CLINICAL AND EPIDEMIOLOGICAL RESEARCH

Extended report

Efficacy of prednisone 1–4 mg/day in patients with rheumatoid arthritis: a randomised, double-blind, placebo controlled withdrawal clinical trial

T Pincus¹, C J Swearingen², G Luta³, T Sokka⁴

¹ New York University Hospital for Joint Diseases, New York, NY, USA
² Medical University of South Carolina, Charleston, SC, USA
³ Department of Biostatistics, Bioinformatics and Biomathematics, Georgetown University Medical Center, Washington, DC, USA
⁴ Arkisto/Tutkijat, Jyväskylä Central Hospital, Jyväskylä, Finland

^{Correspondence to} Dr T Pincus, Department of Rheumatology, Room 1608, NYU-Hospital for Joint Diseases, 301 East 17th Street, New York, NY 10003, USA; tedpincus{at}gmail.com

Objective: A randomised 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versus placebo in patients with rheumatoid arthritis (RA), treated in usual clinical care with 1–4 mg/day prednisone, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets.

Methods: All patients were from one academic setting and 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: (1) equivalence: 1–4 study prednisone 1 mg tablets taken for 12 weeks to ascertain their efficacy compared with the patient’s usual tablets before randomisation; (2) 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; (3) 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 randomised, 15 to prednisone and 16 to placebo, with three 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 and 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.

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