Charité study examines low-dose glucocorticoids for rheumatoid arthritis

Cortisone is highly effective against rheumatoid arthritis, often imprecisely referred to as rheumatism. However, medical guidelines advise against taking it over the longer term due to a number of side effects mainly observed with the high doses that used to be common. Yet, there is actually a lack of meaningful data on administering small doses of cortisone over a longer period of time. A study conducted by Charité - Universitätsmedizin Berlinand published in Annals of Internal Medicine* now reveals though that - for one thing at least - patients' blood pressure does not increase after a two-year treatment with low-dose cortisone. Moreover, the weight gain often negatively associated with this medication is moderate, at around one kilogram (about 2.2 pounds).

Cortisone is the colloquial term used to describe the group of glucocorticoids. These active agents are produced naturally by the body as well as synthetically. Among other effects, they inhibit the immune system's response. For that reason, cortisone preparations have long been used to treat a wide range of inflammatory diseases, including autoimmune disorders such as rheumatoid arthritis. They are effective in reducing inflammation in joints, alleviating pain, and mitigating the physical impediment caused by the disease or illness.

Cortisone is used contrary to guidelines

"Because cortisone preparations are so effective against rheumatoid arthritis, 30 to 50 percent of patients still take them two years after their diagnosis - despite the current medical guidelines and recommendations," explains Dr. Andriko Palmowski, first author of the study conducted by the Department of Rheumatology and Clinical Immunology at Charité. "The guidelines and recommendations actually advise that cortisone should only be administered on a temporary basis - if at all. Otherwise, there is a risk of significant side effects." However, while many of these side effects have been widely proven for the high cortisone doses that used to be prescribed much more frequently, the data is less conclusive for the lower doses that are favored nowadays. Dr. Palmowski: "We therefore don't know exactly how severe the side effects are for low-dose cortisone preparations."

In the past, some observational studies indicated, for example, that taking small doses of cortisone over the long term to treat rheumatoid arthritis increases blood pressure and leads to weight gain. "However, observational studies only have limited informative value due to various distorting effects," emphasizes Prof. Frank Buttgereit, Deputy Head of the Department of Rheumatology and Clinical Immunology at Charité, who led the study. "For greater conclusiveness, a higher-quality study design is required in the form of randomized controlled trials." There has actually already been a handful of these kinds of trials, where it is decided at random which trial participants receive the drug and which of them receive a placebo. Viewed in isolation though, none of these trials included enough patients to conduct a reliable statistical analysis of the two side effects.

Charité study analyzes data from over 1,100 people

Charité's research team therefore took the blood pressure and body weight measurements from five of the randomized controlled trials that had already been completed and analyzed them as a whole. This produced a pool of data from a total of more than 1,100 people with rheumatoid arthritis from 12 European countries who had either received low-dose cortisone preparations or a placebo or control drug over a period of two years. In addition, all patients received a long-term concomitant medication to better mitigate their illness, as is standard practice. The result: patients undergoing the cortisone therapy did not experience a significant change in their blood pressure levels and only gained an average of 1.1 kilograms more than the participants in the control group. Similar observations were made among higher-risk patients who were already overweight or had high blood pressure at the start of the trial.

"The results of our study do not make the guidelines obsolete, given that glucocorticoids can also cause other serious side effects such as osteoporosis, diabetes, cardiovascular diseases, or greater susceptibility to infections," concludes Prof. Buttgereit. "However, for many rheumatoid arthritis sufferers and the doctors treating them, the concern regarding increased blood pressure and weight gain is an important criterion when deciding for or against cortisone therapy. But it shouldn't be, since neither effect is of great relevance, as our results show. Instead, the decision-making process should focus more on the other side effects."

To weigh up the pros and cons of a treatment with low-dose cortisone more effectively in the future, Charité's research team is now planning to collect high-quality data on other side effects. The next one to be investigated will be osteoporosis.

*Palmowski A et al. The Effect of Low Dose Glucocorticoids Over Two Years on Weight and Blood Pressure in Rheumatoid Arthritis: Individual Patient Data from Five Randomized Trials. Ann Intern Med 2023 Jul 14. doi: 10.7326/M23-0192

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Original publication

Reducing corticosteroid use in rheumatoid arthritis (press release dated July 30, 2020)

Contact

Markus Heggen
Press Spokesperson
Charité - Universitätsmedizin Berlin
t: +49 30 450 570 400

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