Acthar Results

Learn how Acthar helped patients in 2 separate studies

Taking Acthar helped some patients with symptomatic sarcoidosis:

Decrease their steroid dose

Manage their symptoms

In one study, a number of patients taking Acthar were able to lower their steroid use

The main goal of this prospective study was to find out if taking Acthar allows patients to decrease their steroid dose. The entire study lasted a total of 24 weeks.

A total of 18 patients took part in this study. All of them were diagnosed with symptomatic sarcoidosis. In addition, these patients:

Were all taking at least 5 mg of steroids for 3 or more months

Experienced a 5% loss in lung function (breathing problems) in the year before the study

Notable results:

During the course of the study, doctors checked the patients on a regular basis. Some positive signs were identified. These included:

Significant improvement of oxygen transfer from the lungs into the blood. This was observed after 24 weeks of treatment

Much less fatigue. This was noted at week 24 of the study

At the end of the study, the data showed a number of outcomes:

More than half of the patients were able to reduce their steroid dose by at least half. Nine out of 16 patients who completed the study decreased their steroid use by at least 50%

One-third of these patients stopped taking steroids completely. By the end of the study (24 weeks), 3 patients stopped taking steroids

Some patients were not able to reduce their steroid dose. Three patients continued on their full steroid dose for the entire study (24 weeks)

There were certain limits of this study.

Acthar is not a cure. Though Acthar has been shown to help some patients, not all patients may experience the same results as those seen in this study. It's important to keep the following in mind:

  • This study was based on a small group of sarcoidosis patients. A total of 18 patients were in this study
  • The patients who were in this study were on many treatments in addition to Acthar. The results seen in these patients may not all be due to Acthar. For example:
    • Improvement in a patient's lung function and/or fatigue cannot be a confirmed result of treatment with Acthar
    • A decrease in a patient's dose of steroid cannot be proven to be the result of treatment with Acthar

Side Effects

Eight (8) patients experienced the following side effects on the day(s) when Acthar was taken:

  • Anxiety (feeling nervous)
  • Swelling (also known as fluid retention)

In another study, some patients taking Acthar saw improvements.
Some patients also lowered their steroid dose

The main goal of this retrospective chart review study was to see if Acthar was effective when used to treat sarcoidosis.

Forty-seven patients took part in this study. All were diagnosed with symptomatic sarcoidosis. In addition, they:

Were either currently taking steroids or had taken steroids in the past

Received at least 1 dose of Acthar

Had at least 6 months of treatment follow-up. This means that doctors checked the patients’ health up to at least 6 months after their Acthar treatment was discontinued

Did not respond to at least 1 sarcoidosis treatment before taking Acthar

Patients were monitored throughout the study. Doctors checked patients for improvements in certain organs affected by their condition. These included the lungs, skin, eyes, liver, central nervous system, as well as other organs.

Twenty-nine of the 47 patients in the study took Acthar for 3 months or more.

Results from this review:

11 patients saw improvement. This means that tests showed a positive change in affected organs. Also, 8 of these 11 patients were able to reduce their steroid dose by 50% or more

16 patients were stable. This means that tests showed no change in affected organs. Even so, these patients reduced their steroid dose by 50% or more

2 patients had a relapse. This means that tests showed a worsening in affected organs. These patients had to maintain or increase their steroid dose

There were certain limits of this study.

Acthar is not a cure. Though Acthar has been shown to help some patients, not all patients may experience the same results as those seen in this study. It's important to keep the following in mind:

  • This study was based on a small group of sarcoidosis patients. A total of 47 patients were in this study
  • The patients who were in this study were on many treatments in addition to Acthar. The results seen in these patients may not all be due to Acthar

Side Effects

Ten (10) patients stopped taking Acthar because they experienced one of the following side effects:

  • Anxiety (feeling nervous)
  • Swelling (also known as fluid retention)
  • Weakness
  • Allergic reaction at the injection site
  • Pain at the injection site
  • Infection

Talk with your doctor about Acthar. Only he or she can determine if Acthar may be right for you.

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

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 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.

H.P. Acthar® Gel
(repository corticotropin injection) [H P AK-thar jel]

What is H.P. Acthar Gel?

Acthar is a prescription medicine for people with symptoms of sarcoidosis.

Acthar is injected beneath the skin or into the muscle.