Dermatomyositis and Polymyositis patients now have another treatment option to consider.
It's called Acthar and it's made by a company called Questcor Pharmaceutcals. A paper detailing the recent treatment of five dermatomyositis and polymyositis patients with Acthar was recently published. We've put together a Q&A to enable you to be more informed about this treatment option.
What is Acthar?
H.P. Acthar Gel, commonly known as Acthar, is a prescription medication that is FDA approved for the treatment of dermatomyositis and polymyositis. Acthar contains the hormone ACTH, which stands for adrenocorticotropin ("a-DRE-no-cor-ti-co-tro-pin"). Acthar is a gel when refrigerated; at room temperature, it changes to liquid form, ready for injection.
Why haven't I heard of Acthar before?
Acthar was originally approved by the FDA in 1952. It is approved for use in 19 different conditions, including dermatomyositis and polymyositis.
Questcor is a small specialty pharmaceutical company based in Hayward, California. Questcor acquired Acthar from Aventis in 2001. Aventis was going to stop manufacturing Acthar when Questcor stepped in and purchased the product. The company then made a major investment in the product's manufacturing capabilities to ensure Acthar would be available to anyone who needed it. Questcor also started actively researching Acthar to determine what patient populations would benefit most from the drug.
Questcor is now marketing the product in four treatment categories: infantile spasms, MS relapses, proteinuria related to nephrotic syndrome (a kidney disease) and now dermatomyositis and polymyositis. The company is focused on educating physicians about Acthar and conducting more research into how it works.
How does Acthar work?
Acthar is designed to provide a prolonged release of the medication after it is injected. Acthar is not a steroid; it works by helping your body produce its own natural steroid hormones, such as cortisol, corticosterone, and aldosterone.
How is Acthar administered?
Acthar is an injection that can be given subcutaneously (beneath the skin) or intramuscularly (into the muscle). Acthar can be used when and where it is most convenient for you. It can be self-injected or given to you by a friend, family member, caregiver, or your healthcare provider. Questcor, the maker of Acthar, has a free service that allows you to have a licensed nurse visit you at your home and train you on how to self-inject.
What patient is right for Acthar?
Only your healthcare provider can make that determination. Typically, Acthar is used when other medications do not completely relieve all of your symptoms. It can also be used if you are having difficulty dealing with the side effects of other medications used for dermatomyositis and polymyositis.
Are there any studies showing Acthar's effectiveness as a treatment for PM and DM?
There was a recent study published in the peer-review journal Drug Design, Development and Therapy on a retrospective case series evaluating Acthar in the treatment of PM and DM. Acthar was administered to five patients who had previously failed multiple steroid and immunosuppressant treatment regimens. The patients received injections of Acthar over the course of 12 weeks or more. Improvement in PM and DM symptoms related to disease exacerbations was seen in all five patients. Symptom improvements included increased muscle strength, resolution of disease-related skin manifestations and improvements in the ability to perform tasks associated with daily living. All of these patients tolerated the treatment well with no significant side effects reported. The paper, "Treating refractory dermatomyositis or polymyositis with adrenocorticotropic hormone gel: a retrospective case series," was authored by Dr. Todd Levine, M.D., Co-Director of the Neurophysiology Department at Banner Good Samaritan Medical Center, Assistant Professor at the University of Arizona in Neurology, and Member of Phoenix Neurological Associates. Dr. Levine also serves on the Medical Advisory Board of The Myositis Association.
How safe is Acthar?
ACTH (the hormone within Acthar) has a well-established safety profile . Common side effects of Acthar are similar to those seen with steroid medicines and may include fluid retention, change in glucose tolerance, increased blood pressure, behavior or mood changes, increased appetite, or weight gain.
Can I get financial assistance for Acthar?
Questcor, the maker of Acthar, has the Acthar Support & Access Program (A.S.A.P.) which offers a wide range of support. A.S.A.P. is a free service provided by Questcor that works directly with your healthcare provider to secure the best possible insurance coverage for you with the lowest possible patient copay. Typical copayments for Acthar have been, on average, $50 or less. A.S.A.P offers 100 percent copay assistance for qualifying patients. Acthar is available at no cost for qualified uninsured or underinsured patients through Questcor's patient assistance programs. To learn more about A.S.A.P. visit www.acthar.com or call A.S.A.P. at 1-888-435-2284.
How do I obtain Acthar?
Once your doctor has prescribed Acthar, the order is processed at a specialty pharmacy that delivers Acthar directly to your home.
Where can I get more information?
For more information on Acthar, please consult your healthcare provider. Questcor supplies information on Acthar at www.acthar.com.