Prednisone is a corticosteroid approved by the U.S. Food and Drug Administration (FDA) to treat many different conditions, including those affecting the skin, gastrointestinal tract, blood, eyes, nervous system, kidneys, lungs, muscles, and bones. It can be used to treat allergies, specific infectious diseases, and to prevent rejection following organ transplants. Prednisone also has proven effective in treating the symptoms of sarcoidosis.
How prednisone works
Sarcoidosis is an inflammatory disease characterized by the formation of granuloma, or clumps of immune cells in different tissues and organs throughout the body. Normally, when a foreign threat such as a virus or bacteria enters the body, immune cells surround it, destroy it, and then leave the site of infection. Granulomas in sarcoidosis, however, do not disappear. Instead, the immune cells stay clumped together, interfering with the normal function of the tissue where they formed. Eventually, this can lead to tissue scarring.
Prednisone works by mimicking the effect of cortisol, a naturally-occurring steroid hormone in the body. It makes the immune system less sensitive to what it perceives as threats. It binds to a protein receptor called the glucocorticoid receptor, which is found in almost every cell in the body. When bound to cortisol or prednisone, the glucocorticoid receptor moves to the nucleus of the cell where it activates anti-inflammatory genes and inhibits pro-inflammatory ones. Prednisone also may inhibit the maturation of certain immune cells called T-cells. Overall, prednisone reduces the formation of granulomas by reducing inflammation.
Prednisone in clinical trials
A Phase 3 clinical trial (NCT02200146) compared the effectiveness of two doses of prednisone alone (0.5 mg per day and 0.15 mg per day taken by mouth) or in combination with hydroxychloroquine (a medicine normally used to treat or prevent malaria infection) in people with pulmonary sarcoidosis. Although the trial was completed in 2013, no results have been published yet.
An observational study (NCT03324503) that is currently recruiting participants in the U.S., the U.K., and the Netherlands will use computerized tomography (CT) imaging to assess patient outcomes following treatment with prednisone at a daily dose of 20 mg. Patients must not have already received prednisone or other sarcoidosis treatment for three months prior to enrollment in the study. The trial sponsor plans to enroll 24 patients and is expected to be completed in November 2018.
A Phase 4 clinical trial (NCT03265405) is recruiting pulmonary sarcoidosis patients in India to compare the effect of a low (20 mg/day) and medium (40 mg/day) dose of prednisone treatment for six months. The study will follow-up the patients for 18 months after the start of the treatment to measure the re-occurrence of symptoms through CT scans, blood tests, and lung function tests.
Additional information about prednisone
Steroid medications such as prednisone can weaken the immune system and patients may become more sensitive to infections and other diseases. Other side effects of prednisone include headaches, weight gain, high blood pressure, dizziness, and nausea.
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