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

被引:48
作者
Pincus, T. [1 ]
Swearingen, C. J. [2 ]
Luta, G. [3 ]
Sokka, T. [4 ]
机构
[1] NYU, Hosp Joint Dis, Dept Rheumatol, New York, NY 10003 USA
[2] Med Univ S Carolina, Charleston, SC 29425 USA
[3] Georgetown Univ, Med Ctr, Dept Biostat Bioinformat & Biomath, Washington, DC 20007 USA
[4] Jyvaskyla Cent Hosp, Jyvaskyla, Finland
关键词
LOW-DOSE PREDNISOLONE; CORTICOSTEROID-THERAPY; JOINT DESTRUCTION; DISEASE; MORTALITY; CARE; METHOTREXATE; DRUG; GLUCOCORTICOIDS; QUESTIONNAIRE;
D O I
10.1136/ard.2008.095539
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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versus placebo in patients with rheumatoid arthritis ( RA), treated in usual clinical care with 1-4 mg/day prednisone, withdrawn to the same dose of 1 mg prednisone or identical placebo tablets.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.
引用
收藏
页码:1715 / 1720
页数:6
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