Objective: Several randomized controlled trials (RCTs) and meta-analyses have confirmed clinical efficacy of glucocorticoids in RA. Concerns regarding safety associated with medium- to long-term use in RA have limited their use in clinical practice. In this meta-analysis, we assessed the toxicity related to medium- to long-term (defined as 1 year or longer) glucocorticoid therapy in RA.
Methods: MEDLINE, EMBASE and CINAHL databases were searched for RCTs of glucocorticoids in RA. RCTs fulfilling the following criteria were included: double-blinded, placebo-controlled, lasted 1 year or longer, used prednisolone (or equivalent) and in English. Toxicity was assessed by number of the patients withdrawn for adverse events (AEs), and the numbers of serious adverse events (SAEs) and AEs. RCTs were compared by meta-analysis using odd ratios (OR) with 95% CIs.
Results: Six RCTs with total of 689 patients met the inclusion criteria. All RCTs lasted >or=2 years. All studies allowed concomitant use of NSAIDs and DMARDs. Toxicity of glucocorticoid therapy based on number of patients withdrawn was limited (OR = 1.09; 95% CI 0.52, 2.25). Using number of AEs per patient-year (OR = 1.19; 95% CI 0.91, 1.57) and SAEs (OR = 1.06; 95% CI 0.67, 1.67) produced similar results. Efficacy/toxicity ratio was good for glucocorticoid therapy (number needed to harm/number needed to treat = 0.25).
Conclusion: Medium- to long-term glucocorticoid therapy in RA is associated with limited toxicity compared to placebo.