Efficacy of Low-Dose Glucocorticoids in Clinical Trials

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 stepdown 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 Published online: September 12, 2014 Theodore Pincus, MD Rush University Medical Center Chicago, IL 60612 (USA) E-Mail tedpincus @ gmail.com © 2014 S. Karger AG, Basel 1021–7401/14/0222–0046$39.50/0