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

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A randomised placebo controlled 12 week trial of budesonide and

prednisolone in rheumatoid arthritis

ls of the Rheumatic Diseases 2004;63:688-695

http://ard.bmjjournals.com/cgi/content/abstract/63/6/688

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.

J R Kirwan1, R Hällgren2, H Mielants3, F Wollheim4, E Bjorck5, T

Persson5, C Book6, S Bowman7, M Byron8, N 9, M Field10, L Kanerud11,

M Leirisalo-Repo4, M Malaise12, A Mohammad2, R Palmer13, I F

sson14, B Ringertz15, P Sheldon16, M Simonsson, N Snowden17 and F

Van den Bosch3

1 Rheumatology Unit, Bristol Royal Infirmary, Bristol, UK

2 Department of Rheumatology, Akademiska Sjukhuset, Uppsala, Sweden

3 Department of Rheumatology, University Hospital of Gent, Gent, Belgium

4 Department of Rheumatology, Lund University Hospital, Lund, Sweden

5 Astrazeneca R & D Lund, Sweden

6 Department of Rheumatology, Universitetssjukhuset MAS, Malmö, Sweden

7 Department of Rheumatology, Birmingham Heartlands and Solihull

Hospital NHS Trust, Birmingham, UK

8 Department of Rheumatology, Weston General Hospital, Weston Super

Mare, Avon, UK

9 Department of Rheumatology, Royal Hants County Hospital, Winchester,

Hampshire, UK

10 Centre for Rheumatic Diseases, University Department of Medicine,

Glasgow Royal Infirmary, Glasgow, UK

11 Department of Rheumatology, Huddinge University Hospital, Huddinge,

Sweden

12 Department of Rheumatology, CHU Sart-Tilman-Bat B35, Liège, Belgium

13 Rheumatology Clinic, Solihull Hospital, Solihull, West Midlands, UK

14 Spenshult, S-313 92 Oskarsström, Sweden

15 Department of Rheumatology, Karolinska Sjukhuset, Stockholm, Sweden

16 Department of Rheumatology, Leicester Royal Infirmary, Leicester, UK

17 Department of Rheumatology, North Manchester General Hospital,

Manchester, UK

Correspondence to:

Dr R Kirwan

Academic Rheumatology Unit, University Division of Medicine, Bristol

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

© 2004 by BMJ Publishing Group Ltd & European League Against Rheumatism