Acthar has been assessed for treatment of dermatomyositis (DM) and polymyositis (PM) in patients from a number of clinical settings. All of the patients studied in these settings had DM or PM.

Dr. Aggarwal Open-labelProspective Study

A total of 11 patients were included at the start of this study. (One patient dropped out of the study for reasons not related to Acthar treatment. This patient was not included in the study results.) Of the remaining 10 patients, all of them were treated with Acthar. Six patients had DM and 4 had PM. DM and PM patients did not differ in their response to treatment.

  • Seven out of the 10 patients saw an improvement in their condition:
    • All patients decreased or discontinued steroid use
    • Two patients saw some improvement, but this improvement did not continue to the end of the study. Another patient saw no improvement
  • Serious side effects reported were viral infections, bone loss, and chest pain

 

Dr. Levine Registry

In this review, 24 patients with DM or PM were treated with Acthar. Seven patients had DM and 17 had PM. More than half of these patients experienced an improvement in their disease activity. Ten of the patients experienced mild to moderate side effects. These included worsening of diabetes and swelling of the legs.

A total of 4 patients—2 with DM and 2 with PM—were treated with Acthar.

  • Three patients saw an improvement, while 1 patient saw no change:
    • Two patients with PM experienced an improvement in muscle strength and a decrease in muscle pain 
    • One of the 2 patients with DM saw her rash improve; the other saw no change
    • Steroid dose was lowered for the 3 patients who saw improvement
  • One patient had blurry vision during Acthar treatment, but it resolved before treatment was stopped

A total of 5 patients were treated with Acthar. Three of them had DM and 2 of them had PM. All 5 patients experienced a decrease in their disease activity:

  • All 5 saw an increase in muscle strength based on muscle testing
  • Two of the 3 patients with DM saw an improvement in their skin symptoms
  • One patient with DM experienced a decrease in joint pain

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM).

Acthar is injected beneath the skin or into the muscle.

Acthar is not a cure. Though Acthar has been shown to help some patients, not all patients may experience the same results. Keep in mind that patients observed in clinical settings were on several treatments in addition to Acthar. The results seen in these patients may not all be due to Acthar.

Important safety information
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DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Allergies to pig-derived proteins
  • Have been given or are about to receive a live or live attenuated vaccine
  • Suspected congenital infections (in children under 2 years of age)
  • If you have been told that you have Cushing’s syndrome or Addison’s disease

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking. Include all nonprescription medicines, vitamins, and herbal supplements that you are taking.

What is H.P. Acthar® Gel?
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Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM).

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus).

Acthar is a prescription add-on medicine for the short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis.

Acthar is injected beneath the skin or into the muscle.

Important safety information

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Allergies to pig-derived proteins
  • Have been given or are about to receive a live or live attenuated vaccine
  • Suspected congenital infections (in children under 2 years of age)
  • If you have been told that you have Cushing’s syndrome or Addison’s disease

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking. Include all nonprescription medicines, vitamins, and herbal supplements that you are taking.

What is H.P. Acthar® Gel?

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM).

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus).

Acthar is a prescription add-on medicine for the short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis.

Acthar is injected beneath the skin or into the muscle.

What is the most important information I should know about Acthar?

  • Never inject Acthar directly into a vein
  • Always inject Acthar beneath the skin or into the muscle
  • Follow your doctor’s instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor’s appointments. It is important for the doctor to monitor you while taking Acthar

Acthar and corticosteroids have similar side effects.

  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long term, your body may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, or retain too much fluid. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt and taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping
  • If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
  • You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your body may develop allergies to Acthar. Signs of allergic reaction are:
    • Skin rash and itching
    • Swelling of the face, tongue, lips, or throat
    • Trouble breathing
  • Long-term Acthar use can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
  • Acthar may cause osteoporosis (weak bones)
  • Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan on becoming pregnant

What are the most common side effects of Acthar?

The most common side effects of Acthar are similar to those of steroids. They include:

  • Fluid retention
  • High blood sugar
  • High blood pressure
  • Behavior and mood changes
  • Changes in appetite and weight

Specific side effects in children under 2 years of age include:

  • Increased risk of infections
  • High blood pressure
  • Irritability
  • Symptoms of Cushing’s syndrome
  • Thickening of the heart muscle (cardiac hypertrophy)
  • Weight gain

The above side effects may also be seen in adults and children over 2 years of age.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-778-7898.

Please see full Prescribing Information