Background Oral glucocorticoids are widely used to treat patientswith rheumatoid arthritis, but their effect on joint destruction,as assessed radiologically, is uncertain.
Methods We conducted a randomized, double-blind trial comparingoral prednisolone (7.5 mg daily for two years) with placeboin 128 adults with active rheumatoid arthritis of less thantwo years' duration. Except for systemic corticosteroids, othertreatments could be prescribed. The primary outcome variableswere the progression of damage as seen on radiographs of thehand after one and two years, as measured by the Larsen index,and the appearance of erosions in hands that had no erosionsat base line. The radiographs were viewed jointly by a radiologistand a rheumatologist who were unaware of the treatment assignmentand the time point at which the films were obtained.
Results The statistical analysis of radiologically detectedchanges was based on 106 patients for whom there were filmsobtained at base line and two years later. After two years,the Larsen scores increased by a mean of 0.72 unit in the prednisolonegroup, indicating very little change, and by 5.37 units in theplacebo group, indicating substantial joint destruction (P =0.004). Of the 212 hands of these patients, 147 (69.3 percent)had no erosions at the start of the study. At two years, 15of the 68 such hands in the prednisolone group (22.1 percent)and 36 of the 79 such hands in the placebo group (45.6 percent)had acquired erosions (difference, 23.5 percentage points; 95percent confidence interval, 5.9 to 40.7; P = 0.007). The patientsin the prednisolone group had greater reductions than the patientsin the placebo group in scores on an articular index and forpain and disability at 3 months; for pain at 6 months; and fordisability at 6, 12, and 15 months (all P<0.05). There wasno difference between groups in standardized scores for theacute-phase response. The adverse events were typical of thoseencountered with antirheumatoid drugs.
Conclusions In patients with early, active rheumatoid arthritis,prednisolone (7.5 mg daily) given for two years in additionto other treatments substantially reduced the rate of radiologicallydetected progression of disease.
Source Information
Address reprint requests to Dr. Kirwan at the University Department of Medicine, Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom.
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