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 randomised double-blind placebo-controlled GLORIA trial

Abstract

Objectives: To investigate the effect of 2 years of add-on prednisolone 5 mg/day on body weight and composition in patients with active rheumatoid arthritis (RA) aged 65+ and the relation with disease activity.

Methods: The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis trial, a pragmatic, placebo-controlled, double-blind, randomised controlled trial investigated the balance of benefit and harm of 2 years of prednisolone 5 mg/day added to standard care in 451 patients with active RA aged 65+. In the current study, 449 patients were included, and body weight and Disease Activity Score of 28 Joints were measured at baseline and after 3, 6, 12, 18 and 24 months. In 57 patients, body composition was assessed at baseline and after 2 years with dual-energy X-ray absorptiometry. Data were analysed with longitudinal mixed models.

Results: The mean (95% CI) change in body weight was 0.9 (0.3 to 1.6) kg in the prednisolone group and -0.4 (-1.1 to 0.2) kg in the placebo group (difference 1.3 (0.5-2.2), (p<0.01)). The treatment effect was independent of disease activity suppression and comprised mostly increase in (appendicular) lean mass after 2 years. There was no significant increase in total fat mass, nor redistribution of fat mass from peripheral to central tissues.

Conclusions: Patients with active RA aged 65+ treated with prednisolone 5 mg/day for 2 years gained about 1 kg in weight, compared with minimal-non-significant-weight loss on placebo. Our data suggest that the small increase in weight is mostly lean mass, rather than increase or redistribution of fat mass traditionally associated with glucocorticoid treatment.

Keywords: Arthritis, Rheumatoid; Glucocorticoids; Inflammation.

Figure 1

Changes in weight compared with baseline in the prednisolone (5 mg/day) and placebo group depicted in a ‘null zone graph’. The null zone (grey area) is derived from the CI around the difference obtained from the t-test. There is a statistically significant difference in change in weight compared with baseline between the treatment groups when the mean of weight change of both groups falls outside the null zone; that is, from 6 months after starting treatment.