Twelve clinical trials have documented that
prednisone or
prednisolone in doses of 10 mg/day or less is efficacious to improve function, maintain status and/or slow radiographic progression in patients with
rheumatoid arthritis (RA). An early trial reported by de Andrade et al. [Ann Rheum Dis 1964;23:158-162] in 1964 indicated that 5 mg of
prednisolone at night was preferred to 5 mg of
prednisone in the morning. Harris et al. [J Rheumatol 1983;10:713-721] documented the efficacy of 5 mg/day of
prednisone in a non-double-blind trial in 1983. Two important trials in the 1990s by Kirwan [N Engl J Med 1995;333:142-146] using 7.5 mg/day, and the COBRA study by Boers et al. [Lancet 1997;350:309-318] with step-down from 60 mg rapidly tapered to 5 mg/day led to strong advocacy of low-dose
glucocorticoids. In 2002, the first Utrecht Study [Ann Intern Med 2002;136:1-12] indicated that 10 mg/day
prednisone slowed radiographic progression, a finding confirmed and extended in 2005 by Svensson et al. [
Arthritis Rheum 2005;52:3360-3370] with 7.5 mg/day, and Wassenberg et al. [
Arthritis Rheum 2005;52:3371-3380] with 5 mg/day of
prednisolone. In 2008, Buttgereit et al. [Lancet 2008;371:205-214] reported CAPRA-1, which documented that modified-release
prednisone or
prednisolone taken at bedtime led to lower morning stiffness and
IL-6 levels compared to usual morning
prednisone. In 2009, Pincus et al. [Ann Rheum Dis 2009;68:1715-1720] reported a withdrawal clinical trial, in which patients who took 3 mg/day were gradually withdrawn to placebo, and dropped out at a significantly higher rate than control patients who were 'withdrawn' to
prednisone. In 2012, a second Utrecht Study [Ann Intern Med 2012;156:329-339], CAMERA-II, documented that 10 mg of
prednisone added to a 'treat-to-target' strategy with
methotrexate provided incremental slowing of radiographic progression. An Italian study of patients with early RA who received step-up
disease-modifying antirheumatic drug therapy over 2 years plus
prednisolone or not indicated higher rates of clinical remission and sustained remission associated with 7.5 mg/day of
prednisolone [
Arthritis Res Ther 2012; 14:R112]. The CAPRA-2 trial [Ann Rheum Dis 2013;72:204-210] documented that modified-release nighttime
prednisone or
prednisolone was significantly more efficacious than placebo. Taken together, these 12 clinical trials indicate that low-dose
glucocorticoids prednisone or
prednisolone provides symptomatic relief, improved functional status and slowing of radiographic progression for patients with RA. © 2014 S. Karger AG, Basel.