Abstract
This is a review of the evolution of the use prednisone in the treatment of rheumatoid arthritis (RA). Cortisone was introduced in 1949 and shortly thereafter, the Mayo investigators found that low divided doses with slow tapering were effective and caused fewer side effects. In 1959, a British double blind 2 year study of prednisolone treatment in early RA demonstrated effectiveness and reduced bony erosions. This experience was lost over time and empiricism and efforts to reduce side effects dominated practice for the next 35 years. Since 1995, a number of controlled studies of low single daily doses of prednisone in early RA have been reported by European investigators. They have shown clinical improvement, reduced bony erosions, augmentation of the effect of dmards and few side effects. During the last 25 years, the molecular actions of glucocorticoids have been elucidated. The time relationship of the dose to the biologic and clinical effects has been established. As a result of the information on the diurnal effect of glucocorticoids and the documentation of the effect occurring 5-6 hours after the dose and dissipating by 24 hours, a delayed release preparation of prednisone has been developed. With the rediscovery of the effectiveness of low single daily morning dose of prednisone in early RA by controlled studies and the demonstration of the onset and duration of the clinical effect of low dose of prednisone, it is now possible to use low doses of prednisone rationally and effectively in the treatment of RA. It remains to be determined whether a single morning, single evening or a twice a day low dose is the most effective and safe. It is doubtful if the new delayed release prednisone is any more effective than the usual immediate release prednisone if given at the same time.
Highlights
It has been a long struggle in the medical community to learn to use prednisone rationally and appropriately in the treatment of rheumatoid arthritis (RA)
It is instructive to review this story. It started with the paper published in the Mayo Clinic Proceedings in April 1949, by Hench and Kendall describing 16 patients with early active RA treated with 100 mg of cortisone acetate given intramuscularly daily
With Rayos on the market, it has the potential of capturing some of the regular prednisone market without being proven more effective. The tragedy of this would be an escalation of the health care cost of treating RA at this time, because Rayos is going to be many times the cost of regular prednisone. In this era of biologics, it must be remembered that probably the most effective, safe, and inexpensive drug that can be used in RA is prednisone
Summary
It has been a long struggle in the medical community to learn to use prednisone rationally and appropriately in the treatment of rheumatoid arthritis (RA). With knowledge about the molecular mechanisms of action of glucocorticoids, the relationship of dose and time to the beneficial effects and controlled studies showing the effectiveness and safety of low single daily doses of prednisone in the treatment of RA, physicians can use prednisone more rationally and effectively. On the market is a new prednisone product, Rayos, which is a delayed release prednisone [1,2]. It was designed based on the diurnal effect of glucocorticoids and a signal paper describing the peak effect of low doses of prednisone 5 hours after administration [3,4]. The studies leading to the development of this product have provided important insight into the relationship of dose and time to the onset of and duration of clinical effects
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