News Release

Use of glucocorticoids in rheumatic disease: Weighing the balance of benefits and harms

New data released at EULAR suggest a favourable balance in the long term

Peer-Reviewed Publication

European Alliance of Associations for Rheumatology (EULAR)

Guidelines suggest glucocorticoids should be used as bridging therapy in RA, but many patients are treated chronically with low doses. The effects of withdrawal in this group has not been studied extensively. Abdullah Almayali shared findings from GLORIA – a 2-year, double-blind trial evaluating the long-term benefits and harms of low-dose glucocorticoids added to standard care. Specifically, they investigated disease flares and signs of adrenal insufficiency after withdrawal of blinded trial medication.

After tapering, disease activity increased significantly in the prednisolone group, but was stable in placebo. For signs of adrenal insufficiency, the mean number of signs for prednisolone was 1.1 versus 0.9 for placebo at final trial visit, and 0.8 versus 0.8 at follow-up. No differences were seen in cortisol levels, and no patients developed clinical hypoadrenalism during further follow-up.

The group concluded that tapering prednisolone moderately increases disease activity, and numerically increases the risk of flare without any evidence of adrenal insufficiency. This suggests that withdrawal of low-dose prednisolone is feasible after 2 years of administration.

Professor Dr Maarten Boers’ group studied the effects of prednisolone (5 mg/day for 2 years) in 451 RA patients aged 65 and older in a pragmatic, double-blind, placebo-controlled trial.

Several benefits of therapy were observed. Disease activity rapidly declined to stabilize after 1 year, and was lower on prednisolone than placebo. The contrast in early response was larger in patients who were adherent to protocol on stable treatment, and there were more responders on prednisolone. Joint damage progression over 2 years was significantly lower on prednisolone versus placebo.

Over the study period, harm was experienced by 60% and 49% of prednisolone- and placebotreated patients, respectively – giving a number needed to harm of 9.5. Adverse events of special interest (serious and prednisolone-associated) were 278 versus 206 for prednisolone and placebo, respectively, and the difference was most marked for infections. Other glucocorticoidspecific adverse events of special interest were rare, without relevant differences.

The findings suggest that add-on, low-dose prednisolone has beneficial long-term effects on disease activity and damage progression in older RA patients on standard treatment. The trade-off is a 24% increase in adverse events, but these are mostly mild to moderate – suggesting a favourable balance of benefit and harm in the long term.

Further research presented by Dr Joanna Robson explored the impact of glucocorticoids on health-related quality of life (HRQoL). The study was intended as the basis for development of a Patient-Reported Outcome Measure (PROM) to be used both in trials and in clinical practice. Patients from the UK, US, and Australia who were treated with glucocorticoids in the last 2 years for a rheumatic condition were invited to take part in semi-structured qualitative interviews

A list of 134 candidate items was developed from six initial themes. After removal of duplications and ambiguity, the remaining 62 items were tested and refined by piloting with patient research partners, iterative rounds of cognitive interviews, and a linguistic translatability assessment. The result is a draft questionnaire of 40 items, which is currently being tested in an online large-scale survey to determine the final scale structure and measurement properties.

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