Add-on low-dose prednisolone has beneficial long-term effects in older adults with rheumatoid arthritis (RA), according to study results published in Annals of the Rheumatic Diseases.
Researchers performed a double-blind, randomized controlled trial of adults aged 65 years or older with an established diagnosis of RA. Conducted at 28 clinical centers across 7 countries in Europe, the study patients were randomly assigned to receive either prednisolone 5 mg/d or placebo for 2 years. Patients were allowed to continue concomitant treatment throughout the trial, excluding other glucocorticoids.
The primary outcome was improvement in disease activity per the Disease Activity Score-28 (DAS28). Reduction in joint damage was also assessed using the Sharp/van der Heijde (SvH) score. Adverse events were monitored throughout the trial duration. Adverse events of interest included serious events, glucocorticoid-specific events, and events causing study discontinuation. Longitudinal models were used to estimate the difference in study outcomes between the prednisolone and placebo arms.
A total of 451 patients (70.1% women) were randomized to receive either prednisolone (n=224) or placebo (n=225). The mean baseline age was 72 years and the mean disease duration was 11 years. The majority of patients (79%) were on disease-modifying treatment at baseline, including 14% on biologics. A total of 63% of the prednisolone group and 61% of the placebo group completed the study. Discontinuation due to adverse events occurred at equal rates between study arms; mean time in study was 19 months.
At 2 years follow-up, DAS28 score was 0.37 points lower with prednisolone compared with placebo (95% confidence limit [CL], 0.23; P <.0001), constituting substantial differences in disease activity. Joint damage progression per the SvH score was also 1.7 points lower with prednisolone vs placebo (95% CL, 0.7; P =.003). More patients in the active treatment group experienced an adverse event of interest (60% vs 49%), for a relative risk of 1.24 (95% CL, 1.04; P =.02). In particular, the prednisolone group experienced significantly more infections compared with the placebo group (n=253 vs n=184). However, other glucocorticoid-specific events were rare.
Results from this study indicated that long-term prednisolone use conferred beneficial reductions in disease activity, though the risk for adverse events was elevated compared with placebo. The researchers noted that because concurrent treatment was permitted, the direct effects of prednisolone were more difficult to interpret. However, by enrolling patients taking disease-modifying drugs, this study is more generalizable to the patient population.
The study authors concluded, “[A]dd-on low-dose prednisolone has beneficial long-term effects in senior patients with established RA, with a trade-off of 24% increase in patients with mostly non-severe [adverse events]; this suggests a favourable balance of benefit and harm.”
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Boers M, Hartman L, Opris-Belinski D, et al for the GLORIA trial consortium. Low dose, add-on prednisolone in patients with rheumatoid arthritis aged 65+: the pragmatic randomised, double-blind placebo-controlled GLORIA trial. Ann Rheum Dis. Published online May 31, 2022. doi:10.1136/annrheumdis-2021-221957