RESEARCH - Efficacy of 1-4 mg per day of prednisone in patients with RA

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Ann Rheum Dis. 2008 Dec 15.

Efficacy of 1-4 mg per day of prednisone in patients with rheumatoid

arthritis: a randomized, double-blind, placebo-controlled withdrawal

clinical trial.

Pincus T, Luta G, Swearingen CJ.

NYU Hospital for Joint Diseases, United States.

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prednisone per day, withdrawn to the same dose of 1 mg prednisone or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.

PMID: 19074913

http://www.ncbi.nlm.nih.gov/pubmed/19074913

Read the full text here:

http://ard.bmj.com/cgi/rapidpdf/ard.2008.095539v1

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