Tuesday, February 12, 2013 12:00 pm – 1:00 pm EST This discussion is archived.

Acthar, the only FDA-approved drug for myositis, has been available to treat myositis for years, but just recently has drawn attention because of Dr. Levine’s small study resulting in the improvement of several patients who had not responded to other drugs.

Dr. Levine, who is on TMA’s medical advisory board, is a member of Phoenix Neurological Associates. He is the founder and director of the Samaritan ALS clinic and co-director of the neurophysiology department at Banner Good Samaritan Medical Center.

Ask a Question
TMA:

Dr. Todd Levine:

I wanted to thank you for asking me here this afternoon. I will try to answer as many questions as possible.

  • Is Acthar useful for IBM patients?

    Participant:

    Is Acthar useful for IBM patients? Does this medication have any side effects? Has it been tried on IBM patients? Do you recommend a 60 years old patient with IBM take this medication? Where I can get this medication?

    Dr. Todd Levine:

    Acthar has not been studied in IBM, nor is it approved for patients with IBM. There is no way for me to know if it would benefit patients with IBM.

  • Is Acthar a possible treatment for patients with other muscle diseases?

    Participant:

    Is Acthar a possible treatment for patient with DM/lupus, severe muscle wasting and weakness, ILD, and history of allergies to all previous immuno-suppressant drugs? Rituxan not advised due to allergies.

    Dr. Todd Levine:

    Acthar is primarily being considered in patients who have failed multiple other therapies, so you could discuss it with your doctor.

  • Number of Studies

    Participant:

    A recent article by Andrew Pollack in the New York Times said Acthar was “developed in the 1950s, by a division of Armour, the meatpacking company that once ruled the Union Stock Yards of Chicago. As in the 1950s Acthar is still extracted from the pituitary glands of slaughtered pigs—essentially a byproduct of the meatpacking industry. In 2007, it (Questcor) raised the price overnight, to more than $23,000 a vial.” The current price is $28,000 for a 5-milliliter vial, according to the article. Has there been any trials or studies other than your recent small 5 patient study?

    Dr. Todd Levine:

    There are small studies underway to evaluate the utility of Acthar but there are no large studies planned that I am aware of. There is a large national registry that I am coordinating to see the effects of Acthar, so we hope in the next year or two to have a better understanding.

  • Skin Symptoms

    Participant:

    Does Acthar or methotrexate work better for the skin symptoms of dermatomyositis?

    Dr. Todd Levine:

    We do not know the answer to this question.

  • Acthar vs. Prednisone

    Participant:

    Why would Acthar be prescribed instead of prednisone?

    Dr. Todd Levine:

    Prednisone would be used first line in most cases, but if patients fail prednisone then your doctor could consider the use of Acthar.

  • Acthar vs. Other Medications

    Participant:

    What does Acthar do that other medications used for DM or PM cannot do?

    Dr. Todd Levine:

    Acthar binds to receptors called melanocortin receptors that are found on immune cells and may work to change the immune system differently than other medications and this could improve the immune response in PM/DM.

  • Insurance Coverage Options

    Participant:

    If my insurance will not pay for use of Acthar, are there any options for me to have it be covered?

    Dr. Todd Levine:

    The company does have patient assistance programs to help in these cases.

  • Why has this treatment not been used before for myositis?

    Participant:

    Why has this treatment not been used before for myositis?

    Dr. Todd Levine:

    I don’t know..It has been FDA approved for over 50 years.

  • Acthar Results

    Participant:

    What results have you seen in patients treated with Acthar?

    Dr. Todd Levine:

    I have seen patients who have not responded to several medications do quite well with Acthar.

  • Acthar Insurance Coverage

    Participant:

    If the FDA approves of Acthar, why would some insurers not be willing to cover it?

    Dr. Todd Levine:

    Hopefully they will. It has been covered in all of my PM/DM patients so far as long as they have failed other therapies first.

  • How do specialists receive the most recent continuing medical education with myositis-related diseases?

    Participant:

    Are papers presented at the Rheumatology and Neurology Conferences and Symposiums on treatment for more severe cases of myositis with other overlap diseases? My concern is how many specialists with limited experience or even a lot of experience receive the most recent continuing medical education with myositis-related diseases. I have been on about everything with no remission since 2007 and continue to get worse.

    Dr. Todd Levine:

    This type of information is shared at conferences as well as journals. So we are trying to figure out better therapies all the time.

  • People with JO1 antibodies

    Participant:

    Is there indication yet on how this drug will work for people with JO1 antibodies?

    Dr. Todd Levine:

    None of the 5 patients I published had Jo-1 antibodies, so I do not have any experience with this subset. This is one of the questions we are trying to address with the registry I am running.

  • Can Acthar help strengthen my muscles?

    Participant:

    I am 42 years old female. I have PM for 13 years. My CPK numbers are good and almost normal in the last 3 years but my muscles are weak that I can’t walk stairs or get up from the floor. Do you think Acthar my help strengthen my muscles ?

    Dr. Todd Levine:

    We do not know who the best candidates are for Acthar therapy. Since it is an FDA approved therapy it is reasonable to discuss it with your doctor.

  • Would Acthar be an effective replacement for Prednisone?

    Participant:

    I am very sensitive to the side effects of prednisone. Even 5 mg causes me irritability. Would Acthar be an effective replacement? Are there fewer side effects, and are there other side effects that prednisone does not have?

    Dr. Todd Levine:

    Acthar causes your body to release its own steroids as opposed to taking outside steroids. The potential side effects are the same as steroids. In my published case series and longer-term follow up the side effects seem to be less than prednisone but we do not know if there is a difference, so you would have to watch for the same issues.

  • Can I take Acthar with prednisone?

    Participant:

    I am a DM patient. Prednisone hasn’t really helped me but my doctor believes it is keeping me from getting worse. Can I take Acthar with prednisone?

    Dr. Todd Levine:

    I have treated patient with Acthar while they are on prednisone and this was published in my case series. One would have to watch for side effects and potential interactions but I did not see any in a small number of patients.

  • Acthar and Mood Swings

    Participant:

    My physician weaned me off prednisone because the mood swings were too unpleasant. Would Acthar be a better choice? I have PM.

    Dr. Todd Levine:

    It is hard to know, but it may be worth discussing this with your doctor.

  • Acthar and Osteoperosis

    Participant:

    I am a dermatomyositis patient. I have severe osteoporosis, presumably from long-term prednisone use. Would Acthar also cause osteoporosis?

    Dr. Todd Levine:

    Acthar can still cause osteoporosis.

  • Can Acthar be administered at home?

    Participant:

    Is Acthar something I can inject at home, or is it always done in the physician’s office?

    Dr. Todd Levine:

    Acthar is available as a self injection so all of my patients do it at their home themselves. The company offers some training as well free of charge.

  • My neurologist is unfamiliar with Acthar.

    Participant:

    I was talking to my neurologist about Acthar and he said he was unfamiliar with it. I am wondering why he has never considered it in my care.

    Dr. Todd Levine:

    The drug has been FDA approved and used to treat other autoimmune diseases like MS. There is not much data on its use in PM/DM. I think doctors will start to hear more about it and start to consider it more.

  • Should I ask my rheumatologist to switch me to Acthar?

    Participant:

    I am on prednisone and it is working well and I am getting stronger. I have PM. However, I read that Acthar is better than prednisone because it stimulates your body’s natural steroid production. Should I ask my rheumatologist to switch me to Acthar?

    Dr. Todd Levine:

    You are correct about the difference between exogenous steroids, ones you take from pills or injections and Acthar which causes your body to produce its own. There have been no studies to say which is better.

  • Recommendation for someone with PM

    Participant:

    I have PM and my situation is getting worse. Prednisone did not help me. My physician tried Rituxan but I seemed to be prone to infections. She is now trying to decide between trying Acthar and IVIG. I still take methotrexate. What would be your recommendations?

    Dr. Todd Levine:

    I am sorry but I can’t comment on individual cases but it sounds like your doctor is considering good options. You have to discuss it with her.

  • Acthar for someone with PM and ILD?

    Participant:

    I have PM and now I have been diagnosed with ILD despite long-term steroids and cellcept, which haven’t helped much. Would Acthar be a possibility for me?

    Dr. Todd Levine:

    I have used Acthar in one patient with a history of ILD and she did well. However it has not been studied in large numbers. Again it would be worth talking to your doctor.

  • Methotrexate and Acthar

    Participant:

    As a woman with PM, I tried prednisone without success. I am currently still taking methotrexate. If I was trying Acthar, would it be taken in conjunction with methotrexate, or have the studies found it works better by itself?

    Dr. Todd Levine:

    The case series I published looked at patients who took Acthar along with other drugs. It was used for very refractory patients. The decision though would need to be made by your doctor.

  • Acthar for PM

    Participant:

    Would you recommend Acthar for someone with PM diagnosed 17 years ago who has been resistant to medications and IVIG, experiencing restrictive lung disease and dropped head due to severely deteriorated para spinal muscles?

    Dr. Todd Levine:

    I think most physicians who have been using Acthar for PM/DM are using it in their difficult refractory cases.

  • Negative Study Side Effects

    Participant:

    What negative side effects were observed in your study?

    Dr. Todd Levine:

    My case series treated patients for three months only and the only side effect was some taste disturbance. Longer term studies are needed to know the adverse effects. I am hoping the registry will help us understand this data better.

  • Switching to Acthar

    Participant:

    If a patient is responding successfully to prednisone, what would be the advantage of switching to Acthar?

    Dr. Todd Levine:

    It is very hard to mess with success. I usually don’t change a patient who is doing well unless side effects become an issue.

  • Achtar trial similar to the RIM trial for rituximab?

    Participant:

    Are there plans to conduct an Achtar trial similar to the RIM trial for rituximab to find the most effective treatment for DM, PM patients?

    Dr. Todd Levine:

    There is a large national registry underway to study how patients respond to Acthar but at the moment because of the time and expense of a study like RIM I am unaware of any plans for a similarly sized study with Acthar.

  • Do you think Acthar my help me strengthen my muscles?

    Participant:

    I am 42 year old female. I have had PM 13 years. My CPK numbers are good and almost normal for the last 3 years but my muscles are so weak that I can’t walk up stairs or get up from the floor. Do you think Acthar my help me strengthen my muscles ?

    Dr. Todd Levine:

    I think when new drugs become available it tends to be used in the toughest cases that are refractory to standard drugs. So it may be worth talking to your doctor about Acthar.

  • Does the manufacturer have any programs to make the drug available to people whose insurance doesn't want to cover it?

    Participant:

    It appears that my insurance company does not want to pay for Acthar. Does the manufacturer have any programs to make the drug available? My physician believes it might be a good choice for me.

    Dr. Todd Levine:

    There are patient assistance programs run by the company. When I last heard the company had gievn out over 150 million dollars in free drugs.

  • How long does it take for Acthar to take effect in the body?

    Participant:

    How long does it take for Acthar to take effect in the body?

    Dr. Todd Levine:

    In the case series I published most patients felt an improvement after three months but this was only 5 patients. So it would need to be something that you work through with your doctor.

  • Recent Patient Results

    Participant:

    Can you discuss more recent patients results with acthar, especially since your prior study? Also, can you discuss if there is still a positive reception from insurers on the reimbursement front?

    Dr. Todd Levine:

    I have prescribed it to about 5 other patients since the opriginal 5 and the majority have done well and felt that it helped. Insurance companies have approved all of my patients but that is because they have failed other therapies- in most cases many other therapies. The drug company has a very good patient program to help get the drug covered by insurance.

  • Any advice as to how to best ensure I am not producing too much cortisol?

    Participant:

    I have severe psoriatic arthritis, mild rheumatoid arthritis and mild myositis. I can not tolerate prednisone. Insurance has approved Acthar and I received the medication in the mail and am very excited. I do have anxiety as I am fearful of becoming cushinoid with too much cortisol. My rheumatologist said the day after my first Acthar injection I will do a 24-hr urinary cortisol test to ensure I am not producing too much cortisol. She wants a follow up in a week as she said it takes a few days to begin to work. I am taking 40 units twice a week. I am not sure if I should take the injection in the am or evening. Would one 24 urine cortisol test the day after first injection be sufficient to determine if I am taking a safe dose if it takes several days to get into my system? Would I not need to take the urine cortisol after the medicine is optimized? I am running out of medication options with the psoriatic arthritis and know I have to try as I am unable to stand/walk for long & in a wheel chair. My quality of life is poor. Any advice you can share as to how to best ensure I am not producing too much cortisol would be greatly appreciated.

    Dr. Todd Levine:

    There is no way for you to control how much cortisol you produce. The doctor is paying very close attention to this and can adjust the dose of the medication based on the cortisol results if she wishes. It sounds like you have a good doctor and you two are working as a team to figure out how best to use Acthar. Good luck.

  • Where can we read your published cases?

    Participant:

    Where can we read your published cases that you spoke of earlier in this session?

    Dr. Todd Levine:

    It was published in a journal called Drug Design development and therapy in June of 2012. It may be available on the myositis webpage if not you can google acthar and myositis and find it.
    Note:  Find Dr. Levine’s Study at:  http://www.myositis.org/storage/documents/Levine_paper.pdf.

  • About how many other doctors are using Acthar in difficult refractory cases?

    Participant:

    “…..most physicians who have been using Acthar for PM/DM are using it in their difficult refractory cases” You said this earlier. About how many others doctors are using this drug in this type of situation? Is there any way to find out who these doctors are and where they treat?

    Dr. Todd Levine:

    I know of dozens who have begun to use it in PM/DM. I don’t know how you would find them in your areas though. Sorry.

  • Best Time of Day for Injection?

    Participant:

    Is there a time of day that is better to take the injection, am or pm?

    Dr. Todd Levine:

    Most take it in the morning.

  • Cost Prohibitive

    Participant:

    How many injections and what quantity per injection is usually prescribed with Acthar? At a cost of $28,000 per 5 ml vial, it appears to be cost prohibitive.

    Dr. Todd Levine:

    It is very expensive, but so is IVIG. And most insurers pay for IVIG. The dosing is not set so the cost depends on how often and how many units your doctor prescribes.

  • I just recently completed a 12 week Acthar session

    Participant:

    I am a 43 year old female diagnosed with PM. Just recently completed a 12 week Acthar session. Is there a timeframe between each session that is “normal” to wait before starting another one?

    Dr. Todd Levine:

    I don’t believe there is anything set in stone. I have had some patients that I have treated continuously now for up to nine months and other patients who I treat for 12 weeks and then they do well and I have chosen to stop and see what happens.It is all individualized. Like the disease is different in everyone, so is the therapy.

  • Why did you become interested in trying Acthar?

    Participant:

    Why did you become interested in trying Acthar for your patients when few other doctors seemed to be using it for myositis?

    Dr. Todd Levine:

    It was a drug that was used by neurologists to treat multiple sclerosis patients who did not respond to steroids. So it seemed to make sense to try it in other autoimmune diseases where steroids had not worked. And it was FDA approved. And I guess for my really difficult to treat patients I was running out of other options.

  • Publishing Acthar results for other doctors?

    Participant:

    Are you or will you or any of the other doctors using Acthar, try to gather their information and results to publish or make available to other doctors not yet using it?

    Dr. Todd Levine:

    Yes. The company has paid for and sponsored a registry that I initiated to try to do just this. If we can collect data on the patients who receive Acthar over the next two years we will know much more about it then we do know and we will also help make other doctors aware of whether it works.

  • What info do you gather to say that Acthar has been effective in your patients?

    Participant:

    What criteria, tests and info do you gather to say that Acthar has been effective in your patients?

    Dr. Todd Levine:

    I primarily follow their muscle strength, so I am looking to see if they get stronger. In some of the DM patients the rash has also improved.

  • Would you recommend rituximab or Acthar?

    Participant:

    I am a male of 40, jo-1, on IVIG & imuran for last year. CPK is 3000, feeling ok, sit most of the day. If I walk or stand for more than one hour, then muscles are painful by end of day. I am off methotrexate and prednisone for 6 months. I have fatty liver. Would you recommend rituximab or Acthar?

    Dr. Todd Levine:

    You would be considered a refractory patient who has tried many other therapies. Acthar could certainly be something to discuss with your doctor.

  • Did the FDA have to approve Acthar for DM/PM in recent years?

    Participant:

    My understanding that this drug has been FDA approved for a long time for other uses than DM/PM. Did the FDA have to approve it for DM/PM in recent years? If so, what did they use as their guidelines/ proof for use in DM/PM?

    Dr. Todd Levine:

    In 2010 the FDA reexamined the label with all of the indications for Acthar and decided to leave PM/DM as an indicated disease. This was not based on any recent data or studies.

TMA:

TMA would like to extend a special thanks to Dr. Levine for being with us and graciously spending the time to answer your questions. This concludes today’s discussion. Thanks to all the members who participated today.

Dr. Todd Levine:

Thank you all for your great questions today. I hope you found this helpful and I wanted to thank the TMA for arranging this.