Patients aged at least 65 years with active rheumatoid arthritis (RA) treated with add-on prednisolone (5 mg/day for 2 years) gained approximately 1 kg of primarily lean mass, rather than the increased fat mass usually attributed to glucocorticoid treatment, according to study results published in Rheumatic & Musculoskeletal Diseases Open.
Investigators performed a sub-study of the Glucocorticoid Low-dose Outcome in Rheumatoid Arthritis (GLORIA; ClinicalTrials.gov Identifier: NCT02585258) trial: a placebo-controlled, double-blind, randomized, controlled trial assessing the benefit vs harm of 2-year treatment with prednisolone plus standard care among patients aged at least 65 years with RA.
Using this patient population, investigators assessed changes in body weight and composition following 2 years of treatment with 5 mg/day add-on prednisolone. Patient body weight and Disease Activity Score of 28 Joints (DAS28) were measured at baseline 3, 6, 12, 18, and 24 months. Dual-energy X-ray absorptiometry was used to assess body composition at baseline and after 2 years of add-on prednisolone treatment among certain patients.
A total of 449 patients were included in the study analysis. The majority of patients were women, mean bodyweight was 75 kg, and mean body mass index (BMI) was 27 kg/m2.
Overall, the 57 patients with body composition analysis data had lower mean DAS28 scores (P <.05), with a trend towards lower age, greater height, and lower BMI, compared with the placebo group.
Researchers found a mean change in body weight among the prednisolone-treated group of 0.9 (95% CI, 0.3-1.6) kg compared with -0.4 (95% CI, -1.1 to 0.2) kg in the placebo group. This resulted in a between-group difference of 1.3 kg (95% CI, 0.5-2.2 kg; P <.01).
Similarly, mean change in BMI was 0.4 (95% CI, 0.1-0.6) kg/m2 among the prednisolone-treated group vs -0.1 (95% CI, -0.4 to 0.1) kg/m2 among the placebo group. This resulted in a between-group difference of 0.5 kg/m2 (95% CI, 0.2-0.8 kg/m2; P <.01).
Most of the increase in body weight in the prednisolone-treated group consisted of lean mass. No notable increase in total fat mass or redistribution of fat from peripheral to central tissues was found.
The effect of prednisolone treatment on body weight appeared to be independent of its effect on the suppression of disease activity.
Study limitations included the inability to assess the effects of changes in disease activity on body composition due to the small number of body composition measurements available. Additionally, researchers did not collect data on the diet and physical activity level of the study patients.
“No unfavourable changes in body composition such as increase or redistribution
of fat mass were found. Further research is needed to unravel the effects of different (cumulative) dosages of glucocorticoids on body composition,” the study authors concluded.
Disclosure: One or more of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Güler-Yüksel M, Kuijper M, Bos R, et al. Changes in body weight and body composition in patients with active rheumatoid arthritis aged 65+ treated with 2-year low-dose add-on prednisolone in the randomized double-blind placebo-controlled GLORIA trial. RMD Open. Published online June 9, 2023. doi:10.1136/rmdopen-2022-002905