for treatment of any additional problems seen on lesser effective medicines? That is such a pertinent line of questioning. Insurance companies are not fools; they adjust when money makes sense. Don't be surprised if they change their policy about covering Ocrevus, if that is what you want.

                    Please look up MS med comparisons at this site to see that Ocrevus is more effective than most. And, it costs less than several.

                    In any case, you need to hear directly from your insurance what they will and will not cover. Please do call because it is so easy for things to get screwed up, people make mistakes all the time, and you may actually have coverage you are not aware of at the moment.

                    Your preference may be for Ofatumumab and I see nothing wrong at all in that choice.

                    As far as the time to the trial... Oh my goodness! I think you would have to be out of your mind not to wait until late October if you could get into the trial you want. In the long run your husband has better chances of being healthier on the better, more effective treatment than Gilenya. Just make darn sure your husband would be getting Ofatumumab not teriflunomide which is Aubagio.

                    If the place you call is not recruiting be sure to ask for other MS centers where that trial is recruiting. Obviously, the cost of treatment would be zero so that is a plus for everyone.

                    Calm your fears and stay steady. Chances are that your husband is RRMS and barring an immediate flare-up, you guys have plenty of time to get this right. Most of my bad decisions were made hurriedly. There is always time for getting it right. The long run is always so much better when we do.

                    Good Luck! Stay the course, you are doing so well, bless your heart.

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