Frågedatum: 2006-02-24
RELIS database 2006; id.nr. 22541, DRUGLINE
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Can oral budesonide (Budenofalk) 9 mg once daily be expected to have any effect on psoriatic arthri



Fråga: Can oral budesonide (Budenofalk) 9 mg once daily be expected to have any effect on psoriatic arthritis? A woman with psoriatic arthritis and collagenic colitis has been treated with prednisolone 5 mg once daily. Her gastroenterologist has started treatment with budesonide due to some worries of systemic steroid side effects. However, he has not reduced the dosage of prednisolone. The questioner now wonders if the dosage of prednisolone could and should be reduced.

Sammanfattning: Although the systemic bioavailability of budesonide is limited it may have some effect on the clinical symptoms of rheumatoid arthritis and articular symptoms of inflammatory bowel disease. Whether this is true for psoriatic arthritis is unknown. As systemic glucocorticoid exposure should be kept as low as possible, a slow reduction of prednisolone dose might be tried.

Svar: Budenofalk is an enteric coated capsule of gastric acid resistant granules containing budesonide. The first-pass metabolism is extensive and the systemic bioavailability is approximately 10%, but higher in the presence of inhibitors of cytochrome P450 3A4 (CYP3A4) (1). No data have been found on the relative glucocorticoid potency of budesonide.

However, two rather small, but randomised controlled trials, have shown an effect of budesonide on rheumatoid arthritis compared to placebo (2,3). The second compared budesonide 3 or 9 mg to placebo or prednisolone 7.5 mg. Budesonide 9 mg and prednisolone 7.5 mg was found to be superior to placebo in reducing the number of swollen and tender joints (3).

Another analysis (unclear if prespecified or post-hoc) of three trials of budesonide at different dosages compared to prednisolone 40 mg in Crohn´s disease focuses on the effect of budesonide on joint pain. This analysis shows comparable effects of 9 mg budesonide and prednisolone 40 mg, whereas there was no difference in joint pain in the groups receiving placebo or budesonide 3 mg or 15 mg daily (4).

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