The results of the 2-year European GLORIA study have been published in Annals of the Rheumatic Diseases, and are presented June 3, at the annual European Rheumatologists Congress. Boers is pleased with the results: “For years it was thought that you shouldn’t give prednisolone for too long because of negative side effects. But our study shows that in this low dose, the benefits outweigh the drawbacks.”
Less medication
The study was a randomized double-blind trial. 451 patients with rheumatoid arthritis received either a daily dose of 5 mg prednisolone or a placebo in addition to standard treatment for 2 years. The patients on prednisolone had less pain and joint damage, fewer painful and swollen joints, were not as tired, and functioned better physically. The standard treatment could be adjusted during the study if the disease flared up, but this was less often necessary in the prednisolone group than in the placebo group.
More infections
Participants in the prednisolone group did experience more –mainly – mild adverse effects (60%) than people in the placebo group (49%): especially infections were more common. Bone fractures were rare and slightly more frequent in the prednisolone group as were various types of skin complaints. Weight gain was rare and inadequate functioning of the adrenal glands has not been reported.
Revising guideline
Boers says these results give cause to revise existing guidelines for the treatment of RA. “Now the advice is to prescribe only short-term prednisolone, because of the alleged long-term long-term side effects. In practice, however, prednisolone in low doses is already often prescribed for a longer term. The GLORIA study shows that this can be done safely and effectively.” Important prerequisites are accurate monitoring, prevention and treatment of possible side effects.
The study group
The study participants in both groups differed little. They were on average 72 years old, the majority were women, and they had about the same average disease activity. Most were treated not only for RA, but also for other conditions, such as high blood pressure. On average, the patients were taking 7 types of medication. In the prednisolone group, 89% of the patients took the study medication every day. In the placebo group it was 88%, so almost the same. At the start of the study, one-third of the patients had osteoporosis (bone decalcification). Almost all patients were prescribed calcium tablets and vitamin D during the study.
Read the article in Dutch here.