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| |  ACR: Symptom Benefit for Rheumatoid Arthritis Patients May be Achieved with Either Budesonide 9 mg or Prednisolone 7.5 mg Daily By Jerry Ingram ORLANDO, FL -- October 27, 2003 -- Patients with rheumatoid arthritis (RA) may experience improvements in symptoms when they take budesonide 9 mg/daily or prednisolone 7.5 mg/daily, according to a European study presented here on October 26th at the Annual Scientific Meeting of the American College of Rheumatology. "One thing this study shows is that low doses of prednisolone in rheumatoid arthritis cause very few side effects. In fact, the placebo group had more side effects," said John R. Kirwan, MD, lead researcher, University of Bristol, Bristol, United Kingdom. "The second thing the study shows is that when we stopped steroids after 3 months of treatment, we carried on watching the patients blindly. Steroid patients got worse again and back to the same as the placebo patients but they didn't get any worse than that. They didn't overshoot in disease which is reassuring." For this double-blind, randomised controlled trial, researchers enrolled 143 patients with active RA to compare use of budesonide 3 mg daily, budesonide 9 mg daily, prednisolone 7.5 mg daily and placebo. For a period of 12 weeks, they observed patterns of clinical response and changes occurring in the 4 weeks following discontinuation of therapy. Patients on budesonide 9 mg experienced significant improvements in tender joint count and swollen joint count compared to placebo (28% for tender and 34% for swollen joint counts, P<0.05). Comparable results were seen with prednisolone 7.5 mg, but budesonide 3 mg proved to be less effective. Patients on budesonide 9 mg had a 42% improvement on the ACR20 response criteria and patients on prednisolone 7.5 mg had a 56% improvement. Both prednisolone 7.5 mg and budesonide 9 mg provided a rapid and significant decrease in symptoms and signs between 2 and 8 weeks of treatment initiation. Researchers noted no difference in pattern of symptom control between prednisolone and budesonide. In addition, adverse effects were equally common in all treatment groups. Treatment benefits were consistent throughout the 3-month treatment period and there were no apparent rebound symptoms after discontinuation of treatment. The European research team also observed that adverse incidents with low dose of glucocorticoids were low over the 12 week period.
[Study title: A Randomised Placebo-controlled Trial of Budesonide and Prednisolone in Rheumatoid Arthritis. Abstract P210]
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