Efficacy of 1-4 mg per day of prednisone in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled withdrawal clinical trial.

Author(s): Pincus T, Luta G, Swearingen CJ

Affiliation(s): NYU Hospital for Joint Diseases, United States.

Publication date & source: 2008-12-15, Ann Rheum Dis., [Epub ahead of print]

Publication type:

OBJECTIVE: A randomized double-blind placebo-controlled withdrawal clinical trial of prednisone versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1-4 mg prednisone per day, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets. METHODS: All patients were from one academic setting; all trial visits were conducted in usual clinical care. Patients were taking stable doses of 1-4 mg prednisone, with stable clinical status, documented quantitatively by patient questionnaire scores. The protocol included three phases: "equivalence" - 1-4 study prednisone 1-mg tablets taken for 12 weeks, to ascertain their efficacy versus the patient's usual tablets prior to randomization; "transfer" - substitution of a 1-mg prednisone or identical placebo tablet every 4 weeks (over 0-12 weeks) to the same number as baseline prednisone; "comparison" - observation over 24 subsequent weeks taking the same number of either placebo or prednisone tablets as at baseline. The primary outcome was withdrawal due to patient-reported lack of efficacy versus continuation in the trial for 24 weeks. RESULTS: Thirty-one patients were randomized, 15 to prednisone and 16 to placebo, with 3 administrative discontinuations. In "intent-to-treat" analyses, 3/15 prednisone and 11/16 placebo participants withdrew (p=0.03). Among participants eligible for the primary outcome, 3/13 prednisone versus 11/15 placebo participants withdrew for lack of efficacy (p=0.02). No meaningful adverse events were reported, as anticipated. CONCLUSION: Efficacy of 1-4 mg prednisone was documented. Evidence of statistically significant differences with only 31 patients may suggest a robust treatment effect.