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For many patients, the decision to begin treatment is daunting. Medications to treat sarcoidosis often have negative side effects. Additionally, many sarcoidosis patients end up on multiple medications, making it difficult to tell if a new complication is a symptom of sarcoidosis or just a side effect of another medication. The following list may make the decision to begin a new medication a little less daunting. This list can also help you identify what the side effects of your current medications are and help you learn more about other potential treatment options if needed.

If you would like more information on sarcoidosis treatment options, check out our treatment protocol! It was written by our Scientific Advisory Board to help both healthcare providers and patients better understand the treatment options for sarcoidosis.

First Line Therapy – Corticosteroids

First line therapies are the most commonly used treatment methods that work for a large majority of patients. For sarcoidosis patients, corticosteroids are the first line therapy. Corticosteroids help to reduce systemic inflammation, thereby slowing, stopping, or even preventing organ damage. Prednisone is one of the most commonly prescribed corticosteroids for sarcoidosis. Patients usually take a daily dose between 5 and 40 mg. Unfortunately, corticosteroids/Prednisone are known to have some negative side effects such as:

  • Osteoporosis
  • Diabetes
  • Hypertension
  • Weight Gain
  • Cataracts
  • Glaucoma
  • Nausea
  • Vomiting
  • Headaches
  • Acne
  • Moonface/Fluid Retention
  • Changes in Appetite

Second Line Therapies

If you require treatment beyond corticosteroids, you may be prescribed a second-line therapy. Second-line therapies are treatments that are also effective in treating sarcoidosis, but may not work for as many people as a first line therapy. Being prescribed a second-line therapy does not mean your doctor did not prescribe you the right medication the first time, it just means your body didn’t react as expected so they are going to try something different. It is good to keep in mind that the chance of second-line treatments having good results is usually slightly less likely than first-line treatments.

Off Label Therapies

An Off Label Therapy is an FDA-Approved drug for an unapproved use. Before drugs can be approved for a specific use, the company who owns the drug must “submit clinical data and other information to the FDA for review. The company must be able to show that the drug is safe and effective for its intended use.”2 If you are prescribed a drug for its approved use it means:

  • That the FDA has looked at both the benefits and the risks of using this drug for this treatment
  • There is scientific data backing up the decision to use the drug
  • There are approved guidelines on how to safely and effectively use the drug

Once a medication has met the above criteria, healthcare providers can then prescribe the medication for unapproved uses. You doctor may prescribe you an unapproved medication for one of the following reasons:

  • You have not had any improvement when using the approved treatment for your disease
  • Your medical condition or disease does not have an approved treatment

The FDA recommends that if your doctor is considering prescribing an off-label medication, you should ask them the following questions2:

  • What is the drug approved for?
  • Are there other drugs or therapies that are approved to treat my disease or medical condition?
  • What scientific studies are available to support the use of this drug to treat my disease or medical condition?
  • Is it likely that this drug will work better to treat my disease or medical condition than using an approved treatment?
  • What are the potential benefits and risks of treating my disease or medical condition with this drug?
  • Will my health insurance cover treatment of my disease or medical condition with this drug?
  • Are there any clinical trials studying the use of this drug for my disease or medical condition that I could enroll in?

Commonly Used Off-Label Medications

Below are some of the medications that are commonly used to treat sarcoidosis if the first line therapy is not effective. Many of the drugs are immunosuppressants, or drugs that weaken your immune system. While the exact causes of sarcoidosis are not known, the inflammation that occurs is the result of the immune system going into overdrive. This is why many of the medications that are commonly prescribed for sarcoidosis are immunosuppressant drugs.

Hydroxychloroquine (Plaquenil®)

When hydroxychloroquine is used with other medications it can be used to treat some auto-immune diseases. Doctors will use hydroxychloroquine to treat auto-immune diseases when other medications have not been successful or a patient cannot be on those medications. Hydroxychloroquine is also used to treat chronic lupus and prevents pain/swelling in arthritis. It is not known exactly how/why it works.3 Primarily, though, hydroxychloroquine is used to treat malaria. Hydroxychloroquine:

  • Is most effective in sarcoidosis patients with
    • Skin involvement
    • Joint manifestations
    • Hypercalcemia
  • Patients should have an eye exam every 6-12 months
Cyclophosphamide (Cyotoxan®, Endoxan®)

Cyclophosphamide works by limiting your immune system’s response to diseases. It works by slowing down or stopping cell growth. Cyclophosphamide is classified as a chemotherapy drug and is commonly used to treat some cancers. 8 Cyclophosphamide:

  • Is only used for severe disease not controlled by other medications due to its high toxicity
  • Is effective for some people, particularly useful for severe disabling neurosarcoidosis that has not responded to other medications
  • Side effects include:
    • Nausea
    • Vomiting
    • Anorexia
    • Alopecia
    • Acne
    • Leukopenia
    • Oral Ulcers
    • Skin hyperpigmentation
    • Fatigue
  • Patients should have a CBC and hepatic and renal function test every 1-3 months

Patients should also have urinalysis every month

Azathioprine (Imuran®)

Azathioprine is an immunosuppressant that is commonly used to treat rheumatoid arthritis, a disease in which the body attacks your healthy joints. Weakening the immune system helps prevent more damage to your joints from rheumatoid arthritis.5 Azathioprine is also commonly used after kidney transplants to prevent organ rejection. Azathioprine:

  • Is roughly as effective as methotrexate in treating sarcoidosis
  • Is used when a patient has trouble on methotrexate
  • Side effects include:
    • Diarrhea
    • Abdominal Cramping
    • Oral ulcers
    • Myalgia
    • Malaise
    • Jaundice
    • Blurred vision
  • Patients should have a CBC and hepatic and renal function test every 1-3 months
Leflunomide (Arava®)

Leflunomide is an immunosuppressant that is commonly used to treat rheumatoid arthritis, a condition where the immune system attacks healthy joint tissue. Leflunomide helps reduce the joint damage and accompanying pain and swelling. This makes it easier for people with rheumatoid arthritis to move about.7 Leflunomide:

  • Is an alternative for patients who do not response well to methotrexate
  • Side effects include:
    • Liver enzyme elevation
    • Diarrhea
    • Abdominal Cramping
    • Peripheral Neuropathy
  • Patients for the first six months should have monthly CBCs

Methotrexate is an immunosuppressant that works by slowing down or stopping the growth of cells.4 When other medications have not worked, methotrexate is used to control severe psoriasis or rheumatoid arthritis. Methotrexate is also commonly used to treat some types of cancer. Methotrexate:

  • Is one of the most commonly prescribed corticosteroid-sparing therapies for sarc
  • Is effective, low cost, and has low risk of side effects compared to other sarc meds
  • Can be given orally or subcutaneously
  • Patients should have a CBC and hepatic and renal function test every 1-3 months
  • Patients may need folic acid supplementation
Mycophenolate Mofetil (CellCept®)

Mycophenolate is an immunosuppressant that is used to treat lupus, rheumatoid arthritis, vasculitis, and inflammatory bowel and eye diseases.6 It is also used with other medications to keep your body from rejecting a transplanted organ. Mycophenolate:

  • Is used to treat a number of autoimmune and inflammatory diseases
  • Side effects include:
    • Diarrhea
    • Leukopenia
    • Sepsis
    • Vomiting
  • Patients should have a CBC and hepatic and renal function test at least every 3 months
Adalimumab (Humira®)

Adalimumab is used for some kinds of arthritis to reduce pain and swelling. It can also be used to treat some skin disorders. There is a protein the body that causes joint swelling and damage in arteritis patients and red scaly patches in psoriasis. Adalimumab blocks this protein preventing these side effects. By blocking this protein, adalimumab reduces joint damage and can help preserve joint function.10 Adalimumab:

  • Is a TNF inhibitor given by subcutaneous injection that has been approved for several forms of arthritis
  • Can help reduce sarcoidosis symptoms
  • Should be considered for patients who have been treated successfully with infliximab but have developed antibodies
  • Side effects include:
    • Abdominal pains
    • Nausea
    • Diarrhea
    • Dyspepsia
    • Headache
    • Rash
    • Pruritus
    • Sore Throat

Recommended that patients have a PPD or interferon gamma release assay for tuberculosis prior to beginning therapy

Infliximab (Remicade®)

Infliximab is used to treat a variety of conditions including certain types of arthritis, bowel diseases, and severe skin diseases. Infliximab works for all of these conditions because they are all a result of the body attacking its own, healthy tissue. Infliximab works by blocking the tumor necrosis factor alpha- you might hear your doctor use the term “anti-TNF therapy” when talking about this medication. Blocking this decreases swelling and inflammation. It also helps to weaken your immune system; this can slow down or stop damage.9 Infliximab:

  • Is effective in patients that did not respond to other treatments
  • Side effects include:
    • Abdominal pain
    • Nausea
    • Diarrhea
    • Dyspepsia
    • Headache
    • Rash
    • Pruritus
    • Sinusitis
    • Sore throat
  • Patients should have a PPD or interferon gamma release assay for tuberculosis prior to beginning therapy
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