Prednisone is a synthetic hormone in tablet form. It is very similar to a steroid hormone produced by the body called cortisone that acts as an immunosuppressant (an agent that suppresses the immune response).
Prednisone is approved by the U.S. Food and Drug Administration (FDA), commercialized by several pharmaceutical companies, and prescribed to treat many illnesses, including myasthenia gravis.
How prednisone works
The body’s immune system produces antibodies that normally help fight off infections and threats. In myasthenia gravis, antibodies mistakenly attack the connections between nerve and muscle cells causing weakness and fatigue in voluntary muscles.
As an immunosuppressant, prednisone works by “damping down” the activity of the immune system, reducing the production of antibodies and helping the transmission of messages from nerves to muscles. This is thought to improve muscle strength, weakness, and fatigue.
Prednisone in clinical trials
Prednisone was assessed in myasthenia gravis patients in an international, randomized, single-blind Phase 3 clinical trial (NCT00294658). The study’s purpose was to determine whether surgical removal of the thymus, combined with prednisone treatment, is more effective in treating individuals in whom myasthenia gravis is not caused by a thymus tumor, than prednisone therapy alone.
Researchers found that patients whose thymus was removed had a lower time-weighted average quantitative myasthenia gravis (QMG) score, a score of disease severity, than those who only received prednisone. The results of the study, which included 126 patients, were published in The New Journal of Medicine.
The safety, tolerability, and effectiveness of prednisone in patients with ocular myasthenia gravis were evaluated in a randomized, double-blind Phase 3 trial (NCT00995722), named EPITOME’. The primary outcome of the study was treatment failure. First, all patients were treated with pyridostigmine. Those whose symptoms failed to remit then continued to take pyridostigmine and were also randomized to receive either prednisone or placebo.
The results, published in the Muscle & Nerve journal, showed that the treatment failed in all patients in the placebo group, whereas it only failed in 17 percent of the patients in the prednisone group. Moreover, patients in the prednisone group required 14 weeks to achieve sustained minimal manifestation status and an average prednisone dose of 15 milligrams per day while no patients in the placebo group reached those parameters.
A Phase 4 trial (NCT00987116) assessed the best tapering strategy of reducing the dose of prednisone in 118 people with myasthenia gravis. The study compared the traditional dose of prednisone given every two days with a more rapid withdrawal strategy, using half of the dose given daily. Both strategies aim for a complete stop of prednisone treatment before 12 months to avoid significant side effects associated with long-term use of the medication. The study was completed in October 2017. No results have been published to date.
The most common adverse effects associated with prednisone use include increased appetite, weight gain, difficulty sleeping, irritability, diabetes, thinning of the bones, cataracts, glaucoma, and hypertension.
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