A randomised placebo controlled 12 week trial of budesonide and prednisolone in RA

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Ann Rheum Dis. 2004 Jun;63(6):688-95.

A randomised placebo controlled 12 week trial of budesonide and

prednisolone in rheumatoid arthritis.

Kirwan JR, Hallgren R, Mielants H, Wollheim F, Bjorck E, Persson T, Book

C, Bowman S, Byron M, N, Field M, Kanerud L, Leirisalo-Repo M,

Malaise M, Mohammad A, Palmer R, sson IF, Ringertz B, Sheldon P,

Simonsson M, Snowden N, Van Den Bosch F.

Academic Rheumatology Unit, University Division of Medicine, Bristol

Royal Infirmary, Bristol BS2 8HW, UK. john.kirwan@...

OBJECTIVES: To compare budesonide, a locally acting glucocorticoid with

minimal systemic exposure, with conventional glucocorticoid treatment

and placebo in rheumatoid arthritis. METHODS: A double blind,

randomised, controlled trial over 12 weeks in 143 patients with active

rheumatoid arthritis, comparing budesonide 3 mg daily, budesonide 9 mg

daily, prednisolone 7.5 mg daily, and placebo. Particular attention was

paid to the pattern of clinical response and to changes in the four week

period following discontinuation of treatment. RESULTS: There were

improvements in tender joint count and swollen joint count on budesonide

9 mg compared with placebo (28% for tender and 34% for swollen joint

counts, p<0.05). Prednisolone 7.5 mg gave similar results, while

budesonide 3 mg was less effective. ACR20 response criteria were met by

25% of patients on placebo, 22% on budesonide 3 mg, 42% on budesonide 9

mg, and 56% on prednisolone 7.5 mg. A rapid and significant reduction in

symptoms and signs in response to budesonide 9 mg and prednisolone 7.5

mg was evident by two weeks and maximal at eight weeks. There was no

evidence that budesonide provided a different pattern of symptom control

from prednisolone, or that symptoms became worse than placebo treatment

levels after discontinuation of glucocorticoid treatment. Adverse

effects attributable to glucocorticoids were equally common in all

groups.

CONCLUSIONS: The symptomatic benefits of budesonide 9 mg and

prednisolone 7.5 mg are achieved within a short time of initiating

treatment, are maintained for three months, and are not associated with

any rebound in symptoms after stopping treatment.

PMID: 15140776

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