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

Kirwan, JR ; Hallgren, R ; Mielants, H ; Wollheim, Frank LU ; Bjorck, E ; Persson, T ; Book, C ; Bowman, S ; Byron, M and Cox, N , et al. (2004) In Annals of the Rheumatic Diseases 63(6). p.688-695
Abstract
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... (More)
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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Annals of the Rheumatic Diseases
volume
63
issue
6
pages
688 - 695
publisher
BMJ Publishing Group
external identifiers
  • pmid:15140776
  • wos:000221382500014
  • scopus:2442716571
ISSN
1468-2060
DOI
10.1136/ard.2003.008573
language
English
LU publication?
yes
id
fce89448-e1ca-457f-a38f-c0c51e3c0153 (old id 279196)
alternative location
http://ard.bmj.com/content/63/6/688.abstract
date added to LUP
2016-04-01 16:32:28
date last changed
2022-03-30 08:36:00
@article{fce89448-e1ca-457f-a38f-c0c51e3c0153,
  abstract     = {{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&lt; 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.}},
  author       = {{Kirwan, JR and Hallgren, R and Mielants, H and Wollheim, Frank and Bjorck, E and Persson, T and Book, C and Bowman, S and Byron, M and Cox, N and Field, M and Kanerud, L and Leirisalo-Repo, M and Malaise, M and Mohammad, A and Palmer, R and Petersson, IF and Ringertz, B and Sheldon, P and Simonsson, M and Snowden, N and Van den Bosch, F}},
  issn         = {{1468-2060}},
  language     = {{eng}},
  number       = {{6}},
  pages        = {{688--695}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{Annals of the Rheumatic Diseases}},
  title        = {{A randomised placebo controlled 12 week trial of budesonide and prednisolone in rheumatoid arthritis}},
  url          = {{http://dx.doi.org/10.1136/ard.2003.008573}},
  doi          = {{10.1136/ard.2003.008573}},
  volume       = {{63}},
  year         = {{2004}},
}